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27–661PDF 2018

A GLOBAL UPDATE ON ALZHEIMER’S DISEASE

HEARING

BEFORE THE

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, 

GLOBAL HUMAN RIGHTS, AND 

INTERNATIONAL ORGANIZATIONS

OF THE

COMMITTEE ON FOREIGN AFFAIRS 

HOUSE OF REPRESENTATIVES

ONE HUNDRED FIFTEENTH CONGRESS

FIRST SESSION

NOVEMBER 29, 2017

Serial No. 115–89

Printed for the use of the Committee on Foreign Affairs

(

Available via the World Wide Web: http://www.foreignaffairs.house.gov/ or

http://www.gpo.gov/fdsys/

(II)

COMMITTEE ON FOREIGN AFFAIRS 

EDWARD R. ROYCE, California, Chairman 

CHRISTOPHER H. SMITH, New Jersey 

ILEANA ROS-LEHTINEN, Florida 

DANA ROHRABACHER, California 

STEVE CHABOT, Ohio 

JOE WILSON, South Carolina 

MICHAEL T. MCCAUL, Texas 

TED POE, Texas 

DARRELL E. ISSA, California 

TOM MARINO, Pennsylvania 

MO BROOKS, Alabama 

PAUL COOK, California 

SCOTT PERRY, Pennsylvania 

RON DESANTIS, Florida 

MARK MEADOWS, North Carolina 

TED S. YOHO, Florida 

ADAM KINZINGER, Illinois 

LEE M. ZELDIN, New York 

DANIEL M. DONOVAN, JR., New York 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

ANN WAGNER, Missouri 

BRIAN J. MAST, Florida 

FRANCIS ROONEY, Florida 

BRIAN K. FITZPATRICK, Pennsylvania 

THOMAS A. GARRETT, JR., Virginia 

JOHN R. CURTIS, Utah 

ELIOT L. ENGEL, New York 

BRAD SHERMAN, California 

GREGORY W. MEEKS, New York 

ALBIO SIRES, New Jersey 

GERALD E. CONNOLLY, Virginia 

THEODORE E. DEUTCH, Florida 

KAREN BASS, California 

WILLIAM R. KEATING, Massachusetts 

DAVID N. CICILLINE, Rhode Island 

AMI BERA, California 

LOIS FRANKEL, Florida 

TULSI GABBARD, Hawaii 

JOAQUIN CASTRO, Texas 

ROBIN L. KELLY, Illinois 

BRENDAN F. BOYLE, Pennsylvania 

DINA TITUS, Nevada 

NORMA J. TORRES, California 

BRADLEY SCOTT SCHNEIDER, Illinois 

THOMAS R. SUOZZI, New York 

ADRIANO ESPAILLAT, New York 

TED LIEU, California

AMY PORTER, Chief of Staff THOMAS SHEEHY, Staff Director

JASON STEINBAUM, Democratic Staff Director 

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND

INTERNATIONAL ORGANIZATIONS

CHRISTOPHER H. SMITH, New Jersey, Chairman 

MARK MEADOWS, North Carolina 

DANIEL M. DONOVAN, JR., New York 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

THOMAS A. GARRETT, JR., Virginia 

KAREN BASS, California 

AMI BERA, California 

JOAQUIN CASTRO, Texas 

THOMAS R. SUOZZI, New York 

(III)

C O N T E N T S 

Page

WITNESSES 

Marie Bernard, M.D., Deputy Director, National Institute on Aging, National 

Institutes of Health .............................................................................................. 6

Roger Glass, M.D., Director, Fogarty International Center, National Institutes 

of Health ............................................................................................................... 8

Mary Mittelman, Dr.P.H., research professor, Alzheimer’s Disease and Related Dementias Family Support Program, New York University .................. 27

Richard Mohs, Ph.D., chief scientific officer, Global Alzheimer’s Platform 

Foundation ............................................................................................................ 35

Mr. Michael Splaine, principal, Splaine Consulting ............................................. 41

LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING 

Marie Bernard, M.D., and Roger Glass, M.D.: Prepared statement ................... 10

Mary Mittelman, Dr.P.H.: Prepared statement .................................................... 30

Richard Mohs, Ph.D.: Prepared statement ............................................................ 38

Mr. Michael Splaine: Prepared statement ............................................................. 44

APPENDIX 

Hearing notice .......................................................................................................... 60

Hearing minutes ...................................................................................................... 61

Material submitted for the record by the Honorable Christopher H. Smith, 

a Representative in Congress from the State of New Jersey, and chairman, 

Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations: 

Joint testimony of Alzheimer’s Association and Alzheimer’s Impact Movement ................................................................................................................... 62

‘‘External Validity of the New York University Caregiver Intervention: Key 

Caregiver Outcomes Across Multiple Demonstration Projects’’ .................... 67

‘‘The Minnesota Economic Model of Dementia: Demonstrating Healthcare 

Cost Savings with the New York University Caregiver Support Intervention’’ ................................................................................................................... 75

‘‘Estimating The Potential CostSavings From The New York University 

Caregiver Intervention In Minnesota’’ ............................................................ 83

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A GLOBAL UPDATE ON ALZHEIMER’S 

DISEASE 

WEDNESDAY, NOVEMBER 29, 2017

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH,

GLOBAL HUMAN RIGHTS, AND INTERNATIONAL ORGANIZATIONS,

COMMITTEE ON FOREIGN AFFAIRS,

Washington, DC. 

The subcommittee met, pursuant to notice, at 2:00 p.m., in room 

2172 Rayburn House Office Building, Hon. Christopher H. Smith 

(chairman of the subcommittee) presiding. 

Mr. SMITH. The subcommittee will come to order, and good afternoon, everybody. I apologize for the delay. We had a series of votes, 

and we have one later, too, so I do want to get right to it. 

I want to thank you for being here. Today, as we open today’s 

hearing, there are an estimated 47 million people in the world living with Alzheimer’s disease and other forms of dementia—more 

than the entire population of Spain, according to a report by the 

Alzheimer’s Disease International. 

The number of victims who have Alzheimer’s is projected to double every 20 years. So we are in a race like few other diseases because it is proliferating so fast throughout the globe. 

And according to Dr. Marie Bernard, the deputy director of the 

National Institute on Aging, who we will hear from momentarily, 

the number is estimated to grow to 115 million by 2050 as populations around the world age. 

Although there is early onset but predominantly it is one of the 

byproducts of all of us aging and there seems to be a higher proclivity the older one gets, and it has been estimated that once 

somebody reaches 85 the chances of some form of dementia is 

about one out of two. So it’s a very, very serious problem. 

The total estimated global cost of addressing this condition today is $818 billion, but by as early as next year it is estimated that this 

cost will rise to at least $1 trillion—that is per year—and then it 

will go up from there. 

As we all know, Alzheimer’s is a cruel disease, robbing its victims of their memories and their very identities and robbing their 

families and friends of the person they know and love. 

It is excruciatingly painful for someone to lose themselves gradually, and I have spoken myself to many individuals, especially 

those who are early onset who have young families and are dealing 

with the agony that they know it is progressing. 

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There is no cure. There are drugs, five of them so far, and others 

that are in the pipeline that treat symptoms but there is no actual 

cure. And so it is very tough and it takes a very heroic person to 

cope and manage with that. 

We also know that the families have to deal with a very painful 

ordeal, as well the care givers, the loved ones, the family and the 

friends. 

In 1999, along with then-Congressman, now Senator Ed Markey, 

I co-founded the Congressional Task Force on Alzheimer’s disease, 

which I still co-chair today with Maxine Waters, to bring this disease to the forefront of the congressional agenda to advance support for Federal research and to increase awareness. 

The task force worked in partnership with the Alzheimer’s Association to unanimously pass the National Alzheimer’s Project Act—

or PL 111, which established an advisory committee of private and 

Federal experts to work with the secretary of HHS to comprehensively assess and address Alzheimer’s research, institutional services, and home and community-based care with the goal to identify 

a cure or disease-modifying therapy for dementia by 2025. 

Today, there are over 170 members of the House and Senate in 

the task force. 

This year, we worked very hard in a bipartisan way to get an in- crease of some $414 million to the Alzheimer’s research funding at 

NIH. 

Under HHS Appropriations Chairman Tom Cole’s extraordinary 

leadership, the fiscal year 2018 omnibus appropriations bill was enacted. It was passed in September of this year. It included a $400 million increase for Alzheimer’s disease research at the National Institutes of Health. This would bring total 

funding to $1.8 billion. Currently funded at $1.4 billion, NIH spending on Alzheimer’s research has almost tripled since fiscal year 2015 when $589 million was allocated for such research. 

Shockingly, the majority of people with Alzheimer’s or other 

forms of dementia have not received a diagnosis so they are unable 

to access the care and the treatment of symptoms that they so desperately need. This is true in the developed world but it’s even 

truer in the developing world. 

Michael Splaine points out in his testimony today that detection 

and diagnosis are a stubborn problem everywhere. Research shows 

that most people currently living with dementia have not received 

a formal diagnosis, he will testify. In high-income countries, 20 to 

50 percent of dementia cases are recognized and documented in primary care. 

This treatment gap, as he calls it, is certainly much greater in 

low and middle income countries. Without a diagnosis, there can’t 

be treatment care or organized support or the opportunity to volunteer for clinical research. 

Of course, even when Alzheimer’s or other forms of dementia are 

diagnosed, care is too often fragmented, uncoordinated, and unresponsive to the needs of people living with the condition. 

In response, last Congress I introduced the Health Outcomes 

Planning Education—or HOPE—for Alzheimer’s Act of 2015 to provide Medicare coverage for care planning session for patients newly 

3

diagnosed with Alzheimer’s disease for family care givers or legal 

representatives. 

In recognition of this great unmet need, the legislation garnered 

310 bipartisan co-sponsors. Ultimately, the Medicare adopted an 

amended version of the HOPE Act—actually an improvement—for 

final rule for calendar year 2017’s positions fee schedule. 

Of course, Alzheimer’s robs its victims not only of their memories 

but also of their awareness, but also their lives. In the American 

Journal of Public Health, a research survey of years of life lost 

versus the number of deaths between 1995 and 2015, annual 

deaths due to Alzheimer’s complications in the U.S. alone rose from 

20,607 in 1995 to 110,568 in 2015. 

During that period, Alzheimer’s rose from the 14th leading cause 

of death among ailments in this country in 1995 to number six in 

2015. 

For the record, this is my fourth hearing I have chaired on Alzheimer’s disease. On June 23rd in 2011, we held a hearing on the 

global strategies to combat the devastating health and economic 

impacts of Alzheimer’s. 

On November 21st, we held a hearing on the G8 Dementia Summit and beyond, and then in 2014 on the actual summit report 

from the G8 and now today’s hearing, of course. 

Today’s hearing is intended to examine the existing potential options for prevention and treatment of this devastating disease and 

the harrowing statistics cited earlier likely will be much worse in 

developing countries if they had accurate identification of Alzheimer’s and records of victims and of deaths. 

As our hearing testimony will demonstrate, there is hope for Alzheimer’s patients, their families and friends. There is a surge, particularly for research. 

For example, a research team from Columbia University’s Medical Center in 2013 said they had finally traced Alzheimer’s to its 

early developmental stages of discovery that they believe could lead 

to more effective treatments. 

In science translational medicine 3 years ago, Australian researchers explained a noninvasive ultrasound technology that 

clears the brain of neurotoxic amyloid plaques—structures that are 

responsible for memory loss and a decline in cognitive function in 

Alzheimer’s patients. 

By 2016, scientists at the Institute of Regenerative Medicine at 

the University of Zurich said they were amazed to find that their 

patients treated with the highest dose of an antibiotic drug experienced an almost complete clearance of the amyloid plaques that 

prevent brain cells from communicating, leading to reversible memory loss and cognitive decline. 

Our witnesses today will tell us more about these and other advances that, again, the United States is walking point in the world 

in this and we have two tremendous witnesses and experts who are 

doing their best and their staffs to make sure that we get there 

sooner rather than later. 

I would also just point out for the record this Congress I’ve joined 

my colleagues in introducing the BOLD Act, which would establish 

Centers of Excellence and it is designed to really take this to the 

4

next level—to have congressional support for this effort in a more 

robust way. 

I have also reintroduced Kevin and Avonte’s Law. It passed last 

year in the House. It deals with the wandering issue. 

We know that when Alzheimer’s or autism individuals have the 

bracelet, they are found usually within 30 minutes. When they 

don’t and they go wandering, it can catastrophic if not a cause of 

death from drowning and a whole host of other reasons if they are 

not rescued from that wandering. 

Next week, I will reintroduce the Global Brain Health Act to increase research on prevention and treatment of autism, hydrocephalic condition and Alzheimer’s and other forms of dementia. 

This legislation, which I first introduced in 2015, would encourage the building of treatment capacity for these brain disorders 

among care givers in developing countries and support increased 

international cooperation in research and implementation of strategies on prevention and treatment. 

I would like to now yield to Dr. Bera for any opening comments 

he might have. 

Mr. BERA. Thank you, Mr. Chairman, and thank you for having 

this hearing. It, obviously, is incredibly important. 

Anytime you can say neurotoxic amyloid plaques in Congress 

that is a good day, particularly, as a physician. 

So I am trained in internal medicine and taking care of many 

Alzheimer’s patients and, you know, the urgency of addressing this 

issue and, you know, looking for ways to mitigate the disease but 

also ultimately looking at ways to reverse and cure disease are, obviously, our ultimate goals. 

You know, I think we often focus here domestically on what we 

need to do to help address this issue. But, you know, I work pretty 

closely with our Alzheimer’s Association and I think the Alzheimer’s Association has done a wonderful job elevating the level 

of dialogue but also elevating the dialogue on, you know, why this 

is a global epidemic. 

Often when we think about global health we are thinking about 

the communicable diseases that are out there. But there really is 

as—you know, there are more developed nations around the world. 

We have got to spend more time thinking about the impact of 

noncommunicable diseases like Alzheimer’s disease. 

You know, as we start to think about those public health approaches, from my public health background, you know, there is a 

number of things that, you know, are the low-hanging fruit—you 

know, the lifestyle modifications, the things that you can do to certainly slow down and mitigate disease. 

A second step is building the public health infrastructure in the 

global community to help both families and patients manage and 

navigate that disease and, again, I do think we are going to see 

this coming tidal wave as people live longer in the global community, the lack of infrastructure and the lack of readiness to, you 

know, manage this tidal wave of folks with—with dementia and 

with Alzheimer’s disease and other noncommunicable diseases, for 

that matter. 

And then, you know, long term this is a global challenge and I 

look forward to hearing from the witnesses. You know, we can 

5

quantify the direct costs of Alzheimer’s but then also the indirect 

costs of Alzheimer’s in terms of, you know, both the patient as well 

as the impact on families and care givers. 

And then, ultimately, you know, part of the reason why I am 

such a strong advocate for making investments in the NIH and 

making investments in research is the return on that investment 

if we are able to find a cure or even better therapies to mitigate 

disease and slow down disease is going to be, you know, pretty significant, because if we don’t we will be spending billions upon billions of dollars on the back end. And this is not just a U.S. challenge. This is a global challenge. 

So, Mr. Chairman, I think this is a incredibly timely topic and 

I look forward to hearing from the panelists. So thank you. I yield 

back. 

Mr. SMITH. Thank you, Dr. Bera. 

I would like to now yield to Mr. Donovan for any comments he 

might have. 

Mr. DONOVAN. Thank you very much, Mr. Chairman. Thank you 

for conducting this very important hearing. 

Many of the things that this committee does deals with diseases 

and things people are suffering from that we don’t suffer from in 

this country. 

When I came to Congress, 2 weeks later at 58 years old I had 

my very first baby. Her mother actually describes her as my very 

last baby, by the way. 

But so all of a sudden, maternal health and infant health, prenatal care became so important to me because it was personal to 

me. And I always say that Yellow Rose Catherine was—she hit the 

birth lottery. 

She was born on May 19th of 2015 on the same day tens of thousands of other children were born, except she was born on Staten 

Island in New York City and has had every one of her vaccinations, 

every one of her well visits, and children born that same day who 

didn’t hit that birth lottery didn’t have the same advantages she 

did. So there’s a lot of things this committee has done has been 

personal to me. 

I am also the only son of an Alzheimer’s patient. My mother died 

the year before I was elected after suffering for 4 years. 

I was blessed. I had her until she was 89 years old and her mother died when she was 9. So I always say I had my mother for 50 

more years than she had her own mother. 

But I watched this woman become someone I didn’t know—a 

woman who was always calm who became violent—a woman who 

would sit and just stare even when you speak to her because she 

no longer could communicate or understand what you’re saying. 

And I learned a lot about the disease—not as much as my friend, 

Dr. Bera, but—about the proteins that grow on people’s brains and 

how advancements in medicine now are finding ways to slow that 

protein growth down, maybe stop it altogether, maybe at some 

point actually have medication that could remove the proteins from 

people’s brains that may cure the disease is our hope. 

I know that we gave the National Institute of Health in the 21st 

Century Cures Act billions of dollars to help the advancement of 

some treatments and cures for things like Alzheimer’s. 

6

So I just wanted to tell my personal story just so I could tell you 

how much I appreciate you being here and how important this is 

in a global health environment, but how personally it has touched 

me. So I thank you both for being here today and thank you, Mr. 

Chairman. 

Mr. SMITH. Thank you very much. 

At this time, let me introduce our distinguished witnesses and, 

again, thank them for their tremendous leadership, beginning with 

Dr. Marie Bernard, who serves as deputy director of the National 

Institute on Aging at the National Institutes of Health. 

Dr. Bernard serves as the principal advisor to the NIA director, working closely with the director in overseeing approximately $2 

billion in aging research conducted and supported annually by the 

institute. 

Dr. Bernard co-chairs two department Health and Human Services Healthy People 2020 objectives—older adults and dementias, 

including Alzheimer’s disease. 

We will then hear from Dr. Roger Glass, who I’d point out is also 

from New Jersey originally—from Summerville, New Jersey. He 

serves as the director of the Fogarty International Center and associate director for international research at the National Institutes 

of Health. 

Dr. Glass has maintained field studies in India, Bangladesh, 

Brazil, Mexico, China, and elsewhere in the world. He has received 

numerous rewards including the prestigious Charles Shepherd 

Lifetime Scientific Achievement Award presented by the Centers 

for Disease Control and the Charles—Dr. Charles Merieux Award 

from the National Foundation for Infectious Diseases for his work 

on the rotavirus vaccines in the developing world. 

Two experts and two very much welcomed witnesses to our subcommittee. 

Dr. Bernard? 

STATEMENT OF MARIE BERNARD, M.D., DEPUTY DIRECTOR, 

NATIONAL INSTITUTE ON AGING, NATIONAL INSTITUTES OF 

HEALTH 

Dr. BERNARD. Well, good afternoon, Chairman Smith, Representative Bera, Representative Donovan. 

I am happy and honored to represent the National Institute on 

Aging, one of the 27 institutes and centers at NIH. We, at the NIA, 

lead NIH’s Alzheimer’s disease research and as deputy director I 

bring my experience as an academic geriatrician. 

I could very much empathize with the points that were made 

with regards to the prevalence of this illness and the personal impact that it had on families. 

When I saw patients on a daily basis it was heartbreaking to see 

the impact that this had on those patients and, importantly, on 

their family members and to recognize that I didn’t have much in 

my armamentarium that I could bring to the care of those individuals at that time. 

It’s encouraging to be at NIH at this point and to see the blossoming of more and more information that is developed with global 

partners that will hopefully get us to the point that we will have 

a prevention or cure for this illness. 

7

We have, in fact, over the decades supported a number of international studies that have led us to a greater understanding of the 

illness and I will spend what time is allocated to me to briefly highlight three of those. 

First, we are making significant advances in our understanding 

of the course of Alzheimer’s disease from our health and retirement 

study. 

This is a 20-year-old national sampling of older adults in the 

United States—people 50 years of age and older who have followed 

through to their death—and it has allowed us to see the natural 

course of aging as well as the natural course of the development 

of Alzheimer’s disease. 

This study has recently had a new component added to it that’s 

an international component—the Harmonized Cognitive Assessment Protocol, or HCAP. 

We have the hope that if we can get researchers across the globe 

to harmonize the way that they go about cognitive assessments, we 

will be able to better understand the course of the illness and to 

sort out the genetic, social, and environmental influences that impact Alzheimer’s disease. 

We are supporting the deployment of HCAP and HRS, or Health 

and Retirement Study, like studies in England, Mexico, China, and 

India, as well as a smaller scale study in South Africa. This will 

provide us an unprecedented scientific opportunity. 

A second important need is for means to make the diagnosis of 

Alzheimer’s earlier than the current standard, which is when a 

person has cognitive and functional problems. 

There are many promising new findings, particularly as a result 

of something called the Alzheimer’s Disease Neuroimaging Initiative, or ADNI. ADNI is a worldwide collaboration with organizations in Europe, Japan, Australia, Taiwan, Korea, China, and Argentina. 

ADNI has led to the identification of biomarkers, proteins, and 

images of the brain that allow us to measure the onset and progression of this disease. 

A decade ago, the only way that you could definitively say that 

someone likely had Alzheimer’s disease or had Alzheimer’s disease 

was by autopsy. 

But now we can see in a living brain the deposition of amyloid 

plaques and tau tangles in an individual and follow its course before they have clinical symptoms. 

As we make progress with validating this and other biomarkers, 

we hope to translate this into useful clinical tools. 

Third, NIA-supported investigators are conducting prevention 

and treatment trials that are globally—or have a global reach. 

One such study which has received quite a bit of attention is the 

Autosomal Dominant Alzheimer’s Disease Trial involving the 

world’s largest group of early-onset familial Alzheimer’s disease—

approximately 300 extended family members in the country of Columbia who share a rare genetic mutation that guarantees that by 

middle age they are going to have Alzheimer’s symptoms. 

The trial focuses on whether an anti-amyloid drug, crenezumab, 

can prevent or delay the onset of cognitive decline. 

8

We are very grateful to this family and all participants in Alzheimer’s disease and related trials. They are true heroes who have 

allowed us to learn and continue to learn about this disease. 

Finally, I would say that my patients would tell me every day 

that they did not want to live—to grow older if they did not have 

their cognitive capacity because they did not want to become a burden to their families. 

We, with global partners, are working diligently to develop answers to their concerns. With the global rise of Alzheimer’s prevalence, the situation is urgent, as you well-articulated, and we are 

using every possible approach to diminish the impact of this disease as rapidly as possible. 

Thank you for allowing me to testify, and I look forward to your 

questions. 

Mr. SMITH. Thank you so very much, Dr. Bernard, for your testimony and for your insights. 

Dr. Glass? 

STATEMENT OF ROGER GLASS, M.D., DIRECTOR, FOGARTY 

INTERNATIONAL CENTER, NATIONAL INSTITUTES OF HEALTH 

Dr. GLASS. Thank you, and good afternoon, Chairman Smith, 

Acting—Ranking Member Bera, and distinguished member Donovan. 

I too had a father with Alzheimer’s and I sympathize and went 

through the same experience. 

I am Roger Glass. I am the director of the Fogarty International 

Center at the National Institutes of Health and I am honored to 

join my colleague, Dr. Bernard, here in discussing how we are confronting the global burden of Alzheimer’s disease. 

Diseases like Alzheimer’s and like flu and ebola know no borders. 

People throughout the world suffer from this disease and will benefit from treatments and cures. 

We need to find the brightest minds everywhere to assist in this 

endeavor as well as to identify populations with unique environmental or genetic risks because the high quality research that we 

do doesn’t happen only in the United States. It happens elsewhere. 

In order to take advantage of these international situations, we 

need the best trained scientists with high ethical standards, with 

good data management capabilities, with laboratories capable of 

conducting the research that’s absolutely essential. 

Fogarty International Center at NIH facilitates building these research partnerships leading to capacity, building capacity for researchers internationally to create the next generation of scientists 

who will address the Alzheimer’s condition. 

These scientists who will address these problems in the future 

are just being trained today. As Dr. Bernard mentioned in her remarks, NIA is supporting the study in Colombia of an extended 

family with a genetic mutation for familial Alzheimer’s. 

This family is now center stage for much of our research on Alzheimer’s cures and preventions. This partnership began in the 

early 1990s when an American investigator, Ken Kosik, then at 

Harvard, met a Colombian physician, Dr. Francisco Lopera. 

Dr. Lopera, as a young neurologist, had a patient with Alzheimer’s and found that the patient’s father and grandfather had 

9

Alzheimer’s, and because of his curiosity as a young physician, not 

as a researcher, he sought out and ultimately developed a cohort 

of 5,000 people with this genetic problem and it was from this conversation 6 years later of these American and Colombian investigators that they began a decade-long collaboration to look and see 

what they could learn about the epidemiology and genetics of Alzheimer’s. 

This investigation has proved incredibly fruitful beyond our 

wildest expectations. In the 1990s, these doctors received a grant 

from Fogarty to work together. 

By 2004 and ’07, the National Institute of Aging and Fogarty 

were both engaged in supporting this collaborative research. 

And this research involved not only following up on the cohort 

but training people in laboratory methods, in building capacity so 

that we could actually conduct quality research under the best ethical standards in the field. 

At the same time, it also engendered collaborations between communities that were invested. These were not patients in Colombia. 

These were community participants in research—a big difference. 

Preparing for scientists to conduct high-impact research is critical to the Fogarty agenda and what began as a partnership between these two scientists—individual scientists is now at the cutting edge of what’s become a $100 million clinical trial, the first in 

the world for early prevention of the progression of Alzheimer’s disease. 

It is a unique study that couldn’t be done anywhere else and this 

cohort was really an incredible finding and discover of Dr. Lopera. 

He’s an essential part of the research team as is his laboratory in 

Colombia—in Medellin, Colombia. 

