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78–139 2013

ALZHEIMER’S DISEASE: THE ONGOING 

CHALLENGES 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

SECOND SESSION 

DECEMBER 9, 2010 

Serial No. 111–162 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 


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COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

JERRY MCNERNEY, California 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 


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SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

JOHN D. DINGELL, Michigan 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JANE HARMAN, California 

CHARLES A. GONZALEZ, Texas 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

NATHAN DEAL, Georgia, 

Ranking Member 

RALPH M. HALL, Texas 

BARBARA CUBIN, Wyoming 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 


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C O N T E N T S 

Page 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 1 

Hon. Phil Gingrey, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 3 

Hon. Lois Capps, a Representative in Congress from the State of California, 

opening statement ................................................................................................ 4 

Hon. John Barrow, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 5 

Hon. Donna M. Christensen, a Representative in Congress from the Virgin 

Islands, opening statement ................................................................................. 6 

Hon. Zachary T. Space, a Representative in Congress from the State of 

Ohio, opening statement ...................................................................................... 7 

Hon. Anna G. Eshoo, a Representative in Congress from the State of California, prepared statement .................................................................................. 57 

Hon. Joe Barton, a Representative in Congress from the State of Texas, 

prepared statement .............................................................................................. 59 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, prepared statement ................................................................. 63 

Hon. Marsha Blackburn, a Representative in Congress from the State of 

Tennessee, prepared statement .......................................................................... 65 

WITNESSES

Marcelle Morrison-Bogorad, Director, Division of Neuroscience, National Institute on Aging, National Institutes of Health ..................................................... 9 

Prepared statement .......................................................................................... 12 

Harry Johns, President and Chief Executive Officer, Alzheimer’s Association .. 22 

Prepared statement .......................................................................................... 25 

Eric J. Hall, President and Chief Executive Officer, Alzheimer’s Foundation 

of America ............................................................................................................. 31 

Prepared statement .......................................................................................... 33 

Marc Cantillon, M.D., Executive Director, Coalition Against Major Disease, 

Critical Path Institute ......................................................................................... 39 

Prepared statement .......................................................................................... 41 

SUBMITTED MATERIAL

Article entitled, ‘‘Evidence for Neurocognitive Plasticity in At-Risk Older 

Adults: The Experience Corps Program,’’ in Journal of Gerontology: Medical 

Sciences, 2009, submitted by Mr. Shimkus ....................................................... 68 


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ALZHEIMER’S DISEASE: THE ONGOING 

CHALLENGES 

THURSDAY, DECEMBER 9, 2010 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 1:47 p.m., in Room 

2322, Rayburn House Office Building, Hon. Frank Pallone, Jr., 

[chairman of the subcommittee] presiding. 

Present: Representatives Pallone, Engel, Capps, Barrow, 

Christensen, Space, Gingrey, and Markey. 

Staff Present: Ruth Katz, Chief Public Health Counsel; Sarah 

Despres, Counsel; Steve Cha, Professional Staff Member; Allison 

Corr, Special Assistant; Alvin Banks, Special Assistant; Elizabeth 

Letter, Special Assistant; Ronald Allen, Staff Assistant; Clay 

Alspach, Minority Counsel, Health; Sean Hayes, Minority Counsel, 

Oversight and Investigations; and Ryan Long, Minority Chief 

Counsel, Health. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. The meeting of the House subcommittee is called 

to order. And today we have a hearing on Alzheimer’s disease and 

its ongoing challenges, and I will recognize myself for an opening 

statement. 

As many of us know, Alzheimer’s disease is an irreversible progressive brain disease that slowly destroys memory and thinking 

skills and, eventually, even the ability to carry out the simplest 

task. Damage first strikes the areas of the brain that control memory, and problems in memory are the first symptoms to be noticed 

in early stages of Alzheimer’s disease. As deterioration progresses 

to other areas of the brain, problems with other brain functions develop as well, as severe Alzheimer’s disease can affect every part 

of the brain and rob its victims of their very lives and dignity. 

Alzheimer’s disease is fatal. It is estimated to be the sixth leading cause of death in our country. NIH estimates that as many as 

5.1 million Americans may have Alzheimer’s today, and this figure 

is expected to grow to 13.5 million Americans by 2050. 

The truth of the matter, though, is that these figures give an incomplete snapshot of Alzheimer’s disease and related dementias. 

Alzheimer’s disease is, at the heart, a family disease, as the intense 

caretaking that those afflicted with the disease requires places a 


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heavy financial and emotional burden on the family. The serious 

medical complications related to Alzheimer’s disease mean that 

caregivers often struggle to maintain work outside their home to 

earn a living, while balancing a never-ending schedule of monitoring and treatment for family members living with the disease. 

For many adults, known as the sandwich generation, they are 

duly responsible for caring for their aging parents while they are 

also caring for their children. And Alzheimer’s has a devastating 

impact not just on families but on our national economy. It is projected that the national cost associated with caring for those with 

Alzheimer’s exceeds $172 billion each year, with the figure expected to rise to $1 trillion by 2005. And these costs represent the 

burden on Medicare, Medicaid, private insurance caregiving and 

out-of-pocket costs for families. Of this figure, $123 billion can be 

attributed to Medicare and Medicaid alone. 

Until we cure Alzheimer’s, it is imperative that our health care 

system provides stronger support for families caring for loved ones 

with the disease. The Affordable Care Act, which we passed earlier 

this year, establishes the Community Living Assistance Services 

and Support, or CLASS programs, a new national long-term care 

insurance option. This legislation also provides Medicare beneficiaries with free annual wellness visits, which may increase the 

detection of early cognitive impairment, enabling patients and families to better plan for care needs. And, finally, the Affordable Care 

Act will ensure that Americans living with Alzheimer’s disease and 

other preexisting conditions will not have to worry about having 

their insurance coverage discontinued or denied. 

In the future, whether families are subject to the triumph or 

tragedy of Alzheimer’s will be dependent on the innovation and 

new drugs and therapies being investigated in laboratories across 

our Nation. And today we are going to hear from the National Institute on Aging at the NIH about the great work their scientists 

are doing to better understand, diagnose, and treat Alzheimer’s disease. NIA’s translation objectives have focused on supporting early 

drug discovery and preclinical drug development of novel compounds for Alzheimer’s therapy. 

We are also going to hear from the Coalition Against Major Diseases within the Critical Path Institute on its efforts to improve applied regulatory science and how this will strengthen our ability to 

treat diseases like Alzheimer’s. 

And, finally, we will hear from the Alzheimer’s Association and 

Alzheimer’s Foundation of America about the key research they are 

supporting, as well as their initiatives and resources that help support day-to-day caretaking of individuals with Alzheimer’s. 

Now, many of the members of this committee have been touched 

by Alzheimer’s and expressed interest in examining the complex 

issues related to the disease. I do want to highlight the exemplary 

leadership and advocacy for Alzheimer’s disease by a member of 

our full committee, Mr. Markey. I think he is going to be able to 

come today, but he basically has been touched, of course, by his 

late mother’s own struggle with the disease, and because of that 

and for a lot of reasons he has been an energetic leader in Congress 

and also chairs the Congressional Caucus on Alzheimer’s disease. 

So he may be joining us later, but I did want to mention him today. 


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And I will now recognize for an opening statement our ranking 

member, Mr. Gingrey. 

OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. GINGREY. Mr. Chairman, thank you. And I certainly want to 

thank our witnesses for their patience with us today. The witnesses 

will testify, as we hear from them, Alzheimer’s disease presents a 

looming threat to the health of our Nation, and today I think the 

number is as many as 5 million Americans in the United States 

have this dreaded disease. And the scientific community is in 

agreement that these numbers will only increase significantly in 

the coming years as our society ages. 

According to the United States Census Bureau, the number of 

seniors age 65 and older will actually double to about 72 million 

in the next 20 years as these baby boomers all reach retirement 

age. However, as Dr. Morrison-Bogorad will testify, the generation 

behind them, I think this is what is referred to as Generation X, 

and these are the folks born between 1965 and 1980, it is a significantly smaller generation than the baby boomers. 

So why is this comparison significant for the purposes of the 

hearing today? As Alzheimer’s is a degenerative and, as of yet, incurable disease that requires constant monitoring, the role of the 

main caregiver often falls to our family members, as we all know. 

According to a study conducted by the Alzheimer’s Association, an 

estimated 11 million Americans provide 12.5 billion hours of unpaid care annually for people, usually their loved ones, with Alzheimer’s and other dementias. 

The disease also does require large amounts of medical care in 

addition to in-home and community-based services. This high use 

of medical services results in substantial cost to the Federal Government, States, employers, and indeed families. 

If the number of Alzheimer’s patients does indeed double over 

the next 20 years as many predict it will, we could be facing a 

health care crisis if the number of family caregivers declines, and 

of course the costly care for these patients ultimately shifts to paid 

health care professionals. 

Alzheimer’s disease is also a personal issue for me. My wife’s 

mother, Laura Neill Ayers, was a very healthy and vibrant 88-yearold woman. She didn’t hear very well. I think she loved that. But 

she was active. She loved to watch sports, and she spent time in 

her room every day watching baseball. Her husband, Bill Ayers, actually played baseball for the New York Giants in the 1940s, and 

Laura picked up her love of the game from her husband. Watching 

baseball became one of her favorite pastimes and thoughts of 

spring training I think kept her warm all winter long. 

Seemingly overnight, all of that changed. She was diagnosed 

with dementia and, we suspect, Alzheimer’s halfway through her 

89th year, and the woman that we know and love was changed forever. Gone was the active woman, 88. In her place was a woman 

that seemingly was trapped inside her own body, unable to enjoy 

the comforts of these golden years. 


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I cannot begin to describe how emotionally destructive this disease was, as many of you I am sure know, not only for my motherin-law but for my entire family. 

There are many stories like this one that help underscore the importance of finding a cure. Today there are no known treatments 

to prevent, cure, or even delay the onset of Alzheimer’s. The five 

drugs currently approved by the FDA have been shown to be successful in reducing the symptoms of the disease, but much more 

needs to be done to ultimately find a cure. 

And so with that thought in mind, I would like to welcome all 

of our witnesses here today. Specifically, I am interested in hearing 

from Dr. Marc Cantillon, the executive director of the Coalition 

Against Major Diseases for the Critical Path Institute. As Dr. 

Cantillon will touch on in his testimony, the goal of his organization is to promote a forum for scientists from the FDA, academia, 

and industry to evaluate innovative testing methods for the use in 

drug development. 

As members of this subcommittee have heard during past hearings, pharmaceutical drug development in the United States can 

benefit from greater collaboration between industry and the FDA. 

To the FDA’s credit, they have recognized this fact in many areas, 

including antibiotic drug development, something for which I and 

a bipartisan group of members on this subcommittee will be advancing pieces of legislation in the 112th Congress. 

As a representative of the citizens of the 111th of Georgia, I believe the government works best when its processes are constantly 

scrutinized and reformed, when necessary, to ensure they work as 

efficiently as possible. That theory applies not only to Congress and 

the White House, but government agencies as well. Therefore, I 

hope to learn more about this phrase, ‘‘applied regulatory science,’’ 

during the question-and-answer portion of the hearing and how it 

might improve patient access to quality care. 

Mr. Chairman, thank you for scheduling this hearing today. And 

with that, I see my time has expired and I yield back. 

Mr. PALLONE. Thank you, Mr. Gingrey. 

Mr. GINGREY. Mr. Chairman, I did want to ask for unanimous 

consent to submit for the record our actual subcommittee ranking 

member, Mr. Shimkus, a study that comes out of John Hopkins, 

‘‘Evidence for Neurocognitive Plasticity in At-Risk Older Adults,’’ 

and the experience of that study. 

Mr. PALLONE. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. PALLONE. Next for an opening statement, the gentlewoman 

from California, our vice chair, Mrs. Capps. 

OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mrs. CAPPS. Thank you, Chairman Pallone, for holding this, the 

final Health Subcommittee of the 111th Congress. And I want to 

thank you for your wonderful service as chairman over the last 4 

years. 

Alzheimer’s disease is a very topical subject for this hearing, because the challenges faced by patients and their loved ones are so 

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tem. Long term, these are some of the challenges which fit with 

Alzheimer’s so well: long-term care availability and its costs; respite care; an adequate workforce; and research for better treatments and a cure. 

Now, that is just touching the surface of the many challenges 

that we face with this and so many other chronic conditions. And 

thankfully, the new health care law provides much-needed relief 

for many of these concerns. One of these is the new long-term care 

insurance option. There is also Medicare prescription cost relief. 

And there is opportunities for training the next generation of 

health professionals; in addition, the Cures Acceleration Network, 

along with what our chairman mentioned as the CLASS Act. And, 

of course, we have a lot more that we should undertake now within 

this framework of the new legislation. 

Some of these other steps we can take, such as passage of legislation that I am very proud to cosponsor in the National Alzheimer’s 

Act I know you are going to be addressing today in your testimony, 

including the National Alzheimer’s project, with the goal being that 

we can provide and develop a comprehensive strategy for how to 

address Alzheimer’s disease, how to continue, as many of you have 

been doing over these past many years. 

So I do look forward to hearing from our witnesses today about 

the latest in Alzheimer’s research. I understand there are some 

very critical breakthroughs that have been working their way 

through the clinical trials and so forth, and also what you see for 

us in guidance in the next Congress as pressing needs that patients 

and so many of them, increasing numbers of their family members 

and caregivers, are going to experience. 

As has also been mentioned, there is probably not one person in 

this room who hasn’t been touched personally by this devastating 

disease. And we need to know it is a crisis proportion, really, in our 

society now, how to best equip ourselves and our communities to 

cope with it. 

So I yield back and look forward to today’s hearing. 

Mr. PALLONE. Thank you. And I also wanted to thank you also 

as the vice chair. You have been really tremendously helpful, and 

so often giving us insight on issues because of your practical experience also as a nurse and your background. So thank you. 

Our next member for an opening statement, the gentleman from 

Georgia, Mr. Barrow. 

OPENING STATEMENT OF HON. JOHN BARROW, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. BARROW. Thank you, Mr. Chairman. I want to thank you 

also for your leadership throughout the 111th Congress on this 

committee. 

The poet said that comparisons are odious, and at the personal 

level no one wants their personal trauma or tragedy compared to 

someone else’s. But at the level of public health and social impact, 

I think some comparisons are useful. The scourge of cancer has 

many faces. The scourge of Alzheimer’s has a very definite profile, 

many different impacts on folks, but a very different impact in 

terms of the family. 


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I think it is useful to point out that we didn’t really begin to 

marshal the Nation’s resources in the war on cancer until folks 

could say, everybody knows somebody who has been touched by 

cancer. I think it is fair to say that everybody now knows somebody 

who has been touched by Alzheimer’s. Nobody knows the particular 

impact it has on family and on the communities of interest around 

families that is the hallmark of this dreaded disease. So I think we 

can take inspiration from the fact that so many folks are impacted 

by this. 

I think it is important to point out also in ways that supplement 

what others have said, the cost of this disease. The uncompensated 

care and the out-of-pocket expense to our system is staggering and 

growing exponentially in ways that I think compare very unfavorably to some of the other diseases that we deal with at a social 

level. Right now, we are spending something like $170-plus billion 

a year in compensated and uncompensated care, taking into account the fair market value of the services that folks are being 

forced to render and not getting any kind of compensation for at 

all. That is coming out of our gross social product. It is projected 

to cost our society something on the order of $1 trillion a year at 

current growth levels by the time we reach 2050. So it is staggering in its potential for exponential growth and impact on folks. 

The point is, this is not only the right thing to do in terms of 

the quality of the life of folks affected by this. It has never been 

truer to say that this is not only the right thing to do, but it is the 

smart thing for us to do, to marshal our resources in more effectively and economically managing and treating and preventing this 

dreaded disease. 

So, with that, I look forward to hearing the testimony of our witnesses and thank them for coming today. And I thank you, Mr. 

Chairman, for making this, the last hearing of this committee and 

this Congress, a very large issue that we are going to be dealing 

with for a very long time. 

With that, I yield back. 

Mr. PALLONE. Thank you, Mr. Barrow. 

Next, the gentlewoman from the Virgin Islands, Mrs. 

Christensen. 

OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A 

REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS 

Mrs. CHRISTENSEN. Here thank you, Mr. Chairman. And thank 

you for holding this hearing. And thank you, welcome to the folks 

who are here to testify. And thank you not only for taking the time 

to be here but for the work that you all are doing. I really appreciate the approach that is being taken to this devastating disease, 

a disease that is devastating to not only individuals but families 

and communities, and potentially to our country, because it is a 

wholistic approach, looking at prevention, treatment, and research, 

but also looking at the caregivers who are often forgotten. 

I wanted to call attention to several areas. 

First, the cost of care. Due to the cost of care, this disease has 

the potential to bankrupt our health care system unless we invest 

in all of these aspects today. In fact, by 2050, it is estimated that 


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13.5 million Americans will be suffering from Alzheimer’s, and the 

cost might be as much as $1 trillion a year. 

Second, there is a grave discrepancy between the funding for research for this sixth leading cause of death compared to other leading causes of death, where billions are being spent compared to just 

over $400 million on Alzheimer’s. 

Third, I want to call attention to the fact that racial and ethnic 

minorities are disproportionately impacted with Alzheimer’s, with 

African Americans being twice more likely and Hispanic Americans 

1.5 more likely to suffer from Alzheimer’s and other dementias, despite the fact that they are underdiagnosed compared to their 

white counterparts. 

And I wanted to mention, too, other pieces of legislation just to 

show that the Congressional Black Caucus has been aware and engaged in this issue for several years. One is H.R. 4123, the Alzheimer’s Treatment and Caregivers Support Act, introduced by 

Representative Maxine Waters, and H.R. 1192, the Alzheimer’s 

Family Assistance Act, introduced by Eddie Bernice Johnson. Both 

of these bills, like the others that are being mentioned in the testimonies, will help to take the fight against Alzheimer’s several steps 

forward and be a part of this solution to this devastating problem. 

So, again, thank you, Mr. Chairman. And thanks, all of you, for 

being here. 

Mr. PALLONE. I thank the gentlewoman. 

And next is the gentleman from Ohio, Mr. Space. 

OPENING STATEMENT OF HON. ZACHARY T. SPACE, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF OHIO 

Mr. SPACE. Thank you, Mr. Chairman. Today is my final hearing 

in committee, and I wanted to first express my gratitude to Mr. 

Chairman and to Chairman Waxman, as well as members on both 

sides of the aisle, for their work in some of the most profound 

issues of the day and even a generation: issues like energy and 

health care and the transformational effect that the whole 

broadband era has brought to this country and to our culture. And 

while we didn’t accomplish everything that I think we had set out 

to accomplish, we got a lot done. And there is a lot to be done. 

My district back in Ohio is a very rural district. It is Appalachian 

Ohio, where the people are good and they work hard, a lot of good 

things going for us back there. But there are a lot of challenges 

that we have, and we share those challenges with the rest of rural 

America. And one of the things that is unique about this committee, I think, is the effect that it can have on bridging the divide 

that exists between urban and suburban America and rural America. And certainly the divide does exist when it comes to accessing 

education, certainly with regards to accessing health care. And I 

encourage the committee to be every bit as ambitious in tackling 

some of those challenges in the upcoming session of Congress. 

With respect to the issue of today, Alzheimer’s, I sympathize 

with the remarks of my colleague and friend from Georgia, Mr. 

Barrow; $172 billion a year, those are war-like numbers. In other 

words, those are the kind of numbers you spend when you go to 

war. If you couple the amount of money that we are spending as 

a society on a disease like Alzheimer’s with what we are spending 


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on diseases like diabetes, cancer, and the list goes on and on, it 

soon reaches the trillion-dollar level. In fact, Alzheimer’s alone, by 

the year 2050, will reach that level. And we cannot sustain that as 

an economy. 

When John Barrow says it is not only the humane thing to do, 

it is the right thing to do, what he is saying is if it is not important 

enough to deal with these issues simply because of the mitigation 

of human suffering that occurs as a result of these diseases, then 

certainly we should be able to justify it because of the cost. And 

like Alzheimer’s and diabetes and cancer, the answer, at least from 

the congressional perspective, is in medical research. We cannot 

simply rely upon the private sector to tackle these diseases, not 

simply because it is not the right thing to do but we can’t afford 

it. 

For every dime we invest today in research, we will receive a return of dollars in the future. Many dollars. So I urge this committee in future efforts, including its efforts with regards to Alzheimer’s, to bear in mind the obligation that we have as an institution, as a government, and the duty we have to our people to conquer these diseases through early diagnosis, advanced diagnosis, 

advanced treatment, and above all, cure. Let’s not forget cure. 

With that, Mr. Chairman, again thank you for your leadership, 

and it has been a pleasure serving on your committee. 

Mr. GINGREY. Mr. Chairman, could I have a brief point of personal privilege, a friendly point of personal privilege? 

Mr. PALLONE. Absolutely. 

Mr. GINGREY. And let me first of all, to my friend from Ohio, Mr. 

Space—and he truly is my friend and he and I know that—indeed 

we will miss him. He is a great member with a great heart, and 

I think the words that he just expressed to this committee indicate 

the type of person that he is. And, Zack, we will miss you and I 

really enjoyed serving with you. And I hope we will keep in touch, 

my friend. 

Also, I wanted to say to you, Mr. Chairman, and I say this on 

behalf of my colleagues who I guess are on airplanes about now, 

trying to get home to their families, and not the least of which, of 

course, would be ranking member John Shimkus. We have really 

enjoyed serving with you, under you, on this Health Subcommittee 

of Energy and Commerce, not always agreeing on every vote, in 

fact disagreeing a lot of times. But no one could be more agreeable 

when he disagrees. Mr. Chairman, We respect you and hold you in 

high regard and look forward to serving with you in the 112th. 

Mr. PALLONE. Well, thank you. I really appreciate that. And I 

want to say the same about you. Your input not only as a physician, but just in general, has been fantastic. And I kind of wish 

that Mr. Shimkus was here today, too, because I wanted to say 

how easy it was to work with him in the last—I guess not 2 years, 

a little over a year or so. And it is true, I think, that even though 

we often disagree on a lot of issues, that we have been able to work 

together on many issues. And it kind of bothers me sometimes 

when the media, I guess, pays attention to the differences and 

doesn’t highlight how many bills we have actually passed out and 

worked on together and got signed into law that were very important for the American people. So thank you. 


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And let me say about Mr. Space. Again, I know that I am really 

going to miss him. He has really contributed a lot and he has been 

a friend on so many issues. So thank you. Thank you very much. 

So we will get to our panel. Let me welcome you, first of all. We 

only have one panel today, so I will introduce the members. 

Starting on my left is Dr. Marcelle Morrison-Bogorad, who is director of the Division of Neuroscience at the National Institute on 

Aging, with the National Institutes of Health. 

And next is Mr. Harry Johns, who is president and chief executive officer of the Alzheimer’s Association. 

And then we have Mr. Eric J. Hall, who is president and chief 

executive officer of the Alzheimer’s Foundation of America. 

And, finally, Dr. Marc Cantillon, who is executive director of the 

Coalition Against Major Disease, from the Critical Path Institute, 

and also happens to be a constituent, so I should know how to pronounce his name, from one of my towns, Kingsbury. So thank you 

in particular for being here today. 

We have 5-minute opening statements that become part of the 

record, and each of you can also submit additional statements in 

writing for inclusion if you would like. 

STATEMENTS OF MARCELLE MORRISON-BOGORAD, DIRECTOR, DIVISION OF NEUROSCIENCE, NATIONAL INSTITUTE 

ON AGING, NATIONAL INSTITUTES OF HEALTH; HARRY 

JOHNS, PRESIDENT AND CHIEF EXECUTIVE OFFICER, ALZHEIMER’S ASSOCIATION; ERIC J. HALL, PRESIDENT AND 

CHIEF EXECUTIVE OFFICER, ALZHEIMER’S FOUNDATION OF 

AMERICA; AND MARC CANTILLON, M.D., EXECUTIVE DIRECTOR, COALITION AGAINST MAJOR DISEASE, CRITICAL PATH 

INSTITUTE 

Mr. PALLONE. And I will now recognize Dr. Morrison-Bogorad. 

STATEMENT OF MARCELLE MORRISON-BOGORAD 

Ms. MORRISON-BOGORAD. Thank you very much, Chairman. And 

I really thank you for inviting me to appear before you today to discuss the pressing issue of Alzheimer’s disease. 

The National Institute on Aging is the lead institute for Alzheimer’s disease of the NIH. So in this regard I want to tell you 

that you can now download copies of our 2009 congressionally mandated ‘‘NIH Progress Report on Alzheimer’s Research’’ from the 

NIH Web site. 

I am retiring at the end of this year and am truly sad that a cure 

for Alzheimer’s has not been found on my watch. But the momentum is there, and I believe that my successor will have this joy. 

Federal researchers, other scientific agencies, the private sector, 

and not-for-profit are collaborating as never before to try to solve 

the mysteries of this disease. For example, we have regular meetings with each of the entities that will testify at this hearing. We 

have partnered with the Alzheimer’s Association on many occasions, and ongoing is a joint venture on updating the definition of 

AD. 

The Alzheimer’s Foundation of America and other organizations 

held House and Senate briefings a couple of weeks ago where Richard Hodes, director of NIA, was asked to testify. And we work with 


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the Coalition Against Major Diseases for the Critical Path Institute 

on matters related to innovations and marker use on clinical trials. 

The NIA plans and manages an extensive program to better treat 

and ultimately to prevent Alzheimer’s. How do we do this? Well, 

from our Alzheimer’s Summit in 2006, the 2010 State of the 

Science Conference, from numerous specialized workshops, from 

program review by our NIA Council every 4 years, we get input 

from all these sources, and from these decide on the best ways to 

advance Alzheimer’s research commensurate with our funding. 

For example, at the 2006 Summit, it was recommended that we 

develop a project focusing on early onset AD families. We have 

since funded the International Dominantly Inherited Alzheimer’s 

Network to study preclinical disease in these families. Earlier this 

year, an NIH State of the Science Conference reported that there 

was, so far, insufficient evidence that any behavioral interventions 

for AD or age-related cognitive decline were effective, and that we 

ought to devote more resources to these questions. 

Even before the report was finalized, we had stepped up our 

funding of clinical trials to get definitive evidence whether or not 

various exercise and cognitive interventions might impact age-related cognitive decline, mild cognitive impairment, and AD. Now 

we are funding around 20 such trials. 

The Alzheimer’s Disease Neuroimaging Initiative is another example of our leadership. ADNI is a very successful public-private 

partnership to identify biological and imaging markers for better 

ways of monitoring AD clinical trials and also identifying persons 

at risk for the disease preclinically. Here we initiated the process 

through a series of meetings where we brought together all interested parties to discuss what initiative would be most useful for 

them for development in a precompetitive setting, and these discussions led to funding of ADNI in 2004, with substantial financial 

support from industry and from not-for-profits such as the Alzheimer’s Association, coordinated by the Foundation for NIH. 

Another aspect of our planning process is to ask our director for 

funds to specifically target new areas that need to be developed. An 

example is our Translational Initiative. Partly through these targeted funds, this important and innovative portfolio has grown to 

over 60 projects, each aimed squarely at bringing a new drug to the 

stage where it can get FDA approval for performing clinical trials. 

This is a particularly important area for us to develop, as pharmaceutical companies are often unwilling to put monies into the beginnings of the drug discovery process and translational research. 

One reason that drug trials have not worked so far may be that 

the drugs are given too late in the disease to have any effect, but 

prevention trials to test those possibilities take a lot of money and 

time under current protocols. We are developing new methodologies, and in the meantime we have been able to fund a number of 

prevention trials by the simple way of adding cognitive measures 

on to trials started for other clinical conditions often by other institutes. So it is a cheap way of funding these trials. 

But other possible drug therapies for Alzheimer’s are directed 

against unique aspects of the disease, and so for these more specialized interventions NNIA must continue to develop AD-specific 

trials. 


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We make difficult decisions all the time about where to put our 

resources. We do not have a crystal ball to tell us what approach 

will eventually pay off in relieving suffering from this frightening 

disease. We are committed to trying every promising avenue, and 

we will succeed. Thank you. 

Mr. PALLONE. Thank you very much. 

[The prepared statement of Ms. Morrison-Bogorad follows:] 


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Testimony before the 

Subcommittee on Health 

Committee on Energy and Commerce 

United States House of Representatives 

Alzheimer's Disease: Ongoing Challenges 

Statement of 

Dr. Marcelle Morrison-Bogorad 

Director 

Division of Neuroscience 

National Institute on Aging 

For Release on Delivery 

Expected at 10:00 a.m. 

December 9, 2010 
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Good morning, Chainnan Pallone and Distinguished Members of the Subcommittee: 

Thank you for inviting me to appear before you today to discuss Alzheimer's disease, a 

devastating disorder with a profound impact on individuals, families, the health care system, and 

society as a whole. I am Dr. Marcelle Morrison-Bogorad, and for fourteen years I have been 

Director of the Division of Neuroscience at the National Institute on Aging (NIA), a part ofthe 

National Institutes of Health and the lead federal agency for Alzheimer's disease research. I am 

delighted to be here today to tell you about the progress we are making, in partnership with the 

research and advocacy communities, regulatory bodies and industry, toward understanding, 

treating, and preventing Alzheimer's disease. 

We humans have created our complex societies not because we have bigger hearts or 

hands, but because we have bigger and more complex brains. Our intelligence has allowed us to 

create conditions that enable most of us to live longer lives. These added years bring enormous 

opportunity and richness to our lives. But at the same time, advancing age brings us face to face 

with a growing burden of chronic, age-related diseases, including Alzheimer's disease. 

Alzheimer's disease is a major public health issue for the United States. Today, it is 

estimated that 2.4 million I to 5.1 million2 people in the United States have Alzheimer's disease. 