Colombia is not unique in this. While the topic of today’s discussion is Alzheimer’s disease, the Fogarty Center has also been involved in many other neurological problems such as research on 

cerebral malaria, neuro HIV, hydrocephalus in Uganda, epilepsy in 

Zambia, chronic psychotic disorders in Tanzania, and stroke outcomes in Zimbabwe, just to name a few. 

Fogarty supports—takes science where the problems are and 

where the opportunities are for the most rapidly accelerating advances in research. And we also are concerned in developing true 

partnerships for research and advancing capacity building. 

Like Dr. Lopera, who is a unique investigator in a unique setting 

with a unique population of this familial Alzheimer’s disease, it’s 

leading us to, hopefully, more rapid cures. 

From this partnership and with NIH support, we are already advancing discovery research. We are already working in basic research in Colombia in collaboration with the U.S. 

The group in Colombia is now an integral part and a central part 

of the U.S. research endeavor on Alzheimer’s and the results of this 

endeavor both for the U.S. population and for the population in Colombia and around the world will all benefit from this activity. 

Fogarty is essential for building these international collaborations and we work very closely with NIA and with other institutes 

at NIH to do this important international collaboration. 

Thank you very much. 

[The prepared statement of Dr. Bernard and Dr. Glass follows:]

10


27661a-1.eps

House Foreign Affairs Subcommittee on Africa, Global Health, Global Human Rights and 

International Organizations 

Hearing Titled, "A Global Update on Alzheimer's Disease" 

November 29, 2017 

Written testimony on behalf of the following witnesses from the 

National institutes of Health (NIH) 

Marie A. Bernard, M.D, Deputy Director, National Institute on 

Aging, NIH 

Roger Glass, M.D., Ph.D., Director, Fogarty International Center, 

NIH 
11


27661a-2.eps

Good afternoon, Chairman Smith, Ranking Member Bass, and distinguished members of 

the Committee. I am Marie A. Bernard, M.D., Deputy Director of the National Institute on Aging 

(NIA), which is one of the 27 Institutes and Centers of the National Institutes of Health (NIH). I 

am joined by my colleague, Dr. Roger Glass, the Director of the Fogarty International Center at 

NIH. It is an honor to be here today to discuss NIH's efforts to stem the rising tide of 

Alzheimer's disease, a devastating condition and a public health issue of increasing relevance 

and urgency, both in the United States and globally. 

An Issue of Mounting Concern 

As all of us are only too well aware, Alzheimer's disease is a currently irreversible, 

progressive brain disease that slowly destroys memory and thinking skills and eventually even 

the ability to carry out the simplest tasks of daily living. In most people with Alzheimer's, 

symptoms first appear after age 60, although a much smaller subset of patients see onset at 

earlier ages. Although treatment can help manage symptoms in some people, there is currently 

no cure for this devastating disease. While my focus today will be on Alzheimer's disease, other 

forms of dementia, including frontotemporal dementia, vascular cognitive impairment/dementia, 

Lewy body dementia, and mixed dementi as, are also important topics of research at the NIH, and 

I will be sharing some of our activities in these areas with you as welL 

Results of a recent meta-analysis1 indicate that 35.6 million people lived with dementia 

worldwide in 20 I 0, with numbers expected to double almost every 20 years, to 65.7 million in 

2030 and 115.4 million in 2050. Notably, the 2015 World Alzheimer Report estimates that 58% 

of all people with dementia live in low or middle-income countries 2 In the United States alone, 

as many as 5.3 million people age 65 and older are living with Alzheimer's disease. Although 

several large epidemiological studies suggest that age-specit!c prevalence rates of dementia, 

1 Prince M ct al., The Global Prevalence of Dementia: A Systematic Rcvic\v and Mctaanalysis. i\lzhci.Incr's m1d Dementia 9: 63-

75,2013. 

2 Alzheimer· s Disease Intematwnal. \Vorld Alzheimer Report 2015: ·'The Global Impact of Dementia.·· 

http://www. worldal;rrcport20 15 .org/download~/\\orld-ab·hcimLT -rq1ort-20 1 5 .pdr 

2 
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including Alzheimer's disease, are declining, 1 it is nevertheless also true that risk for the disease 

is greatest in the "oldest old"- those over 85. Because this age group is projected to grow 

substantially in the coming decades- from approximately 5.8 million in 2010 to some 19 million 

in 20504 - it is certain that unless we identify a way to prevent or etiectively treat Alzheimer's, 

the number of atl'ected Americans will rise significantly within the lifetime of many of us here 

today5 

The NIA-funded Health and Retirement Study (HRS), a 20-year-old nationwide survey of 

the health, economic, and social status of older Americans, has added a new data resource-the 

Harmonized Cognitive Assessment Protocol-to help advance population studies of cognitive 

impairment and dementia. Additional grants are funding harmonized assessments for nationally 

representative studies in England, Mexico, China, and India, as well as a smaller-scale field 

study in rural South Africa. These investments will provide unprecedented scientific 

opportunities for the epidemiological study of Alzheimer's and related dementias beginning in 

2018. NIA also funds other initiatives to study trends in dementia prevalence and incidence 

around the world. Finally, we support the Integrative Analysis of Longitudinal Studies of Aging 

and Dementia research network, which is composed of investigators associated with over 100 

longitudinal studies on aging and dementia. This initiative facilitates cross-national research on 

determinants and dynamics of within-person aging-related changes in cognitive and physical 

capacities. 

Identifying Risk and Protective Factors 

Identification of individuals at risk may suggest strategies for disease prevention. NIA 

supports a number of studies aimed at identifying at-risk individuals, including several with 

international reach and scope. 

For example, NlA supports a study of the biomedical and socio-economic conditions that 

influence cognition, including susceptibility to dementia, among members of the Survey of 

3 Lm-sonliD, YaftC K, and lang.a K.M. Nc\V lnsights into the Dementia Epi.Ucmic. New Lngland Journal of.Aiedicine 369: 22-25-

2277.2013. 

4 Vincent Grayson K. and Victork'1 A. Velkoff. The Next four Decades, The Older Population in the United States 2010-2050. 

Current Population Reports P25-1138. U.S. Census Dureml Vilashington D.C. 2010 . 

., llcbc1t Lli ct al. Alzheimer disease in the United States (2010-2050) estimated using. 2010 census. American Acadenw o.f 

Neurologv go: 17n-l n3, (2013). 

3 
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Health, Aging, and Retirement in Europe (SHARE), a large and population-representative study 

that is harmonized with the HRS and currently deployed in 27 Continental European countries 

plus Israel. NIA also supports the COhort Studies of Memory in International Consortium 

(COSMIC), an international consortium of prospective longitudinal population-based cohorts 

examining the risk and protective factors for cognitive decline and the development of dementia. 

Established in 2012, COSMIC has developed into a consortium of 26 studies from 16 countries 

in five continents, with a combined sample size of>70,000, and is now uniquely placed to 

address some of the salient questions in relation to the epidemiology and biomarkers of 

neurocognitive disorders. 

Identification of genetic risk factors provides insight about mechanisms that lead to 

development of Alzheimer's and other forms of dementia. A number of genetic loci -fixed 

sections of DNA that contain one or more genes- for Alzheimer's have been identified among 

whites of European ancestry, but the genetics of Alzheimer's among other populations is not as 

well understood. Investigators with the NIA-supported Alzheimer's Disease Genetics 

Consortium conducted a large genome-wide association study that included participants of 

European ancestry, Atrican Americans, Japanese, and Israeli Arabs, and identified several loci of 

interest, most- but not all- of which appeared to be implicated in the disease in more than one 

etbnic group. These findings highlight the importance and value of trans ethnic studies for 

identifying susceptibility loci for Alzheimer's disease 6 

Diagnosing Alzheimer's Disease 

Biomarkers, or changes in the quantities of genes, proteins, or metabolites, whose 

presence in a living organism can be measured to indicate the presence of disease, are essential 

to the development of diagnostic techniques and treatments. As recently as 2004, there were no 

established biomarkers for Alzheimer's. Today, not only can we image both amyloid plaques and 

tau tangles (the neuropathological hallmarks of Alzheimer's disease) in the living brain, but we 

have also identified many other potentially promising biomarkers, from blood proteins to early 

changes in an individual's sense of smell. The N1A-supported Alzheimer's Disease 

6 Jun GRetal. Transethnic genome-wide scan identifies novel Alzheimer's disease loci. Alzheimer's and Dementia 

13: 727-738,2017. 

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Neuroimaging Initiative (ADNI), which was established in 2004 to identify and validate 

neuroimaging and fluid biomarkers, has contributed to much of this important progress. 

ADNI is a member of the World Wide Alzheimer's Disease Neuroimaging Initiative 

(WW-ADNI), a global collaboration coordinated by the Alzheimer's Association to help detine 

the rate of progression of mild cognitive impairment and Alzheimer's disease, and to develop 

improved methods for identifying the appropriate patient populations to participate in clinical 

trials. WW -ADNI also aims to standardize the methods used for conducting imaging scans and 

gathering and testing t1uid samples so that data trom all sites can be readily combined and easily 

understood by researchers. With participating organizations in Europe, Japan, Australia, Taiwan, 

Korea, China, and Argentina, WW-ADNI will allow researchers to gain a worldwide picture of 

the physical changes that lead to Alzheimer's disease. 

Treatment 

In addition to diagnosis, biomarkers can be used to track response to treatment. The 

Accelerating Medicines Partnership-Alzheimer's Disease (AMP-AD) Biomarkers Project is 

exploring the utility of tau PET imaging and novel fluid biomarkers for tracking response to 

treatment and/or disease progression among anti-amyloid therapies being tested in certain Phase 

1111 clinical trials. Screening and baseline data trom the trials will be made broadly available 

through the Global Alzheimer's Association Interactive Network collaborative platform. Trial 

data and biological samples will also be shared after the trials are completed. 

NIA-supported investigators are also conducting prevention and treatment trials with 

global reach. For example, the Autosomal Dominant Alzheimer's Disease Trial involves 

approximately 300 members of an extended family in Colombia who share a rare genetic 

mutation that triggers Alzheimer's symptoms in middle age. This family represents the world's 

largest occurrence of early-onset familial Alzheimer's disease. This trial focuses on whether an 

antibody treatment, crenezumab, can prevent or delay the appearance of Alzheimer's disease. 

Notably, Fogarty support enabled the University of Antioquia in Colombia to create a vivarium 

where rodent models of Alzheimer's have been studied and housed. Another NIA-supported 

initiative, the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), conducts 

clinical trials among individuals with the rare early-onset form of the disease. DIAN-TU 

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currently manages the world's first clinical trial to prevent development of Alzheimer's in 

families at genetic risk of early-onset disease. This groundbreaking trial is being pertormed at 

sites in the United States, Canada, Australia, and across Europe. 

DIAN-TU investigators also manage the DIAN Expanded Registry (DIAN EXR), an 

international research registry for individuals with early-onset Alzheimer's and those known to 

be at risk. Patients and family members enrolled in DIAN EXR can learn about current research 

and clinical trials, gain access to genetic counseling and testing, and attend international family 

conferences that will enable them to connect with scientific and medical experts as well as other 

families atl'ected by this devastating condition. 

International Collaboration 

In an interconnected world, it is essential that Nlli continue to invest in a research 

workforce that can respond to evolving challenges that atl'ect us all. As demonstrated in the 

Colombian trial example, these discoveries are often made by U.S. and toreign scientists 

working in close collaborations that enable the best and brightest minds to tackle complex health 

challenges together. 

Through its Global Brain Disorders Research program, Fogarty also provides 

opportunities tor investigators to conduct research specifically on nervous system function and 

impairment, including Alzheimer's disease. In partnership with 10 other NIH Institutes and 

Centers (including NIA), this program supports international collaborative research relevant to 

low- and middle-income country settings. 

NIA remains committed to speeding the pace of global research by large-scale sharing of 

data with qualified researchers around the globe. For example, ADNI data have been widely 

available since the initiative's establishment, and data from AMP-AD and the Alzheimer's 

Genetics Consortium are also made available to investigators worldwide. Data from the HRS and 

its sister studies in other countries are likewise freely available without any embargo period. 

The International Alzheimer's Disease Research Portfolio (IADRP), developed by the 

NIA in collaboration with the Alzheimer's Association, enables public and private funders of 

Alzheimer's research to coordinate research planning, leverage resources, avoid duplication of 

funding etl'orts and identify new opportunities in promising areas of growth. Currently, the 

6 
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database contains information about over 8,300 unique projects representing over 30 funding 

organizations in II countries. 

Alzheimer's disease and related forms of dementia devastate families in every corner of 

the world. At the National Institute on Aging and the Fogarty International Center, it is our hope 

that through cooperation and coordination with our partners around the globe, we will make 

much-needed and long-anticipated progress in finding a prevention or a cure. 

This concludes my testimony. I welcome the opportunity to answer your questions. 

7 
17

Mr. SMITH. Dr. Glass, thank you very much for your testimony 

and your leadership as well. 

Let me just ask the question with regards to imaging, which you 

mentioned a moment ago, Doctor. What kind of brain imaging are 

we talking about? CAT scan? MRI? 

Obviously, that is not available in most developing world settings, and since there is such a under—large numbers of people 

never get a diagnosis—about 50 percent or less in the United 

States—how quickly is this technology being advanced so more people will get a definitive word earlier on so some of these drugs that, 

again, only deal with symptoms can be applied to mitigate those 

symptoms? 

Dr. BERNARD. So what I was describing as opportunities with imaging and looking at proteins are meant to be in the research setting currently. 

But they are being refined and we are beginning to look at things 

in the blood—in the peripheral blood. We are looking at things like 

changes in smell. 

We are looking at things like the development of depression 

symptoms years before a person actually has dementia as things 

that will help us to be more precise in making that diagnosis clinically. 

So it all comes together to help us. We don’t quite have something that can be translated directly from the research lab that is 

anything better than we currently have in terms of looking for 

symptoms right now. 

Mr. SMITH. Just let me ask you, Dr. Glass, about Uganda and 

the situation with hydrocephalic condition. 

I have had five hearings on that. We have a bill that would address that need and we actually had doctors—Dr. Benjamin Warf, 

who developed a non-shunt intervention to help people who have 

water on the brain, and it is amazingly effective and not much by 

way of having to redo it. 

You mentioned risk factors. Obviously, genetics is a risk factor. 

We all know that, and one of those studies you mentioned, that’s 

a big focus. 

But when you talk about environmental risk factors, we know 

that in the area of autism environment does play a very serious 

role, and NIH has chronicled that in its reports. 

I am wondering if other areas of investigation are being pursued 

including toxic chemicals of various kinds. Lyme disease—I chair 

the Lyme disease caucus as well and it’s a huge problem in my district, in my state, and in our region—is grossly under reported, and 

there have been studies that found that people with Lyme that dementia was one of the consequences, and I am wondering if that’s 

being looked at. 

So maybe if you could speak to the environmental side of it, if 

you would. 

Dr. BERNARD. So I will start off and say that from the environmental perspective, yes, we have a number of studies that are looking at various environmental toxins that may be contributing to 

problems with the development of Alzheimer’s that’s particularly 

assisted by projects that are looking at people in the long term and 

looking at what has happened to them. 

18

We are also looking at education, looking at diet, looking at geographic location. All of those may contribute. I quite honestly do 

not know specifically about Lyme disease. We could look back and 

get back to you on that. 

But a variety of things environmentally and socially seem to be 

associated with differences in the frequency with which various 

groups have Alzheimer’s disease. 

Mr. SMITH. Dr. Glass, do you want to add anything? 

Dr. GLASS. I don’t know of other risk factors for Alzheimer’s, although Hispanics have an increased risk and an earlier presentation. 

But for other neurological diseases, we know a lot of about infections like malaria and other meningitities. We know about heavy 

metals and exposures. 

We know about foods in Africa, for instance, like manihot, which 

has a cyanide that leads to poisoning, and alcohol, of course, and 

fetal alcohol. 

So there are other toxins. But for Alzheimer’s we don’t have 

those yet and we could look into and provide that information. 

Mr. SMITH. I’d appreciate that, for the record. 

The international response has become increasingly aggressive 

and robust. In 2012, the WHO released a document, ‘‘Dementia: A 

Public Health Priority,’’ and I and Greg Simpkins and others on 

our subcommittee met with Dr. Margaret Chan, a former WHO director general and she had a real heart for this as do so many others at the WHO. 

In 2013, the G8—now G7 without Russia—but the G8 committed 

to more research funding, and that is Canada, France, Germany, 

Italy, Japan, Russia, the United Kingdom, and, of course, the 

United States. 

And I am wondering if you could tell us that plus the newest 

2017 WHO action plan. PAHO—the Pan-American Health Organization—has a plan. People seem to be coming up with action plans, 

and that’s all great, but how well are they being implemented? 

Are the other countries, for example, like us—we are tripling our 

NIH funding. It’s a bipartisan effort. Again, I mentioned Tom Cole, 

the chairman who’s doing a wonderful job. He’s got a heart for this. 

The Alzheimer’s Association never lets up in pushing this and 

having a great impact. 

In my own State, Christine Hopkins is the Alzheimer’s Ambassador. We all have one. She is constantly in contact with me and 

I think that is a great way of advocating on behalf of patients and 

caregivers. 

Katie Macklin is the director in our area and I was just at a 

march for Alzheimer’s in Bradley Beach. There was over 1,000 people. So the Alzheimer’s Association are here and they will be submitting testimony as well. 

We are really pushing for the private sector to come up with 

money augmented, of course, and leveraged by the public sector 

money. 

Are the others doing it as well? Is Japan, is Germany, the U.K., 

the other G8—the more affluent countries coming up with the resources so synergistically we’ll see a great surge in research? 

19

Dr. BERNARD. So I can certainly say that we track what’s happening internationally and something that was developed jointly 

with the Alzheimer’s Association is something called the International Alzheimer’s Disease Research Portfolio that allows us to 

see across the globe what is going on. 

It currently has more than 8,000 projects representing 30 funding agencies, 11 different countries. We also work through the department in being responsive to what the World Health Organization is doing to work across the globe in Alzheimer’s projects and 

we are aware that various countries have developed plans as we 

have. So I will probably defer to my colleague, Dr. Glass, for further elaboration. 

Dr. GLASS. The most important risk factor for Alzheimer’s is age. 

We see an aging of the population around the world, which is why 

this has become such a tremendous problem, as we look forward, 

and I think it’s because of that aging that many groups including 

the Japanese and the English have invested in this heavily. 

I think as new diagnostic methods become available so you can 

actually make a proper diagnosis, the importance of Alzheimer’s 

globally will be observed in each of the countries that does the surveys. 

And so with the improvement of diagnostics that don’t require a 

dead brain, we’ll be able to understand the prevalence and increasing incidence over time. 

Mr. SMITH. Just two final questions. Is there a best estimate if 

things don’t change where we will be by 2025 and 2050? I gave one 

estimate and there’s highs and lows, of course. They were all guesstimates. 

Do you think we will reach the goal of a disease-modifying therapy by 2025, which was the G8 push, which is the WHO push, 

which is our push with NAPA, the bill, that we all got behind and 

pushed a couple of years ago? Do you think we will get there? I 

mean, is there enough critical mass of resources to get us there, in 

your opinion? 

Dr. BERNARD. I was going to say that we are very grateful for 

the additional resources that have been provided and, again, as a 

clinician, I am really excited because there has been the opportunity to invest broadly in basic research that’ll help us to better 

understand what’s happening mechanistically with this illness, an 

explosion of recognition of genes that are related to it. 

We went from only knowing four genes a little more than a decade ago to more than 24. Lots of clinical studies, 100 or so, with 

results coming out in the next many years that’ll help us to understand which direction we need to go. 

Enhancement of population-based studies that’ll help to answer 

some of the questions that you were asking about toxic exposures, 

social factors, et cetera. 

So I think that there’s great momentum going on and we’ll have 

to see. 

Dr. GLASS. I would concur. You know, we have more tools to research Alzheimer’s today than we’ve ever had when my dad passed 

away. We have imaging techniques, which are extraordinary, genetic entrees to the disease, animal models for Alzheimer’s that 

allow us to test out new drugs. 

20

And so we are in a position better today than ever before to accelerate the advances. The fact that we have so many monoclonals 

in clinical trials and drugs that are being tested could—if any of 

them delay the progression of the disease they will have a huge impact on the cost of care. 

So I think in the short run we have clinical trials that are ongoing now. Also, the trial in Colombia—if it’s successful we will all 

benefit. 

If it fails, it will tell us that we are barking up the wrong tree 

and we need to find other targets that would be more susceptible 

to—for new drugs. So either way, I think we are on a roll that 

we’ve never had before and the opportunities are clearly before us. 

Mr. SMITH. As I mentioned in my opening, I will be reintroducing 

the Global Brain Health bill next week. It deals with three diseases: Autism, Alzheimer’s and hydrocephalic condition, referencing 

what you mentioned about Uganda, Dr. Glass. 

Dr. GLASS. Yes. 

Mr. SMITH. It concerns me that USAID, and I have had conversations with Mark Green, the new administrator. It’s important that 

we do infectious diseases, communicable diseases, but brain health 

has been left to CDC and to the diplomacy area, not to the actual 

assistance at the country level. 

So my hope is that we will be able to get this bill passed and 

begin moving in the direction of funding—those kinds of initiatives 

as well. 

Dr. Bera. 

Mr. BERA. Thank you, Mr. Chairman. 

Dr. Bernard, you talked about longitudinally following older 

Americans and so forth. 

Is—as you are building this database and looking at that database and now adding in folks from around the world as well in that 

database, what kind of patterns are—has it been around long 

enough and what types of patterns, potentially, are emerging? 

Dr. BERNARD. Thank you for asking that question, because what 

we are seeing is, in the United States, at least, that the incidence 

of Alzheimer’s disease may be decreasing in certain segments of the 

population. 

Whether that is because of better education, better blood pressure control, better nutrition, we don’t know. But we are seeing 

other sorts of things like we are being able to determine that if you 

make it to age 70 without cognitive impairment that you still have, 

as a man, a almost one out of four chance of developing Alzheimer’s, as a woman a one out of three chance of developing Alzheimer’s disease, and we are seeing—when we compare across 

countries that there seems to be a socioeconomic status relationship. 

You know, the higher the socioeconomic status, the longer one 

puts off the likelihood of developing an Alzheimer’s type dementia. 

So there is, clearly, a social component to this and we are looking 

forward to further disentangling that. 

Mr. BERA. Do you see a pattern with level of educational attainment? So, you know, lower rates of Alzheimer’s disease in folks 

with higher educational attainment? 

21

Dr. BERNARD. It appears that that there is such a correlation—

that the rate of the development of the disease, the age at which 

one develops the disease is—the rate is lower. 

The age at which you develop is older. So there seems to perhaps 

be some sort of protective or beneficial effect of education. 

Mr. BERA. So when I used to practice medicine, I would tell my 

patients to do crossword puzzles every day. It wasn’t—just something that I was telling them to do in terms of exercising your 

brain and go into distant memories and——

Dr. BERNARD. Yes. Yes. We have a number of studies where we 

are trying to really disentangle exactly what makes the difference. 

Whether it’s doing crossword puzzles or the brain games are out 

there, et cetera, we don’t have definitive evidence that that’s truly 

impactful. 

We do have one study, something called the Active Study, that 

demonstrated that if you trained people in a particular component 

of cognition that that was beneficial for that component like speed 

of processing of information or memory or things like that. 

But it’s not clear that it truly can put off dementia. In fact, we 

had the Agency of Health Research and Quality and the National 

Academy of Science, Engineering, and Medicine to look at that very 

carefully for us recently and they—their assessment was that we 

are not yet at the point that we can say definitively that those 

things that we recommended for patients are going to make a difference. 

But it certainly can’t be harmful and particularly if they’re enjoying those sorts of things. I do the same sort of thing as well. 

Mr. BERA. Dr. Glass, do you want to add anything in addition to 

that? 

Again, you know, as we—as we do when we do medical research 

we are creating this huge database and we are looking for patterns. 

In terms of risk stratification now and, you know, as, you know, 

we try to come up with better diagnostic tools, what are some of 

the, you know, outside of family history of Alzheimer’s what are 

some of the risk factors that we ought to be thinking about and 

educating the public on and, certainly, educating our physicians on 

as well in our workforce? 

Dr. BERNARD. So, certainly, it appears that people who are likely 

to develop an Alzheimer’s type dementia are the people who live for 

a longer period of time, the people who may not have as high a 

level of education, people who have had problems with high blood 

pressure and diabetes and that’s the reason some of the populations that are considered to be under represented populations in 

the United States may have a higher prevalence, as Dr. Glass alluded to. 

There may be some role for past significant head trauma—things 

of that sort. But, you know——

Mr. BERA. We are not—we still haven’t quite seen definitely 

those patterns emerge out of the—out of the database? 

Dr. BERNARD. There are risk factors that we’ve seen. Whether 

they are modifiable risk factors is the—is the question. 

Dr. GLASS. Let me just add, Congressman Bera—Dr. Bera—even 

with in the Colombia cohort, which comes from a single founder, 

there are genetic mutations that have been introduced over the last 

22

200 years so that the age of onset, the speed of progression, are all 

idiosyncrasies—differences that we can understand by linking the 

genetics with the phenotype and with the progression. 

So we can actually learn a lot about the genetics by plotting 

those individuals. So I think there’s—when we deal with the melting pot of the United States with genes that have been mixed from 

all over, much more difficult to do and I think that we’ll learn a 

lot more from this cohort and perhaps from others, which have 

these familial modifications. 

Mr. BERA. Dr. Bernard, with a family history of Alzheimer’s disease, what is the risk of developing Alzheimer’s disease? Can we 

say definitively or——

Dr. BERNARD. What we can say is that if you have an APOE 4 

gene or two versions of the APOE 4 gene that you have a very high 

risk. We can’t say there’s 100 percent likelihood but a very high 

risk of developing Alzheimer’s disease. 

If you have an amyloid precursor protein mutation presenilin one 

or presenilin two, those are associated with early onset Alzheimer’s 

disease. 