While estimates vary, depending on how dementia is measured, scientists agree that without 

breakthroughs in prevention or early treatment, the number of people with Alzheimer's will 

increase significantly as society ages. Studies suggest that the number of people with the disease 

doubles for every 5-year age interval beyond age 65, and the U.S. Census Bureau estimates that 

the 65-and older population will double to about 72 million during the next 20 years, starting 

with the oldest "baby boomers" who will turn 65 in 2011. The ranks of the very elderly, those 85 

years old and older and at the highest risk of developing Alzheimer's disease, will increase even 

1 Plassman BL, Langa KM, Fischer GG, Heeringa SG, Weir DR, Ofstedal MB, Burke JR, Hurd MD, Potter GG, 

Rodgers WL, Steffens DC, Willis RJ, Wallace RE. Prevalence of dementia in the United States: the Aging, 

Demographics, and Memory Study. Neuroepidemiology 2007;29(1-2):125-132. 

2 Hebert LE, Scherr PA, Bienias JL, Bennett DA, Evans DA. Alzheimer disease in the US population: prevalence 

estimates using the 2000 census. Archives f!fNeurology 2003;60(8): 1119-1122. 

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more rapidly, potentially tripling their numbers by 2050. At the same time, the relatively small 

size of the "Generation X" cohort that follows the baby boomers may lead to a decrease in the 

number of potential caregivers by 2050, indicating that a higher share of the caregiving burden 

may need to be assumed by the health care system. 

The staggering complexity of the brain and our incomplete understanding of fundamental 

aging mechanisms have made seeking a cure for Alzheimer's disease in our older population a 

difficult task indeed. We know vastly more than we did even five years ago, but, if we have 

learned one thing, it is just how complex a disease Alzheimer's is. I can report to you today, 

however, even amid such challenges, that we have made and are continuing to make dramatic 

gains in our ability to understand, diagnose, and treat Alzheimer's disease, progress that offers us 

the hope of reversing current trends. 

What has brought us to this point is a sustained research program employing different 

approaches to the research challenge. This can involve the support of individual investigators 

who have a particular research theory or larger scale studies employing the newest technologies 

to mine extensive data sets to find genes or risk factors related to Alzheimer's disease. Some 

research questions, for example, are straightforward and can be pursued with relatively small 

grants. One recent finding, as a case in point, suggests that a genetic mutation may be involved 

in impairing the ability of neurons to break down and re-use helpful proteins, as well as 

compromising efforts to clear away harmful waste proteins and other debris; the insight helps tell 

us what may underlie the pathology of one of the mutations responsible for early onset 

Alzheimer's, and that perhaps also may contribute to late onset disease. Ultimately, this 

information will allow us to design interventions that may prevent or reverse the processes that 

underlie disease. 

NIA also encourages and engages in partnerships to create synergy and leverage 

resources within and among scientists, institutions and organizations. NIH-supported 

investigators often combine their expertise through Program Project Grants, in which a number 

of collaborators with different skills work together on a common problem. Investigators on one 

NIA-supported Program Project have worked together to show that around 20 percent of older 

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adults who are functioning normally have Alzheimer's characteristic amyloid plaques in their 

brains, and that many have subtle cognitive and brain changes typical of a person with the 

disease. Today, we are supporting long-term follow up studies of these individuals: How many 

of them will develop Alzheimer's disease? And when? And how are they able to function with 

levels of amyloid plaques in their brains that correlate with diagnosis of the disease in other 

individuals? 

In further support of collaborative research, NIA facilitates and participates in a number 

of strategic partnerships. The largest public-private partnership in Alzheimer's research is the 

Alzheimer's Disease Neuroimaging Initiative (ADNI), testing whether serial magnetic resonance 

imaging (MRI), positron emission tomography (PET), other biological markers, and clinical and 

neuropsychological assessment can be combined to measure the progression of mild cognitive 

impairment (MCI), often a precursor condition to Alzheimer's disease, and early onset of the 

disease, as well as to measure more accurately the effectiveness of potential therapies. NIA's 

partners in this groundbreaking endeavor include a number of other NIH Institutes (National 

Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National 

Institute of Nursing Research, National Institute on Drug Abuse, National Institute for Research 

Resources, and the National Institute of Biomedical Imaging and Bioengineering), 

pharmaceutical and diagnostic companies, and manufacturers of imaging equipment, as well as 

non-profit organizations and foundations, with important participation from the U.S. Food and 

Drug Administration. The partnership with private sector is managed by the Foundation for NIH, 

which Congress authorized several years ago to encourage and facilitate such projects. 

Using imaging techniques and biomarker measures in blood and cerebrospinal fluid 

(CSF), ADNI investigators have already established a method and standards for testing the levels 

of AD's characteristic tau and beta-amyloid proteins in the CSF, have correlated levels of these 

proteins with changes in cognition over time, and have determined that changes in these two 

protein levels in the CSF may signal the onset of mild Alzheimer's. Last year, funding under the 

American Recovery and Reinvestment Act expanded the scope of the original ADNI research by 

allowing enrollment of participants at an even earlier stage ofMCI, when symptoms are less 

severe, and this year the ADNI2 was funded to enroll a new cohort of participants and expand 

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on the collection of biological measures. ADNI data are freely available on line, and over 170 

papers worldwide have been published using ADNI data. ADNI's success has fueled similar 

studies in a number of other countries. 

A high priority for the NIH is the identification of possible risk and protective factors for 

cognitive impairment and dementia. One approach encourages and supports use of national 

surveys of health and well-being to learn more about not only disease risk, but effects on 

families, use of health care services, and more. For example, investigators with the long-running 

Health and Retirement Study, the nation's leading source of combined data on health and 

financial circumstances of Americans over age 50, collect data on the cognitive health of older 

Americans. NIA also works with the U.S. Census Bureau and the Federal Forum on Aging 

Related Statistics to coordinate data collection in the area of cognitive impairment and dementia. 

In recent years, there has been an explosion of knowledge from large-scale efforts, 

particularly in providing new clues about risk factor genes and possible environmental and 

lifestyle factors involved in Alzheimer's disease and cognitive impairment. Identifying risk 

factor genes pinpoints the brain pathways that are involved in the initiation of disease 

pathologies, and provides novel avenues for drug targeting. Until recently only one risk factor 

gene for late-onset Alzheimer's - the E4 allele of the APOE gene - had been validated. The 

advent of new technologies to find risk factor genes necessitated the identification of thousands 

of patients and controls for testing - far too many for anyone investigator to assemble - so we 

asked researchers in the genetics community to form a consortium and pool resources to find the 

remaining genes. The Alzheimer's Disease Genetics Consortium was funded last year, and in 

just one year, affiliated researchers have identified and confirmed an astonishing four additional 

risk factor genes. These investigators have gone on to form an international consortium with 

members of the European Union, an interaction facilitated by funding from the Alzheimer's 

Association, which will expand the pool of participants even further and facilitate even more 

rapid discovery of the remaining Alzheimer's genes. As with all our large studies, the data will 

be made broadly available to the scientific community. 

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A related area in which extensive scientific collaboration has been invaluable has been 

the study of families who are genetically predisposed to develop Alzheimer's disease in early to 

middle age. Such early-onset disease is rare, and individual investigators usually cannot identify 

enough individuals to study by themselves. NIA therefore established the Dominantly Inherited 

Alzheimer's Network (DIAN), a consortium of scientific investigators to identity, recruit, 

evaluate, and follow up individuals from families beset by early onset dominantly inherited 

Alzheimer's disease. The scientists involved in this study hope to identify the sequence of brain 

changes in early-onset Alzheimer's before symptoms appear. Understanding this process could 

provide insight as well into the more common late-onset form of the disease. Eventually, the 

investigators intend to conduct a clinical trial in this group. DIAN includes a number of sites in 

the United States as well as in England, and Australia. 

As basic knowledge accumulates, it is critical to apply what we have learned, as quickly 

as possible, to the ultimate goal - the development of interventions and therapies to treat or 

prevent Alzheimer's disease. NIA has a longstanding interest and commitment to translational 

research, and efforts shifted into high gear in 2004 when NIA launched a set of initiatives 

focused on supporting early drug discovery and preclinical drug development of novel 

compounds for Alzheimer's therapy. The goal of this translational program is to increase the 

number of investigational new drugs that can be then clinically developed either by the 

pharmaceutical industry or through publicly-supported clinical trials. In addition, the program 

supports the repurposing and reformulation of existing drugs, already approved for other disease 

conditions such as antihypertensive drugs, as well as the preclinical development of naturally 

occurring compounds. To date, these translational initiatives have supported more than 60 

projects aimed at discovering and developing novel compounds for more than a dozen different 

therapeutic targets such as amyloid, tau, various neurotransmitter and growth factor receptors, 

inflammation, ApoE, and more. NIA also co-funds a number of aspects of preclinical 

development for Alzheimer's disease through the trans-NIH Rapid Access to Interventional 

Development (NIH-RAID) Program (f1ttp:/lnihroadmap.nih.govlraidl). 

To support the extensive research efforts needed to understand the disease process and to 

test possible interventions, the NIA has organized institutions and studies to facilitate research 

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and collaboration. The 29 NIA-supported Alzheimer's Disease Centers (ADCs) across the U.S., 

are an invaluable resource and the source of many fundamental discoveries about Alzheimer's. 

These Centers combine the expertise of clinicians, pathologists, and many other scientists for 

studies across the research spectrum, from the longitudinal study of cognitively normal 

individuals and those in the early stages of disease to the clinicopathological study of their brains 

after death. The ADCs have provided essential resource and infrastructure support to efforts as 

diverse as clinical trials and ADNI. To maximize the combined efforts of the ADCs, NIA 

supports the National Alzheimer's Coordinating Center, which has made possible many new 

studies incorporating data from tens of thousands of participants seen annually from across the 

country, and additionally has provided essential infrastructure for DNA collection from Center 

participants for the Alzheimer's Disease Genetics Initiative. Data and biological samples are 

shared with scientists not in the Center network. 

Many clinical studies collect data on aspects of neurological and behavioral function, but 

the fact that different studies may not employ the same tests or agree on methodologies can 

make it difficult to compile data across the full range of normal neurological function, and to 

compare data across studies. Through the support of the NIH Blueprint for Neuroscience and 

the NIH Opportunity Network for Research in the Basic Behavioral and Social Sciences, a brief 

yet comprehensive measurement tool for assessment of cognitive, emotional, sensory and motor 

function is being developed. Known as the NIH Toolbox for Assessment of Neurological and 

Behavioral Function, these measures can be used to uniformly assess cognitive performance 

and to track changes in performance across the lifespan. In addition, NIA is currently 

partnering with the Alzheimer's Association to update the diagnostic criteria for Alzheimer's 

disease for the first time in 25 years. The new criteria, to be applied primarily in a research 

setting where they can be validated, will incorporate knowledge gained over a quarter-century 

of research, including the role of biomarkers in Alzheimer's dementia diagnosis. 

To assess the state of knowledge in developing interventions to prevent Alzheimer's 

disease the NIH last April convened the collaborative State of the Science Conference on 

Preventing Alzheimer's Disease and Cognitive Decline. The expert panel not experts in 

Alzheimer's research but experts in other aspects of biomedical research and caregiving - noted 

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that research is providing some important clues, but concluded that no interventions to prevent or 

delay the onset of age-related cognitive decline or Alzheimer's disease have been scientifically 

validated. The conference was convened by NIH in collaboration with HHS's Agency for 

Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the 

Centers for Medicare and Medicaid Services. 

NIA already has studies underway in a number of areas highlighted by the panel as areas 

in need of additional research. Several seek to determine whether behavioral interventions such 

as exercise or cognitive training might stem the development or progression of age-related 

cognitive decline or Alzheimer's disease. We know that exercise for example is good for healthy 

aging in a variety of ways, and observational studies and some short-term clinical trials have 

suggested that it might be beneficial in delaying the symptoms or preventing dementia or 

cognitive decline. Testing whether it may have an effect on Alzheimer's is very important. One 

very large clinical trial, the Lifestyle Interventions and Independence for Elders (LIFE), aims to 

determine whether a specific regimen of exercise reduces disability in the elderly, and a 

cognitive component to that study has been designed to determine whether exercise affects 

cognitive decline or development of Alzheimer's. 

The major clinical trial programs sponsored by NIA are the Alzheimer's Disease 

Cooperative Study (ADCS) and the pilot clinical trials initiative. These programs are in addition 

to continued support of investigator initiated clinical trials for Alzheimer's, MCI and age-related 

cognitive decline. The ADCS, a large clinical trials consortium with sites throughout the US and 

Canada, is a major initiative for Alzheimer's disease clinical trials in the Federal Government, 

addressing treatments for both cognitive and behavioral symptoms. The ADCS mission is to 

advance research in the development of clinical trial designs, instruments, and interventions that 

might be useful for treating patients with Alzheimer's disease, particularly interventions that 

might not be developed by industry. 

NIA currently supports over 60 clinical trials targeting aspects of Alzheimer's disease 

and cognitive decline, including those being conducted by the ADCS. Both pilot and large scale 

trials are being undertaken, addressing a wide range of interventions to prevent, slow, or treat 

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Alzheimer's and/or cognitive decline or to address behavioral problems in person with the 

disease. Experts in the field are coming to believe it likely that any treatment will be more 

effective if started before the disease takes hold, and so there is a particular emphasis on 

prevention trials in presymptomatic individuals using biomarkers identified through ADNI (or 

elsewhere, as appropriate). However, prevention clinical trials are very expensive. To optimize 

efficiency and pool resources, we collaborate with other NIH Institutes to incorporate cognitive 

endpoints into relevant existing and planned trials. One such study is the National Heart, Lung, 

and Blood Institute's (NHLBI's) Systolic Blood Pressure Intervention Trial (SPRINT), which 

will evaluate the health effects of lowering systolic blood pressure either to a target level of 140 

or to a target level of 120. The add-on study, SPRINT-MIND, is funded by NIA and the National 

Institute of Neurological Disorders and Stroke (NINDS) and will assess the effect oflowering 

systolic blood pressure on cognitive decline and development ofMCI and Alzheimer's disease. 

The study will also include brain imaging to measure treatment effects on brain structure, 

including white matter lesions typical of vascular disease. In partnership with the Food and Drug 

Administration, NIA also maintains the Alzheimer's Disease Clinical Trials Database, which 

provides information about Alzheimer's disease clinical trials at sites throughout the U.S. 

Finally, a number of studies have demonstrated that the chronic stresses of caring for a 

family member with dementia can cause lasting psychological and even physical consequences, 

and NIA works extensively with other agencies on interventions to meet the needs of 

Alzheimer's caregivers. An initiative with the National Institute of Nursing Research, Resources 

for Enhancing Alzheimer's Caregiver Health (REACH), has shown that a personalized 

intervention consisting of home visits, structured telephone support sessions, and telephone 

"check-ins" can significantly improve the quality oflife for caregivers of people with 

Alzheimer's disease. The REACH intervention is currently being translated more broadly 

through a partnership between the Veterans Health Administration Geriatrics and Extended Care 

Unit and the Memphis V A Medical Center, with participating centers in 15 states. The 

Administration on Aging is also implementing the REACH intervention at centers in Georgia, 

North Carolina, and Florida. 

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A core part ofNIA's mission is to disseminate information about research, aging and 

health to a variety of audiences. The NIA-sponsored Alzheimer's Disease Education and 

Referral Center (ADEAR) is the Federal government's leading source of evidence-based 

information about Alzheimer's disease and age-related cognitive change, providing resources to 

older people and their families, health professionals, and the general public. The Institute offers 

free publications and online materials about the disease and caregiving, a toll free telephone 

number for seniors and others without web access, details about clinical trials on Alzheimer's 

disease and a library for experts working with Alzheimer's patients. (ADEAR is located at 

www.nia.nih.gov/alzheimers and at 1-800-438-4380.) 

It is difficult to predict the pace of science or to know with certainty what the future will 

bring. However, the progress we have already made will help us speed the pace of discovery, 

unravel the mysteries of Alzheimer's disease's pathology, and develop safe, effective 

preventions and treatments, to the benefit of older Americans. 

Thank you for giving me this opportunity to share with you the challenges and 

accelerating progress regarding Alzheimer's disease research. I would be happy to answer any 

questions you may have. 

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Mr. PALLONE. Next is Mr. Harry Johns. 

STATEMENT OF HARRY JOHNS 

Mr. JOHNS. Thank you very much, Chairman Pallone, distinguished members of the committee. I want to also thank Ranking 

Member Shimkus and all of you for holding this hearing this afternoon. 

My name is Harry Johns. I am the president and CEO of the Alzheimer’s Association. The Alzheimer’s Association was created in 

1980 and is the leading voluntary health organization in both the 

provision of Alzheimer’s care and support, and in the funding of 

Alzheimer’s research, as the largest nonprofit funder of Alzheimer’s 

research in the world. 

To do our job well, we spend a lot of time listening, listening to 

people with Alzheimer’s, their caregivers, their families, to researchers, our many collaborators, and to hundreds of thousands of 

our advocates. We hear their stories and experiences, and they inspire us to go further, faster, to provide better care, and ultimately 

the cure that we all seek. We listen to those families in your districts and we listen to our own families. 

My mother had Alzheimer’s disease herself. Any of us who have 

seen the disease up close don’t want to see it again, for anyone to 

have the disease or to be a caregiver. Regrettably, we know it is 

going to happen much more ahead of us. 

You know, the effects of Alzheimer’s, as it has been stated previously, are truly devastating at the human level. In this country 

alone, as previously referenced, we estimate actually there are 

about 5.3 people who have the disease, about 200,000 of them 

younger onset, younger than 65. And by the middle of the century 

it could be as high as 13.5, or even as high as 16 million individuals in the United States alone. Today, there are 35 million people 

worldwide who have the disease. 

Today, if you do develop Alzheimer’s, we can say with certainty, 

absolute certainty, that you will either die with the disease or of 

it. And of the 10 leading causes of death, as previously mentioned, 

Alzheimer’s is now sixth, Alzheimer’s is growing by far the most 

rapidly, a 50 percent increase between 2000 and 2007, the last year 

that statistics are available. And it is the only one of the top 10 

causes of death that has nothing to do to prevent, stop, or even 

slow it. For perspective, even though Alzheimer’s is likely seriously 

underreported, already today it is killing more people than diabetes 

and more people than breast cancer and prostate cancer combined. 

The 11 million caregivers in the United States, Alzheimer’s can 

literally take everything they have to give: their time, their money, 

their jobs, and their own good health. And it happens every day, 

oftentimes never to be recovered. One study at least indicates that 

people who are caring for a spouse with Alzheimer’s can actually 

predecease the individual with the disease. 

The economic impact of Alzheimer’s is also devastating, truly 

staggering numbers. You have already mentioned the $172 billion 

in costs today for Alzheimer’s going as high as $1 trillion by the 

middle of the century, which was reported in the Alzheimer’s Association’s trajectory report earlier this year. And those are in today’s 

dollars. Those are not inflated dollars. Those are dollars rated in 


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today’s terms. A total of $20 trillion over the next 40 years just to 

pay for the care costs, not an additional cent for the research we 

so badly need. And our country is simply not ready for this onslaught of Alzheimer’s that is already upon us. 

Let’s take the case of research funding. You know, we have made 

significant progress in other diseases, in fact, in no small part because of the significant investments we have made in those diseases. Research spending at the Federal level for cancer is about 

$6 billion today; for a cardiovascular disease about $4 billion; for 

HIV/AIDS it is about $3 billion. Now, all of those are good investments. They have paid off in lives saved, and they are going to continue to pay in that way for our country. But in Alzheimer’s, we 

are only spending $469 million a year, despite those other huge impacts we have already discussed. 

We know that more money invested in research save lives, but 

we also know that too little money invested in research actually 

costs lives and ultimately will drive those very huge care costs into 

the trillions. Today, right now, we spend $250 in America on care 

cost for Alzheimer’s and dementia compared to $1 invested in research; 250 to 1. 

So to address the underinvestment in Alzheimer’s research, the 

Alzheimer’s Association strongly supports the Breakthrough Act. It 

is a bill that authorizes $2 billion in Alzheimer’s research. 

But the Alzheimer’s Association will not ask others to do what 

we won’t do ourselves. We play an unparalleled role in the research 

community in Alzheimer’s, globally as well as in the United States, 

and that certainly includes direct investment in Alzheimer’s and effectively investing in science. 

Our peer-reviewed research program since its inception has fund- ed $279 million worth of research to 1,900 investigators, making us 

the largest funder in the nonprofit world. And through partnerships and our own funding, we have played some kind of a part in 

every major advance over the past 30 years as a result. 

But as I discuss these necessary investments in Alzheimer’s research, and more broadly, I certainly recognize that our country is 

currently engaged in a very appropriate and very necessary conversation about our fiscal situation, our fiscal situation as a country, and we have to address that. But Alzheimer’s, unaddressed, is 

one of our most devastating issues, both human and financial, as 

we have all discussed. So we must aim at what is the highest return potential we have for investments, Alzheimer’s one of them. 

So if we can’t fix Alzheimer’s, I don’t think we can fix Medicare. 

Medicare costs three times more for each individual in the system 

who has Alzheimer’s than it does for a normal individual. 

Mr. PALLONE. Mr. Johns, I have been trying not to cut anybody 

off because we only have the one panel. 

Mr. JOHNS. Let me wrap really quickly then, Mr. Chairman. 

Certainly I want to mention the National Alzheimer’s Project 

Act, and I want to thank this committee for its leadership. I certainly again want to recognize Congressman Markey who you mentioned for his leadership as the author; certainly recognize Dr. Burgess who has also provided leadership on this. And we know, of 

course, the Senate passed the bill yesterday. We look forward to 

the real possibility of the House passing it. We urge you to pass 


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24 

it. And we look forward to working with this committee and the 

Congress to realize the ambition of the Alzheimer’s Association, its 

vision, a world without Alzheimer’s disease. 

Mr. PALLONE. Thank you. 

[The prepared statement of Mr. Johns follows:] 


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U.S. House of Representatives 

Energy and Commerce SUbcommittee on Health 

Testimony of Harry Johns 

President and CEO 

Alzheimer's Association 

December 9, 2010 

Alzheimer's: On Course to be the leading Public Health Crisis of the 21 51 Century 

Today, the effects of Alzheimer's disease are devastaUng - to the estimated 5.3 million Americans with the 

disease, to their more than 11 million caregIvers, and to the nation as a whole as we all share the 

tremendous costs of contending with the Alzheimer cnsis. 

Tomcrrow, the devastation of Alzheimer's disease will grow far wcrse. In fact, it is on course to be our 

country's leading public health crisis of the 21 st century, and the defining disease of the Baby Boom 

generation. If we don't succeed in changing the trajectory of this disease, by the middle of the century as 

many as 16 million Americans could have Alzheimer's. 1 

We can make highly confident projections about the future growth of Alzheimer cases because these 

estimates are directly rooted in the broad demographic transfonnation underway, the graying of America. 

While Alzheimer's Is not a nonnal part of aging, age is the largest risk factor for the disease. One in eight 

Americans over 65 have Alzheimer's; age 85 and above almost one in two Americans have the disease.2 

And so as our nation continues to age rapidly over the coming years - the first Baby Boomer turns 65 in just 

23 days - Alzheimer cases will begin to mount at an ever increasing pace. Without the discovery and 

delivery of effeCtive intervenUons, len million American Baby Boomers will develop Alzheimer's disease.3 

And the lives of many millions more will be upended by the emotionally, physically and financially draining 

toll of caring for them. 

But how concemed should we be with thesa trends? The numbers are large, but do they represent a true 

crisis? To candidly pose a question no doubt on the minds of some, Is Alzheimer's really as bad as the 

diseases many think of most often as public health crises? Those familiar with Alzheimer's know the 

answer to this question to be a resounding "yes." 

Too many Ame~cans are still unaware of the true, devastating impact of this disease. We are changing this, 

but harmful myths persist, and they must be challenged because they are partly responsible for the fact that 

our nation has neglected confronting this disease for far 100 long. 

Perhaps the most pemicious of these lingering societal myths is that Alzheimer's is 'just a littie memory 

loss." As those of you who, like me, have personally witnessed loved ones suffer the impact of this disease 

know all too well, nothing could be further from Ihe truth. Aizheimers is a progressive, degenerative and 

ultimately fatal disease. It is cruel, and il is a killer. It kills by insidiously clogging and destroying the most 

vilal of organs - the brain. In fact, II is one of the surest killers we know of. If you develop Alzheimer's we 

can say with absolute certainty thai you will either die with it or from it. A1zheimers is already lhe sixth 

1 Alzheimer's Association. 2010 Alzheimer's Disease Facts and Figures. Available at 

http://www.alz.org/alzOelmers_diseas9_facts_and_figures.asp 

2 Alzheimer's Association. 2010 Alzheimer's Disease Facts and Figures. 

3 Alzheimer's Association. 2008 Alzheimer's Disease FaGis and Figures. 
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leading cause of death in this country and, of the ten leading causes of death, is by far the fastest growing, 

According to the Centers for Disease Control and Prevention, Alzheimer deaths increased by more than 

50% from 2000 to 2007, the most recent year for which data are available,ln 2007, Alzheimer's killed more 

Americans than diabetes, and more than breast cancer and prostate cancer combined,4 

If you look at the top ten causes of death in America today, you notice something else thaI Is very striking, 

and very alarming, Alzheimer's is the only one of the top ten causes of death in the United States that 

remains without effective therapies, treatments, or preventative strategies, This must change, And It will, 

when we recognize this disease for the threat It is and respond accordingly, 

Another aspecl of Alzheimer's is ils effect on others. It upends the lives of caregivers almost as surely as it 

does for those with the disease Itself, Caregivlng for Alzheimer's can literally lake everything a caregiver 

has to give, Many caregivers experience negative health effects associated with caregivlng, 5 The 

manifestation, the degeneration and the progression of the disease varies with the Individual, but the broad 

outlines are the same, If diagnosed early after symptoms first appear, Ihe individual with the disease often 

can continue 10 enjoy a positive and functional (though Impaired) life for a time; sometimes even for a few 

years, However, the individual will progressively lose functions until caregivers must be available 24 hours 

a day, at home or in a residential care facility. 

In one study of family caregivers, 59 percenl of caregivers fe[1 as though they were 'on duty' 24 hours a day 

during the last year of life for the person with dementia, 72 percent acknowledged that 'they experienced 

relief when the person died,' 6 A National Alliance for Caregivlng and MRP study found two-Ihirds of 

employed family caregivers of people wKh Alzheimer's and other dementia's had to go in late, leave early or 

take time off because of caregivlng, Another study showed that caregivers of people with Alzheimer's or 

other dementia were 31 percent more likely to reduce hours or quit work altogether when caring for 

someone without behavioral symptoms when compared to caregivers of other older people, For the similar 

group of individuals caring for someone with behavioral symptoms of Alzheimer's or another dementia, the 

comparative likelihood of needing to reduce hours or to quit a job was 68 percent. 7 

America/s Economic Toll from Alzheimer's 

The economic factors of Alzheimer'S rival the human devastation of the disease. According to the 

Alzheimer's Association's report, Changing tile Trajectory of Alzheimer's Disease: A National Imperative, we 

are currently spending $172 billion annually on Alzheimer's and other dementia care In America, $88 billion 

of that is for Medicare alone, which is 17 percent of the total Medicare budget. Medicare beneficiaries with 

Alzheimer'S or another dementia cost the system three times more than otherwise comparable individual in 

Medicare who does not have a demenlia 8 For Medicaid, the cost multiplier for someone with dementia is 

nine times more than a comparable individual, S 

Alzheimer's also serves as a cost multiplier for other conditions, 95% of Americans with Alzheimer's or 

another dementia have one or more other serious medical conditions as well, Largely because Alzheimer's 

strips away an individual's ability to manage other conditions such as diabetes or cardiovascular disease 

4 'Deaths: Final Data for 2007,' National Vital Statistics Report Vol, 58, No, 19, National Center for Health Statistics, 

2010 http://www.cdc.govlnchsffastatsldeaihs.htm 

S Marla Shriver and the Alzheimer's Association, The Shriver Report: A Woman's Nation Takes on Alzheimer's, 2010, 

http://alz,orglshriverrepor!iindex,html 

I Alzheimer's Association, 2010 Alzheimer's Disease Facts and Figures 

7 Alzheimer's Association, 2010 Alzheimer's Disease Facts and Figures 

3 Alzheimer'S Association, Changing Ifle Trajectory of Alzheimer'S Disease: A NationallmperaUve 

9 Alzheimer's Association, 2010 Alzheimer's Disease Facts and Figures 

2 
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successfully, the costs of care for people with lhese other conditions are far higher when they also have 

dementia. For instance, average per person Medicare payments for a person with diabetes are $12,979, but 

for a person with both diabetes and Alzheimer's or another dementia average annual costs are $20,655. 

The same is true for heart disease - those with only heart disease have average Medicare claims of 

$14,640, while those that also have Alzheimer's or another dementia have annual costs of $20,780. 10 

The Trajectory report estimates that durtng the next 40 years, the cost of Alzheimer's and other dementias 

will exceed $20 trillion. Millions will gel Alzheimer's and other dementias, and milfions will suffer. Milnons 

more will care for them and will suffer in different ways. So, Alzheimer's Is going to cost us $20 billion11 and 

all we will have to show for it are the long list of the dead, personal heartbreak, and the other devastating 

effects on caregivers and families. 

Our country is engaged in a collective and very appropriate conversation about what should be done to 

address our current fiscal situation. What is notably absent from these discussions - and particularly in 

conversations about Medicare and Medicaid - is a systematic examination of the cost drivers behind our 

antiCipated out-year liabilities. When we look at how we can lake costs out of the system while improving 

outcomes, much as any successful manager might look to reduce the costs and improve the efficiency of a 

business operation, we quickly see that Alzheimer's should be a core part of these Medicare discussions. 