They tend to be autosomal dominant, meaning that very likely 

you are going to develop Alzheimer’s disease associated with that. 

That’s with the Colombian cohort. And then just simply a family 

history, yes. 

I mean, if you have family members who’ve had an Alzheimer’s 

type dementia you may be at greater risk as well. Whether it’s related to one of those other genes that we’ve discovered of late or 

a combination of the genes or environmental factors or social factors, not totally clear at this point. 

Mr. BERA. And in terms of risk stratification, so patient presents 

with a family history of Alzheimer’s disease, how readily available 

are the genetic testing and, you know, again, just to try to think 

about risk stratify? 

Dr. BERNARD. So I think that there are private entities that are 

available that can do the genetic testing. We certainly have a system—Alzheimer’s disease centers that are set up to bring people in 

to participate in research programs and some of these centers are 

focusing on people who have genetic risk. 

And I would again put a plug in for people to be involved with 

such things because we need lots of different people—a diversity of 

people involved in these studies to really understand what—how is 

it going to present in different groups. 

Mr. BERA. And do we know, are there any prospective studies 

going on right now where you are taking folks with a confirmed diagnosis of Alzheimer’s type dementia, taking—taking their family 

members and prospectively following those family members, looking for patterns? Are those studies ongoing? 

Dr. BERNARD. So we have a number of studies that are looking 

at people who, by biomarkers—you know, they have the changes in 

the brain, they may have a genetic abnormality but they are not 

yet symptomatic—and we are looking at various interventions to 

try to make a difference in their outcomes. So to that degree, yes. 

Mr. BERA. Now, and at this stage with what we do know, there’s 

nothing that prevents us from educating our health care workforce. 

23

If someone has that family history of Alzheimer’s disease, you 

know, they ought to look at those other mitigating factors—manage 

their diabetes a little bit better, you know, look at those other lifestyle changes, you know, look at alcohol consumption and, you 

know, again, those other mitigating factors that may not prevent 

them from developing Alzheimer’s but may slow down the evolution 

of the disease, look at maintaining brain activity through, you 

know, whether it is, you know, brain games or crossword puzzles 

or, you know, maintaining physical well-being—those are all reasonable interventions that we can do at—probably have a cost benefit but also, you know—is that an accurate statement? 

Dr. BERNARD. I think that’s a fair statement—that National 

Academies and Agency Research and Quality Study that I referenced they said that we do not yet have definitive evidence but 

there’s encouraging though inconclusive evidence that controlling 

blood pressure and hypertension, physical activity can make a difference and inconclusive but possibility of cognitive engagement. 

So yes, I would hope that my colleagues, your colleagues, would 

do all of the things that you’d mentioned as well as encourage 

those patients to think about getting involved in a clinical study. 

Mr. BERA. Great. I could ask 100 more questions but I will yield 

back. Thank you. 

Mr. SMITH. Mr. Donovan. 

Mr. DONOVAN. Well, now that Dr. Bera has made Dr. Glass and 

myself feel real comfortable about asking about family history of 

two people who have Alzheimer’s patients as parents—no, thank 

you, Doc. This entire process is an education for me. 

And I wanted to ask about—we are talking about studies and 

being able to diagnose, and Dr. Bernard, I remember when they’d 

say you needed an autopsy to actually do a diagnosis. I remember 

that. 

Are we advancing also in how we are treating patients now with 

Alzheimer’s as we are waiting for the studies to conclude and how 

advanced have we gone? 

I can’t believe what you said in your testimony about, I think, 

identifying four genes 10 years ago or so. Now we could identify 24. 

That’s an incredible advancement for the person on the panel who’s 

not a physician. 

So has our treatment gotten better as your studies have advanced and developed? 

Dr. BERNARD. So we, unfortunately, do not have a true treatment. We have drugs that can slow down symptoms for a period 

of time but it really doesn’t change the course of the illness. 

So at the same time that we are vigorously looking for that prevention or a cure, we are also supporting research that’s looking at 

being more effective at caring for the individual with Alzheimer’s 

disease and for their caregiver. 

In fact, on the NIH campus just last month there was a summit 

on Alzheimer’s caregiving with some 500-plus researchers, advocates, people living with dementia, and it was really edifying to 

hear them reviewing what’s there and noting that we have a lot 

of interventions that are effective and can be generalized. 

24

There are opportunities for further enhancements there. Some 

450 recommendations came from that study. So we are sifting 

through that and seeing what we can do to further enhance things. 

But I would like to think that we are further down the road in 

terms of paying attention to issues of caring for individuals with 

Alzheimer’s and for their caregivers. There is still room for further 

improvement. 

Mr. DONOVAN. Anything to add, Doctor? I am sorry. 

Dr. GLASS. Not really. 

Mr. DONOVAN. Okay. 

Dr. GLASS. It would be nice that we had a cure. There are certainly cultural differences in giving care and keeping people at 

home versus in institutions—definitions that people use. 

And we have supported research on caregivers in the Spanish 

language because the way you make a clinical diagnosis based on 

history is linked to the terms that are used for dementia and for 

acceptance of the disease and I think that’s an area where we are 

learning. 

But not breakthroughs as such, just in the care giving—quality 

of care giving. 

Mr. DONOVAN. I certainly understand that. I mean, my mother 

suffered for 4 years, as I said. A woman from Trinidad and a 

woman from Ghana treated my mother like she was their own 

mother for 4 years. 

These people became part of our family. We still have Thanksgiving with these two women and my mother passed 2 years ago. 

And the toll that takes on people—it was almost like at some point 

my mother had this innocence about her. 

She didn’t understand what was going on with her body and her 

mind. It was everybody around her who were suffering. So the emphasis, and Dr. Bera said it too—the recognition and focus on some 

of the caregivers of Alzheimer’s patients I think is just as important as caring for the patient. 

When you are successful and we do develop a treatment or a 

cure, another one of my fears is that as we—I spoke earlier about 

global health with maternal health and child health or even prenatal health, is that we are not getting those things that we actually do have now here for our children to some of those developing 

countries—those folks who are—don’t have the resources we have, 

and I suspect we’ll probably have the same problem after your success in finding treatments and cures for Alzheimer’s of getting 

whatever is developed to folks in less developed areas of our world 

and do you see that as something that—I know we have to concentrate on first finding the treatment and the cure but once we 

do, getting it to folks outside of our own country I suspect the folks 

in our own country for the most part anyhow will—this will be 

more readily available to them than places in other parts of our 

world. 

So as we see with immunizations for children or prenatal care 

from mom, my fear is that after you are successful we might have 

the same problem getting the resources to the folks who need them 

outside of our own country. Do you see that as an issue? 

Dr. GLASS. I will make two comments. I thought it was very 

thoughtful about your mother and I think part of the issue in care 

25

giving is how do we train caregivers to give the quality of care that 

your mother got from these two women. 

My father was in exactly the same situation and that quality of 

care and how we train people to provide this is essential. Some of 

this we can learn through global collaborations. 

On the other part of your question, can the interventions that we 

develop in the United States be carried abroad? We have a whole 

agenda at Fogarty on implementation science—of taking what 

we’ve learned and implementing it in developing countries. 

We have learned, for instance, how to prevent mother-to-child 

transmission of HIV. But in many countries this has not reached 

all the pregnancies and mothers, and if you miss a pregnancy, 

you’ll have a child born with HIV who will need treatment for life. 

So in the area of implementation strategies, that has really become a priority for our research of taking what we’ve learned and 

implementing in developing countries. 

I think, Chairman Smith, one other thought I—since you mentioned Dr. Warf, one of the values of global health research from 

his research is that he developed methods to treat hydrocephalus 

without needing to revise shunts every few years in children in developing countries because you can’t take them in for repeat surgery. 

So through two procedures that he’s adapted that were known 

but mixed together, one to open the outflow of cerebral spinal fluid, 

the other to cauterize the choroid plexus that produces CSF—the 

spinal fluid—he could decrease the flow, increase the outflow, decrease the input, and so he could do a single operation without the 

revision. 

That operation is now being used in the United States to treat 

our children with hydrocephalus. So it’s through that research done 

in Uganda by an outstanding American neurosurgeon, seeing the 

need in that country to bring that technology home to our own children, it is another benefit of, I would say, reverse technology transfer—learning from the developing world these kinds of lessons. 

It will make American children survive better with hydrocephalus as well. 

Mr. DONOVAN. Since everyone mentioned a doctor, and you are 

the only two doctors that I know besides Dr. Bera, Tony Fauci is 

a friend and I remember him saying at one of our conferences that 

if you are successful finding a cure for Alzheimer’s, the amount of 

money that we gave NIH in the 21st Century Cures Act it will pay 

for itself, the amount of money we spend on treating this disease. 

I thank you both for your work. Besides being here today, I 

thank you both for your work—the people who will benefit once you 

are successful. 

Thank you all. 

Mr. SMITH. Thank you, Dan. 

Let me just conclude and ask you, if you could—the 2017 WHO 

Action Plan—on November 13th we know the Bill and Melinda 

Gates Foundation and now it’s $100 million for Alzheimer’s research—the U.N. itself has established a Global Dementia Observatory to collate and disseminate key dementia data from member 

states to support evidence-based service planning and strengthening of policies as well as health and social care systems. 

26

What is your opinion of the WHO Action Plan? The steps, obviously, are a whole of government approach for ourselves. Are you 

happy with it? Do you feel that this is really going to be transformational? 

Dr. GLASS. First of all, we were delighted to hear about the 

Gates contribution to Alzheimer’s, and I think as Bill and Melinda 

Gates age, they realize that this a risk that’s before them as well. 

So their investment is really appreciated and shows a broadening 

of global interest in this—in this endeavor. I think the fact that the 

U.N. has a Global Action Plan is also wonderful recognition of the 

importance of this problem globally and it remains to be seen how 

this will be rolled out. 

But the fact that it’s there and it’s recognized and it’s recognized 

by so many international partners is an awakening to the—to the 

importance of the burden of this disease for all of us globally. 

Mr. SMITH. Thank you. 

Dr. BERNARD. I would just support what my colleague has said. 

We think that this is something that needs all the best and brightest minds put toward it and what we have observed is that as 

other countries are putting resources toward it, there are more and 

more scientists with whom we can collaborate and that’s only to 

the good of all. 

Mr. SMITH. Thank you for your leadership. Thank you for being 

here today. Is there anything else you’d like to add before we go 

to panel two? 

Thank you so very much. 

I would like to now welcome to the witness table our second 

panel, beginning with Dr. Mary Mittelman, who serves as research 

professor at the Department of Psychiatry and Rehabilitative Medicine, and director at NYU Alzheimer’s Disease and Related Dementias Family Support Program at NYU’s School of Medicine and the 

Langone Health at NYU. 

Dr. Mittelman was principal investigator of a randomized controlled trial of the NYU caregiver intervention funded for 20 years 

by the National Institutes of Health, the results of which have been 

published widely. 

Dr. Mittelman has expanded her research focus to interventions 

that include the person with dementia as well as the caregiver. 

She’s the founder of the Unforgettables, a chorus of people with dementia and their family members, which rehearses and gives regular concerts in New York City. 

We will then hear from Dr. Richard Mohs, who is the chief scientific officer for the Global Alzheimer’s Platform—GAP—Foundation, a patient-centered nonprofit organization devoted to enhancing the speed and quality with which new treatments for Alzheimer’s disease are developed. 

He retired in 2015 from Eli Lilly and Company where he held 

several leadership positions including VP for neuroscience early 

clinical development and leader of the Global Alzheimer’s Drug Development Team. 

He also serves as a member of the Board of Governors for the 

Alzheimer’s Drug Discovery Foundation, a member of the board of 

directors of Cogstate Limited based in Melbourne, Australia, and 

27

senior associate editor for Alzheimer’s and Dementia, the journal 

of the Alzheimer’s Association. 

Then we will hear from Michael Splaine, who is owner and principal at Splaine Consulting, a small advocacy and government affairs consulting firm with a very big impact based in Washington, 

DC. 

Immediately prior to starting the company he was Director of 

State Government Affairs in the Public Policy Division of the Alzheimer’s Association, leading its grassroots network to accomplish 

State policy priorities including comprehensive State Alzheimer’s 

plans. 

Well known as an advocacy trainer and grassroots organizer, Mr. 

Splaine has also been faculty for Alzheimer’s Disease International 

University public policy and is active in ADI’s World Health Organization’s Strategy Group and is now advancing its policy agenda 

with U.N.-based opportunities in New York and Geneva. 

Thank you all for being here and please, Dr. Mittelman, if you 

would begin. 

STATEMENT OF MARY MITTELMAN, DR.P.H., RESEARCH PROFESSOR, ALZHEIMER’S DISEASE AND RELATED DEMENTIAS 

FAMILY SUPPORT PROGRAM, NEW YORK UNIVERSITY 

Ms. MITTELMAN. Thank you. I got into this field because my 

mother had dementia. I am trained as a psychiatric epidemiologist 

and when my mother had dementia my family really did not cope 

very well. In fact, the dementia probably drove us apart rather 

than bringing us together. 

And after she died, I decided to try to figure out whether there 

was a way to help families like mine to cope better with the illness. 

And I was lucky enough to meet four women who were working 

at NYU, helping caregivers as volunteers and I—and I saw what 

they were doing and I decided to try to write a—to run a clinical 

trial of what they were doing. 

So I wrote a grant proposal to the NIMH and was funded from 

1987 to 2010, ultimately, by the NIMH and the NIA to study an 

intervention that was based on what these women had been doing 

at NYU. 

The intervention, which we subsequently named the NYU Caregiver Intervention, is a multi-component intervention and it is individualized to the needs of every caregiver. It starts with a comprehensive assessment of the primary caregiver and then there is 

an individual counselling session, the point of which is to help the 

caregiver to understand the need—her need or his need for support 

from other family members, friends, and formal support. 

And then there are four family counselling sessions with family 

members that the caregiver nominates as important to him or her 

and a final individual session. 

So there are six counselling sessions in a period of 4 months. But 

since Alzheimer’s disease can last as long as 20 years in an otherwise healthy person, we thought it was important to provide ongoing support. 

So other parts of the intervention that provide ongoing support 

are recommendations that the caregiver join a support group that’s 

28

run by the Alzheimer’s Association or other organizations like it 

and also we were available for what we named ad hoc counselling. 

So any caregiver or family member who participated in our study 

was able to call the counselor at any time for as long as they 

stayed in the study and some caregivers actually stayed in the 

study for more than 18 years. 

So in that time I was—in the time I was funded and because people stayed in the study for so long, I was able to demonstrate incredible benefits of this intervention compared to the usual care 

that people were able to get at NYU at the time. 

And, basically, the most important component that was not available to the control group in our original randomized control trial 

was the family counselling. 

So we think the family counselling was the key and most important ingredient in this package in the multi-component intervention. 

So what were some of the benefits that we were able to demonstrate? We were able to show that family—the first thing that 

happened was that the primary caregiver was more satisfied with 

the support that he or she got from family members and friends. 

This then led to significantly reduced symptoms of depression, 

significantly reduced symptoms of stress, improved caregiver physical health, and by those—by those changes all through improving 

family support for the primary caregiver we were able to keep the 

person with dementia at home on average a year and a half longer 

than the people who got our usual care. 

So this is a really powerful intervention and its—and its power 

is through social support. More recently, we were able to show that 

this intervention could safe huge costs to the health care system 

in a study that we published in Health Affairs in 2014. 

We showed that the State of Minnesota with a population of 

about 5.5 million people could, if every caregiver got the NYU caregiver intervention, save $996 million in 15 years. 

That factoid, not all the other things I told you about—depression and stress and physical health—but that fact was brought to 

the attention of the governor of the State of New York who, because of it, allocated $75 million to family support programs of 

which now I am running one. 

And I think—and our program is really, while we would have to 

do what is mandated by the State, is really—the core of it is improving social support for the family caregiver. 

And I think that everything that we’ve done has been about social support and that is something which doesn’t cost necessarily 

a lot of money and I think in any country that could—that would 

want to learn how to would want health care providers to learn 

how to do this intervention. 

It could be done at a relatively low cost and in developing costs 

often labor is cheap and pharmaceutical interventions may be very 

expensive. 

So because of our—of our success, even before the Health Affairs 

article, people in other countries were interested in doing the 

study. 

We did the three-country study in the U.S., the U.K., and Australia, which replicated our findings of reduced depression in careVerDate 0ct 09 2002 12:14 Jan 09, 2018 Jkt 000000 PO 00000 Frm 00032 Fmt 6633 Sfmt 6633 F:\WORK\_AGH\112917\27661 SHIRL
29

givers even though all of the people in the study—all the patients 

in the study were getting Donepezil, which was an approved drug 

for dementia. 

We have done a study in Israel that showed similar findings and 

we did a study in—we are currently doing a—finishing a study in 

Spanish Harlem, which is showing the effects, again, of this intervention. 

So I am here to say that there is something right now that 

works—that it isn’t a drug and it won’t cure the disease but I can 

help people to live better with the disease, and I think that while 

we are waiting for an intervention—a pharmaceutical intervention, 

it is incumbent upon all societies to do the best they can to improve 

the quality of life of family caregivers and people with dementia. 

So some of the more recent interventions that I am involved with 

you mentioned the chorus, which I founded in 2011, is a very relatively inexpensive intervention. People with dementia sing with 

their family members. 

They rehearse for concerts and they give concerts. They learn 

new songs, which is something nobody believed could happen. So 

people with dementia are learning 18 new songs for every concert, 

not only giving pleasure to themselves, not only finding support 

with other people like themselves, but giving pleasure to the community. 

So I think that what we can do right now is to improve social 

support for family caregivers and for people with dementia. 

Thank you. 

[The prepared statement of Ms. Mittelman follows:]

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27661b-1.eps

Counseling and Support Can Reduce Emotional, Physical and Financial Costs of Dementia 

A Vision for International Expansion of an Evidence-Based Intervention 

"Everyone is interested in research on drug trials and how 

drugs can improve cognitive function. I think that we should 

be equally concerned with well-being and quality-of-life for 

those with dementia, their caregivers, and their families." 

Alzheimer's disease has devastating effects on both patients and on the families who care for 

them. Drugs produce only modest improvements and the possibility of curing or preventing 

Alzheimer's disease remains far in the future. In the meantime, as the population continues to age, 

the financial and emotional cost to patients and families as well as the cost to the federal health 

care budget continues to grow. This problem is growing more quickly in developing countries than 

in industrialized countries. While new pharmaceutical interventions may provide more benefits 

than those that are currently available, they are likely to be expensive, and may be unaffordable by 

many families dealing with dementia. In addition, migration of young adults to cities or from other 

countries to the United States while older family members have remained behind, means that 

family caregivers are often widely dispersed 

The NYU Caregiver Intervention (NYUCI) can be provided to caregivers at relatively low cost, 

particularly in countries where wages are relatively low. The intervention has demonstrated 

multiple benefits over the past 30 years. Online training in how to conduct the NYUCI both in 

person and via videoconferencing is available. The NYUCI can be used in combination with 

pharmaceutical intervention, and provides additional benefits. The nihilism among physicians, 

who avoid diagnosing dementia because there is currently no drug that can slow or reverse the 

progression of dementia could be counteracted by more widespread knowledge of the power of 

psychosocial interventions like the NYUCI.If there are more patients diagnosed, there are more 

patients potentially available for clinical trials of drugs to treat AD. 

The goal of the NYUCI is to improve the well-being of family caregivers, and thereby to enable 

them to keep the person with dementia at home longer than would otherwise have been possible. 

The main mechanism for improving caregiver well-being is improving social support, largely 

through helping the caregiver and other family members to interact in positive ways, but also by 

1 
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27661b-2.eps

providing referrals to appropriate resources in the community. Because every family has different 

needs, the intervention is individualized. counseling. Because most caregivers would benefit from 

more understanding and help from their families, the intervention includes family counseling. 

Because Alzheimer's disease can last for many years and its effects change over time, the 

intervention is nottime-limited. 

The NYUCI, developed atthe NYU School of Medicine, in New York, USA, is an evidence-based 

multicomponent intervention that provides counseling, education and support to family 

caregivers of relatives living with dementia, either in person or via video teleconferencing. It 

includes individual consultation, family consultation, and 'ad-hoc' -additional phone or video 

telecounseling as needed-for primary caregivers and other family members. 

When they enroll,, caregivers receive a comprehensive assessment of their needs, strengths and 

resources, the support they receive and would like to receive from family members and friends, 

and their emotional and physical health. They then have six consultations over a four month 

period. First, they have an individual consultation with a trained counselor, to further explore 

their needs and encourage them to think about the family members they would like to include in 

the following sessions. There are then four consultations with family members selected by the 

caregiver. Then there is an individual session to discuss what has been achieved, and what issues 

still remain and how to potentially address them. A vital component of the intervention is that 

counselors continue to provide what we call ad hoc counseling, which is consultation and support 

for caregivers and their families for as long as needed usually on the telephone or by email. Thus, 

counselors are available to help caregivers and their families deal with crises and with the 

changing nature of the patient's symptoms, to provide information and referrals for additional 

help, and help them understand and manage their reactions to the patient's behavior. Caregivers 

are also encouraged to join support groups that met regularly, as an additional source of ongoing 

information and support from their peers. The NYUCI received the first global award for 

psychosocial interventions from Alzheimer's Disease lnternationaljFoundation Mederic 

Alzheimer. 

The NYUCI was first evaluated in a randomized controlled trial, which began in 1987 and lasted 

for more than 20 years, with funding from the National Institute of Mental Health and the National 

Institute on Aging (NIA). More than 400 husbands and wives of patients with Alzheimer's disease 

enrolled in the original study over a 10 year period, beginning in 1987. Some stayed in the study 

for as long as 18 years. The exceptionally long duration of the study made it possible for us to 

assess both the short and the long term effects of the intervention. The study was a randomized 

controlled trial, in which participants either received the NYUCI, or the usual care available to 

caregivers at NYU at the time. 

The beneficial effects of the NYUCI have been well documented in peer-reviewed journals. The 

initial 20-year randomized controlled trial demonstrated that the NYUCI had long lasting benefits; 

caregivers were more satisfied with the support they received from family and friends 1, 

experienced fewer symptom of depression', were less reactive to dementia-related behaviors3 and 

2 
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27661b-3.eps

were physically healthier than those who received usual care4. As a result, caregivers who 

received the NYUCI were able to keep the person with dementia at home for an average of a year 

and a half longer than those who received usual services5. These benefits were largely achieved 

through improving social support- the number of people to whom the caregiver felt close, and the 

caregiver's satisfaction with emotional support and with assistance from family and friends 6 

Many additional randomized controlled trials and successful community implementations of the 

NYUCI in the United States and abroad, in England, Israel, and Australia have achieved similar 

results. 

In the Three Country Study (US, UK and Australia, all participants with dementia received 

donepezil, one of the drugs that are currently available to mitigate some of the symptoms of 

dementia, while half the caregivers in each country received the NYUCI. We demonstrated that the 

caregivers who received the NYUCI became less depressed over the two year period in which they 

participated in the study? This suggests the potential greater power of a combination of drug plus 

psychosocial intervention for maximum positive effect 

Evidence of the effectiveness of the NYUCI led the Administration on Aging to fund translations 

of the NYUCI in six states-Minnesota, Florida, Georgia, California, Wisconsin, and Utah-through 

the Alzheimer's Disease Supportive Services Program. Minnesota was the earliest, and the longestrunning, implementation and included 228 caregivers. The implementation of the NYUCI in 

Minnesota was associated with improved outcomes in multiple key domains for caregivers of 

people with dementia that have critical clinical and public health implications. Consistent with the 

original study of the NYUCI, assessments showed decreased depression and distress among 

caregivers. Participating in a greater number of caregiver counseling sessions was also associated 

with longer time to nursing home placement for the person with dementia. Given the challenges 

faced in the community setting, web-based training for providers and video-conferencing for 

caregivers may be a cost-effective way to realize the maximum benefits of the intervention for 

vulnerable adults with dementia and their families. 8 

A recently completed randomized controlled trial in Israel was the first to confirm the effectiveness of 

the NYUCT in a non- English speaking country, especially its long-term effects in reducing depression. 

As a consequence of the study's positive results the NYUCI is now being implemented by many 

municipalities across Israel. 

The potential cost savings from keeping people with dementia out of expensive institutional care 

for a year and a half are substantial. A model of the economic impact of the NYUCI estimated that 

the state of Minnesota (with a population of only 5.5 million) could save as much as $996,000,000 

in direct healthcare costs in 15 years if all caregivers for those with dementia participated, solely 

due to lower rates of institutionalization.9 Potential direct cost savings to Medicaid were also 

substantia]..lO By improving the physical and emotional well-being of caregivers, the NYUCI 

undoubtedly achieves additional healthcare cost savings. 

3 
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27661b-4.eps

Not every health professional has access to telemedicine capabilities for training in providing 

the NYUCI, but some will and can transmit the information they receive to others. 

Furthermore, the content of the training can be put on DVDs, which could be distributed to 

those who do not have internet access. 

Many people in developing countries are poor, and many of them work at home, which makes 

it difficult to provide care for a person with Alzheimer's disease at home. Others leave the 

person with dementia alone at home in order to go to work There are very few, if any, 

institutions to provide patient care outside the home. A program of training for home care 

workers could be developed in tandem with training of professionals to provide the NYUCI. 

Thus paid help (which could be other relatives) could supplement the efforts of the primary 

caregiver. This could provide jobs as well as help to meet caregjvers' needs. 

Traditional healers provide ongoing health care in many in rural areas using "home remedies," 

and are respected by their clients. Unless they are made part of the process of disseminating 

and providing the intervention, they may interfere and oppose new treatment strategies such 

as the NYUCI. They should be given the opportunity to learn about dementia and its effects on 

caregivers, and about the potential effectiveness of interventions like the NYUCI. Perhaps they 

should also be trained to provide the intervention. Traditional healers in Africa have a 

continental association that could be worked with on this. 