Alzheimer'S Association commissioned research again backs this up. The Association retained a health 

economics teM! at Dartmouth University to examine the costs of Alzheimer'S and other dementias in 

Medicare claims data. Then, we commissioned The Lewin Group to build upon this analysis with an 

economic model that produced not just the Mure economic costs reported in the Trajectory Report, but also 

the savings our country could expect with incremental research advances. Among other findings, the model 

demonstrated that a therapeutic intervention that led to even a five year delay In onset would cut the 

projected cost of Alzheimer's over the coming decades almost in half.12 

Voluntary Efforts to Overcome the Alzheimer's CrisiS 

Given the dimensions of this challenge, what's to be done about it? Particularly in these difficult times, no 

one would propose relying solely on the govemment to solve this crisis. A core part of the solution must, and 

should, be the voluntary efforts of Americans across the country. 

That is why the Alzheimer's Association exists: to organize and apply this voluntary commitment to 

overcome this crisis in as compassionate, effective, and strategiC a manner as possible. From my vantage 

point with the leading voluntary health organization in Alzheimer care and support, and the largest nonprofit 

funder of Alzheimer research, I am pleased to report that the commitment of Volunteers is not just alive and 

welf throughout our country, but is making a tremendous contribution to addressing the crisis just described. 

The mission of the Alzheimer's Association is to eliminate Alzheimer'S disease through the advancement of 

research; to provide and enhance care and support for all affected; and to reduce the risk d dementia 

through the promotion of brain health, 

Our vision is a world without Alzheimer's and, since 1980, we have moved toward this goal by advancing 

research and providing support, information and education to those affected by Alzheimer's and related 

dementias. We provide information and care consultations at all stages of the disease - and are available to 

do so every hour of the day, every day of the week, every week of the year. Across the country, we provide 

10 Alzheimer's Associatkln, 2010 Allheimer's Disease Facls and Figures 

12 Alzheimer's Association, Changing the Trajectory of Alzheimer's Disease: A National Imperative 

12 Alzheimer's Associalkln, Changing the Trajectory of Alzheimer's Disease: A National Imperative 

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support groups and other community interventions to make a difference In the lives of those who have the 

disease and those who are affected by it. 

To find the ultimate answers 10 the disease, we fund cutting-edge research in top laboratories around the 

world. The Alzheimer's Association's peer-reviewed research grant program has awarded more than $279 

million to 1,900 scientists since 1982 - making the Alzheimer's Associalion the largest non-profit funder of 

Alzheimer research. Through partnerships and funded projects, the Association has been part of every 

major research advancement in the field over the past 30 years. We support novel approaches that drive 

new thinking. We fund science aimed at treatment and diagnosis as well as psychosocial Interventions. 

And, we annually convene the largest research meeting In the world. the Alzheimer's Association 

Intemational Conference on Alzheimer's Disease (MICAD), drawing together the global Alzheimer research 

community to advance the science. 

But American volunteers cannot solve this crisis alone. While the best way fOlWard will include publicprivate partnerships and collaborations with organizations like the Alzheimer's Association, our government 

must do far more than it does today. It is what the American people clearly expect. According to a report 

that the Alzheimer's Association recently released with Maria Shriver, The Shriver Report: A Woman's 

Nation Takes on Alzheimer's, 78% of all respondents believe that it is "the responsibility of the govemment 

to help find a cure for a way to prevent Alzheimer's." Almost no one-only 7% of the U.S. populationbelieves a great deal of progress is being made to find a cure. Compared to how much progress they think 

is being made in heart disease, cancer, diabetes, and strokes, Americans rank Alzheimer's dead last. 13 

And so, in addition to our work In care and research, the Alzheimer's Association is also expanding our 

efforts In advocacy, fighting for crltlcal Alzheimer research, prevention and care initiatives at the state and 

federal level, all driven by an aggressive, strategic approach to overcoming this disease as quickly, 

effectively and efficiently as possible. 

How the Government Can Effectively Address this Crisis 

Working with Alzheimer champions in the House and Senate, the Alzheimer's Association has collaborated 

in the drafting of three critical pieces of legislation that together would dramatically transform our national 

stance toward this disease and generate bold, strategic action. These three bills are the National 

Alzheimer's Project Act, the Alzheimer's Breakthrough Act, and the Health Outcomes, Planning, and 

Education (HOPE) for Alzheimer's Act. 

Planning: The National Aizheimer's Project Act 

We are heartened that the first of these bills, the National Alzheimer's Project Act (NAPA), is poised for 

passage In the remaining days of this Congress. We ask your support for this critical legislation. 

Our federal govemment currently has no systematic plan to overcome Alzheimer's. No plan for investing in 

research to stop it. No plan to handle the cost of care if it isn't stopped. No plan for having enough 

residential care facilities for that inevitable point in the disease process when even the most dedicated 

caregivers can no longer handle the care at home, or a plan for new approaches to homecare. We have no 

articulation of objectives, timelines, assignment of responsibilities or any of the routine hallmarks of 

disciplined, effective management. Despite the millions of American lives and the trillions of American 

dollars at stake, we are drifting into the future rather than marching to a clear destination. 

13 Maria Shriver and the Alzheimer's Association. The Shriver Report: A Woman's Nation Takes on Alzheimer's. 

2010. 

4 
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Building on the recommendations of the Alzheimer's Study Group, an independent, bipartisan panel created 

to evaluate the govemmenfs current efforts to combat the disease, NAPA would create a national strategic 

plan for the Alzheimer's disease crisis. It would also establish an inter-agency council to work with the 

Secretary of Health and Human Services to comprehensively assess and address Alzheimer research, care, 

Institutional services, and home and community based programs. NAPA would ensure strategic planning 

and coordination of the fight against Alzheimer's across the federal government as a whole. 

The Alzheimer's Study Group called for this action by 2010, and NAPA would set it in motion. Thanks In part 

to the leadership and foresight of members of this committee together with other members of the House and 

Senate, we appear on track to hit this mark. 

Research: The Alzheimer's Breakthrough Act 

But with what we hope and expect will be the passage of NAPA in this Congress, we must tum to the gfartng 

fact that whafs most needed in Alzheimer's is investment in more research to change the course of the 

disease as soon as possible. The science community is upbeat about the potential for Alzheimer advances, 

but as the boomer generation ages to the point of what is considered the earliest age of typical onset, 65, 

we need to act now. 

Based on the most recentiy available data, federal funding for cancer is about $6 billion, for cardiovascular 

diseases about $4 bRilon, and for HIV/AIDS about $3 billion. These have all proven to be smart, important 

investments that should continue based on their high returns in lives saved. 14 By contrast, not counting the 

one-time stimulus funds, total federal funding for Alzheimer research is cunrentiy just $469 million. 

We already spend $25,000 in care costs for every $100 we spend on Alzheimer research. IS By the middle of 

the century, we will spend more than $1 trillion annually for care for Alzheimer's and other dementias If we 

don't change the course of the disease. 16 Those care costs are not due to inflation-the costs are In teday's 

dollars. 

The Alzheimers Breakthrough Act would begin to address our woefully shortSighted underinvestment in 

Alzheimer's research. As investment in other diseases such as cancer, heart disease and H1VIAIDS 

demonstrates, adequate medical research investment more than pays for itself, not just in improved quality 

of life for those with Alzheimer's and their caregivers, but for the economic health of the country as well. 

Care and Suppot1: The Health Outcomes, Planning and Education (HOPE) for Alzheimer's Act 

Yet even if we increase our investments, we cannot simply walt for the breakthroughs that will one day end 

Alzheimer's. Research takes time to yield results and in the meantime there is much we need to do to 

improve care and support for those contending with this disease. 

Today, our health system does not work well for Alzheimer'S care and support. The HOPE for Alzheimer's 

Act would make immediate contributions to the lives of the more than five million Americans with the 

disease today and their caregivers. 

14 Nationalinslillltes of Health, Estimates of Funding for Various Research, Condition, and Disease Categories 

(RCOCl, 2010. htlp:llreportnih.gov/rcdclcategariesl 15 Alzheimer's ASSOCiation, 2010 Alzheimer's Disease Facts and Figures. 

16 Alzheimer's Association, Changing the Trajectory of Alzheimer's Disease: A National Imperative. 

5 
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To provide better medical care and outcomes for individuals with Alzheimer's and other dementlas, the 

dementia must first be detected, the disease causing it must then be diagnosed, care must be planned, and 

the diagnosis must be noted in the patient's medical record. 

Figures on diagnosis differ, but it is likely that less than half of people with dementia have been formally 

diagnosed. Worse, although African-Americans and Hispanics are more likely than whites to have 

Alzheimer's and dementla17, studies ccnducted In physician offICes and clinics show that African-Americans 

and Hispanics are less likely than whites to have a diagnosis of the condition. 

If enacted, the HOPE for Alzheimer's Act will Increase detection and diagnosis of dementia in primary care 

settings necessary for the proviSion of critical Information and referrals to support services. It will atso insure 

that Medicare beneficiaries have access to a package of services that will include a diagnostic evaluation, 

care planning and medical record documentation. Finally, It will help Individuals with newly diagnosed 

dementia and their family caregivers understand the diagnosis, plan for predictable problems, avoid crises, 

and mainlain the best possible quality of life. 

The HOPE for Alzheimer's Act will deliver important improvements in outcomes and serve as a strong 

foundation for subsequent efforts to improve Alzheimer's care and support. We must lay this foundation as 

quickly as possible. 

Hope for the Future -If We Act Quickly and Decisively Today 

I get the benefit of exposure to scientists working worldwide to end this disease. I also have the opportunity 

to see so many others dedicated to providing care and support to those who will have the disease before we 

finally end it, and all of the volunteers, staff and donors who advance the mission of the Alzheimer'S 

Association each and every day. Because of their collective energy, I remain optimistic about Alzheimer 

advances. I believe that we will succeed. We must. 

I'm ccnfldent that we will prevail against Alzheimer's. It's not a matter of "if; it's a matter of 'when." But 

"when" needs to be sooner rather than later. It's too late for my mother, and it's too lale for the millions more 

who have died or who have progressed too far in their disease. Until we realize our vision of a world without 

Alzheimer's, the Alzheimer's Association will keep pursuing every possible approach to support those facing 

the disease and every possible way to find the answars we need to end it. 

On behalf of the millions I represent this morning, I ask for your leadership in securing the success we need 

10 address Alzheimer's, a true public health crisis for America. 

Thank you. 

17 Alzheimer's Association, 2010 Alzheimer's Disease Facts and Figures. 

6 
31 

Mr. PALLONE. Mr. Hall. 

STATEMENT OF ERIC J. HALL 

Mr. HALL. Chairman Pallone, members of the committee, thank 

you so much for convening this hearing and for inviting the Alzheimer’s Foundation of America to testify. I am Eric J. Hall. I am 

the AFA’s founding president and chief executive officer, and I am 

truly honored to be here to testify on behalf of our member organizations and families that we care for across the country. 

AFA was formed in February of 2002 to provide optimal care and 

services to individuals confronting dementia, and to their caregivers and families, through member organizations dedicated to improving quality of life. Today our membership consists of more than 

1,400 organizations, including grassroots not-for-profit organizations, government agencies, public safety departments, and longterm care communities. 

Our services include a toll-free hotline staffed by licensed social 

workers, educational materials; Care Advantage, which is a free 

quarterly family caregiver magazine that right now reaches about 

1 million readers; professional training programs; AFA Teens, 

which is a Web-based support and scholarship program; and our 

National Memory Screening Date. As a foundation, our money is 

generated and disbursed by grants to service organizations as well 

as respite grants to families who are in need. 

Recognizing the severe fiscal challenges facing our Nation, it is 

more important than ever to leverage available private-sector resources in a cost-effective manner to support public-sector initiatives. AFA makes substantial investments in care and services to 

tackle the enormous challenges associated with Alzheimer’s disease 

and related dementias for both individuals and their family caregivers. 

But the needs of the population are going to overwhelm our resources in the years to come. The National Institute on Aging reports that as many as 5.1 million Americans over 65 are, today, 

dying of Alzheimer’s disease, and those numbers are projected to 

increase dramatically in the coming years. The rapidly rising costs 

associated with this disease will put an enormously heavy burden 

on families, businesses, and government economically. 

It is our opinion that increased investment in preventing, treating, and/or curing chronic diseases of the aging, such as Alzheimer’s disease, is perhaps the single most effective strategy in reducing national spending on health care. Chronic diseases associated with aging account for more than 75 percent of Medicare and 

other Federal health expenditures. Unprecedented increases in 

these diseases as the population ages are one reason why the Congressional Budget Office projects that total spending on health care 

will rise to 25 percent of the U.S. GDP by 2025. 

Simply put, our Nation does not have the luxury of time to wait 

to address the health research needs of this population. Standard 

& Poors’ recent report titled ‘‘Global Aging 2010: An Irreversible 

Truth,’’ stated that no other force, no other force is likely to shape 

the future of national economic health, public finances, and/or policymaking at the irreversible rate at which the world’s population 

is aging. Standard & Poors believes that the cost of caring for peoVerDate Mar 15 2010 01:01 Apr 06, 2013 Jkt 078139 PO 00000 Frm 00037 Fmt 6633 Sfmt 6633 E:\HR\OC\A139.XXX A139

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ple will profoundly affect growth prospects and dominate public finance policy debates worldwide. 

As we have learned from the experience that we have all had 

with polio, heart disease, HIV/AIDS, cardiovascular, and other diseases, medical research and breakthroughs can have a profound 

impact on reducing health care costs. 

As the extension of life expectancy from age 47 in 1900 to almost 

80 in 2000 demonstrates, medical advances enormously increase 

national productivity and prosperity. Yet those benefits can only 

come about if NIH makes the needed investments and research 

aimed at preventing, treating, or curing age-related diseases and 

extending healthy life. 

AFA, again, recognizes the serious fiscal challenges facing our 

Nation, which will require Congress to carefully scrutinize future 

funding priorities. We believe it is critical to leverage critical resources within the private sector, including not-for-profit organizations such as our own, to support proven, cost effective initiatives, 

and that is why we will all need Congress to be our partner. 

This subcommittee and the full Energy and Commerce Committee have played a critical role in overseeing and supporting the 

mission of the NIH, and we respectfully urge your support for continued commitment to NIA’s important research. AFA is seeking 

$1.4 billion, an increase of $300 million in fiscal year 2012 National 

Institute on Health budget specifically for the National Institute of 

Aging. This funding is the minimum essential to sustain the research needed to make progress in attacking the chronic diseases 

that are driving mass increases in our national health care costs. 

That level of funding would make the NIA’s baseline consistent 

with comparable research initiatives conducted elsewhere under 

the auspices of NIH. 

If NIA funding is not significantly increased, we stand to lose a 

generation of more young and emerging investigators in aging and 

Alzheimer’s disease. This would be an enormous waste, since the 

NIA is poised to accelerate the scientific discoveries that can be 

translated quickly into effective prevention and efficient health 

care to reduce the burden of this silver tsunami of age-associated 

chronic diseases. 