International availability of the NYUCI will have a global impact on the cost and care of people 

affected by Alzheimer's disease, helping families with the proven benefits of counseling and 

support. We have developed and tested an online NYUCI training and certification program for 

professionals that can be translated into any language. The online training in providing the NYUCI 

in person and via video teleconferencing can further be embedded, in whole or in part, in 

educational courses to make this effective psychosocial intervention culturally relevant, scalable 

and widely available. The NYUCI has been implemented by mental health providers such as social 

workers, nurses and psychologists. We recognize the importance of the context of caregiving, 

health care policy and service delivery and therefore would want to partner with stakeholders in 

developing a linguistically and culturally specific training program based upon local needs. Our 30 

years of experience in providing, studying and creating training materials for the NYUCI has given 

us unique expertise in how to operationalize its essential core concepts and yet remain flexible to 

specific culturally appropriate realities in each setting. 

1. Oren tea P, Clay 0]. Roth DL, Mittelman MS. Predictors of improvement in social support: 

Five-year effects of a structured intervention for caregivers of spouses with Alzheimer's 

disease. Soc Sci Med. 2006Aug;63(4):957-67. PMID: 16616406 

2. Mittelman MS, Roth DL, Coon OW and Haley WE. Sustained benefit of supportive 

intervention for depressive symptoms in Alzheimer's caregivers. Am j Psychiatry. 2004 

May:161(5):850-6.PMID: 15121650. 

3. Mittelman MS, Roth DL, Haley WE & Zarit, SH. Effects of a caregiver intervention on 

negative caregiver appraisals of behavior problems in patients with Alzheimer's disease: 

4 
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Results of a randomized trial. j Gerontol B Psycho! Sci Soc Sci. 2004 jan;59(1):P27-34.PMID: 

14722336. 

4. Mittelman MS. Roth DL. Clay OJ, Haley WE. Preserving health of Alzheimer's caregivers: 

Impact of a spouse caregiver intervention. American journal of Geriatric Psychiatry 2007, 

15,780-789. PMlD: 17804831. 

5. Mittelman MS, Haley WE, Clay, 0, Roth, DL. Improving caregiver well-being delays nursing 

home placement of patients with Alzheimer disease. Neurology 2006, 67(9): 1592-1599. 

PMlD: 17101889. 

6. Roth DR, Mittelman MS, Clay OJ, Madan A & Haley, WE. Changes in social support as 

mediators of the impact of a psychosocial intervention for spouse caregivers of persons 

with Alzheimer's disease. Psychology and Aging 2005, Dec:20( 4), 634-644. PMID: 

16420138. 

7. Mittelman MS, Brodaty H, Wallen AS & Burns A. A 3 Country Randomized Controlled Trial 

of a Psychosociallntervention for Caregivers Combined with Pharmacological Treatment 

for Patients with Alzheimer's Disease: Effects on Caregiver Depression. Am J Geriatr 

Psychiatry. 2008 Nov;16(11):893-904. NIHMSID:NIHMS113830. PMCID: PMC2753499. 

8. Mittelman MS and Bartels Sf. Translating research into practice: Case study of a community-based 

dementia caregiver intervention. Health Affairs 2014 Apr: 587-595. PMID: 24711319 

9. Long KH, Moriarty JP, Mittelman MS and Foldes SS. Potential Cost Savings with the NYU 

Caregiver Intervention in Minnesota. Health Affairs 2014 Apr: 596-604. PMID: 24711320. 

10. Foldes, SS, Moriarty JP, Farseth PH, Mittelman MS & Long KH. Medicaid Savings From The 

New York University Caregiver Intervention for Families with Dementia: Gerontologist, 

2017, Vol. 00, No. 00, 1-10, doi:10.1093jgerontjgnx077. 

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Mr. SMITH. Thank you, Dr. Mittelman. That is so encouraging, 

and thank you for your leadership and for providing this subcommittee with those insights. 

I would like to put that article, if you would. We could find it and 

make it a part of the record because that would——

Ms. MITTELMAN. The Health Affairs article? 

Mr. SMITH. Yes. 

Ms. MITTELMAN. Okay. Yes, I have the list—there is a list in my 

testimony of all the articles but I am happy to send it to you. 

Mr. SMITH. Great. Thank you. We will look it up and download 

it and put it in. Thank you. 

Dr. Mohs. 

STATEMENT OF RICHARD MOHS, PH.D., CHIEF SCIENTIFIC 

OFFICER, GLOBAL ALZHEIMER’S PLATFORM FOUNDATION 

Mr. MOHS. Thank you, Chairman Smith. Thank you for inviting 

me. It’s a real pleasure especially to follow Dr. Mittelman. 

Most of my career has been devoted to trying to develop new 

medicines for Alzheimer’s disease and I wish I could report that we 

had been more successful up to now. 

But I can tell you what we’ve been trying to do and give you 

some thoughts about how we could maybe make that happen faster. But medicine alone is not the answer and so the programs that 

Dr. Mittelman and people like her are developing are going to be 

an integral part of the management program for dementia forever, 

essentially. 

So the Global Alzheimer’s Platform Foundation for which I now 

work is a not for profit organization, was founded by patient advocates to help speed the completion of high-quality clinical trials of 

potential new therapies for treating and preventing Alzheimer’s 

disease. 

It is the belief of GAP’s founders, primarily George and Trish 

Vradenburg, along with John Dwyer, that only through rapid and 

rigorous testing of potential new treatments we will be—will we be 

able to make progress in alleviating the suffering caused by Alzheimer’s disease. 

The foundation has worked with academic investigators, government agencies, pharmaceutical companies, and other organizations 

similar to GAP outside the United States to develop networks of 

clinical trial sites that conduct—that can conduct studies quickly 

and with high quality. 

GAP has found eager partners for our efforts in the European 

Union where there is something called the EPAD Network for the 

European Prodromal Alzheimer’s Disease network, and Japan has 

a JPAD network, Australia has an APAD network, and we have 

partnerships developing in other regions around the globe. 

Before joining GAP, I was for 14 years, as was mentioned, at Eli 

Lilly and Company where I was responsible for clinical testing of 

several potential new medicines for Alzheimer’s disease including 

two that reach large global late phase studies. 

Before Lilly, of course, I had an academic career in New York at 

Mount Sinai School of Medicine where we also did smaller scale 

studies. 

36

Both of the compounds at Lilly that reached late phase testing 

were very promising scientifically. They actually did address some 

aspects of what is called the amyloid cascade hypothesis. But neither showed sufficient efficacy to enable registration as actual 

medicines for prescription. 

The four-phase three trials that we did—there is usually two 

phase three trials for each new potential medicine—included a 

total of 4,694 patients with mild to moderate Alzheimer’s disease 

and these were conducted in 31 countries simultaneously. 

Approximately 40 percent of those seen were seen at clinical sites 

in North America, 21 percent at sites in western Europe, 10 percent at sites in Japan, 9 percent at sites in Mexico and South 

America, 8 percent at sites in eastern Europe including Russia, 7 

percent at Asian countries outside of Japan, and 5 percent in South 

Africa and Australia. 

From these experiences with GAP and Lilly and a lot of years 

trying to develop new medicines, I’d like to share the following observations about the global burden of disease and give you some 

thoughts about how I think the process of medicine development 

might be made a little better. 

First of all, in all the countries where GAP and Lilly have 

worked we found a high degree of interest in cooperation from clinicians, health authorities, regulators, patients, and families. 

It is not difficult if you go into any of these countries to find people who are concerned about Alzheimer’s disease and who are eager 

to contribute in some way to try and develop a treatment. It is just 

a matter of trying to show them what it is they can do. 

I would say that in spite of their limited efficacy, the currently 

approved medicines for Alzheimer’s disease are pretty widely used 

globally. 

We were, of course, testing our therapies as add-on to standard 

of care—standard of care, which in most countries did include the 

already approved medicines, even though they have limited efficacy, and what we found was that in North America, western Europe, and Japan over 90 percent of all the study patients that we 

found who had a diagnosis of Alzheimer’s disease were already receiving an AD medication. 

But in every country where we went it was over 70 percent. I 

don’t say that this is typical of everybody in that country because 

there are a lot of undiagnosed people. But they are available and 

they are used. 

It was interesting relative to Dr. Mittelman’s presentation that 

the primary care givers assisting patients with AD as they navigated through the clinical trials process varied by region. 

That is required because these people have some impairment 

that every study participant has to have a care giver or somebody 

who comes with them to participate in the study. 

In North America, western Europe, South Africa, Australia, and 

Japan, it was usually primary care givers were spouses—about 70 

percent in all those regions—while in the other regions—eastern 

Europe, other Asian countries, and Mexico/South America, the primarily care givers were much more likely to be adult children or 

some other neighbor or person involved with the patient. 

37

Now I move on to some issues and I think it’s clear from what 

we heard earlier from the first panel we have learned a lot about 

Alzheimer’s disease. There are a lot of opportunities, but this is a 

tough nut to crack, scientifically. 

I have spent 40 years at it and there are a lot of smart people 

out there working at it very hard every day. But it’s proved to be 

hard. So I’d like to just give you a couple observations about how 

the system I think could be a little bit better. 

I think developing drug candidate molecules for clinical testing 

based on new biological findings about AD could be faster. Basically, when you find some new bit of biology, the therapeutic implications are not always obvious and it takes somebody who knows 

about what a medicine has to look like to make that translation. 

I think policies that facilitate communication and collaboration of 

academic scientists with those in the biopharmaceutical industry 

could be helpful to enable more rapid discovery of high-quality clinical candidate molecules accompanied by the biomarkers and other 

kinds of technology that’s necessary to do clinical testing. 

If you just take the history of our drugs to date, the cholinergic 

deficiency in Alzheimer’s disease was found in 1976. 

The first cholinergic therapy was not approved until 20 years 

later and that was a well-known area of biology. What we know 

about A beta or amyloid, the structure of that protein was originally discovered in 1986. We still do not have an A beta-related 

therapy, although we have tried but it’s a tough nut. 

I think also the conduct of clinical trials could be faster. Streamlining processes of study review, contracting with sites, review by 

ethics committees, and site certification could reduce time to completing clinical testing. 

It is often a bureaucratic nightmare to get these studies up and 

running. Granted, this is a human endeavor that will always have 

some human elements in it. But I think some of these are partly 

manmade problems. 

Many current clinical trials are designed for patients who are not 

yet demented but have subtle clinical signs or biomarker evidence 

that they are at risk for AD. This is a lot of the current work that’s 

going on on either primary or secondary prevention. 

The problem is those people are not diagnosed in the current 

clinical care environment. We have heard that earlier. Such patients are not regularly identified in clinical practice and are very 

difficult to find for clinical trials. 

So if you go out to find them, the epidemiology tells me there is 

lots of them out there. We just can’t find them readily for trials, 

and I think that policies that would encourage early diagnosis of 

at-risk patients would speed the completion of trials as well as provide drug benefit to patients. 

So those are my observations. Thank you very much for your attention. 

[The prepared statement of Mr. Mohs follows:]

38


27661c-1.eps

Name: 

Title: 

Organization: 

Committee: 

Subcommittee: 

Date: 

Hearing: 

Richard C. Mobs, Ph.D. 

Chief Science Officer 

Global Alzheimer's Platform Foundation 

Committee on Foreign Affairs 

Africa, Global Health, Global Human Rights, and 

International Organizations 

November 29, 2017 

A Global Update on Alzheimer's Disease 

Thank you to the subcommittee for inviting me. I am Richard Mohs, Chief 

Science Officer for the Global Alzheimer's Platform (GAP) Foundation a not-forprofit organization founded by patient advocates to help speed the completion of 

high quality clinical trials of potential new therapies for treating and preventing 

Alzheimer's disease. It is the belief of our founders, primarily George and Trish 

Vradenburg along with John Dwyer that only thru rapid and rigorous testing of 

potential new treatments will we be able to make progress in alleviating the 

suffering caused by Alzheimer's disease. The foundation has worked with academic 

investigators, government agencies, pharmaceutical companies and, very 

importantly, other similar groups outside the United States, to develop networks of 

clinical trial sites that can conduct studies quickly and with high quality. GAP has 

found eager partners for our efforts in the European Union with its EPAD network, 

Japan with it's JPAD Network, Australia with APAD and we have partnerships 

developing in other regions of the globe. 

Before joining GAP I was, for 14 years, at Eli Lilly and Company where, for 5 

years I led the Global Alzheimer's Development team. In that role I was responsible 

for clinical testing of two potential new medicines for AD, semagacestat and 

solanezumab. While both compounds were very promising scientifically, neither 

showed sufficient efficacy in global phase 3 studies to enable registration. 

Conducting the trials, however, gave me considerable insight into the impact AD has 

around the globe and the ways patients, families, and health care systems cope with 

the epidemic. The four phase 3 clinical trials for these compounds included a total 

of 4,694 patients with mild to moderate Alzheimer's disease from 31 countries. Of 

the total approximately 40% were seen at clinical sites in North America, 21% at 

sites in Western Europe, 10% at sites in Japan, 9% at sites in Mexico and South 

America, 8% at sites in Eastern Europe including Russia, 7% in Asian countries 

outside of Japan, and 5% in South Africa and Australia. 

From these experiences with the GAP Foundation and Eli Lilly and Company I'd like 

to share the following observations about the global burden of this disease and the 

prospects for developing new treatments. 

1. In all of the countries and regions where GAP and Lilly have worked we have 

found a high degree of interest and cooperation from clinicians, health 

authorities, regulators, patients and families It was not difficult anywhere to 
39


27661c-2.eps

find people concerned about the disease and eager to work toward better 

treatments. 

2. The clinical presentation and care burden of patients is quite similar across 

geographies, countries and health systems. Memory problems, difficulty in 

communication and progressively greater need for assistance in activities of 

daily living are found in all patients regardless of country. 

3. In spite of their limited efficacy, the currently approved medicines for AD are 

widely used and are an integral part of medical management. The highest 

use is in North America, Western Europe and japan where over 90% of 

enrolled patients with AD were receiving one or more medications for AD, 

but over 70% of study patients with AD in every region were taking at least 

one AD medicine. 

4. The primary caregivers for patients with AD varied by region. Patients with 

AD enrolled in clinical trials are required to have a caregiver or study partner 

who knows them well and will assist in monitoring adherence to medication 

along with the patient's symptoms, daily functioning, and changes in health 

status. In North America, Western Europe, South Africa/ Australia and Japan 

approximately 70% of primary caregivers were spouses while in other 

regions primary caregivers were more likely to be adult children or other 

study partner. These differences may be relevant to the integration of 

behavior management plans with medication. 

5. There is a need to improve the efficiency of the drug discovery and 

development process. Novel ideas about how to treat and prevent AD are 

slow to get from basic science laboratories to clinical testing. Policies that 

facilitate communication and collaboration of academic scientists with those 

in the biopharmaceutical industry are necessary to enable rapid discovery of 

high quality clinical candidate molecules accompanied by biomarkers and 

other tools needed for clinical testing. 

6. The conduct of clinical trials could be faster. The process of starting clinical 

studies, identifying clinical trial sites and enrolling patients is slower that it 

needs to be if we are to test all of the promising compounds available. 

Streamlining processes of study review, contracting with sites, review by 

ethics committees and site certification could reduce time to complete 

clinical testing. 

7. There is a need for more global collaboration on the discovery, development 

and testing of potential new treatments for Alzheimer's disease. Active 

participation by US agencies with international groups such as the World 

Health Organization (WHO), Organization for Economic Cooperation and 

Development (OECD) and the World Development Council (WDC) is needed 

to insure faster development and more efficient use of resources globally to 

meet this global challenge. 

8. There is a growing discrepancy between the way patients with AD are 

diagnosed in ordinary clinical practice and the way they are enrolled in 

clinical trials. In clinical practice patients are usually diagnosed fairly late in 

disease when symptoms are unequivocal and cannot be ignored. Many 

clinical trials are now designed to test prevention therapies in patients who 
40


27661c-3.eps

are at high risk because of biomarkers but with few of no disease symptoms. 

Finding appropriate patients for these prevention studies is very difficult. 

9. To develop truly effective ways to treat, manage and delay the onset of AD 

will require many studies of potential medicines, behavioral interventions, 

patient assistance technologies and combination approaches. These studies 

should be done quickly, with rigorous methodology and with results 

communicated quickly to investigators, patients and clinicians so that we 

can, collectively develop and disseminate the best treatment approaches. 

Thank you very much for your attention. 
41

Mr. SMITH. Thank you so much for your testimony and, again, 

for your leadership as well. Thank you. 

Mr. Splaine. 

STATEMENT OF MR. MICHAEL SPLAINE, PRINCIPAL, SPLAINE 

CONSULTING 

Mr. SPLAINE. Good to see you. Thanks for the opportunity to appear before the subcommittee today. I’ve been working with people 

with Alzheimer’s and their families since 1986. 

Currently, I am a consultant and since 2011 our consultancy has 

served as the policy and advocacy advisor to Alzheimer’s Disease 

International. 

ADI is the global umbrella for over 90 national Alzheimer’s Associations including the U.S. Alzheimer’s Association. 

Of historical note—and I am a little bit of a historian because 

I’ve been around—this whole panel has been around—it is worth 

noting that the U.S. Alzheimer’s Association and ADI share common founders. 

In fact, 4 years after the Alzheimer’s Association was established 

by Jerome Stone and others, they established Alzheimer’s Disease 

International. So some sense of this being a global issue was there 

even in the very beginning in the early 1980s. 

Our current work with Alzheimer’s Disease International has put 

my associate, Kate Gordon, and myself in the middle of a burst of 

international energy and work streams that are moving on the 

issue of dementia and moving it closer to a public health priority 

that experts believe it needs to be. 

My plan with limited time is to hit the high points on what I 

think are key developments that have not been covered by other 

witnesses. 

The facts are stark, and in the introduction to the hearing, Mr. 

Smith kindly cited the facts that I have on record as well. 

One possible fact that was not cited by the chairman that might 

be of special interest to this subcommittee is the publication of a 

report on Alzheimer’s disease in sub-Saharan Africa that is less 

than 6 weeks old. It was published by ADI. 

It estimates that there are 2.13 million persons with dementia in 

that region, a number that is expected to roughly double every 20 

years. 

Sometimes there’s a belief that Alzheimer’s can’t and dementia 

issues can’t really be truly global. But with the publication of that 

report and the facts therein, I think that has been put to bed. 

Well, let me review some key global developments. First of all—

and there’s a graphic in my testimony that kind of tries to demonstrate this—dementia is increasingly understood to be a life 

course disease by policy makers, not merely a disease of older persons, not merely a condition of complete and utter disability, although the public perception that a person with Alzheimer’s disease must necessarily be older and quite disabled and the latter 

stages of the disease persists. 

This opportunity to diagnose early and having early stage persons involved in many facets of the work is putting a different face 

on what it means to live with dementia. 

42

Even further to the left in that curve that you have in your packet is a representation of what the Lancet Commission and others 

have recently found that there is action to be taken by public 

health authorities on modifiable risk factors for dementia. 

Keep in mind that population health personal results may vary. 

We are talking about the health of the entire population. But it’s 

pretty clear it can be summarized simply as what’s good for your 

heart is good for your brain—is actionable today by public health 

authorities and in fact there are many examples of that going on 

around the world. 

A second important trend or a second important global development is that we continue to have detection and diagnosis as a stubborn problem everywhere. 

Although cited earlier, let me just repeat what you cited earlier, 

which is that without diagnosis there can’t be treatment care and 

organized support or the opportunity to participate in research. 

I think some of our gap in research is the diagnostic gap and I 

think this gap should also be of interest to any health system as 

persons with impaired thinking and another chronic disease are expensive because thinking is important to navigating complex health 

decisions and treatment regimens that are only frequently seen in 

deep crisis. 

Third, I want to mention and in fact already mentioned before 

the committee that in the Americas in 2015, PAHO/OPS adopted 

a regional dementia action plan and in 2017 just a few months ago, 

the World Health Assembly adopted a global dementia aging plan. 

Taking a right spaced approach, these action plans call on and 

will provide technical support for national government plans and 

policies over the next 5 years to take advantage of our newer understandings of dementia and to plan nation by nation a response 

across the spectrum of the disease. 

I note that 30 countries have published national plans and nearly 100 subnational governments, States, or regional governments 

have taken action. 

But I will also note that in our view only one country has taken 

serious action on dementia without a strong civil society push. It 

is almost as if we have a three-legged stool where the advocacy as 

well as the knowledge of the issues and advocacy capacity are important to move forward. 

On rights, another subject of great interest to this committee, let 

me note that persons with Alzheimer’s disease are in some cases 

using the Convention on Rights of Persons with Disabilities as a 

platform for action on care and support. 

Dementia has been a special issue in the Organization for American States Regional Convention on the rights of older persons, now 

out for ratification, and in a regional declaration on older person’s 

rights by the African Union. 

Dementia and its consequences has also been a major topic in the 

ongoing work of the U.N. Open Ended Working Group on the rights 

of older persons. 

Last, and I’ll leave the rest to my written testimony, a broader 

community of interest in dementia as a social issue is emerging. 

It is taking many forms such as the organizing of nearly 20,000 

young professionals in Indonesia around the issue of Alzheimer’s 

43

who don’t have family experience, as well as issues being an agenda item at the World Economic Forum in Davos or this week at the 

Salzburg Global Seminar 

Also in the wake of the Japanese tsunamis we saw for the first 

time disaster authorities paying attention to the problem of Alzheimer’s disease. 

Multiple international organizations helped raise awareness during Alzheimer’s Awareness Month, and even Pope Francis made a 

major address on World Alzheimer’s Day last fall. 

It is fair to mention that myriad scientific meetings and cooperation are increasingly becoming the norm. The world’s largest scientific meeting on Alzheimer’s disease is hosted and will be hosted 

in our country by the Alzheimer’s Association in Chicago in July. 

It will be followed this year immediately by the Annual Conference of Alzheimer’s Disease International, truly a global gathering. 

As I was preparing this testimony, my last thought is faces come 

to mind—faces of families such as my sisters, my Aunt Lee, my 

Aunt Marilyn—all Alzheimer’s care givers—my mother-in-law, but 

also faces of people like Lucien and Lee Yu and even two women 

from Yemen who started an Alzheimer’s Association—its fate unknown at this moment—in Yemen. 

I also think about researchers in Poland, in the Czech Republic, 

all over eastern Europe that I’ve met and enjoyed their company. 

There truly is a global view in my head. 

I also can’t not mention that I am here today principally because 

131⁄2 years ago my brother gave me a kidney. So thank you again, 

Dan. 

I am done. 

[The prepared statement of Mr. Splaine follows:]

44


27661d-1.eps

Statement of Michael Splaine 

Owner and Principal, Splaine Consulting, Policy Advisor Alzheimer's Disease International 

COMMITTEE ON FOREIGN AFFAIRS 

Subcommittee on Africa, Global Health, Global Human Rights and International 

Organizations 

November 29, 2017 

"A Global Update on Alzheimer's Disease" 

Thank you for the opportunity to appear before the subcommittee today and otTer a global view 

update on dementia. I have been working with persons with Alzheimer's disease and related 

disorders and their families since 1986. Since 20 II our consultancy has served as policy and 

advocacy advisers to Alzheimer's Disease International (yvww alz.co.uk) the umbrella 

organization of over 90 national Alzheimer associations around the world, including the US 

Alzheimer's Association (www alz.onr). 

Tt is worth noting that the US Association and ADT share a common founder--the late Jerome 

Stone-thus there was some sense of dementia being more than a domestic issue was present in 

the early 1980's even as we saw initial organizing around the problem. 

Our work with ADI has put my associate Kate Gordon and I in the middle of a burst of 

international energy and work streams that are moving the issue of dementia closer to the public 

health priority experts believe it needs to be. My plan with my limited time today is first review 

a few key facts and then highlight on key developments that other witnesses have not covered. 

The facts are stark. Globally 47.5 million people live with some form of irreversible dementia, 

(hHps:f.!ww\V.alz.co.uk/research/world·report .. 20!5) a number that will grow to !30 million by 

2050 with most of the new cases and burden of disease falling on lower and middle income 

ountries. Global cost of AD is estimated at just above 1% of global GDP ($818 billion USD) 
45


27661d-2.eps

150 

~ 125 e: 

E "'

'0 "' 100 

:S 

-~ 

.!!! 

<:>. 75 0 

""' <:>. 

0 50 ~ 

~ 

~ 25 

0 

Number of people with dementia in low and middle inceme countries 

compared tll high inoome countries 

2015 2020 2025 21130 2035 2040 2045 2050 

Of possible special interest to this subcommittee has been the publication of a report on AD in 

Sub Saharan Africa (lmnBi\yww ,illz.coJ.J.kire~~;n:.;:b!.dem<;]nJj.>!:::.'i1!l2.:.&_a.hfin1Il::ill.tis;_£Ulii0 which 

estimates 2.13 million persons with dementia now live in the region, a number that is expected to 

roughly double every 20 years. 

Let me now review seven key global developments. 

1. Dementia is increasingly understood to be a life course disease by key policymakers, not merely a disease of older persons. Population aging is driving the numbers 

but slowly the general public perception of dementia that it must necessarily be an older 

person quite disabled in the latter stages of the disease is changing, as some persons 

diagnosed early in the disease have put a different face on what it means to live with 

dementia. Perceptions are also changing in countries rich in scientific resources we can 

image changes in the brain before symptoms develop, and anywhere in the world we can 

begin to use the tools of public health to reduce population risk of dementia in late life. 

True, awareness raising activities have a more complicated story to tell with a 30 year 

disease process to describe as illustrated below, and everywhere in the world there is 

constant messaging needed that dementia is not a normal part of aging, but the life course 

view is taking hold increasingly in policy circles. 
46


27661d-3.eps
47


27661d-4.eps

2. Detection and diagnosis are a stubborn problem everywhere. Research shows that 

most people currently living with dementia have not received a formal diagnosis. Tn high 

income countries, only 20-50% of dementia cases are recognized and documented in 

primary care. This 'treatment gap' is certainly much greater in low and middle income 

countries. Without a diagnosis, there can't be treatment, care and organized support or 

opportunity to volunteer for clinical research. This gap should be of interest to health 

systems as persons with impaired thinking and other chronic disease are expensive and 

have ditllcult lives navigating complex health decisions and treatment regimens and are 

frequently only seen in deep crisis. 

United States figures suggest that only about 50% get a formal diagnosis, and more 

troubling is the fact that as many as 30% or persons with a diagnosis in their medical 

record have not been informed of their diagnosis. 

3. In the Americas, in 2015 PAHO/OPS adopted a regional dementia action plan and 

in 2017 the World Health Assembly adopted a global dementia action plan. 

Taking a right based approach, these action plans call on and will provide technical 

support for national government plans and policies over the next 5 years to take 

advantage of this newer understanding of dementia and to plan response across the 

spectrum of disease. 

30 countries have published national plans, but I would note that only one country has 

taken serious action on dementia without a strong civil society push. (with its deeper and 

more personal knowledge of the issues and its advocacy capacity.) 

On rights let me note that persons with ADRD are in some cases using the Convention on 

Rights of Persons with Disabilities as a platform for action on care and support and that 

dementia has been a special issue in the OAS regional convention on the Rights of Older 

Persons (now out for ratification) a regional declaration on older persons rights by the 

African Union and a major topic in the ongoing work of the UN Open Ended Working 

Group on Aging and its special rapporteur. 

4. A broader community of interest in dementia as a social issue is emerging. 

This is taking many fonns, such as social media awareness raising and organizing by 

young students and workers in Indonesia, myriad dementia friendly community programs 

unique to place and culture or dementia being an agenda item at the World Economic 

Forum in Davos or as it is this week at the Salzburg Global Seminar. In the wake of the 

Japanese tsunamis, natural disaster authorities have begun better planning for persons 

with dementia in those circumstances. Multiple international NGO's help raise awareness 

during World Alzheimer's Month (bttps://www.woridaizmonth.onr) Even Pope Francis 

made a major address on World Alzheimer's Day! 
48


27661d-5.eps

5. Dementia is gaining recognition in the non-communicable disease movement 

Beginning with the UN Political Summit and Declaration on NCO's in 2011 through the 

present moment, dementia issues have been raised in two ways-from a public health 

perspective dealing with shared risk factors for NCO's in late life with brain health 

messaging integrated into a smoking cessation campaign and from the perspective of the 

challenges of self-managing chronic disease when one is seriously cognitively impaired. 

It is important to note that this is promising but that the community has yet to see the 

declaration intent on dementia implemented in NCO plans generally. 

6. (Some) political leadership has embraced action on dementia (some of the time). 

In December 2013 the G-8 (now G-7) held a major summit 

h ttps, :'/t,:ol"'',\TVv. fl.tlV, uk/fl:ovcnrn lent/ publ i catiOils/~:8-dementia-sum mit- agreement and then 

convened several follow on high level meetings and activities that set in motion action to 

increase commitments to government backed research funding and greater international 

cooperation on science and policy, including care policy. Of special note is the stimulus 

to the Organization for Economic Co-operation and Development (OECD) to consider 

what changes could be made to promote and accelerate discovery and research and the 

transformation of innovative and efficient care and services. The subsequent formation of 

a World Dementia Council htltJs:f/woriddementiacouncil.or~( which has been an 

advocate for innovative and global finance models, integrated drug development and the 

encouragement of open science collaborative research, including big data. 

7. Myriad strong scientific meetings and cooperation are now the norm. 

The world's largest scientific meeting on Alzheimer's is the Alzheimer's Association 

International Conference (htillJiilvi''0,~'.alz on::iaaici) to be held this July in Chicago, 

followed immediately by the annual conference of Alzheimer's Disease International 

(!llli2c'> ,'iwv;w.alz.co.JJ.k/AQl·cof!ferencP,j Dozens of smaller regional and specialty 

meetings are harnessing scientific interest, opening new theories of the disease and 

supporting thousands of active scientists, especially younger professionals. 
49

Mr. SMITH. Mr. Splaine, thank you very much. Thank you to 

your brother. 

Let me just ask a couple of questions. Again, you are leaders. 

You have made all the difference in the world and I think your 

point, Mr. Splaine, about the importance of advocacy, when people 

have a message that is well-founded and they back it up with empirical data it gets action on Capitol Hill. 

As dysfunctional as people think Congress is these days, we are 

getting some very important things done, and I mentioned earlier 

a tripling of the NIH funding for Alzheimer’s and I do believe we 

will get to there with the 2018 HHS appropriations bill. 

It is no small achievement. I introduced the Ronald Reagan 

Breakthrough Act for years and working alongside of you and others, and we couldn’t get even a markup, and now we are at the 

point where the money is actually flowing and we are talking about 

a tripling—I should underscore a tripling—since 2015. 

So that burst that you talked about needs to become a sustainable surge for the sake of the patients, the families, the care givers 

and so thank you for your advocacy, all three of you, and others 

who have been instrumental in making all the difference. 

I think we don’t focus enough on how health systems could implode over the next 30 years or so. I mean, care givers deflect a lot 

of those costs that would be borne, and Dr. Mittelman, you know 

better than anyone with your work so often it’s the spouse or it’s 

a daughter or a daughter-in-law that steps up to the plate to take 

care of the Alzheimer’s patient. 

I hope you are going to be able to answer this—whether or not 

the WHO new agenda item, the surge that they are making—the 

new seven point, which includes in its seven points providing support for care makers, those living with dementia care givers, and 

it’s one of their seven points. 

Hopefully, they are listening to you and the breakthrough and 

landmark work you’ve done so that they don’t have to reinvent the 

wheel. 

So—yes, please. Could you put on your mic, too? 

Ms. MITTELMAN. I neglected to mention earlier that because we 

were so successful in these randomized control trials of which there 

had been more than one, we were being asked to provide training 

for providers, mostly social workers but also nurses and people in 

allied professions, and we were going all around the world to provide this training, as far as Israel, France, Australia. 

Sometimes it was fun but eventually it got to be too much so we 

got a grant from the NIH to develop online training. So now people 

can receive training on how to provide the intervention online 

when they wish. 

Only in English and in Australian at the moment but—American 

English and Australian—but easily—one could easily imagine how 

this training, which includes videos of both role plays and real 

cases of family care givers being given the counseling, could be incredibly valuable, even if people didn’t do the actual NYU care 

giver intervention as we developed it, to have the training and to 

understand how to work with families to help them to support the 

primary care giver. 

50

Mr. SMITH. How hard is it to access? I mean, can you give the 

web address or——

Ms. MITTELMAN. Well, at the moment it has a cost because it was 

developed with an SBIR grant. 

Mr. SMITH. Okay. 

Ms. MITTELMAN. But it is available and I’d be delighted to talk 

to you about it more online or offline. But in addition to that, we 

encountered another issue that we thought was worth developing 

a solution for, which is the that very often families are dispersed 

and there could be a primary care giver in Miami, Florida and the 

daughter in New York and the daughter can’t participate—couldn’t 

participate in personal counseling or—and felt left out of the care. 

So we developed video—a video conferencing version of our intervention, which we are doing a randomized control trial of right 

now. 

But I think of that as a potential for people who live in other—

who have family members who live in other countries. Perhaps the 

adult child is living in New York and the parents are living in 

China or wherever. 

One could use video conferencing potentially in countries 

where—and for people who have access to the internet to bring 

families together and to provide them and the primary care giver 

with the kind of support that they need. So——

Mr. SMITH. Is WHO accessing your work? 

Ms. MITTELMAN. Not that I know of but, I mean——

Mr. SPLAINE. Well, that—I know a little bit about that work 

stream at WHO and I think they are not just looking at made in 

America programs. I mean, they are the global health organization 

and there are many to the level that we accept in the United 

States—random clinical trial, peer-reviewed journal, evidencebased programs that were not invented in the United States. 

So I think the task of the very small staff working on dementia 

at the World Health Organization—did I say that clearly enough? 

Mr. SMITH. How small? 

Mr. SPLAINE. That—four, six. I mean, a place where this—where 

the United States Government could, frankly, make a real difference, with a couple of secundments of key people from the 

United States to either PAHO or to WHO, which is minuscule dollars compared to what kind of rich resources we have could make 

a huge difference. 

But they are compiling and evaluating and not reinventing the 

wheel. But the wheel goes both ways. One of the things we get 

asked all the time by ADI—representing ADI is can you help us 

access evidence-based Portuguese language, Spanish language programs that were—or Chinese language programs that were invented and validated in other cultures because that is who we are 

dealing with as America ages and changes demographically. 

So I think, you know, it’s bidirectional. It’s multi directional. I 

also think that this—you mentioned health system. 

Let me just say the population aging is global and it’s really an 

opportunity for, from a noncommunicable disease as well as an 

aging point of view, it may be a real opportunity for this committee 

to insist on or take its own top to bottom look at how we make investments as a government, as a people, in global health and 

51

take—start to factor in not just the disease by disease approach but 

really maybe this whole theme of noncommunicable diseases, going 

back again to my testimony about the linkages between risk factors 

between brain health and other health. It might be a real opportunity for the committee. 

Mr. SMITH. I appreciate that. And the idea of secunding U.S. personnel, that is a great idea. We will follow up with you on that one. 

Mr. SPLAINE. Thank you. 

Mr. SMITH. And please take a look again at our global brain initiative bill because the idea is that infectious diseases are 

horrifyingly prevalent in Africa. But, frankly, with Bush’s PEPFAR 

program, which is about $5 billion a year, mother to child transmission ARVs—the pandemic—certainly have been mitigated, and 

other diseases such as malaria are being attacked as they should 

be. But we leave out brain health, except for diplomacy at WHO 

and elsewhere. 

You mentioned African countries, $2.1 million—has the AU—the 

African Union—been responsive at all, as far as you know? 

Mr. SPLAINE. From a rights perspective, the African Union is one 

of only two regions in the world that actually has an explicit rights 

policy for older persons and Alzheimer’s has been part of that story 

because, unfortunately, in some pockets in Africa, people with Alzheimer’s disease are perceived as witches, demonic, and governments like the Government of Ghana literally have disrupted these 

witch camps that were developed as a way of stashing people who 

are, clearly disabled from severe cognitive issues from Alzheimer’s 

disease or other dementia. 

So I think that there is some visibility. You know, they’ve got a 

lot on their plate. But I think population aging is becoming better 

known. 

There have been two regional meetings inside of a year of people 

interested in doing more about Alzheimer’s disease on the African 

continent that have included African Union representatives. 

There is also country by country but also as a region—I hesitate 

to say but I think it’s one of the most active regions in organizing 

around noncommunicable diseases by the Noncommunicable Disease Alliance and other interested parties because that is becoming 

part of the reality of health in the region as well. 

Mr. SMITH. Just two final questions. Let me ask, do you believe 

that we are on track to, by 2525, get a disease-modifying treatment 

or maybe even a cure? 

Are other countries like Japan and China, the U.K., coming forward with sufficient moneys? Particularly on the research side to 

have that critical mass Manhattan Project type of focus? 

Mr. MOHS. There is no doubt that in the countries that have a 

large number of older people, particularly Japan and certainly 

China and western Europe, you’ll find a lot of money being devoted 

to Alzheimer’s research. 

So I don’t think that that is the issue. I think there is a certain 

amount of discouragement that comes with lack of more tangible 

success. 

But it would help if we have these existing international organizations like WHO and OECD and so forth actually make this a priority because it gives some credibility to these national organizaVerDate 0ct 09 2002 12:14 Jan 09, 2018 Jkt 000000 PO 00000 Frm 00055 Fmt 6633 Sfmt 6633 F:\WORK\_AGH\112917\27661 SHIRL
52

tions that are trying to do something about this to go ahead with 

international cooperation and the perception that this is really a 

high priority globally. 

Ms. MITTELMAN. Can I make a comment? 

Mr. SMITH. Yes, please. 

Ms. MITTELMAN. Well, I think that when there are—when we are 

trying to find people to participate in clinical trials of new drugs, 

if we have psycho social interventions as well as we did in the 

three-country study, there may be more—these trials may seem 

more attractive to participants. 

Mr. MOHS. I think that is quite true, and it’s interesting that for 

a brain disease to not more fully recognize the interplay between 

psycho social and medical interventions is a little odd. 

I mean, it’s hard for me to imagine in cardiology that they would 

think that medicine without exercise and weight control is going to 

solve the problem. 

But we just have to get an understanding that all these things 

have to work together and I think from a patient acceptability 

standpoint the psycho social interventions are much more tangible 

and immediate and provide a more immediate benefit for people 

who participate in these trials. 

Mr. SMITH. And just the final question—I do have others that I 

would like to submit to you—the issue of brain imaging that we 

discussed in panel number one, you say there is a viable diagnostic 

tool, going forward, particularly for early onset? 

Mr. MOHS. Well, we were involved in the development of some 

of those early amyloid imaging technologies when I was back in the 

pharmaceutical industry and I think it has an assisted a lot in getting more biologically uniform people entering into clinical trials. 

Its role in ordinary clinical practice in the absence of directly related therapies is much more limited. But there has been discussions about that. 

But it’s, clearly, a great advance to have a brain disease where 

you can actually see the pathology in life. That’s something we 

have almost never had for any brain disease in the past. 

Mr. SMITH. Mr. Garrett. 

Mr. GARRETT. Thank you, Chairman Smith, and thank you, 

members of the panel. And my apologies—I was in another committee and we got here as quickly as I could. 

I did not imagine that I would have the opportunity in the Foreign Affairs Committee to discuss Alzheimer’s and so I am delighted that that opportunity has presented itself and I thank the 

chairman again. 

Now, having said that, I will tell you that you probably didn’t 

imagine the direction that I am about to go here. I think it’s fair 

to say that a rising tide lifts all ships. I know that is a cliche and 

I would ask rhetorically, because I don’t want to waste your time, 

whether or not we do medical research well here in the United 

States. 

I think the answer is yes. Relative to the world, we do a pretty 

good job, right? 

But the next rhetorical question would be, would the designation 

of a particular item as a Schedule One controlled substance stymie 

the ability of entities whether government or private to research 

53

said Schedule One controlled substance as it related to medical 

uses. 

And I think the answer—and if anybody disagrees with me you 

are welcome to—you are welcome to chime in. You can interrupt. 

But I think the answer has to be yes. 

And so, obviously, some of you are probably miles ahead of me 

because I am a lawyer, not a doctor, which means you all are 

smarter. 

But as I look through a list of medications derived from plants, 

I find medications that help with blood pressure, with malaria, 

with pain, with dysentery, anti-tumor agents, diuretics, antifungal, sedatives, anesthetics, muscle relaxants—watch me mispronounce—cholinesterase inhibitors, right. I mean, and when you 

look up medical plants you’ll find a list that is literally in the hundreds. 

So the question that I have for members of the panel is—and I 

am not arguing in the favor of any panacea or any overarching 

wonderful solution—but might we be well served to review in the 

United States our scheduling of cannabinoids, whether it’s CBD 

oils extracted from hemp, to allow the research to be done? 

Because as I look for studies that relate to CBD oil and Alzheimer’s specifically I find a lot of them and they all come from the 

Netherlands and Australia and Great Britain, et cetera, and we 

have essentially tied our own hands behind our back with what I 

would argue is an archaic legal structure that denies the opportunity to find potential cures or at least aiding elements by virtue 

of the stigmatization of a particular plant. 

So the question is, could we further potentially better outcomes 

and at least addressing symptoms if we were to free the circumstances that currently stymie the private sector and even public moneys from being used to research cannabinoids? 

Mr. MOHS. I don’t know that I can give you a complete answer 

to that questions. Couple of comments, though. You’re quite correct 

that many current medicines are—were originally discovered as extracts from the natural world—from plants or someplace else—and 

that has been the case throughout the history of the development 

of medicines. 

My own view, and I just speak from a couple of companies that 

I’ve worked with, yes, it would be a—certainly a consideration if 

a—if you were talking about trying to develop a scheduled substance as a new medicine. That means you got to do other studies, 

allowed use liability and potential harm. 

But, you know, we used to have a saying—no side effect, no drug. 

So usually medicines have some unwanted effects along with the 

desired effects and the important part about any medicine development program is that you fully understand both of those so that 

in the end if the judgement is that their benefits outweigh the risks 

that at least that can be approved with an appropriate labeling of 

all the benefits and the risks and it’s the nature of a development 

program that it should investigate both of those things. 

But if your point is that it would be a—weigh kind of negatively 

on a company thinking about developing something where you have 

this whole other side path of trying to mitigate the risk, I think the 

answer is probably yes. 

54

Mr. GARRETT. And there is an inherent cost, right, to that legal 

sort of——

Mr. MOHS. Sure. There is a cost—more studies, more time, more 

potential that you are going to find something. I mean, you don’t 

want to start out with a—with a potential new medicine where you 

know right off the bat that it’s got down sides. I mean, that is——

Mr. GARRETT. And there is no arguing, certainly, that there are 

down sides. But I think if I am correct—and, again, I am going to 

let each one of the members of the panel speak to this—that CBD 

oil, particularly hemp extracted, you don’t get high. I mean, it’s not 

even a side effect as it’s administered therapeutically, right? I 

mean, that is——

Mr. MOHS. I think there are cannabinoid derivatives that actually do not make you high. That’s correct. 

Mr. GARRETT. Yes, sir. And certainly there are some that you 

could—that you could, right? I mean, I am not trying to tell one 

side of the story. 

But anyway, I’ll open the floor to either of you fine folks to just 

comment on whether or not it might be easier and cheaper and 

more cost effective to study potential positives if the scheduling regime in the United States were relaxed to allow more efficient and 

cheaper and more ready studying. 

Ms. MITTELMAN. Oh, I actually think that one of the benefits of 

psycho social interventions is that they have absolutely no negative 

side effects. So I would go in the other direction. 

If I were going to try to do things that were unusual I would try 

to figure out what nonpharmacologic interventions could have 

major impact. 

For example, to go back to the chorus that we founded, nobody 

believed when I started it that people with dementia could learn 

new songs, and they are learning new songs. 

So this is a medicine that has no potential side effects. In fact, 

we did a video of the original chorus and one of the caregivers said, 

‘‘Forget about pills. Just give me this.’’

Now, imagine if singing could have a major impact on learning 

new songs—could have a major impact on neurologic function and 

we don’t think about those kinds of interventions. 

Mr. GARRETT. No, I think what you are saying is brilliant and 

I appreciate it. But I am an all-of-the-above kind of guy, and what 

might work well for one individual or entity might not work as well 

for another. 

But what you are doing is commendable and I admire you. I simply submit that because one things works doesn’t mean another 

doesn’t and I believe we have a regulatory scheme here that is draconian at best and——

Ms. MITTELMAN. I agree with you on that, but I think that what 

you are talking about is thinking out of the box. 

Mr. GARRETT. Yes, ma’am. No, again, we are not arguing. We are 

agreeing. 

Mr. Splaine, am I pronouncing it correctly? 

Mr. SPLAINE. Well, I am not a doctor. Don’t play one on television. So a couple of thoughts. 

55

I wonder whether it’s—you know, is it Schedule One or are there 

other things that prevent this kind of imaginative thinking about 

experimenting with these substances. 

So a couple of thoughts on that. One is we do have a pretty 

strong not invented here ethos in the scientific community and I 

think that is made a little bit more challenged because there is a 

prevailing theory of Alzheimer’s disease in the United States and 

in the United States science establishment that although respected 

in other countries they are investigating along different lines. 

For example, Mr. Smith, I don’t want to correct you except I 

will—I would add the Republic of Korea to your list of very engaged countries about Alzheimer’s also from a research point of 

view. 

Their drug mechanisms of action—remember, Alzheimer’s has 

three parts. It has plaques, tangles, and inflammation. They are almost completely zeroed in on inflammation and it’s something that 

is almost completely not ignored but it’s not a mainstream in the 

United States. 

It’s attacking the amyloid. So I think that is just something to 

think about is the prevailing theory keeping this out of consideration rather than Schedule One. 

Last, our language about Alzheimer’s treatments is most unfortunate in that somewhere in the 1980s we started talking about 

disease-modifying drugs and mere symptomatic treatments and we 

have minimized social interventions. 

We have minimized the drugs we have by calling them mere 

symptomatic treatments. I would submit what is insulin? A mere 

symptomatic treatment? Yes, but it also—I mean, what do people 

want when they live with a disease? 

I can tell you first hand as somebody who has lived with disease, 

we want treatments that allow us to get on with our lives. 

So I think sometimes the language and holding out for—this is 

why I get really uncomfortable about will we have a cure by 2025. 

We have this language we have developed in Alzheimer’s about 

symptomatic treatment versus disease-modifying treatment and I 

think that too is a barrier to people thinking outside the box. 

Mr. GARRETT. So let me——

Mr. SPLAINE. So I think it’s those other things that are going on 

in the Alzheimer’s scientific thinking, not so much that it’s a 

Schedule One problem. 

Mr. GARRETT. Well, let me—let me—at the indulgence of the 

chair very quickly—submit that while we search for a cure in the 

interim we should also be searching for treatments, right? That it’s 

an all-of-the-above, not a—not a one or the other. 

And so while we hope one day to move away from fossil fuels, 

in the interim we are burning oil as we develop wind and solar, 

right. I mean, it’s getting from point A to point B. 

But let me ask you this, and I am leading intentionally because 

I can here—would you not agree that Schedule One designation inhibits research and makes that more tedious and costly for those 

who might be interested in engaging in it? I was actually——

Mr. MOHS. I can’t——

Mr. GARRETT. I was actually addressing that——

56

Mr. MOHS [continuing]. I have never had—I have never had any 

clinical candidate that I was responsible for impeded in its development by scheduling. 

That doesn’t mean somebody else might have and, honestly, in 

my time in the pharmaceutical industry most of our interactions 

with FDA were actually quite helpful. They were leaning forward. 

Now, there may be some areas that I didn’t get into where there 

is some adjustments that need to be made. But I will tell you, they 

were—they were actually quite forward thinking in their treatment 

about approval processes for Alzheimer’s disease. 

I think they knew quite well that it was a very bad disease and 

were willing to work with any sponsor that came to them with any 

reasonable proposal about how to develop a treatment. 

Mr. GARRETT. But if you want to work with willow bark you don’t 

need to get Federal Government permission to get the precursor. 

If you want to work with quinine, you don’t need to write—I 

mean, anyway, thank you for being here and, again, I am not suggesting this is a panacea, just that we should get out of our own 

way, and thank you all for thinking outside the proverbial box. 

But, again, the tact to win this fight I think it’s an all of the 

above and open minds and look at what works and what doesn’t. 

So thank you, Mr. Chairman. 

Mr. SMITH. Thank you, Mr. Garrett. 

I’ll just conclude, and any comments you might want to make, 

any questions that went unasked please, if you could provide those 

answers or just speak to it. 

The idea of a goal that we developed with the NAPA bill and also 

with the G7 and the WHO Assembly, isn’t that it’s—it’s to sharpen 

the mind and to marshal resources, as you know. 

That’s why I’ve asked are we on the right path to either achieve 

it or come close? Even coming close will be an achievement. 

I do—Dr. Richard Mohs, you make the point that to develop truly 

effective ways to treat, manage, and delay the onset of Alzheimer’s 

disease will require many studies of potential medicines, behavioral 

interventions, patient assistive technologies, and the combination 

approaches. 

We are doing that, right? Or are we lagging in any of those 

areas? 

Mr. MOHS. We are—we are doing it. I think it could be—as I 

mentioned, I think it could be done a little faster. The scientific uncertainty is still great and so the only way to tackle that is to accumulate knowledge as fast as you can and that requires a lot of——

Mr. SMITH. Well, how many compounds are being tested as 

unique? 

Mr. MOHS. I think the last we checked there were about 30 

something in phase three and in the 60 range in phase two, and 

usually companies don’t report earlier than that because it’s so iffy 

back there that it’s hardly worth reporting. 

But there is a lot, and that doesn’t even take into account all the 

little labs and so forth around the world. But on problems like this 

you need a lot of ideas. 

You need a lot of studies to help resolve the uncertainty about 

those ideas and the communication from different laboratories to 

57

each other so that they don’t repeat and follow up on unpromising 

areas is very important. 

Mr. SMITH. I want to thank you again for your leadership and 

for being here today and helping to inform this subcommittee and, 

by extension, the U.S. Congress. 

And I thank you again. The hearing is adjourned. 

[Whereupon, at 4:16 p.m., the subcommittee was adjourned.] 

(59)

A P P E N D I X 

MATERIAL SUBMITTED FOR THE RECORD

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SUBCOMMITTEE HEARING NOTICE 

COMMITTEE ON FOREIGN AFFAIRS 

U.S. HOUSE OF REPRESENTATIVES 

WASHINGTON. DC 205I5-6128 

Subcommittee on Africa, Global Health, Global Human Rights, lmd International Organizations 

Christopher lL Smith (R-NJ), Chairman 

November 22.2017 

TO: MEMBERS OF THE COMMITTEE ON FOREIGN AFFAIRS 

You me respectfully requested to attend an OPEN hearing of the Connnittee on Foreign Affairs. to be held 

by the Subc01mnittee Africa. Global Healtll Global Hmmn Rights, and lntematiomu Organizations in Room 2172 

of the Rayburn House Office Building (and available live on the Cornrniltee website at 

http:/ lvnvw .f.Q!illgn8.J_:fujrs.hol!~_,_g_gy): 

DATE: 

TIME: 

SUBJECT: 

WITNESSES: 

Wednesdny. November 29, 2017 

2:00p.m. 

A Global Update on Alzheimer's Disease 

Panel I 

Marie Bemard. M.D. 