Breakthroughs from NIA research can lead to treatments and 

public health interventions that can delay the onset or slow the 

progression of costly connections such as heart disease, stroke, diabetes, bone fractures, age-related blindness, Parkinson’s, and indeed Alzheimer’s disease. From a budgetary perspective alone, such 

advances could save trillions of dollars by the middle of this current century. 

At the Alzheimer’s Foundation of America, our incredible 

strength and our quick success has come from collaboration. AFA 

looks forward to working with members of the subcommittee to address the important issues raised in today’s hearing and, in the 

long term, to end the devastation caused by Alzheimer’s disease. 

Mr. PALLONE. Thank you. Thank you, Mr. Hall. 

[The prepared statement of Mr. Hall follows:] 


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ALZHEIMER.S fOUNDATION OF AMERICA 

Written Statement for the Congressional Record by Eric J. Hall 

President and Chief Executive Officer 

Alzheimer's Foundation of America 

Before the United States House Committee on Energy and Commerce 

Subcommittee on Health 

"Alzheimer's Disease: The Ongoing Challenges" 

December 9,201 0 

Chairman Pallone, Ranking Member Shimkus. and members ofthe Committee. thank you for convening this 

hearing and for inviting the Alzheimcr's Foundation of America (AFA) to testifY. I am Eric J. Hall. AFA's 

founding President and Chief Executive Officer. and I am honored to he here today. 

AFA was formed in February 2002 "to provide optimal care and services to individuals contronting 

dementia. and to their caregivers and families-through member organizations dedicated to improving 

quality oflife." Today. our membership consists of more than 1.400 organizations including grassroots 

nonprofit organizations. healthcare facilities. government agencies. public safety departments. and long-tenn 

care communities. Our services include a toll-free hotline staffed by licensed social workers; educational 

materials; care ADvantage. a free quarterly lamily caregiver magazine that reaches I million readers; 

professional training programs; AFA Teens support and scholarship program; National Memory Screening 

Day: and grants to service organizations as well as respite grants to families in need. 

322 EighlbAvcnue,7th Floor, New York, NY 10001 

(866) AFA-8484' Fax: (646) 638-1546 

info@alzfrln.org • www.alzfdn.org 
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Recognizing the severe fiscal challenges facing our nation, it is more important than ever to leverage 

availahle private sector resources in a cost-effective manner to support public sector initiatives. AFA makes 

substantial investments in care and services to tackle the enonnous challenges associated with Alzheimer's 

disease and related dementias for both individuals and their family caregivers. AFA regularly provides 

grants to its nonprofit member organizations so that they can develop or enhance educational and support 

services in their communities. These grants are a critical funding source for these grassroots organizations, 

which playa pivotal role in their communities as hands-on providers of care and services for individuals with 

Alzheimer's and related illnesses, and their families. In addition, AFA provides grants to assist families with 

the cost of respite care, including home care and adult day programs. 

AF A has several resources to help train and support family caregivers, including our "Your Time to Care" 

educational DVD series that addresses specific care issues in the home setting, including: 

Basic Skills for Caring for Individuals with Alzheimer's Disease and Related Dementias at Home 

Wandering ... What It Is and What to Do About It 

Medication Management: From Daily Routines to Communicating with Healthcare Providers and 

Pharmacists; and 

Preventing Falls: Practical Steps to Reduce Fears and Risks 

We would be glad to share copies of any of the listed DVDs with members of the Committee or other 

interested parties. 

Another one of our innovative programs is AFA Teens. AFA Teens is aimed at teens with family members 

affected by the disease and those purely interested in the cause. 

The need for the program was demonstrated by AFA's 2008 ICAN: Investigating Caregivers' Attitudes and 

Needs Survey, which found that three in five caregivers say their children aged 8 to 21 are involved in 

2 
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caring for a loved one with Alzheimer's disease. Children were reported to assist with caregiving 

responsibilities that range from attending doctors' appointments to feeding and dressing their loved ones. 

AFA Teens' dedicated Web site creates an online community for teens, giving them support from experts 

and the opportunity to share experiences and connect with each other through a bulletin board, blog, and 

AFA Teens chapters forming across the country. AF A Teens also awards a $5,000 college scholarship to 

a college-bound student each year. The scholarship is designed to provide an outlet for teenagers to express 

their thoughts about Alzheimer's disease and to engage the younger generation in this cause. 

AF A offers two national training programs that are specifically designed to raise the bar on 

dementia care in the United States: 

Dementia Care Professionals of America (DCPA) is a division of AFA, and offers membership, 

training, qualification and other benefits to individual health care professionals involved in 

dementia care. DCPA provides practical training to healthcare professionals, sets standards of 

excellence through our AF A qualification program, keeps professionals abreast of emerging 

breakthroughs in treatment and care, and supports professionals as they support those in need. 

AFA developed Excellence in Care, www.excellenceincare.org, to partner with care settings in the 

establishment of a nationwide standard of excellence in care for individuals with Alzheimer's 

disease or related dementi as. The program was created with the Avila Institute of 

Gerontology and other industry experts and consists of a comprehensive on-site evaluation and 

consultation on strategies to achieve the established standards and to sustain performance. Key 

areas of review include environment, education, staff-client interaction and programming. 

But the needs ofthe Alzheimer's population are going to overwhelm our resources in the years to come. The 

NIA reports that as many as 5.1 million Americans over 65 are today dying with Alzheimer's disease and the 

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numbers of Americans that will die of this disease are projected to increase dramatically in the coming years. 

Alzheimer's disease will also cause physical and emotional impairments on more and more families and 

caregivers. The growing numbers of Alzheimer's victims and the rapidly-rising costs associated with the 

disease will put a heavy economic burden on families, businesses and government. 

Increased investment in preventing, treating or curing chronic diseases of the aging, such as 

Alzheimer's disease, is perhaps the single most effective strategy in reducing national spending on 

health care. Chronic diseases associated with aging account for more than 75 percent of Medicare and other 

federal health expenditures. Unprecedented increases in these diseases as the population ages are one reason 

the Congressional Budget Office projects that total spending on health care will rise to 25 percent of the U.S. 

GDP by 2025. Simply put, our nation does not have the luxury of time to wait to address the health research 

needs of this population. 

Standard & Poor's recent Report (titled "Global Aging 2010: An Irreversible Truth") stated that "[n]o other 

force is likely to shape the future of national economic health, public finances, and policymaking as the 

irreversible rate at which the world's population is aging .... Standard & Poor's believes that the cost of 

caring for these people will profoundly affect growth prospects and dominate public financ·e policy debates 

worldwide." As we have learned from the experience with polio, heart disease, HIV/AIDS, cardiovascular 

and other diseases, medical research and breakthroughs can have a profound impact in reducing health care 

costs. And the extension of life expectancy from 47 in 1900 to almost 80 in 2000 demonstrates that medical 

advancements enormously increase national productivity and prosperity. Yet, those benefits can only come 

about if NIH makes the needed investments in research aimed at preventing, treating or curing aging-related 

diseases and extending healthy life. 

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The National Institute on Aging (NIA) leads the national scientific effort to understand the nature of aging in 

order to promote the health and well-being of older adults. In stark contrast to the rapidly-rising costs of 

healthcare for the aging, we as a nation are making a miniscule, and declining, investment in the prevention, 

treatment or cure of aging conditions. Out of each dollar appropriated to NIH, only 3.6 cents goes toward 

supporting work of the NIA. Between FY 2003 and FY 2010, NIA-funded scientists saw a 14.7 percent 

reduction in constant dollars. In addition, the success rate of grant applications has declined from 

approximately 30 percent during the early part of the decade to 17.2 percent in FY 2009, with a payline of 

11.8 percent. The announced payline in FY20JO for established researchers is 8 percent (less for larger 

grants) and is estimated to drop further in FY20J 1. This can be attributed to several factors-the changing 

demands on the NIA caused by the slow, progressive character of aging disease and hence the need for larger 

and longer clinical trials; a decline in the number of small, 2-year grants (i.e., R03, R21) awarded and the 

corresponding increase in 5-year grants; and the rise in the costs ofROI grants, attributable to documented 

inflation in the cost of science. Unfortunately, our nation's declining constant-dollar investment in NIA 

research has not kept pace with the demands of aging research or the health needs of older Americans. 

AFA recognizes the serious fiscal challenges facing our nation, which will require Congress to carefully 

scrutinize future funding priorities. We believe it is critical to leverage available resources within the private 

sector, including not-for-profit organizations such as AFA, to support proven, cost-effective initiatives. 

That's why we need Congress as our partner. 

This Subcommittee and the full Energy and Commerce Committee have played a critical role in overseeing 

and supporting the mission of the NIH, and we respectfully urge your support for a continued commitment to 

the NIA's important research. AFA is seeking $1.4 billion, an increase of$300 million, in tbe FY 2012 

National Institutes of Health (NIH) Budget for the National Institute on Aging (NIA). This funding is 

the minimum essential to sustain the research needed to make progress in attacking the chronic diseases that 

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are driving massive increases in our national health care costs. That level of funding would make the NIA' s 

baseline consistent with comparable research initiatives conducted elsewhere under the auspices of the NIH. 

IfNIA funding is not significantly increased, we stand to lose a generation or more of young and emerging 

investigators in aging and Alzheimer's disease. This would be an enormous waste, since the NIA is poised 

to accelerate the scientific discoveries that can be translated quickly into effective prevention and efficient 

health care to reduce the burden of a "Silver Tsunami" of age-associated chronic diseases. Breakthroughs 

from NIA research can lead to treatments and public health interventions that could delay the onset or slow 

the progression of costly conditions such as heart disease, stroke, diabetes, bone fractures, age-related 

blindness, Parkinson's and Alzheimer's diseases. From a budgetary perspective alone, sucb advances 

could save trillions of dollars by tbe middle oftbe curreut ceutury, 

At the Alzheimer's Foundation of America, our strength and success come from collaboration. AFA looks 

forward to working with Members of the Subcommittee to address the important issues raised in today's 

hearing, and in the longer term, to end the devastation caused by Alzheimer's disease. Thank you again for 

the opportunity to testify, and I would be glad to answer any questions you may have. 

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Mr. PALLONE. Dr. Cantillon. 

STATEMENT OF MARC CANTILLON, MD 

Dr. CANTILLON. Mr. Chairman, members and staff, thank you for 

the opportunity to present testimony on this very important topic. 

I am Dr. Marc Cantillon, the executive director of the Coalition 

Against Major Disease of the Critical Path Institute, also known as 

C–Path. 

I am a practicing physician and a neuroscientist, with 15 years’ 

experience in research and drug development at the NIH, academia, nursing homes, and within the pharmaceutical industry. 

C–Path is a nonprofit organization founded in 2005 by the FDA 

and the Arizona community in order to build collaborations that 

identify more reliable and efficient methods to test new medicines’ 

applied regulatory science. 

As you have heard, in spite of the exciting laboratory discoveries 

in Alzheimer’s research, we lack full translation, we lack new medicines that could significantly alter the course of the disease. And, 

indeed, we have seen huge Alzheimer’s disease drug trials fail. 

Nevertheless, there is reason for renewed hope. 

Across the hall into science is a proverb written up that I would 

like to quote. ‘‘Where there is no vision, the people perish.’’ Proverbs. 

Thanks to the work of this subcommittee, the FDA Amendments 

Act of 2007 included a provision for the FDA to create the Critical 

Path public-private partnerships. We are extremely grateful to 

Congresswoman Marsha Blackburn of Tennessee, Congressman Elliot Engel of New York, and Congresswoman Gabrielle Giffords of 

Arizona for their leadership on this legislation. 

The Coalition Against Major Diseases, or CAMD, was one of the 

first of these partnerships launched by the FDA, and it is already 

creating and identifying new tools that will speed the safe development of new medicines for Alzheimer’s and other neurodegenerative diseases. 

CAMD seeks to recreate the sense of urgency and open collaboration that made the unprecedented rapid progress against AIDS possible. Sharing of knowledge was the hallmark and is generally accepted as the reason that the rapid and enduring success was secured against that epidemic. Created by C–Path and the Engelberg 

Center of the Brookings Institute, CAMD is a consortium that currently includes scientists from 12 major pharmaceutical companies, 

NIH scientists, as well as experts from patient organizations such 

as my colleagues here today, the Alzheimer’s Association and Alzheimer’s Foundation. 

The FDA, along with the European Medicines Agency, the EMA, 

and indeed the Japanese PMDA, provide advisers to our over 250 

scientists who participate in CAMD by sharing what they know 

about Alzheimer’s disease and how they can better test new therapies. 

CAMD’s accomplishments have already changed the way we attack this devastating disease. Firstly, CAMD researchers compare 

the way that they and other researchers score dementia, scored dementia in a clinical trial, and subsequently corrected over a dozen 


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inconsistencies. Now it is possible for them and for EMA and FDA 

to compare results directly from study to study. 

This is a great example of applied regulatory science because it 

improves the quality, the accuracy, and efficiency of decisions made 

by both the regulators and the regulated industry of the pharmaceutical industry. 

A first ever, CAMD was able to pool the data from 11 clinical 

trials conducted by several different pharmaceutical companies. 

This has created the largest publicly available Alzheimer’s disease 

database in the world, and it describes the natural course of the 

disease in over 4,000 patients. Over 200 teams of scientists around 

the world are already using this. 

For example, modeling. In the past, former scientists had to design trials based on their clinical experience or data within the 

company or what they read in the medical literature. This database 

allows the individual patient-level data to show progression over 

time in this number of patients. This is far more precise than their 

clinical experience or what they can glean from the medical literature. 

This database also allows them to more accurately predict the 

outcome for a particular trial, or how long the trial must be, or how 

many patients must be included; indeed, how genetic subsets of the 

population might respond differently, et cetera. CAMD is now 

working with NIH and with academic centers to pool their data in 

the same standardized database to further enrich this as a leadingedge tool. 

CAMD is also helping define the FDA’s new qualification process 

described in the new guidance. In this work, CAMD submits data 

and requests that the FDA accept certain brain-imaging tools or 

cerebral spinal fluid tests as qualified for identifying patients much 

earlier in their disease when there is still brain function to be 

saved. 

Yes, there are many reasons for hope. The Critical Path publicprivate partnership is improving the applied regulatory science for 

Alzheimer’s at the FDA. However, we do need your help. Understaffing is a serious problem throughout the FDA and is especially 

serious for CAMD. The FDA needs your support to be able to dedicate the required number of scientists and staff to participate in 

CAMD and other Critical Path partnerships. This is the kind of applied critical science that is changing the way drugs are tested and 

evaluated today, so that Alzheimer’s can be prevented, not just 

slowed. 

I thank you for the opportunity to provide this testimony, and everybody in the CAMD thanks you for your leadership and foresight 

in authorizing the FDA’s Critical Path public-private partnerships 

that are giving new hopes to patients and families at risk for this 

devastating disease. I would be happy to answer any questions. 