Deputy Director 

National lnstitnte on Aging 

Natioml.l Institntes of Health 

Roger Glass, M.D. 

Director 

Fogm1y Tntcm1tional Center 

National Institntes of Health 

Panel II 

Mary Mittelman, Dr.P.H. 

Research Professor 

Alzhcimcr1

s Disease and Related Dcmcntias Family Support Program 

Ne'v York University 

Richard Mohs. Ph.D. 

Chief Scientific Officer 

Global Alzheimer1

s Platform Fom1dation 

Mr. Michael Splaine 

Principal 

Splaine Consulting 

By Direction of the Chairman 

The Committee on Poreign.1j}Gh:~ seeks to make its facilities accessihle to pasons with disahilities. lfvou are i11need of special 

accommodations, please call 202 225-5021 at leastjOurhusiness days in advance of the event, whenel'er practicahle. Questions 

l1'1"fh 1·egard to special accommodations in general (including availahility of Committee materials in alternative formats and 

assistive listening devices) may he directed to the C'ommlftee. 
61

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COMMITTEE ON FOREIGN AFFAIRS 

MINUTES OF SUBCO.Mlv1Jl 'l'EE ON Africa, Gh,ba/1/ealtll, Globallfmmw Rig!dr>, rmd lntmmfioual Orgmti~Hfioi/S HEARTNG 

Day Wednesday llatc November 29, 2017 Room 2172 

Stao·ting Time 2:22pm Ending Time __ 1:16pm _ 

Recesses ~~ (__to __ ) (__to__) (__to __ ) L_ to. __)(__to __ ) (__to. _) 

Presiding Member(s) 

Smith 

Clleck all of tile following 111111 apply: 

Open Session 0 Ext"cutive ~sed) Session D Televi~ed U 

TITLE OF HEARING: 

A Global Update 011 Afzlreimer~' Disease 

SUBCOMMITTEE MEMBERS PRESENT: 

Smith, lJera, DollOI'ml, Garrett 

Electronically Rcconl!&(laped) 0 

Stenographi-c H.ecord lLJ 

NON-SUBCOMMITTEE MEMBERS PRESENT: (Murk with WI *if they are no/members njjit!l committee.) 

HEARING \VITNESSES: Same as meeting notice attached'? Yes EJ No 0 

(Jf "noJJ, please list he low and include title, agency, department, or organization.) 

STATEMENTS FOR THE RECORD: (List any statements submitted for the record.) 

-Smith: Join/ Testimony of Alzheimer's Association a11<l Alzheimer'•· Impact Movement 

-Smith: Extermrl Validity nftlie New York UniJ•ersity Caregiver Interl'ention: Key Caregil'er Outcomes 

Across Multiple Demonstration Projects 

-Smith: The Minnesota Economic Model ofDementia:Demonstmting Healthcare Cost Sr11'ings with tile New 

Ym·k Univer.~·ity Caregb,er Support lnlen,eutinn 

~Smith: Estimnlilrg 11ze Potentitrl Cost Savingr /</·om The New York University Caregiver Intervention In 

Minnesota (Health Affairs) 

TIME SCHEDULED TO RECONVRNJC ___ _ 

or 

TIME ADJOURNED~~~--
62

MATERIAL SUBMITTED FOR THE RECORD BY THE HONORABLE CHRISTOPHER H. SMITH, 

A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY, AND CHAIRMAN, 

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND INTERNATIONAL ORGANIZATIONS


27661e-1.eps
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diagnosed, vYhile a study of India found nearly 90 percent remain unidentified. Individuals living \Yith 

dementia \Yho have not been diagnosed do not have access to treatment, care_ and organized support that 

getting a formal diagnosis can provide. 

\Vhile the statistics arc dire and the outlook may seem bleak, the crisis is forcing gO\.-cmmcnts around the 

world to take action. The G8 Summit on Dementia_ held in London in December 2013, as well as the 

constant work of AD! have set this progress in motion. In May of this year, the World Health Assembl; --

the voting body of the member countries of the World Health Organization (WHO)-- approved a global 

action plan on dementia. It lays out a comprehensive effort by the \VHO. \·vorking \\ith individual 

countries around the \vorld. to address the dementia crisis, especially the care and support needs of those 

living \\ith dementia and their families. Titis effort is of crucial importance in low- and moderate-income 

cmmtries, which \\ill see the greatest grm:vth in dementia cases by mid-century. Tite WHO is also in the 

process of creating a Global Dementia Observatory, so we have better data on the impact of dementia in 

individual countries and can better monitor global progress in addressing the crisis. 

During the 2013 GS Dementia Swnmit, the member cmmtries created what is now known as the World 

Dementia Council (WDC). TI1e President and CEO oftl1e Alzheimer's Association and the Alzheimer's 

Impact Movement (AIM), Harry Johns, is a member of the WDC and leads its Global Care Team. From 

the vvork of the Global Care Team, the WDC last spring released eight principles ofhigh-qualitv care and 

support to which governments around the world should stri\.-e for all those living \·Yith dementia and their 

care partners. 

Finally, it is worth noting that 0\.-cr tvw dozen nations nmY have national plans, thanks to a decade-long 

effort by AD! and Alzheimer's associations in individual countries throughout the world. AD! was also 

the driving force behind the adoption of the first regional plan on dementia by the Pan-American Health 

Organization (PAHO) in 2015. 

This is truly significant progress on a policy level But we are far from conquering this disease and far 

from providing the care and support needed. The work must continue, and support from govemments is 

kev. 

Global Research Efforts 

l11e Alzheimer's Association and Alzheimer1s Impact Movement (AIM) are committed to accelerating the 

global effort to eliminate Alzheimer1

s disease. No single organization can sunnount a challenge as great 

as Alzheimer's. To help achieve our vision of a \Vorld \Vithout Alzheimer1

s_ the Association partners \Vith 

ke:y government_ industry, and academic st..'lkeholders in the global race to end Alzheimer's. 

l11e Association fonnula for progress rests on four pillars: funding, increasing collaborations with 

investigators, sharing data, and overcoming baniers to progress. l11e first pillar is the Alzheimer"s 

Association International Grant Program. Tvpicallv 10 to 15 percent of our grant funds arc expended 

outside the US. Currently, we fimd active grants in 18 countries, and have fimded research in 28 overall. 

V.lc fund across the total spcctmm of Alzheimer's research from molecular biology to medical systems 

investigation. Our funding is pccr-rcviC\Yed by a vast international network of volunteer scientists and 

quality-assured by our Medical and Scientific Advisory Council, a group of distinguished professionals 

who represent a range of dementia research, including bench research, clinical care, community health, 

and support services. In addition to funding research directly. we \vork to ensure the federal investment in 

Alzheimer's research is comparable \vith the public threat of the disease. 
64


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The second pillar of the Alzheimer's Association program is encouraging increased cooperation 

bet\Yeen scientists. The Association is responsible for the largest meeting of Alzheimer· s scientists 

every year. This year, the Alzheimer's Association International Conference (AAIC), attracted over 

5,600 scientists in London to compare. reveal progress, and develop ne\v working collaborations to 

advance treatments for the disease. AAIC provides a platfonn for presentation and discussion of all 

aspects of Alzheimer1

s research from genetics to animal models, pathology. biomarkers. inten-entions. 

and social and behavioral issues. By encouraging the attendance of researchers from around the world, 

the Alzheimer1

s Association is able to bring ne\v innovations in Alzheimer1s research to a single 

thought forum designed to accelerate the understanding of Alzheimer1

s and related dementias. The 

Association is also the home of the International Society for the Advancement of Alzheimer· s 

Research and Treatment a collegial professional society that encourages focus groups for increased 

cooperation. 

The third pillar of our program is sharing ofinfonnation. We publish Alzheimer's & Dementia, the 

official joumal of the Alzheimer-s Association. This JOurnal allows important progress to be collected 

in one place to increase the efficiency of Alzheimer· s research. In 201 L the latest criteria defining 

Alzheimer's disease were published in Alzhe1mer 's & Dementw. We partnered closely with the 

National Institute on Aging (NIA) of the National Institutes of Health to develop the tlrst new criteria 

and guidelines to diagnose Alzheimer· s disease in 27 years. The new criteria and guidelines \Vere the 

result of a two-year effort bv three expert workgroups. Consisting of a total of more than 40 

Alzheimer's researchers and clinicians from around the globe, the workgroups began the in-depth 

process of revievving the original criteria and deciding hmv they might be imprm;cd by incorporating 

research ad\;anccs from the last three decades. These criteria arc nov;,· reshaping our approach to 

Alzheimer's treatment Currently_ tl1e NIA and the Alzheimer's Association are leading an effort to 

develop a new framework to define Alzheimer-s disease in the context of biomarkers to help 

accelerate research. This new research framework will be published in 2018. 

The fourth and final pillar of our program is selectively investing in projects to overcome common 

barriers in the field of Alzheimer's. ProJects include TriaiMatchn.r, World Wide Alzheimer" s Disease 

Neuroimaging Tnitiatiw (WW-ADNT)_ and the Global Biomarkers Standardization Consortium 

(GBSC) focused on cerebrospinal fluid (CSF) biomarkers of Alzheimer's disease. 

Tria!MatchTM is a confidentiaL free. and interactive tool that provides comprehensive clinical trial 

infonnation and an indh. idualized trial matching sen ice for people \\ ith Alzheimer1

s disease and 

related dementias. Recruiting and retaining trial participants is now the greatest obstacle. other than 

funding, to de\· eloping the next generation of Alzheimer1

s treatments. 

WW-ADNI, of which fue Alzheimer's Association is the administrative home, is a collaborative 

effort of scientists from around the \vorJd and is the umbrella organization forneuroimaging initiatives 

being carried out through fue North American ADNI, European ADNI (E-ADNI), Japan ADNI, 

Australian Imaging, Biomarker & Lifestyle Study of Ageing (AIBL)_ ArgentinaADNL lndiaADNI, 

China ADNl and h\O new initiatives in Brazil and Mexico. T11e Initiative Lmites leading international 

investigators in a common effort to: 

• Help predict and monitor the onset and progression of Alzheimer1s disease 

• Establish globally recognized st..1ndards to identify and diagnose Alzheimer1

s disease 

• Document cognitive changes linked to physical changes 
65


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• Share data across the international research community 

Ultimately. we aim to better understand the physical changes that occur in healthy individuals 

compared with individuals ,-...-ith mild cognitive impairment (MCT) and Alzheimer's disease. 

WW -ADNI focuses both on changes in the brain that can be identified with tools such as positron 

emission tomography (PET) and magnetic resonance imaging (MRI) and changes in fluids such as 

blood and CSF. As its name suggests, another area offocus is to involve individuals from multiple 

sites around the world and to follow their progress over se\·eral years to gain a \vorldwide picture of 

the physical changes that lead to Alzheimer's disease. 

Data !rom WW-ADNl are expected to play a key role in identif}'ing e!Iective treatments for 

Alzheimer's, as \Yell as methods that may prevent the disease or slmv its progression. Each 

WW-ADNT site collects participant data on physical changes related to the onset and progression of 

MCT and Alzheimer's (called biomarkers). WW-ADNT is unique in that most of the clinical, 

neuropsychologicaL imaging. and biological data gathered is quickly· made available to the scientific 

community at no cost so researchers can usc the information when designing or evaluating their own 

research. 

l11e Global Biomarkers Standardization Consortium (GBSC) is an international group consisting of 

academic. industry. and goycmment scientists vd1o arc brought together by the Alzheimer's Association 

to standardize the methods and materials used to measure key Alzheimer's biomarkers found in CSF. 

Several studies. including studies invohing data from the ADNI have shown that levels of biomarkers in 

CSF arc often accurate predictors of which individuals will go on to develop Alzheimer"s disease. CSF 

biomarkers ma: be useful not only in aiding early detection of Alzheimer's and improving diagnostic 

accuracy, but also in identifying and monitoring the effects of drugs in clinical trials, understanding the 

molecular changes that lead to Alzheimer's, and helping to ensure that individuals recruited into 

Alzheimer's clinical trials are on a path toward developing the disease. To date. the GBSC has produced 

tvw globally-recognized standard methods for the measurement of amyloid ~l-·-12 protein, a key 

Alzheimer's biomarker. in the CSF 

Changing the Trajectory of Alzheimer's 

Until recently, there was no federal government strategy to address this looming crisis In 2010, thanks to 

bipartisan support in Congress, the National Alzheimer's Project Act (NAPA) (PL. 111-375) passed 

unanimously, requiring the creation of an armuallv-updatcd strategic National Alzheimer's Plan (Plan) to 

help those with the disease and their families today and to change the tra1cctory of the disease for the 

future. The Plan is required to include an evaluation of all federally-funded efforts in Alzheimer" s 

research, care, and services-- along \vith their outcomes. NAPA allmvs Congress to assess \vhcthcr the 

nation is meeting the challenges of this disease for families, communities, and the economy. As mandated 

by NAPA, the Secretary of Health and Human Services. in collaboration with the Advisory Council on 

Alzheimer's Research, Care. and Services. released the first-ever National Plan to Address Alzheimer's 

Disease in 2012. The Advisory CounciL composed ofbotb federal members and expert non-federal 

members_ is an integral part of the planning process as it adTises the Secretary in evaluating and updating 

the annual Plan, makes recommendations to the Secret:'11}' and Congress, and assists in coordinating the 

\York of federal agencies involved in Alzheimer's research, care, and sen:ices. 

In addition to improving health outcomes for people living with Alzheimer's and to reducing the financial 

impact of Alzheimer's on families and our federally-funded programs, NAPA requires the Secretary of 

Health and Human Services to coordinate \Vith international bodies to integrate and inform the tight 

against Alzheimer's globally. TI1e specific dedication oftvvo ongoing strategies within the Plan to 
66

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international collaboration--one to coordinating research efforts and one to enhancing public a\Yareness 

and engagement--underscore its importance in creating a vYorld without Alzheimer· s. 

Having this Plan \Vith measurable outcomes is import.'lnt. But unless there arc resources to implement the 

Plan and the will to abide by i~ ,,-c cannot hope to make much progress. lf\YC arc going to succeed in the 

fight against Alzheimer· s. Congress must provide the resources the scientists need. A disease-modifying 

or pre\·enti\·e therapy \'VOtdd not only save millions of lives but would save billions of dollars in health 

care costs. Specifically, a treatment that delayed the onset of Alzheimer's by fhe years (a treatment 

similar to anti-cholesterol drugs). \\Ould reduce Medicare and Medicaid spending nearly in half in 2050. 

Today, despite the federal investment in Alzheimer's research. vve are only just beginning to understand 

what causes the disease. Americans are growing increasingly concerned that we still lack effective 

treatments that will slow. stop, or cure the disease. and that the pace of progress in developing 

breakthrough discoveries is much too slmv to significantly impact tl1is gro\Ying crisis. Scientists 

ftmdament..1.1ly believe that \Ve have the ideas. the technology. and the will to develop nev•i Alzheimer's 

interventions, but that progress depends on a prioritized scientific agenda and on the resources neceSSai) 

to carry out the scientific strategy for both discovery and translation for therapeutic development. 

Moving Forward 

It vvill take concerted and sustained action from vvorld leaders to tackle dementia. They must commit to 

meaningful, shared steps to drive forward dementia research, agree to a co11aborative global action plan, 

and make significant investment in dementia research to attract, de\--clop and retain the best scientists, 

clinicians, and care professionals. 

Research has transformed the lives of millions living with heart disease. stroke. HIV/AIDS. and cancer. 

Now is the time to make dementia a priority. Countries must commit to increased investment and 

improved coordination in research that vvill transfom1 the lives of people with dementia across the globe 

Thank :.ou again for holding this hearing about the global impact of Alzheimer's disease. The 

Alzheimer's Association and AIM commend the committee and look forward to continued \vork together 

to do all \'\.:e can to improve the lives of those \\ith Alzheimer's, as well as for those who care for them. 
67

MATERIAL SUBMITTED FOR THE RECORD BY THE HONORABLE CHRISTOPHER H. SMITH, 

A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY, AND CHAIRMAN, 

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND INTERNATIONAL ORGANIZATIONS


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2 journal of Applied Gerontology 00(0) 

Design and Methods: Data included baseline/preintervention (N = 294) 

and follow-up visits (approximately 4, 8, 12 months). Results: Linear mixed 

models showed that social support satisfaction increased (p < .05) and 

family conflict decreased (p < .05; Cohen's d = 0.49 and 0.35, respectively). 

Marginally significant findings emerged for quality of life increases (p = .05) 

and burden decreases (p < .I 0). Depressive symptoms remained stable. 

Slopes did not differ much by site. Implications: NYUCI demonstrated 

external validity in nonresearch settings across diverse caregiver samples. 

Keywords 

caregiving, dementia, intervention 

Care giving for family members with dementia can be rewarding (Carbonneau, 

Caron, & Desrosiers, 2010; Kramer, 1997) but is also associated with stress 

that affects caregivers' physical and mental health (Pearlin, Mullan, Semple, 

& Skaff, 1990; Pinquart & Sorensen, 2003). Meta-analyses of78 articles suggest that interventions are effective at improving caregiver outcomes such as 

burden, depressive symptoms, and overall life satisfaction, particularly if the 

interventions include both psychotherapeutic (i.e., counseling) and educational components (Sorensen, Pinquart, & Duberstein, 2002). Interventwns 

that reduce caregiver stress can affect caregiver physical health directly and/ 

or indirectly via these improved mental health processes (Basu, Hochhalter, 

& Stevens, 2015). Zarit and Femia (2008) discuss characteristics of successful interventions with examples drawn from specific interventions in the literature. Interventions that are multidimensional and target the heterogeneous 

goals and needs of caregivers, offer flexibility and adaptability to the curriculum or approach, pay attention to the dosage of the intervention, and match 

their research design to effectively document the desired outcomes are noted 

as particularly successful approaches. 

Between 2008 and 2013, the Administration on Aging (AoA) Supportive 

Services Program (ADSSP) provided funding to replicate empirically validated caregiver interventions, including the Savvy Caregiver (Hepburn, 

Lewis, Sherman, & Tornatore, 2003), REACH II (Elliott, Burgio, & Decoster, 

201 0; Nichols ct al., 2008), and the New York University Caregiver 

Intervention (N'YUCI; Mittelman, Epstein, & Pierzchala, 2003). Caregiver 

support services in California, Florida, Georgia, Minnesota, Utah, and 

Wisconsin were awarded funding to translate the NYUCI in their areas. 

Translation projects were awarded from independent applications, and 

although each site was required to empirically assess program effectiveness, 
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Fauth eta/. 3 

sites were not, a priori, required to participate in a coordinated cross-site 

research comparison. In a post hoc decision, however, three sites (Georgia, 

Utah, and Wisconsin) agreed to pool data for the purposes of (a) assessing 

collective changes over time and (b) comparing outcomes across sites. 

The current article provides a unique opportunity to describe how an intervention program that was originally embedded within a structured randomized control trial in an urban setting (the original NYUCI) translates to 

multiple real-world settings, where there is more "noise" (variability) introduced both within and between sites. When state or regional service providers across the United States (e.g., Divisions of Aging Services, Area Agencies 

on Aging) seek to implement empirically validated programs, they will need 

to be aware ofresults from highly controlled studies with h1gh levels of internal validity (as is presented below, from the original NYUCI). They should 

also be aware, however, of program outcomes from settings that might be 

more similar to their own, for example, when the target population of caregivers is rural, include nonspouses, or vary in ethnicity from the original 

NYUCI. Describing outcomes from these pooled data across participating 

demonstration projects addresses external validity of NYUCI. 

The NYUCI Program: Description ofthe Program 

and Prior Research 

The NYUCI began in 1987 and enrolled 406 participants over a 1 0-year time 

frame with high retention rates. The study involved only spousal caregivers 

of persons with dementia living in the New York City metropolitan area. 

Participants were randomly assigned to the NYUCI treatment group or to a 

usual-care control group (who received advice, infonnation about resources, 

and support services as needed). Details of the l\.TYUCI protocol are published (Mittelman et 2003 ), with a brief overview of the research design 

and intervention included here. 

The program includes 1dentical assessment of caregivers preintervention 

(baseline) and at 4, 8, 12 months follow-up (and for the original study, every 

6 months thereafter, continuing after nursing home placement and up until2 

years after the death of the person with dementia). The assessment battery 

includes demographic characteristics, physical health of the caregiver and 

care recipient, sources of caregiver assistance, behavioral symptoms and 

dementia severity of the care recipient, caregiver burden, depressive symptoms, family conflict, satisfaction with social support, and quality of life 

(QoL). These interviews are conducted face to face by trained NYUCI interventionists/counselors, and they inform both program evaluation and caregiver needs. 
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4 Journal of Applied Gerontology 00(0) 

Over 4 to 6 months with the same counselor, caregivers receive one individual counseling session, followed by four family counseling sessions (caregivers choose who 1 t is that they invite), and one final individual session. 

Sessions occur in caregivers' homes or at counselors' service delivery centers 

based on the preference of the caregiver. In the first individual session, the 

caregiver and counselor discuss expectations, the importance of including 

family members in support of the caregiver and person with dementia, decide 

on family members to be invited to participate, and review the intervention 

timeline. During family sessions, the caregivers and their family members 

discuss the impact of the disease and the experiences of care giving, and the 

family focuses on building a support network for the caregiver and care 

receiver. In the final individual session, the counselor and caregiver review 

the family sessions and focus on integrating the experiences into a plan for 

the future. Caregivers are encouraged to join a support group after the first 

follow-up evaluation and receive ad hoc counseling as needed, generally via 

telephone calls to their assigned counselor if they have specific questions or 

concerns. Follow-up evaluations provide opportunities to assess change and 

have further counseling. 

Randomized control trials of the original NYUCI identified that the intervention was associated with (a) improved caregiver satisfaction with social 

support (Drentea, Clay, Roth, & Mittelman, 2006; Roth, Mittelman, Clay, 

Madan, & Haley, 2005), (b) reduced depressive symptoms (Mittelman et al., 

1995; Mittelman, Roth, Coon, & Haley, 2004) both before and after institutionalization (Gaugler, Roth, Haley, & Mittelman, 2008), and (c) decreased 

distress ratings of behavioral symptoms of the person with dementia 

(Mittelman, Roth, Haley, & Zarit, 2004). Participating caregivers reported 

better health and fewer illnesses longitudinally (Mittelman, Roth, Clay, & 

Haley, 2007) and delayed institutional placement of care recipients 

(Mittelman, Ferris, Shulman, Steinberg, & Levin, 1996; Mittelman, Haley, 

Clay, & Roth, 2006). Long, Moriarty, Mittelman, and Foldes (2014) used 

NYUCI data for economic projections of dollars saved, associated with prevented or delayed institutionalization. 

The Three Country Study-a randomized control study testing NYUCI in 

the United States, England, and Australia-replicated the decrease in depressive symptoms over 2 years for the NYUCI treatment group and found 

increases in symptoms for the control group (Mittelman, Brodaty, Wallen, & 

Burns, 2008). A modified version of tbe intervention in Minnesota with adultchild caregivers (N'YU-AC) found similar results. Caregivers receiving 

NYU-AC were less reactive to behavioral symptoms in the person with 

dementia (Gaugler, Reese, & Mittelman, 2016), showed a 3-year reduction in 

depressive symptoms, and showed increased QoL compared with control 
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Fauth eta/. 5 

group caregivers (Gaugler, Reese, & Mittelman, 20 15). These caregivers also 

kept their parents at home significantly longer than caregivers in the control 

group (Gaugler, Reese, & Mittelman, 20 13). Collectively, these studies support the effectiveness of NYUCI in randomized control studies with high 

levels of internal validity. 

AoA Demonstration Projects: NYUCI Across 

Multiple Sites 

The AoA funded six NYUCI demonstration projects; awardees were 

California ( CA Dept. of Aging), Florida (FL Dept. of Elder Affairs), Georgia 

(Rosalynn Carter Institute for Caregiving and GA Southwestern State 

University), Minnesota (MN Board on Aging), Utah (UT Division of Aging 

and Adult Services), and Wisconsin (WI Department of Health Services). 

Funding for these projects was purposefully focused on service delivery. The 

assessment component in the demonstration projects was intended to document program effectiveness within each site and inform the individualized 

counseling, and the studies were not designed with the anginal intention of 

conducting comparative analyses. However, discussions among participating 

sites during the period of implementation led to a collaboration and pooled 

data, the purpose of which is to report information helpful in discerning 

external validity across diverse locations and samples. To do so, we report the 

extent to which outcomes changed over time (across all available sites) and/ 

or if significant differences emerged in outcomes between sites. 

The California site did not share data for pooled analyses, as their data 

management agreement did not permit pooling with external collaborators. 

Despite requests to amend the original approved protocols, the Institutional 

Review Board (IRB) overseeing the Florida data collection restricted the 

agencies from pooling the data because consent from participants had not 

been collected for these purposes. Minnesota used measures of caregiver outcomes that were different from those used by the other sites, prohibitmg the 

pooling of Minnesota data. Thus, the current manuscript includes data from 

Georgia, Utah, and \Visconsin. We note, however, that outcomes from the 

Minnesota translation project are published elsewhere. The Minnesota translation project reported decreased depressive symptoms and distress. The 

project also identified that attending a greater number of counseling sessions 

was associated with delayed institutionalization of the person with dementia 

(Mittelman & Bartels, 2014). 

The three demonstration sites using the NYUCT protocol and pooling data 

for the current analyses differed from the original study design/protocol in a 

number of ways: First, although the original N'l"UCI utilized spousal 
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6 Journal of Applied Gerontology 00(0) 

caregivers, in the current study only Wisconsin utilized a spousal sample, 

while the other sites include spouses and adult-offspring caregivers (see 

Table l ). Second, the sample in the original NYUCI was drawn from a largely 

White, urban population; however, all subsamples in our investigation were 

more likely to include mral caregivers, and Georgia specifically targeted service delivery to a sample subset of African American caregivers. Finally, the 

original study with high levels of internal validity included a randomized 

control design with a usual-care comparison group. As AoA demonstration 

funding focused on service de livery, it would not support the assessment of a 

control group. Thus, while we compare NYUCI outcomes collectively and 

across sites, we cannot determine how these pooled data compare with a control or usual-care group. 