[The prepared statement of Dr. Cantillon follows:] 


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Testimony before the 

Congress of The United States 

House of Representatives 

Committee on Energy and Commerce 

Subcommittee on Health 

The critical role of public/private partnerships in creating applied regulatory science to 

advance the development of new Alzheimer's disease therapies 

December 9, 2010 

Marc Cantillon, MD 

Executive Director, Coalition Against Major Diseases 

Critical Path Institute 

MCantillon@C-Path.org 

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Mr. Chairman, Members, and Committee Staff: 

Thank you for the opportunity to provide testimony before the Subcommittee on this critically 

important topic. My name is Marc Cantillon, MD, Executive Director of the Coalition Against 

Major Diseases (CAMD) for the Critical Path Institute (C-Path). I am a practicing physician and 

neuroscientist with over 15 years of experience in research at the NIH, academia, and the 

pharmaceutical industry. C-Path is an independent, non-profit organization founded in 2005 by 

the U.S. Food and Drug Administration (FDA) and the Arizona community to build public/private 

partnerships that identify more reliable and efficient methods to test new medicines. 

Critical Path Institute 

C-Path was created in response to what, we believe, is a crisis in drug development, i.e. the 

rapidly declining productivity of the biomedical research and development enterprise. Our goal 

has been to create a forum for scientists from the FDA, academia, biomedical organizations, 

and the pharmaceutical industry to evaluate innovative testing methods for use in drug 

development- innovations that will give patients the earliest access to the safest possible 

medications. We believe that this type of collaboration, a public/private partnership, facilitated 

by a neutral organization such as C-Path, is essential to bring about needed changes in the way 

drugs are developed. C-Path focuses on "applied regulatory science", i.e. the science that 

improves the quality, accuracy and efficiency of decision-making by scientists in the FDA and in 

the regulated industry. 

In order to serve as a neutral and trusted third party for collaborators, C-Path does not accept 

funding from the pharmaceutical industry or other companies that develop products regulated 

by the FDA. Since 2005, over $30 million in federal and foundation grant awards and $11 million 

in contributions from foundations and governments in Arizona have been received to support 

C-Path's work. 

This funding is leveraged by in-kind support from a broad group of stakeholders and enables CPath to manage five separate consortia with a total of over 750 participating scientists from 

FDA, NIH, academia and 30 of the largest global pharmaceutical companies. These stakeholders 

share pre-competitive knowledge and develop consensus on new drug development tools. 

These tools will improve the drug development process, make it more efficient and result in 

new drugs that are safer and more effective. C-Path supports projects that are identified as 

high priority by the FDA and are in the interest of public health. 

CAMO: A Public Private Partnership 

Thanks to the work of this Subcommittee, the FDA Amendments Act of 2007 included a 

provision for the FDA to create Critical Path Public/Private partnerships. Critical Path Institute's 

Coalition Against Major Diseases was one of the first of these partnerships launched by the 

FDA, and was formed to tackle brain disease beginning with one of today's most devastating 

illnesses, Alzheimer's disease (AD). 

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One of the greatest challenges facing biomedical sciences in the 21st century is the 

development of better treatments for neurodegenerative diseases. The two most prevalent of 

these, Alzheimer's disease and Parkinson's disease (PD), exert a heavy and growing human and 

economic burden on our society. Our lack of knowledge about the specific cause(s) of either 

disease is a major obstacle to the development of new treatments that have the potential to 

cure or prevent these devastating and tragic diseases. 

In recent years, billions of dollars have been invested to develop new drugs for Alzheimer's 

disease but so far, all have failed to significantly impact the course of the disease. We firmly 

believe that new, applied regulatory science created through the public/private partnership of 

CAMD will result in new tools and methods that will accelerate the development of treatments 

for Alzheimer's patients that are effective much earlier in the disease. 

Why Alzheimer's Disease for CAMD? 

As the results of a 2009 study by the Alzheimer's Association make clear, the need for CAMD is 

compelling, The study revealed that the health care costs for American's over age 65 is three 

time greater if they have Alzheimer's disease. In the United States, 5.3 million people have 

Alzheimer's, costing the nation's healthcare system $148 billion annually. Alzheimer's has 

become the sixth leading cause of death in the United States. Someone in America develops 

Alzheimer's every 70 seconds, which means more than 450,000 new patients will be diagnosed 

next year. 

As a practicing neuropsychiatrist, I am proud to serve as the leader of CAMD. I have been 

frustrated daily by the limited benefits patients receive from our current treatments for 

Alzheimer's disease. I have spent 15 years conducting clinical trials for Alzheimer's and 

Parkinson's disease patients at the NIH, in universities and in the pharmaceutical industry 

where several trials costing $200-500 million have failed. I am heartened that C-Path's CAMD is 

developing the needed tools that will help make it possible to find effective drugs quickly for 

patients. 

CAMD seeks to recreate the sense of urgency and open collaboration that made 

unprecedented, rapid progress against HIV/AIDS possible. Sharing of knowledge was a hallmark, 

and is generally accepted as the reason for early, and continued, successes against that 

epidemic. 

Created jointly by C-Path and the Engelberg Center at the Brookings Institution in February 

2008, CAMD is a public/private partnership that currently includes twelve major 

pharmaceutical companies (listed below), NIH and five organizations that represent patients 

(including the Alzheimer's Association and the Alzheimer's Foundation here testifying today), 

with advisors representing the FDA and its European counterpart, the European Medicines 

Agency (EMA), National Institute of Neurological Disorders and Stroke (NINDS), and National 

Institute on Aging. CAMD also collaborates with several other organizations, including the 

Michael J. Fox Foundation, the Metrum Institute, Ephibian, and the Clinical Data Interchange 

Standards Consortium (CDISC), as well as over 200 academic scientists around the world. 

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CAMD members are: 

Abbott Alliance for Aging Research Alzheimer's Association 

Alzheimer's Fdn. of America AstraZeneca Pharmaceuticals LP 

Bristol-Myers Squibb Co. CHDI Foundation, Inc. Eli Lilly and Company 

F. Hoffmann-La Roche Ltd Forest Research Institute Genentech, Inc. 

GlaxoSmithKline Johnson & Johnson Michael J. Fox Foundation 

National Health Council 

Parkinson's Disease Fdn. 

CAMD's Progress to Date 

Novartis Pharmaceuticals 

Pfizer, Inc. 

Parkinson's Action Network 

sanofi-aventis 

CAM D's accomplishments have already changed the way we attack this devastating disease. 

Several examples are: 

• CAMD researchers compared the way they had been scoring a person's dementia in 

clinical trials and found over a dozen inconsistencies in the way a score was determined 

for the standard tool, the Alzheimer's Disease Assessment Scale-Cognition or ADAS-cog. 

With these inconsistencies eliminated, it is possible for these investigators, and the FDA, 

to compare the results from study to study. This standardization process for ADAS-cog 

is a great example of "applied regulatory science". 

• In CAMD and for the first time ever, pharmaceutical companies are sharing their clinical 

trial data with one another. CAMD has been able to pool data from 11 clinical trials 

conducted by seven different pharmaceutical companies. This is now the largest 

publicly available Alzheimer's disease database and it describes the natural course of 

the disease in over 4000 patients. Normally to generate new data for this number of 

patients, it would cost $300-600 million and take more than six years in new clinical 

trials. Today, only a few months later, the database has more than 200 users from 

academia and industry in over 34 countries. More information and how to apply for 

access to the database can be found at https://codr.c-path.org. 

• A quantitative disease model that describes the natural progression of Alzheimer's 

disease has been developed using data from the Alzheimer's Disease Neuroimaging 

Initiative. This model is now being tested and improved with the larger and regulatory 

standard database of industry clinical trial data described above. The disease model will 

be used to help design new clinical trials, and has been submitted to the FDA and EMA 

for initial review. Scientists around the world are already using the database and 

models in innovative ways. For example, in the past, scientists designed trials based on 

their personal experience or what they read in the medical literature. Now, thanks to 

this database, they have the individual data for exactly how Alzheimer's progressed in 

each of over 4000 patients. This is far more precise than their personal understanding 

of the disease or what they have gleaned from text books. This database and 

mathematical models of the disease allow them to more accurately predict the outcome 

for a given clinical trial, how long the trial must be conducted, how many patients must 

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be enrolled, how genetic subsets of the population could respond, etc. CAMD is now 

working with the NIH and academic investigators to pool their data to further enrich this 

exciting leading edge tool. 

• CAMD is helping define the FDA's new "Qualification" process, described in the new 

draft guidance released by FDA. (Guidance for Industry: Qualification Process for Drug 

Development Tools, U.s. Food and Drug Administration, October 2010) In this work, 

CAMD is submitting data and requesting that the FDA recognize certain imaging tools 

and cerebrospinal fluid tests as "qualified" for identifying patients much earlier in their 

disease, when there is still brain function to be saved. In this work, CAMD scientists are 

identifying imaging, biochemical, genetic, and molecular biomarkers that have the 

greatest potential to uncover patient populations that are pre-symptomatic and 

therefore have more potential benefit from new therapies. A research plan was 

submitted in fourth quarter to FDA and EMA. 

• For the first time, we now have mutually agreed upon data standards for Alzheimer's 

clinical trials. CAMD investigators, working with the standard setting body, CDISC, 

posted these standards for public comment in an Implementation Guide on Dec 17, 

2010. These common data elements will be used by all CAMD members, but are also 

now published for use by anyone. Having a common data format will enable rapid data 

sharing and accelerated research and drug development. In the near future, all data 

submitted to the FDA for this disease should be in a common format greatly 

accelerating the FDA's ability to quickly evaluate applications. 

Having these new tools is allowing drug companies to more quickly evaluate potential therapies 

and find those that have a beneficial effect on disease progression - and also to more quickly 

stop working on therapies that show no benefit. This will allow them to optimize resources and 

bring therapies more quickly to the FDA and, therefore, more quickly to patients. 

We need your help 

Although CAMD is already improving applied regulatory science for Alzheimer's disease at the 

FDA, we need your help. Understaffing is a serious problem throughout the FDA and is 

especially critical for CAMD. The FDA needs your support to be able to dedicate the required 

number of scientists and staff to participate in CAMD and other critical path partnerships. 

CAM D's work is the kind of "applied regulatory science" that is changing the way drugs are 

tested and evaluated today, not ten years from now. 

I thank you for the opportunity to provide this testimony and everyone at Critical Path Institute 

and CAMD thanks you for your leadership and foresight in authorizing the FDA's Critical Path 

Public/Private Partnerships that are giving new hope to patients and families at risk for this 

devastating disease. 

I respectfully request that my full testimony be accepted to the record. Marc Cantillon, MD 

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46 

Mr. PALLONE. Thank you, Doctor. 

I thank all of you. We will take questions from the members, and 

I will start with myself, and I will start with Dr. Morrison-Bogorad. 

Scientists know Alzheimer’s attacks the brain long before people 

exhibit cognitive decline. But the specifics are crucial because, so 

far, drug after drug has failed to effectively treat Alzheimer’s in 

people who already show symptoms. I know you suggested that 

that was part of the problem, that perhaps the answer is earlier 

treatment before you actually have the signs of the disorder. So 

what I wanted to ask is why are biological markers, whether gene 

mutations or pathological brain changes, important to the development of effective treatments for Alzheimer’s and what research is 

NIA conducting to better understand these markers? I am sort of 

going back to that same issue that you mention, is perhaps we 

should be starting earlier but then we would have to know if people 

have the disorder. 

Ms. MORRISON-BOGORAD. It is probably one of the items that we 

are pushing most of our effort into these days, because we do think 

that understanding the earlier stages of Alzheimer’s disease is very 

important and we have thought that ever since we reissued the request for applications for funding our Alzheimer’s disease centers 

across the country. Because about 8 years ago now we said to 

them, forget about late stages of disease. We want you to really, 

really concentrate on the earlier stages. 

So we have thought about this for quite a long time; and, obviously, one of the things that held us up is not being able to identify 

preclinical stages. That is one of the things that is really being addressed by the Alzheimer’s disease in your imaging initiative, especially in people who aren’t yet showing symptoms or in people who 

are developing mild cognitive impairment, which is a precursor to 

Alzheimer’s. Researchers working together with industry and people funded by us are identifying markers in the cerebrospinal fluid, 

and these markers are lowered beta-amyloid and higher levels of 

protein called tau that signal that a person is approaching the 

stage of mild cognitive impairment. 

The other technology which has been developed by ADNI and by 

others is actually being able to look at in the brains of individuals 

cerebral amyloid plaques through positron emission tomography, 

through imaging. And this is perhaps the most amazing breakthrough over the last several years because that has allowed us to 

see that in a number of folk, older folk, older than 65 or 70, about 

20 percent of these folk who otherwise would have been thought of 

as normal, who are quite normal cognitively, have levels of amyloid 

plaques in their brain that in some cases are equivalent to a person 

with Alzheimer’s disease who can’t at the moment function for 

themselves. 

So the CSF markers and the brain markers are two ways we 

have of identifying preclinical disease which we didn’t have before, 

and they could be used to identify people who have got markers in 

the brain, amyloid in the brain for earlier clinical trials than we 

are able to do right now. So I agree. It is really, really, really important that we develop these markers and that we use them to do 

more efficient clinical trials in the preclinical stage. 


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Mr. PALLONE. I had a second question, but I maybe would prefer 

if anybody else would want to comment on this issue because I 

think it is pretty important. Would any of the others like to—— 

Mr. JOHNS. I simply add that what Marcelle has said is certainly 

one of the most exciting areas that is occurring in Alzheimer’s research today. She has indicated that we have worked together on 

this at the Alzheimer’s Association International Conference on 

Alzheimer’s Disease over the summer. There were significant findings released on this very front. It is potential to go to the point 

where we can actually identify Alzheimer’s presymptomatically in 

the future. It is not ready for the clinic. That is for the lab at this 

point. That is a significant set of advances that are very important 

to us. 

What is of course very important is that we have a parallel in 

treatments. Right now, we are making faster advances on the diagnostic science than we are on treatment side. So what we really 

need to do is catch that up. And that is one of the most important 

reasons for the additional funding that is really needed for Alzheimer’s disease. 

Mr. PALLONE. Thank you. 

Mr. Gingrey. 

Mr. GINGREY. Mr. Chairman, thank you. 

I think I will shift then to the treatment aspect of it and maybe 

come back to very interesting things that the two of you have just 

talked about with regard to early diagnosis. 

Dr. Cantillon—I hope I did better. I know I botched that up pretty bad the first time—I have a lot of respect that the FDA, the 

Food and Drug Administration, performs. With that being said, I 

am interested in exploring how the FDA drug approval process 

might be improved in the hope it may help spur a greater drug development for diseases such as Alzheimer’s. 

I think I mentioned in my opening remarks that I have introduced legislation along with my colleagues here on the committee, 

Energy and Commerce Committee, Health Subcommittee, bipartisan, Mr. Green and Ms. DeGette on the Democratic side and myself and Mr. Rogers from Michigan on this side, the GAIN Act. This 

is in regard to the shortage of antibiotics. So a different disease, 

a different category of drugs, but equally as important. Can you tell 

me, Dr. Cantillon, how applying scientific advances such as the use 

of biomarkers or drug development tools might aid in drug development in this country? 