Method 

Participants 

Recruitment of caregivers took place through state and local aging agencies, 

public resource centers, and the Alzheimer's Association stateiregional chapters, although the sites varied to some extent in their recruitment approaches. 

Most caregivers in Georgia were recruited when they contacted participating 

Area Agencies on Agmg. Utah identified caregivers m a similar way and via 

caregivers' phone calls to the Alzheimer's Association. Wisconsin followed 

similar procedures and added outreach to health care facilities, senior services programs, and community organizations. 

Inclusion criteria varied only slightly by site. All sites required the care 

recipient to have a diagnosis of Alzheimer's disease or other dementia, and 

excluded caregivers who were not primary caregivers, or those with a serious 

mental illness that would prevent participation in counseling sessions, or 

those that did not have at least one family member available to attend family 

counseling sessions. All sites also required the care dyad to live in the community (not be institutionalized) at baseline but not necessarily in the same 

home. Utah and Wisconsin also explicitly stated that they limited participation to English-speaking participants. Wisconsm was the only state to require 

that caregivers were spouses. Georgia required that caregivers endorsed having some burden in their role and the need for assistance. 

Baseline preintervention data come from a total sample of 294 caregivers. 

Table 1 provides rates of attrition and sample characteristics. Georgia had the 

highest rates of attrition. The counselors/interventionists in Georgia could not 

identify one or more particular reasons for lack of interest in follow-up, but 

speculated that with service delivery as their main focus there was a low level 

27661f-7.eps

Table I. Sample Demographic Characteristics of Caregiver (CG) and Person with Dementia (PWD). 

All sites Utah Georgia Wisconsin 

Baseline N 294 (100.0%) 88 (100.0%) I 32 (I 00.0%) 74 (100.0%) 

Follow-Up I n (% retention from baseline) 152(51.7) 55 (62.5) 54 (40.9) 43 (58.1) Follow-Up 2 n (% retention from baseline) 74 (25.2) 36 (40.9) II (8.3) 27 (36.5) 

Follow-Up 3 n (% retention from baseline) 44 (15.0) 24 (27.3) 5 (3.8) 15 (20.3) 

CG kin relationship (%)* 

Adult child 9.6 13.6 12.1 0 

Spouse 89.8 83.0 87.9 100.0 

Other 0.7 2.3 0 0 

CG married (%)* 90.2 90.0 84.8 100.0 CG female(%) 66.9 68.2 63.1 71.6 CG age (M)* 70.8 (SD = I 1.5) 69.1 (SD = I 1.8) 69.2 (SD = 12.3) 75.2 (SO = 8.3) 

PWD female(%) 38.4 35.2 45.9 29.7 

PWD age (M) 76.1 (SD = 9.7) 75.5 (SD = 7.9) 75.6 (SD = I 1.6) 77.7 (SO= 7.9) 

CG ethnicity:% identifying as Hispanic 2.6 5.7 1.5 0 CG race(%)* 

White 88.4 96.6 76.5 100 

American Indian or Alaska Native 0 0 0 0 

Asian 0 0 0 0 

Black/ African American 8.5 0 18.9 0 

Native Hawaiian/Pacific Islander 1.0 1.1 1.5 0 

Other 2.0 2.3 3 0 

CG education (%)* 

Graduate school 14.5 21.6 11.7 10.8 

(continued) 
http://docs.house.gov/Committee/Calendar/ByEvent.aspx?EventID=106679

This material has not been reprinted here in its entirety but may be found at: f


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Table I. (continued) 

All sites Utah Georgia 

Completed college 21.4 28.4 15.6 

Some college 24.8 35.2 15.6 

Completed high school 25.9 13.6 32.0 

Some high school 7.6 1.1 12.5 

Junior high school 3.8 0 7.8 

<7 years of school 2.1 0 4.7 

CG %working* 17.2 23.9 18.6 

PWD global detenoration (M) 4.8(50= 1.12) 4.6 (SD = 1.3) 4.9 (SO= 1.1) 

CG clinically depressed' (%) 31.6 38.6 24.2 

Reasons for attrition 

Lack of interest from CG or family 25 (17%) 7(21%) II (14%) 

members in attending family counseling 

Closure of service provider or other 23 (16%) 9 (27%) 

scheduling difficulties for follow-up 

assessmentsb 

Institutionalization of PWD 9 (6%) 6 (18%) 3 (4%) 

Death of PWD 9 (6%) 4 (12%) 5 (6%) 

CG or PWD declining health 17 (12%) 5 (IS%) 5 (6%) CG death or moved from area 3 (2%) 2 (3%) Other/unknown/lost to follow-up 58 (41%) 2 (6%) 52 (67%) 

Note. All values except attrition information are baseline (preintervention) data. CG = caregivers; PWD = persons with dementia. 

'Clinical depression cutoff scores are I 0 for Geriatric Depression Scale. based on Lyness, et al., 1997 

Wisconsin 

23 

28.4 29.7 

6.8 

1.4 

0 

6.8 

4.8 (SO= 0

36.5 

7 (22%) 

14 (45%) 

7 (22%) 

I (3%) 

2 (7%) 

bA UT Alzheimer's Association branch office closure forced these participants to leave the study. as the remote geographic location did not allo

for counselors in other areas to continue working with these participants. 

*Indicates that chi-square (categorical variable) or A NOVA (continuous variable) differed by site at a level of p < .05. 
75

MATERIAL SUBMITTED FOR THE RECORD BY THE HONORABLE CHRISTOPHER H. SMITH, 

A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY, AND CHAIRMAN, 

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND INTERNATIONAL ORGANIZATIONS


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Executive Summary 

No therapies are known to substantially alter the course of dementia and associated 

treatment costs. However, enhanced support services for caregivers for people with dementia 

have been shown to improve caregivers' capabilities and well-being and delay patients' 

i nstitutio na I ization. 

Using a model that simulated disease progression, place of residence, and costs of care, 

we estimated the economic impact to Minnesota from offering the New York University 

Caregiver Intervention (NYUCI), an enhanced support services program for adult caregivers of 

community-dwelling people with dementia. We estimated the impact ofthe NYUCI on: 

1. the potential healthcare savings to all eligible people in the state, assuming all 

current and future caregivers participate in the NYUCI from 2010 to 2025; 

2. the net health care cost savings, inclusive of program costs, to eligible caregivers, 

assuming three less-than-complete levels of participation in the NYUCI from 2010 to 

2025 (5% of all caregivers, 10% and 30%); 

3. the potential indirect cost savings to all eligible people in the state, assuming all 

current and future caregivers participate in the NYUCI from 2010 to 2025. 

Results indicate that approximately 5 percent more people with dementia would remain 

in the community from year 3 (2013) on, and that 19.3 percent fewer people with dementia 

would die in institutions over fifteen years. During those years, Minnesota could potentially 

save as much as $1.24 billion ($995 million in discounted dollars) in direct healthcare costs. The 

estimated savings in net healthcare costs during those years, including all program costs except 

for program marketing, were $51.8 million, $103.7 million, and $250.5 million, assuming 5, 10, 

and 30% of caregivers participate in the NYUCI, respectively. Estimated potential indirect cost 

savings are also substantial, well exceeding the estimated direct healthcare cost savings. 

These findings suggest that broader access to enhanced caregiver supports is a 

promising way to moderate the growing economic burden of dementia. Substantial long-term 

savings are possible even without a breakthrough in the pharmacologic treatment ofthe 

disease. These direct healthcare cost savings would benefit taxpayers (through reduced 

expenditures for the Medicaid program) and people with dementia and their families, who 

largely pay the medical and facility fees for those in residential care settings. Other payers who 

would benefit include the Medicare program, commercial health plans and long term care 

insurers, to the extent that they fund these formal care services. The substantial indirect cost 

savings with enhanced support services would benefit caregivers and likely their employers 

through improved quality of life and increased productivity. Enhanced support services 

programs for dementia caregivers, such as the NYUCI, are cost-effective ways to manage 

dementia while researchers continue to seek effective treatments for the disease. 

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Background 

ACT on Alzheimer's (ACT) is a voluntary collaborative in Minnesota convened in 2011, 

with the goal of implementing legislative recommendations to prepare the state for the 

personal, social and budgetary impacts of dementia. One of ACT on Alzheimer's five leadership 

groups set out to identify and encourage investment in promising approaches that reduce costs 

and improve care. The leadership group decided to develop a model useful both now and in 

the future to provide Minnesota policy makers and health care leaders with relevant estimates 

of potential cost savings associated with varying dementia care approaches to help guide the 

investment of resources in the future. To this end, the group engaged healthcare researchers 

to develop an economic model to estimate the cost-saving potential of proven interventions. 

Given multiple and diverse stakeholders, the leadership group sought to estimate the 

impact of one or more care interventions from varying perspectives, including the state-wide 

Minnesota societal and health system perspectives as well as from the perspective of the 

Minnesota Department of Human Services, the state's public payer who serves low-income 

Minnesotans with dementia. At this time the model has been configured to estimate potential 

and net cost savings from specific perspectives of interest. The same approaches can be used 

to estimate results from other perspectives and interventions as well as simulate other 

economic outcomes (such as return on investment or cost-effectiveness) with structural and 

parameter changes as appropriate. 

This paper describes the development of the model, including the initial choice of 

intervention and modeling approach, and provides a high-level overview ofthe study methods 

and results. Further methodologic details and more detailed results can be found in Long et al. 

2014 as well as in forthcoming peer-reviewed publications1 

Clinical and Economic Burden of Dementia 

The burden of dementia is widely documented and increasingly recognized in policy 

settings. Although estimates of the prevalence of dementia in the United States vary, few 

doubt that the number of people affected is large and increasing with the aging of the 

population2

• One recent estimate yielded a prevalence of 14.7% in people older than 70 years 

of age, approximately 4.1 million individuals in 20103

. More than 15 million family members 

provide unpaid care for these individuals, often at their own physical and emotional expense4 

Annual dementia-attributable direct costs in this population were estimated at $109 

billion; total cost estimates were $159 to $215 billion, depending on how the monetary value of 

informal caregiving was calculated3

. The direct cost of care alone ranks expenditures for 

dementia similar to expenditures for heart disease and substantially higher than expenditures 

for cancer. These costs are projected to more than double by 20403 Additionally, since nursing 

home costs are a primary driver of dementia-related expenditures, the high rate of 

institutionalization contributes substantially to state and federal expenditures5·'-

Recognition of this burden led Congress to pass and President Barack Obama to sign the 

National Alzheimer's Project Act in 2011. The act required the creation of a national strategic 

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plan to address the escalating crisis of Alzheimer's disease and to coordinate efforts to combat 

the disease across the federal government8 And, even in an era of limited research resources, 

the National Institutes of Health distributed $45 million in new funding in 2013 to support 

innovative studies of Alzheimer's disease9

. Furthermore, the fiscal year 2014 budget included 

an increase of $122 million for Alzheimer's research, education, outreach, and caregiver 

support10. 

ACT on Alzheimer's Collaborative 

In 2009, to tackle the mounting Alzheimer's crisis in Minnesota, the Minnesota 

Legislature charged the Minnesota Board on Aging to establish the Alzheimer's Disease Working 

Group (ADWG) and make recommendations for policies and programs that would prepare 

Minnesota for the future. The ADWG developed a set of recommendations for the Legislature 

in January 2011. A voluntary coalition, now named ACT on Alzheimer's, was subsequently 

formed to focus on implementing the recommendations (see bllp://www.ACTonALZ.org). As a 

statewide collaboration, ACT on Alzheimer's fosters collective ownership and accountability in 

preparing Minnesota for the clinical and economic impacts of Alzheimer's disease and related 

dementias. The collaboration has more than 300 participants and 60+ nonprofit, governmental 

and private organizations. 

A goal of ACT on Alzheimer's was to develop a model useful both now and in the future 

to provide Minnesota policymakers and healthcare leaders with relevant estimates of potential 

cost savings that could be achieved by investing in evidence-based dementia care interventions. 

The Minnesota Economic Model of Dementia was developed as a vehicle for influencing care 

delivery and payment policy to ensure that persons with dementia and their caregivers receive 

optimal care and support in a manner that both improves their quality of life and is likely to 

reduce the State's and other payers' burden. 

Choice of Intervention 

The ACT on Alzheimer's leadership group, focusing on identifying and investing in 

promising care interventions, convened a number of times to discuss the evidence on 

interventions that had the potential to moderate the economic burden of dementia. The group 

considered evidence surrounding early identification of disease, pharmacologic treatments, and 

models to improve continuity of care for persons with dementia. 

Early Identification 

Being able to identify dementia earlier in the course of the disease clearly has clinical 

advantages, including improved coordination and continuity of care around dementia 

progression. Research has demonstrated that early identification alone is possible through 

screening, although whether this approach has any economic benefits is currently 

The Minnesota Economic Model of Dementia Page 4 
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undetermined due to limited research in this area and the absence of therapies that prevent, 

cure or significantly delay symptoms". 

Pharmacologic Treatment 

Currently there are five therapies approved by the United States Federal Drug 

Administration for management of Alzheimer's disease. Most of these medications are 

classified together as cholinesterase inhibitors, which are approved for mild-to-moderate 

Alzheimer's disease. The additional medication option, memantine, is approved for the 

treatment of moderate-to-severe disease. While initially these medication options held great 

promise to delay disease progression, systematic literature reviews have been less favorable 

and currently the effectiveness of drug treatment remains controversial 12 Even if clinical 

benefits exist with pharmacologic treatment, they come at substantial cost and it is unlikely 

that drug treatment is cost-saving or even cost-effective13·H For these reasons access to these 

medications is currently limited in some countries, given the limited value of drug treatment12 . 

Following extensive discussion, the ACT on Alzheimer's leadership group decided that the 

research on pharmacologic treatment is inconclusive regarding clinical effectiveness and the 

potential for cost savings and it was not chosen to be a focus of economic model simulations at 

this time. 

Improved Continuity of Care 

Several types of interventions may be grouped under the concept of improved 

continuity of care or care coordination. The National Coalition on Care Coordination defines 

care coordination as " ... a client-centered, assessment-based interdisciplinary approach to 

integrating health care and social support services in which an individual's needs and 

preferences are assessed, a comprehensive care plan is developed, and services are managed 

and monitored by an identified care coordinator following evidence-based standards of care". 

An expanding body of literature demonstrates that improved coordination of care 

practices are effective in ameliorating behavioral and psychological symptoms in persons with 

dementia and reducing distress in caregivers18.

20 Positive results have been observed in 

multiple controlled and translational studies in clinical and community settings18"

20. Formal 

evaluations have been conducted of several primary-care based coordinated care models for 

persons with dementia21.

23 . These studies suggest substantial benefits for both caregivers and 

people with dementia, including improvement in the quality of care and in behavioral and 

psychological symptoms, without significantly increasing the use of pharmaceutical 

interventions. A recent study of a primary care based collaborative care model documented 

nearly $3,000 in annual savings per patient, largely attributable to reduced rates of 

hospitalization24 However, the literature to date is limited and conflicting as to whether 

economic benefits to these models exist, such as reduced emergency room visits, 

hospitalization, or delayed nursing home admission. 

From an economic perspective, a more promising form of improved continuity of care 

may be the transitional care model that focuses on improving the multiple transfers of persons 

with chronic conditions between hospitals, nursing homes, and community settings, where 

evidence has shown that continuity of care often falters25 . Naylor and colleagues at the 

University of Pennsylvania have shown through a randomized controlled trial that a transitional 

The Minnesota Economic Model of Dementia PageS 
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care model can reduce repeat hospitalizations in a general elderly population 26. This model has 

been studied with favorable results in a dementia population but results are still pending 

academic publication. Currently the evidence in the literature remains limited regarding cost 

savings associated with either primary care-based coordinated care models or transitional care 

models for persons with dementia. 

Enhanced Caregiver Supports 

Nationally, 44% of community-dwelling persons with dementia live with an adult 

caregiver, most often a spouse or adult child 27. In 2012, an estimated 15 million dementia 

caregivers provided 17.5 billion hours of unpaid care28. These caregivers provide a wide range 

of unpaid services, including helping with activities of daily living (ADLs), instrumental activities 

of daily living (IADLs), and managing behavioral symptoms of the disease. Caregivers frequently 

provide this care at the expense of their own wellbeing and productivity29.

31 Caregiver 

stressors in conjunction with care recipient characteristics have been shown to predict nursing 

home admission32. Institutionalization has multiple consequences, not the least economic, 

because nursing home costs can greatly exceed the cost of community-based care. 

Education and support programs for dementia caregivers have been demonstrated to 

have multiple benefits. Studied programs have multiple components and may combine 

individual counseling, family sessions and support, and ongoing assistance to help the caregiver 

cope with the behavioral symptoms that often accompany the progression of disease. Program 

benefits include reduced levels of caregiver stress and depression, reduced time spent 

caregiving, and delayed nursing home placemene3

-

3

'-

Initial Focus for the Economic Model: 

The New York University Caregiver Intervention 

Based on this review of the evidence regarding possible cost saving interventions, the 

ACT on Alzheimer's leadership group reasoned that without a clinical breakthrough that can 

substantially alter the course of disease, the best current evidence-based approach to reducing 

the costs for persons with dementia may be through provision of enhanced caregiver support. 

The Minnesota Economic Model of Dementia was initially used to project the healthcare cost 

savings in Minnesota associated with participation in the New York University Caregiver 

Intervention (NYUCI), a well-studied enhanced caregiver support program. 

The NYUCI was developed in the 1980s to educate caregivers about dementia, involve 

the family to support the primary caregiver, and provide the caregiver with tools to cope with 

the behavioral symptoms oft he disease. This program consists of two individual and four 

family counseling sessions, encouragement to participate in weekly support groups, and 

ongoing ad hoc telephone counseling. Counseling sessions are tailored to meet the needs of 

the caregiver and family. Previously documented benefits, identified through randomized 

controlled trials, include improved levels of caregiver wellbeing and capabilities, and an 

estimated median delay of 557 days before permanent residential placement of the person 

with dementia33 

The Minnesota Economic Model of Dementia Page 6 
81


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Minnesota Economic Model of Dementia 

The Minnesota Economic Model of Dementia is the first formal economic evaluation of 

the cost savings associated with implementing the NYUCI program. It is a population-based 

microsimulation Markov model to simulate disease progression and place of residence of 

Minnesotans with Alzheimer's disease and other related dementias. The model tracks 

individuals as they move through discrete health states and accumulate costs over 15 years 

under two scenarios: (1) no enhanced caregiver supportive services, in which adult caregivers 

of community-dwelling persons with dementia do not receive specialized supportive services in 

addition to usual care; and (2) enhanced caregiver supportive services, in which adult caregivers 

participate in the NYUCI. The model is informed by primary data collection as well as the 

literature on the epidemiology, natural history, costs, and evidence-based management of the 

disease27•

33•35-43 A full discussion ofthe research methods, model specifications, additional 

results and limitations can be found in Long et al. 2014 and the accompanying online Appendix1 

(see http: //www.actonalz.org/economic-impact). 

Model Results 

Potential Hea/thcare Cost Savings 

The Minnesota Economic Model of Dementia was used first to estimate the maximum 

potential cost savings associated with the NYUCI, without incorporating variable 

implementation factors such as program and marketing costs and less-than- complete 

participation rates. These results appeared in Health Affairs in April, 20141 Results suggest 

that significant direct healthcare savings and other benefits are possible. 

- Approximately 5 percent more people with dementia would be able to remain in their 

homes each year rather than moving to a residential facility, after 3 years of program 

implementation. 

- Approximately 19 percent fewer people with dementia would likely die in institutional 

settings after 15 years of implementation. 

- Minnesota could save as much as $1.24 billion ($996 million in discounted dollars) in 

direct healthcare cost savings over 15 years of program implementation. 

These results do not include program and marketing costs. They also assume that all 

unpaid adult caregivers living at home with the estimated 30,872 Minnesotans with dementia 

in 2010, and all caregivers of newly diagnosed future cases, were to participate in the NYUCI. 

While this assumption is unrealistic, these initial results indicated the strong probability that 

enhanced caregiver support is a promising way to moderate the growing economic burden of 

dementia. Accordingly, the ACT on Alzheimer's leadership group decided to extend the analysis 

The Minnesota Economic Model of Dementia Page 7 
82

This material has not been reprinted here in its entirety but may be found at:

http://docs.house.gov/Committee/Calendar/ByEvent.aspx?EventID=106679

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to investigate cost savings under three different "real world" participation scenarios as well as 

account for program costs. 

Net direct hea/thcare cost savings 

The Minnesota Economic Model of Dementia was extended to project the likely net cost 

savings associated with the NYUCI by incorporating estimated program costs and varying 

participation rates of caregivers of people with dementia in Minnesota. Results suggest that, in 

addition to allowing more people with dementia to live and die at home, as noted above, net 

direct healthcare savings are achievable within a few years of program implementation. The 

following table summarizes the net direct healthcare savings at three possible levels of program 

participation by caregivers. 

Projected Cumulative Net Direct Healthcare Cost Savings for Minnesota 

Net Savings: 

After 3 Years 

After 5 Years 

After 10 Years 

After 15 Years 

Proportion of 36,786 Eligible Caregivers in 2011 

Participating in the NYUCI/ 

Initial Number of Caregiver Participants 

s% 1 1,840 10% 1 3,678 30% 1 n,o3s 

$ 281,000 

$6,000,000 

$ 33,000,000 

$ 61,800,000 

$ 2,500,000 

$ 17,200,000 

$ 60,800,000 

$ 103,700,000 

$795,000 

$ 38,300,000 

$ 145,800,000 

$ 250,600,000 

These estimated direct healthcare cost savings account for all program costs but do not 

include costs to increase awareness of the program and encourage participation. These 

marketing costs could not be credibly incorporated into to the model because the approaches 

to marketing the program have not been determined and may vary substantially based on 

methods used. However, the estimated net savings suggest broad latitude to conduct outreach 

and awareness while still providing overall net savings after three or four years of program 

implementation. 

Indirect Costs Associated with Caregiver Burden 

The dementia caregiver burden is substantial. As noted earlier, an estimated 15 million 

caregivers provided 17.5 billion hours of unpaid care nationally in 201228 The indirect costs 

associated with this time spent caregiving have been estimated between $50 to $106 billion, 

depending on how the monetary value of informal caregiving was calculated 3

. The ACT on 

Alzheimer's leadership group was interested in determining whether enhanced caregiver 

support might reduce this economic burden for caregivers, in addition to the direct healthcare 

savings for patients, families, and payers. The Minnesota Economic Model of Dementia, 

therefore, was extended to include indirect costs associated with time spent caregiving. 

The Minnesota Economic Model of Dementia Page 8 
83

MATERIAL SUBMITTED FOR THE RECORD BY THE HONORABLE CHRISTOPHER H. SMITH, 

A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY, AND CHAIRMAN, 

SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH, GLOBAL HUMAN RIGHTS, AND INTERNATIONAL ORGANIZATIONS


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10.1377/hlthoff.2013.1257 

HEALTH AFFAIRS 33 

Kirsten Hall Long (Kirsten(«' 

k~ong l ::JilS u i tmg n C' ~) 

pri~c pai and se11cr health 

PCOI1Jill1St at K 

in St 

James P. Moriarty 15 a 

masters ~ealt1 serv1ces 

" 

MaryS.Mittelmanisa 

re:;ear-ch p· ofe:;~or at the Ne'"' 

[:ty 

StevenS. Foldes 1s a 

596 

By Kirsten Hall Long, James P. Moriarty, Mary 5. Mittelman, and Steven 5. Foldes 

Estimating The Potential Cost 

Savings From The New York 

University Caregiver Intervention 

In Minnesota 

AllSTlU';CT No therapies ar~ lmO\\''n to substantially alter the course of 

de1nentia an (I_ .associated trea:tment C(}sts• However, enhanced. support 

services for caregivers of people with dementia ha.ve beenshownto 

>improve categivers' c~pabilities ·and w~ll-being and delay patients'· 

i~stiht~'n.alization. Using a model that simtllateddisease progression, 

place of residence, and direct costs ofc~re, we _estbnated tile potential 

savings tod\1inn\!sota from off~d)lg the New York Unimsity Categ~ver 

futervention, a.programof enliancedsupport servi.ces. for spouse and 

adult ch.ild ~aregivers !Jf community'dW:elling people .~th d,ementia; to all 

eligible peop~eJn tile state. from. 2019 to 20f5. E.esults in_dicate. that .· 

appro>~:ima~ely 5 percent more people with dementia :W~uld_ remain in _the 

cmnJ.bunity from ye~r 3 (2013) on and that 19.3percent fewer people ~th 

d!'lll,entia would. die in institutloQ.s over fifteen years, During those_ rears 

Minnesota could save $996 million in .direct car..,_ ~{ls~s (~ith a range :of. 

nearly $100 million to $2.64 billion underwo~st: and best-case sc.enMios; 

respectively). These findings suggest that broader access to enhanced 

caregiver supports could produce a positive re,tum_ ()D in:v.e~tment or be 

eost -effective~assumingwidespread. il!lplementation, . reasonable pro grain 

. eosts, and. substantial caregiver•partidp;ttlon. · ' · · 

T he burden cf dementia is widely 

documented a.."'ld increasLLgly recognized by policy makers. Estimates of the prevalence of dementia in the United States v-ary. 

However, few researchers and policy milkers 

doubt that the number of people affected is already large and is increasing as the population 

ages.1 One estimate i~ that l4. 7 percent of people 

ages seventy and older, or approximately 4.1 millio11 people nationwide, had dementia in 2010. 2 

An..rmal direct health care costs for this population that were attributable to dementia have 

been estimated at $109 billion. 2 Thus, expenditures for dementia are near those for heart disease and much higher than expenditures for cancer. Expenditures for dementia are projected to 

APRIL 20l<i 33:4 

more than double by 2040.2 

Recognition of this burden led Congress to 

pass and President Bara..:k Obdma to ~ign the 

National Alzheimer's Proje<.:t Act of 2011. The 

act required the creation of a national strategic 

plan to address the escalating crisis of 

Alzheimer's disease and to coordinate efforts 

to combat the disease acmss the federal government.3 

Even in an era of limited research resources, 

the National Institutes of Health distributed 

$45 million in new flmding in 2013 to support 

innovative studies of Alzheimer's disease. 4 Furtherrnore, the fiscal year 2014 budget included 

an increase of $122 milljon for Alzheimer's 

research, education, outreach, and caregiver 

support.:; 

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More than forty states are developic1g their 

own Alzheimer's disease plans, which are in various stages of implememation. 6 The ACT on 

Alzheimer's Collaborative was founded in Minnesota in 2011 ·with the goal of implementing 

legislative recommendations to prepare the state 

for the personal, social, and budgetary impacts 

of dementia. 

One of the collaborative's five leadership 

groupf' seeks to Jdentify and encolJrage investment in promising approaches to reduce the 

costs and improve the qnality of care for 

Alzhei.'Uer's patients. This leadership group 

commissioned an economic model to estimate 

the cost-saving potential of proven interventions 

in Minnesota. 

The group convcnrd several times to discuss 

the evidence, based on a syste:natic literature 

review, about tested interventions. Pharmacologic options initially held great promise to delay 

the disease's progression and manage patients' 

behavioral symptoms. However, more recent reviews have suggested that such options are more 

likely to be supportive or palliative than capable 

of altering disease progression and can have adverse effects. Thns, their use remains somewhat 

controYersial.'-10 Even if pharmacologic options 

are effective, they have a substantial cost and 

are nol bkely to be cost-saving or even costeffective. 7

''

0 

A growing borl.yofliterature demonstrates that 

nonphamacologic treatnents are effective in 

ameliorating behavioral and psychological 

symptocns in people with dementi,l and reducing 

distress in their Positive results 

have been observed muldple controlled and 

translational ~tudie:. in clinical and community 

~ettings.l,.n 

The primary care setting, where many people 

with dementia are diagnosed, has bern the focus 

of collaborative care models designed to im::egrate dementia treatment guidelines more effectively into clinical care. These models have been 

shown to improve the qllality of care, and research suggest~ that they reduced the use of 

acute care in the short term. 1·' ;, However, the 

short durations of the studies make it difficult 

to know whether the models would have sustained economic benefits. And, as Laura Gitlin 

commented in a recent meta-a::1alysis of nonpharrndcologic treatments, "cost analyses for almost all of the included interventions are woefully missing. 

Models of community-based caregiver support 

that include educatio21and support programs for 

informal-that is, unpaid-caregivers for people 

\v:Jth dementia have demonstrated multiple benefits. Some of the programs that have been studied have multiple components, combining individual counseling, family ~essions and support, 

and ongoing ad hoc assistance to the caregiver. 

Thrse programs aim to educate caregivers about 

dementia, involve the fa:r.nily to support the primary caregiver, ami provide the caregiver with 

tools to cope with the behavioral symptoms that 

often accompany the progression of disease. Repeatedly documented benefits include reduced 

levels of caregiver stress and depression, redllced time spent .:;aregiving) and delayed re~idential placement of the person with dementia.lE-2o 

Formal economic evaluations of enhanced 

support interventions were not availthe ACT on AJzheimer's Collaborative leadership group reasoned that because 

the cost of residential care can greatly exceed 

the cost of communinr-based care, these int~?rventions C"Lirrently off~r the greatest chance for 

savings in the long term. 

Delayed residential care placement as a result of 

e:n_hanced caregiver support was repeatedly observed in the New York University Caregiver 

Intervention (NYUCI), which was originally 

implemented at the NYtJ Langone Medical 

Center. 16·

21·22 In the final analysis of the f\IYUCI 

randomized controlled trial, 406 spouse and 

adult child caregivers of people 'With dementia 

living in the New York metropolitan area were 

randomly assigned to receive ('ither enhanced 

support sen'icrs or usual services and were followed for up to eighreen years. 16 Of the spouse 

and adult child caregiver.~, 60 percent were female, and their average age was seventy-one. 

Few of the caregivers had minority ethnic backgrounds. 

Enhanced support services consisted of six 

sessions of individual and family counseling 

\Vitbin follr months of enrollment in the .t\YUCL 

encour.lgement to participate in an ongoL11g 

weekly support group, and ad hoc telephone 

counseling as needed for an indefinite period. 

Counseling sessions were tailored to meet the 

needs of the spouse caregiwr and f,"lmily. TilE' 

trial demonstrated improved caregiver wellbei."'lg and capabilities and an esti.'llated median 

delay of 557 d.:~ys before the perso11 with dementia was placed in a residential facility. ~ 

A recentadaptationofthe ~I'1JCI to adult child 

caregivers in Minnesota also dt>-'110:'l.strated .substantial delays in residential placement.17 The 

.f\.YUCI model has been implemented in multiple 

demonstration projects, including the Family 

Memory Care Program in fourteen urban and 

rur;:ll site~ in Minnesota.n.n This made the 

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27661h-4.eps

598 

1\i'YlJCI model of care familiar to the leadership 

group of the ACT on Alzheimer's Collaborative 

and a likely candidate for statewide implementation. 

Another randomized trial, Resources for 

Enhancing Alzheimer's Caregiver Health II, or 

REACH II, failed to confirm delayed residential 

placement wirh a similar program of enhanced 

caregiver support 20 However, the limited followup period in that trial made it difficult to detect a 

longer-term effect. Thus, the leadership group 

requested that the rco:1omic model it commissioned estL"llate the potential for sa'\lings in care 

costs of the NYlJCI for all Minnesota adult caregivers ofpeop1e with dementia li\ring in communities throughout the state. ACT leaders asked 

what the health system could save during fifteen 

years-nottakL'tlg program costs L'tlto account-if 

this model of enhanced caregiver services were 

widety available to of people with dem.entia and used 

Stmly 

We developed a population-based Markov model 

to simuliu:-e disease progr12ssion and place of 

residence of Minnesotans ages 65-100 '\.Vith 

Alzheimer's disease or other dementias. The 

model tracked people as they moved through 

discrete health states and accumulated costs duri_ng a period of fifteen years u.::1drr tv.ro scenarios: 

with enhanced caregiver !>Upports, in which their 

spouse or adult child caregivers participated 

in the l\Jl"UCI; and with usual services only-that 

is, without ecilianced caregiver supports in the 

fonn of the NYUCI. 

The model was designed to assess the potential 

cost savings associated with the ~TJ.'UCI ·without 

incorporating variable implementation factors 

such as program and marketing costs and lessthan-complete participation rates. 1l1e model's 

development was informed by the literature on 

the epidemiology, natural history, costs, and 

evidence-based management of dementia. 24-

31 

The online Appendix provides fmther details 

on the model's specifications, 12 

HEALTH STATES Our model included three discrete Markov health states: Jiving in the community, being institutionalized in a residential care 

facility (a nursing home or assi;;,ted living facility), and dead. TI1e eligible population included 

people with dementia who all initially Jived in 

the commu..'tlitywith a spouse or adult child caregiver. Based on severity-specific a1mual probabilities of transitions between health states, the 

model projected and tracked from 2010 to 2025 

the number of people who remained ]n the community ;:rnd their associated costs of care; the 

number who required residential placement, 

APRIL 2014 33:4 

Enhanced caregiver 

support is a promising 

way to moderate the 

growing economic 

burden of dementia. 

therebymcurring addibonal facility fees; and the 

number who died. 

PREVALENCE AND INCIDENCE OF DEMENTIA IN 

MINNESOTA To estimate the number of people 

with dementia, we applied to state population 

trends the prevalence and incidence rates that 

the Rochester Epidemiology Project observed in 

Rochester, Milli"lesota. N-26 We adjusted rates 

upw&rct to account for Rochester's educational 

level, which is higher than the state average, 

because that level is known to be inversely correlated with the risk of dementia/' 

We also adjusted the rates upward to account 

for a documented bias that might be associated 

with improved recognition of dementia in '."linical practice since the early 1990s, when the 

Rochester Epidemiology Project's rates were estimated, for cases that might have been missed 

because of the project's reliance on medical 

records alone to identify people with dementia, 

or both. 23 An additional discussion of prevalence 

rates can be found in the online Appendix. 32 

We distributed the estimated prevalence 

across dJsease severity (mild, moderate, severe) 

as observed in the Canadian Study of Health and 

Agbg, and ·we assumed that incident-rhat is, 

newly diagnosed-cases were of :nild severity. 2

q 

Exhibit ] shows the estimated number<; of 

comm1.mity-dv•lelling Minnesotan!> ¥-ith dementia living with an adult caregiver by severity used 

in the primary-case (sta.:1dard model assumptions) and alternative-case {alternative model 

assumptions) . .malyses. The model assJ..Imed that 

inddt:>ncc rates remainf'd constant ovcrthne; the 

increase L'tl the number of i.n.cirlent cases ret1ected the projected dernop·dphk changes in 

the state's population. 33 

TRANSITION PROBABILITIES Minnesota residents with dementia in our model had an annual 

likelihood of moving among the definrd health 

states based on the estimated probabilities of 

disease progression, residential placement, or 

d)ing. We based the likelihood of disease progression and residential placement on analyses 

ot the CLmsortium to Establish a Registry for 

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27661h-5.eps

EX'HIBIT 1 

Estimated Prevalence Of People With Dementia Living In The Community With A Spouse Or Adult Child Caregiver In 

Minnesota Who Were E!lgible For The New York University Caregiver Intervention (NYUCI), 2010, And Incidence Of 

Dementia In Selected Years 2011-2025 

Primary-case analysis 

(20"/o upward adjustment) 

o:»EOPLE ELIGIBLE FOR NVUCI, 2010 

Mild dementia 14,359 

M:~derJte dementia 

Severe den;enti;:; 

Total 38872 

Alternl:ltive--case analyses, with adjustments of: 

15% upward 25<>/o upward 50"/o downward 

13.761 14,958 7.180 

1S,585 15,437 

ANNUAL INCIDENCE OF DEMENTIA IN MINNESOTA,. SELECTED YEARS 

I (2011} 

5 (2015} 

10 (2820) 

15 (2015) 

5913 

6,496 

so!JRCi Authors' analvsrs of data ftom the 

Alzhei::ncr's Disease (CERAD) database. 30•

14 

CERAD enrolled 1,145 patients with Alzheimer's disease from twenty-tw-o academic 

medical centers between 1986 and 1995, and 

its data have been widely usrd in health economic evaluations of de:nentia care. 33-

37 The members 

of this relatively large and fairly diverse enrolled 

population receive annual J.~sessments. CER.I\D 

data enable reliable estimates of severity-specific 

tran_sition pr0babilities before enhanced caregiver interventions became '\-videly available. 

We assumed, as has been observed in CERAD 

and other Alzheimer's disease registries, that 

residential placement rates increased by disease 

severity but did not differ by duration within a 

given dis east' stage. >o,>r; No data similar to those 

in the CERAD database were avail.J.ble for patients with dementias other than Alzheimer's 

disease. Thus, we assumed that the rates of transitions as observed in the CERAD data applied to 

all people with dementia. 

We reduced the probability of permanent residential placement for people whose caregivers 

received enhanced services, according to theresults observed in the !-.YUCl randomized tlial 

that was: condw.:ted at the NYU Langone _Medical 

Center. This trial is by far the largest and longest 

application of enhanced caregiver support to 

date. 16 

5,667 

5,225 

6.160 

6.757 

2.957 

3,248 

We adjusted the CERAD-based probabilities of 

residential placement for the 28.3 percent reduced risk of placement compared with usualcare controls reported for the 1\J'YUCI. We varied 

rhis effect size based on thC' variability in estimated risks in the alter11ative-case analyses 

(Exhibit 2). 

We based th_e annual probability of death on 

statewide mortality rates calculated by the Center for Health Statistics, Minnesota Dt>partnent 

of Health, to conform to the model's specifications. ln our primary-case analyses we assumed a 

differential mortality of 1.5 for moderate dementia and adjusted for mild and severe disease 

based on the estimated likelihood of death by 

'leverity in the CERAD data, 111 We assumed that 

mortality was unaffected by the I\,YUCI. 

cosTs i/Ve estimated direct cosrs for people 

wirh dementia by residence (community versus 

residential facility) ba:,ed on a."'lalyses of the 

Medicare Current Beneficiary Survey (-MCBS). 31 

The costs were those for medical care and the use 

of nursing homes and assisted living facilities 

across payer types (including out-of-pocket expenses). We adjusted these costs to reflect prices 

in Minnesota aDd strdtifiei.l them by disease seestimated annu.1l direct costs for people 

with dementia Uving in the community were 

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600 

Estimated Annual Probabilities Of Residential Placement For People With Dementia In The Community, With And Without 

The New York University Caregiver Intervention (NYUCI) 

~~ba~~~ity of tra~sltlo::_n __________ _ 

Level of dementia 

In community In residential facility" Without 

(starting status) (transltloned status) NYUCI 

Mild Mild 233% 

Moderate 122 

Severe 016 

Moder<:~te ModerrJte 622 

Severe 373 

Severe Severe 21 90 

$16,177 for mild dementia, $20,643formoderate 

dementia, and $32,213 for severe disease. The 

correspondbg estimates for people with rlem.entia in residential facilities were $1

13,299, 

$55,253, and $86,221. The NYUCJ did not assess 

direct health care costs. Therefore, we assumed 

that these MCBS-based annual costs per person 

with dementia were not affected by the NYUCI. 

ANALYSIS In our model, people with dementia 

progressed through the three health statesinC'urring costs owr a period of fifteen yearsunder the two scenarios described above. Our 

analyses projected and compared populationlevel direct costs by year of follow-up, discounted 

3 percent annually. 

The model tracked outcomes by sex and age 

group for ~ubgroup analyses. In addition, we 

performed several alternative-case analyses m 

te~t the strength of the results. 

LIMITATIONS Assembling the multiple parameters required for our model entailed making 

several assumptions and therefore imposed 

limitations on our results. Rates of dementia 

prevalence and incidence show considerable variation, likely based on trends Ln clinical diagnosis. methods of ascertainment, sampling strategie~. and Vdrying access to health care. 1

,

28 

We performed adjmtments and analyse~ using 

alternative rates of disease detection. However, 

the current and future rates of clinically diagnosed cases of dementia {as opposed to cases 

identified by proactive screening) in Min..Tlesota 

remain uncertai!l. 

Furtbennore, rates of dementia im:rease with 

age but are generally considered to be unchangi.r..g over time. Our model followed this conscnAPRIL 2014 33:4 

With NYUCI 

Altern.atlve-case analyses - ---------------

Primary-case Larger NYUCI Smaller NYUCI 

analysts effect effect 

168% 1.26% 2.24% 

088 0.66 U7 

012 0.09 0.15 

453 3.53 5.97 

2/2 206 358 

1638 12.59 21.14 

sus. Recent studies from Europe have raj sed the 

possibility that rate~ are dcdi1'1L11g. 41 No recent 

US studies exist, but if rates are decreasing, our 

estimated savings are exaggerated. 

Resider::. rial placement rate~ based on CERAD 

data may not apply across Minnesota, even 

though CERAD enroJled patients from national 

academic medical centers. Nonnheless, we assumed that transitior1s to nursing homes for patients with Alzheimer's disease found in CERAD 

data applied to all people with dementia and to 

otht:>r institutional settings. 1he impact of these 

assumptions on our results is unclear. 

For estimated direct cosh., our model assumed 

that futur~ patterns. of care would remain similar 

to current ones. If the relative difference in costs 

betvveen community- and facility-based care 

changed, our results would differ. 

People wlth dementia who remain in the community \vith the NYUCJ might incur marginally 

greater costs for support services than the average community-dweilbg person with dementia 

as assessed in the MCBS. If that were the case, 

our estimated savings would be overstated, However, our results :night br conservative since the 

!\il'UCI (and therefore our model) did not assess 

the potentially cost-saving impact of reduced use 

of emergency deparbne.P..ts, hospitals, and pharmaceuticals that might occur Vlith enhanced 

caregiver support.· 1 

The NYUCI did not ass<>ss the impact of enhanced caregiver supports on the hours spent by 

inforcnal caregivers. Furthermore, no consensus 

exists regarding methods to value th1s. caregiver 

burden. Thus, we chose to focus only on direct 

costs and omitted the su bstautial indirect costs 

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27661h-7.eps

associated with care proyjded by informal caregivers.} If time spent caregiving was greatly 

reduced in the NYUCI, as was observed in 

REACH II, then inclusion of these indirect costs 

would i11crea~e our estimated cost savings.1

g 

We also did notconsiderthe indirect effects on 

caregivers of reduced depression and associated 

health care costs:n Nor did we perform. a costeffectiveness analysi<; that incm1Jorated the potential effects on mortality and quality of life 

associated with delayed residential placement, 

Including these additional caregiwr outcomes, 

as well as mortality and quality-of-life effects for 

the person >vith dementia, .might demonstrate 

different types of NY1JCI benefits. 

Sh.u~y R.;qrJts 

Our model predicted a 38.6 percent increase in 

the pre\.'alence of people with dementia in Minnesota from 2010 to 2025 who initially lived in 

the community with a spouse or adult child caregiver. Exl-.t.ibit 3 s haws the proportjon of our 

population in each health state with and without 

the NYl:CI for selected years of follow-up. 

With ~he ~"'YUCI, the proportionofpcopl('with 

dementia remaiJ'.. bg in the community increased 

by approximatdy 5 percent at year 3, compared 

to Lhe results v.nthout the NYUCI, and that difference persisted in years 5, 10, and 15. For instance, the proportion of people remaining in 

the .-;ornrnunity increased from 60.5 percent to 

65.4 percent, from 58.4 percent to 63.3 percent, 

and from 59.4 percent to 64.0 percent in years 5, 

10, and 15, resprctively (Exhibit 3). In addition, 

the nu.."'llber of people who died in an institution 

from 2010 to 2025 decreased from 32,897 to 

26,557 a 19.3 percent redudion with the NYUCL 

However, the number of people who died L"l the 

commnnity during these fiftern years incr('a.sed 

from 64,137 w 70,286, a 9.6 percent increase 

with the ~ryucr (data not shovm). 

The estimated cumulative population-level potential cost savings associated with the NYUCI 

wrre substantial. They increased from $289 million after five years to $996 million after fifteen 

years (Exhibit 4). At the population level, estimated savings with the N""YUCI in residential 

placement costs after fifteen years were partially 

offset by the higher costs estimated for the care 

of people with dementia in tbe community, because of the higher proportion of communitydwelling patients and no assumed savings in 

per person costs with the L\'YUCI. 

Analyses age group suggested that the cumulative would be higbest for people 

with dementja ages 75-84 ($432 million), reflecting projected population trends for Minne-

~ota. In addition, cumulative savings would be 

higher for '.Vomen than for men ($616 million 

versus $380 million). 

We perfor:ned alternadve-case analyses on the 

variables and methods of greatest uncertaL"lty. 

The variability b estimated cost savings was 

most affected by the NYVCI's effect size dnd 

the assu::ned pre\'alence and incidencr of eligible 

people with dementia. 

For instance, we varied the NYUCI effect based 

on the estimated 95% confidence Jntenral for the 

risk of residential placement.1

h The potential 

(undiscounted) savings with the NYUCl differed 

from $135 million to $2.3 billion, compared to 

the primary-case analysis (undiscouoted) result 

of $1.24 billion. Similarly, we asslJmed a 50 percent reduction in the prevalence and incidence of 

dementia, to refl<>ct a lower prevalence of demrntia recognized in primary care settings-where 

most people with dementia would be offered a 

chance to participate in the NV1JCI. In that case, 

the estimatrd (undiscounted) savings were rrduced to $608 million. 

'We constructed best- and worst-case scenarios 

by varying several model inputs simulta::Jeously. 

The best-case scenario assumed higher numbers 

of people with dementia, a lower mortality rate, 

and a larger intervention effect, and it did not 

discount costs. In cor!l"rast, the worst-case scenario assumed lower numbers of people V~tith 

dementia. a higher mortality rate, a smaller intervention effect, and a higher discount rate for 

co~ts. compared V~<"ith the primary-case analy~is. 

Potential savings in these best- and worst-case 

Distribution Of Three Health States Among People With Dementia In Minnesota Eligible For 

The New York University Caregiver Intervention (NYUCI), By Year 

100 

AO 

60 

40 

20 

Yea" a (20'0) 

Year 5 Year 10 Year 15 (2015) (2020) (2025) 

YearS YearlO Year15 [2015) (2020) [2025) 

'Nitioo11t the NYUC I W1tl1 t~e t-.;YU( I 

soui'IICE Authors' anJlysis of mOdel results. NOTE ~)eorl~ the NYUCI were aRes 55-1 00 

A?RIL 2014 33:4 

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601 
90

This material has not been reprinted here in its entirety but may be found at:

http://docs.house.gov/Committee/Calendar/ByEvent.aspx?EventID=106679

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27661h-8.eps

EXHIBIT',4 

Potential C1.1mulative Direct Cost Savings With New York University Caregiver Intervention 

(NYUCI} For People With Dementia In Minnesota. By Year 

disea<;e combined v.ith phannaceutical treatment and caregiver support in Wisconsin and 

found the approach fiscally attractive. 43 However, the efficacy of drug treatment n'mains controversial, and Weimer and Sager aswmcd that 

caregiver support was equally effective in cases 

identified by proactive screening-which is 

not the standard of practice in most clinical 

settings-and in clinically diagnosed cases. To 

our knowledge, ours is the only :nodel to estimate the population-level cost savbgs of enhanced caregiver support under current practices of identifying patients with dementia. 

Year 

5 

lS 

602 

Cumulative savings for people with dementia(~._) ____ _ 

All 

288,964,986 

673.127,779 

995,0'33,1 98 

In residential facility" 

461 '172,852 

1,072,76 I .8' 8 

1 ,518,120,046 

In community 

-172,207,876 

-399 634,039 

-522,085,8S6 

scenarios were estimated at $2.64 billion and at 

:1early $100 million, respectively, driven largely 

by the variation in the assumed i\'YUCI effect. 

(See thr online Appendix for further details and 

complete results from the alternative-case analyses.)32 

A key question for policy makers is how to reduce 

the massive increase in dementia-related expenditures that is anticipated as the US population 

ages. Our study demonstrates that if a program 

providing multicomponent support for informal 

caregivers of .:.:ommunity-dwelling patients with 

dementia were widely available a...J.d used, it could 

lead to substantial savings in direct health care 

spending. 'lhat would De the case even if there 

were no major breaktlrrough in the prevention or 

rreatment of dementia. 

Our model projected $996 million in cumulative savings in direct costs over fifteen years L'l 

Minnesota. 1his estimare was highly sensitive to 

alternative assu_mprions. Nonetheless, rhe savings remained subslantial in alternative-case a!1-

alyses, ranging from $100 million to $2.6 billion. 

The estimated savbgs were driven Jythe demonstrated effectiveness of the NYUCI in delaying 

residential placement. In addition to offering a 

potential finandal Oenefit for payers and society 

at large, that drtay is concordant with the wishes 

of most people with dementia and their caregivel·s to avoid or delay 1·esidential placement. 

Co~1sistent -with this scenario, our model projected that after fifteen years of having the 

l\TYUCI 3Vailable statewide, 19.3 percent fewer 

people with rlementia would die in institutions. 

Several studies have estin1ated the expenses 

attributable to dementia, but estimates of the 

economic i;npact of nonpharmacologic interventions are rare. David Weimer and Mark Sager 

simulated the early identification of Alzheimer's 

1\PRIL 201.1 33:4 

The observed sensitivity of our results to the 

assumed .Nl'UCI effect size raises the jssue of the 

~TY'UCI's generalizability. Treatment in an urban 

university hospital settin.g among caregivers of 

limited fthnic divfrsiry may differ L"'l effectiveness from treatment applied statewide. Cultural, 

demographic, and socioeconomic factors such as 

interesr in counseling and levels of education 

and income may alter rates of program completion and, ultimately, reskientjal placement.23 

However, suDstantially delayed residential 

placement with the N"'\'1JCiwa.s observed not just 

in the New York metropolitan area with spouse 

caregivers, but also in 1\-linnesota with adult 

child caregivers. This suggests ~hat the l\TYUCI 

may be generalizable to other populatiom:. 17 

We designed our model to investigate savings 

under the assumption of '.videspread program 

availability and complete participation, without 

factorbg in program costs, so we could determine whether sufficient economic potential existed to warrant analyses of return on investment. TI1e sensitivity of our estL'llated savings 

to tbc assumed N'r1.JCI effect size and number 

of p3rticipant~ .wggests that actual ::.avings in 

1\-IiiL'lesota could differ greatly depending on 

the firlelity with which the l\TYlJCI was implemented, program costs, and caregiver participation rates. In fact, these important factors varied 

greatly across sites in the Minnesota NYUCI 

demonstration project, which indicates the need 

for further research o_'l the effective statewide 

replication of the NYUCL2

' 

Our results indicate that er~~anced caregiver supporti~ a promisjng way to moderate the growing 

economic burden of dementia. By quantifying 

the potential savings for a single state, we demonstrated that subsrantiallong-term savings in 

direct costs would be possible even without a 

breakthrough in the pharmacologic treatment 

of dementia. Ol.lr findings arc relevant to the 

larger policy question of where resources should 

be direded in the fight against de.:nentia. MultiDownloaded from con!enl.h~:>altbaffa,m.org by Health Affairs on August 3, 2015 

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