Dr. CANTILLON. Yes. Thank you for that question. 

So, actually, as a medical director of Alzheimer’s and other programs with Schering Plough over the last couple of years before 

CAMD, I did sit on an industry advisory group for this ADNI trial 

that Dr. Bogorad was speaking about. So I was giving some advice 

into the choice of the instruments and that these markers were 

being developed, had my hat on in terms of both drug development 

and facing the FDA with a package for an approval for a treatment. 

The trouble is when you are coming from a drug developer’s 

point of view, this is all very cutting edge. And as I said in my testimony, the science by itself is truly not enough. It is not enough 

to have exciting markers that may predict something that is going 


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48 

on in the brain if it can’t be harnessed into a path and the development steps to use a new drug and prove that. I will give you an 

example. 

So we talked just now about the cerebrospinal fluid. We know 

there are certain proteins that can indicate both the disease and 

perhaps even the type of progression predictive. We would take 

that and we are taking that and in a collaborative way with the 

whole field. So we are just one collaboration that I had mentioned. 

Look at the evidence for that in a critical way, in a scientific manner. 

The regulatory science part is having our regulatory scientific 

colleagues internationally review that in a context of use. Does that 

allow you to choose a population for a trial who are not yet demented? So to call somebody demented, you don’t need to be a doctor. It is very clear that the person does not have their brain functions in the same way for memory and so forth. To find somebody 

that is very early in the disease or even hasn’t fully shown clinical 

symptoms, you need these markers. 

Can we ask for FDA regulatory approval that these are standardized in such a way that they can become a tool, a standard tool 

publicly available to any company in this country or anywhere 

else? Can take off the shelf and put into a program such that, by 

using this tool, they don’t have to defend that tool when they go 

in front of the FDA? That process has already been done in this 

qualification. And instead they can focus on their own particular 

drug that then fits into this pattern and can use that patient population, for example, to show progression over time. Do those people 

who have low tau, high tau, low a-beta or a particular brain picture 

with amyloid, do they progress faster than others and can you 

show a difference in the people who were on drug and off drug? 

That is how the whole development process can make use of this 

science and translate it into something that the FDA can then approve or not approve. 

The FDA did put out a guidance document partially from working with us just 2 months ago, and in that the steps are laid out 

very clearly. Essentially, it is show us the evidence. Very similar—— 

Mr. GINGREY. My time is rapidly drawing to a close, but let me 

quickly ask you, do you think it is important that such drug development tools—biomarkers—that they first receive approval by the 

FDA before being used by industry and the agency to measure the 

safety and efficacy of the drug? Do you think that the FDA would 

have to approve this off-the-shelf kind of testing ahead of time? 

Dr. CANTILLON. The FDA has the possibility just to approve for 

commercial use or other use, but that is not within the context of 

use that we are talking about. The context of use would help that 

tool help define a particular population. So, for example, let me 

give you another—for another consortium. We developed some 

markers for renal injury, for kidney injury. They were brand new, 

and they could allow a drug developer or anybody to show if something was happening very early on before the kidney actually was 

destroyed. These markers went through this qualification process 

and are being very widely used by all companies, including my 

former one, to make decisions about drug development. When they 


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49 

go to the FDA, they don’t need to defend those markers for kidney. 

They have already been approved. So it takes a lot of that work 

away and you can focus on the drug. 

Mr. GINGREY. Doctor, thank you. That does answer my question. 

And I will yield back, Mr. Chairman. 

Mr. PALLONE. Thank you. 

The gentlewoman from the Virgin Islands. 

Mrs. CHRISTENSEN. Thank you. Thank you, Mr. Chairman. 

Dr. Morrison-Bogorad, given the disproportionate impact of Alzheimer’s on minorities, is the National Institute of Minority Health 

and Health Authority Research, which was formally the center 

among the NIH institutions that you are collaborating with? And, 

also, how diverse are the participants in the clinical trials? 

Ms. MORRISON-BOGORAD. It is again something that we paid particular attention to, especially in our flagship clinical trials, the 

Alzheimer’s disease clinical consortium, and there we have made a 

rule that a certain number of people in each clinical trial that we 

run there are minorities. And that has been extraordinarily helpful 

because it has meant that I think a fifth of the folk who participate 

in certain of these studies are minorities. So it is amazing what a 

little rule will do. 

And we certainly have got quite a vibrant program in epidemiology looking at Alzheimer’s disease in minorities and comparing 

that with Alzheimer’s disease. And I would say at the moment the 

results are somewhat equivocal because many of the ways in which 

you define Alzheimer’s disease are also very dependent on things 

like the education of the person who is taking the tests. And many 

older African Americans, of course, for other reasons haven’t had 

the education that they should have had and so they don’t do as 

well on these tests as they should. It doesn’t mean they have Alzheimer’s, however. 

So this is a very, very thorny issue and we have gotten a number 

of very good researchers working on that to actually try and tease 

out what part of the minority burden of Alzheimer’s disease is 

real—and I do believe some of it is because some of the possible 

things that cause Alzheimer’s disease are, as you are aware, much 

more prevalent in minority communities, things like heart disease. 

But I do believe that some of the numbers are a little bit over, perhaps larger than they should be because of this issue on how to determine Alzheimer’s disease in people with different backgrounds. 

Mrs. CHRISTENSEN. That is interesting, because my impression is 

that it is underdiagnosed rather than overdiagnosed in minorities. 

And I will let anybody comment on that. 

But I wanted to ask Mr. Johns, if I can get this question 

straight, because I know this hearing is really about getting funding for Alzheimer’s. And, Mr. Johns, I heard your argument very 

clearly about the need for an increased investment in Alzheimer’s 

to reduce the cost of health care eventually and to perhaps even 

save Medicare. We have been trying to get CBO to score prevention 

for a while, actually introduced legislation to have them do that 

when they are asked by the committee. So, without having scoring 

in place for prevention, how do you foresee getting the funding 

needed, especially in a Congress that is committed to cutting 


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spending? And how important do you think scoring prevention is 

to this particular issue? 

Mr. JOHNS. Well, certainly, as you say, the fact is that CBO 

won’t score what I would describe as a game changer. That is a 

problem I know for all of us when we have interest in what would 

be effectively R&D for our country. We really have—beyond the immediacy of Alzheimer’s, we have what is a potential brain drain in 

our country as a result of research being attracted overseas. While 

it isn’t specific to Alzheimer’s, it is generic and related to Alzheimer’s, as well as other medical research. 

So we have as a country to face what is, first of all, a significant 

problem in that larger regard with medical research but very specific in Alzheimer’s; and, of course, we have the challenge of facing 

our economic realities and also then funding something that cannot 

be scored. We recognize fully the difficulties of this, but we can also 

see from the projections we have done—and we have gone to outside sources at the Alzheimer’s Association to develop what are 

these data. We have actually used the CMS data on expenditures 

on Medicare and Medicaid. We have taken those to Dartmouth. We 

have had the Lewin Group look at all these data and what we have 

identified is that $20 trillion cost over the next 40 years. 

One of the problems we have as a country, of course, is actually 

addressing problems that are longitudinal. Those of you sitting 

across from me know that better than I in terms of how hard it 

is to make those things work. But we certainly know it, too, the 

Alzheimer’s Association and any of us here sitting on this side who 

are trying to change the course of Alzheimer’s disease. We have to 

find the national fortitude to address this already enormous problem. Everyone who has the disease today will die with it or of it. 

We do not have a treatment that stops or even slows it. The devastation of the disease at a human level for all of us who have experienced it personally and for all of those who haven’t, we recognize 

just how bad that is. 

I don’t have the easy answer to your question, but the scale of 

the problem, the enormity of the issue begs for us to find a way 

to answer the question so that we can address this now. We are 

running out of time. 

One of the things that Marcelle mentioned is that the science 

community believes ever more that we need to intervene sooner, 

that the plaques entangles of the disease are deposited earlier in 

life, at least 10 years before the symptoms manifest. If, in fact, we 

don’t make these investments relatively soon, the baby boomers, 10 

million of whom will have this disease, will be a lost cause. And 

the devastation at a human level and the economic toll will be solidified if we don’t move relatively soon. 

Mrs. CHRISTENSEN. Thank you. Thanks. 

Mr. PALLONE. I thank the gentlewoman. 

Next, we have our Alzheimer’s hero here, who actually sponsored 

both of the bills that you mentioned, Mr. Johns, the one that I 

guess is now in the House for action hopefully next week, as well 

as the larger bill. Mr. Markey. 

Mr. MARKEY. Thank you, Mr. Chairman, very much; and I thank 

our witnesses so much for your participation here today. 


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Robert Browning wrote, grow old with me, the best is yet to be. 

But the truth is that for millions of millions of Americans the golden years are now the worst years because of Alzheimer’s and the 

family caregiver who has to help. So this is now at 4 million or 5 

million Americans already an epidemic since, as we know, not only 

does the Alzheimer’s patient have the disease, but one family member has it as well as. So about 10 million Americans right now are 

living with it on a daily basis in their homes or in some facility. 

And when it goes up to 12 million times 2, 24 million, 25 million 

people, the caregiver and the patient, it is going to be an incredible 

moment in American history. So we have an incredible responsibility here to make sure that we put in place a plan. 

And, Mr. Chairman, you made reference to it, which is that the 

National Alzheimer’s Project Act, which I introduced on this side 

along with Christopher Smith, the co-chair of the Alzheimer’s Task 

Force, passed the Senate last night. And Senator Bayh and Senator 

Collins did an excellent job in framing it up and we will be able 

to pass that next week on the House floor. And then we will have 

a plan. We will have something that makes it possible for us to put 

in place something that is the plan to attack this disease. And it 

is long overdue, but it is a good beginning. 

So let me ask you this, and maybe you could reflect upon it, Mr. Johns, if you could. Last year, the Federal Government spent $122 

billion on helping people with Alzheimer’s, but we only invested 

$469 million in finding the cure, and we know we are only at the 

beginning of an explosion of the bills that are going to come in 

across America for the Federal Government to help families with 

Alzheimer’s. Can you reflect upon that, give us your insight as to 

how big it is going to become and why it is imperative that we act 

now? 

Mr. JOHNS. Certainly. And let me thank you, Mr. Markey, for 

your authorship of NAPA and the input and leadership of yours 

and the committee’s in moving that forward. Certainly Alzheimer’s is already costing $172 billion in total, the 

$122 billion you talked about from the Federal Government. Incidentally, at the Medicare level, Alzheimer’s is driving 17 percent 

of the Medicare budget—— 

Mr. MARKEY. Say that again. 

Mr. JOHNS. Seventeen percent of the Medicare budget is driven 

by Alzheimer’s today. The total cost for Alzheimer’s again to the 

country and other dementia is, by the middle of the century, in excess of $1 trillion per year; and by far the bulk of that will be the 

Federal Government’s cost projected from today’s levels with no 

changes. So that it simply won’t be affordable not only on the economic front but again on the human front. 

We can’t accept what will happen to families. We don’t have the 

ability to deal with the end-of-life considerations of the long-term 

care. Families at some point, dedicated as they are, with 70 percent 

of the people who have Alzheimer’s living at home and cared for 

at home, at some point that other percentage as a result of the fact 

that families, no matter how much time they spend, the 24 hours 

a day that they often spend as caregivers, especially toward the 

end of life, is no longer enough or they are simply not capable of 

handling the difficulty of the care at home so that we are not 


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equipped at this point. As you indicated, we don’t have a plan for 

any of these things at this point. NAPA will hopefully address that, 

but we are just not prepared as a country to handle any of these 

problems at the scale they are going to rise to. 

Mr. MARKEY. This is just something that is not as well understood as it should be. My mother had Alzheimer’s, and she was a 

valedictorian. My father was a milkman. And my father always 

said it was an honor that my mother married him. And he used 

to say, as well, if the strength of your brain determined who got 

Alzheimer’s that he would have had it and my mother would have 

been taking care of him. But we know that this is an equal opportunity disease. At age 80, 82, 84, 86, 88, my father kept her in our 

living room with the arms of a milkman, arms the size of my legs; 

and he was able to do it. 

But for many families it becomes exhausting. You can’t do it. 

There is a point beyond which you need help and that helps comes 

increasingly from the Federal Government in the form of $122 billion a year right now. 

But I don’t think actually we are going to be able to solve the 

Federal budget deficit if we don’t dramatically increase the Federal 

investment in research. It will be a trillion dollars a year just for 

Alzheimer’s care in another 15 years, and it is just a number that 

is going to increase exponentially. And despite the efforts of people 

like my father and other families all across the country, these people are heroes, but heroes need help and they need hope. And only 

the National Institutes of Health, really the institutes of hope, really give people the courage to keep on going. 

So this whole effort is absolutely—I think it should be the number one issue, to be honest with you, just from a budgetary perspective. From a humane perspective, yes. Coupled with the Alzheimer’s Breakthrough Act, which I have introduced, and the 

HOPE Act, the Health Outcomes, Planning and Education Act, 

which we have to focus on, we have to put in place the kind of ingredients of this plan that make it possible for us to solve this 

problem. And I commit to you, all of you, that I am going to continue to just work my heart out to make this something that becomes real in people’s lives; and I cannot thank you enough all of 

you for your support. 

And, Mr. Chairman, I thank you for conducting this hearing. I 

don’t think there is a more important subject for us to be discussing as Americans. 

Mr. PALLONE. Thank you. And thank you for all you do, Mr. Markey, on this and other issues. 

Mr. Engel. 

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

Right in the nick of time. 

First of all, I want to thank everyone on the panel. This is certainly a very, very important and—and something I have had a lot 

of concern about. I think that—what all my colleagues have said— 

this is what we ought to be spending money on when we talk about 

some of the other issues. I think we should all agree on issues like 

this. 

Mr. Chairman, I want to ask unanimous consent to insert my 

opening statement in the record. 


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[The information was unavailable at the time of printing.] 

Mr. ENGEL. Let me ask Dr. Cantillon—first of all, thank you for 

your comments. I was told the comments you made before, and I 

deeply appreciate your saying that. The Critical Path Initiative is 

certainly something that is near and dear to my heart. I have 

strongly supported public-private partnerships, and I am pleased to 

learn that this program has been very effective in tackling diseases 

like Alzheimer’s. 

You mentioned in your testimony, Doctor, that one way Congress 

can be helpful is to provide the resources to increasing staffing levels at FDA; and, as I mentioned before, I couldn’t agree more. We 

need to increase resources for the FDA to help them bring drugs 

to market. But, given the limited resources we are working with, 

I was wondering if you could address other ways that we might 

help break down the barriers to translational research and help fill 

in the gap that has opened up between biomedical researchers and 

the patients who need their discoveries, which we unfortunately referred to as the valley of death. 

Dr. CANTILLON. Indeed, thank you and thank you for your support for these partnerships. 

I think that the partnership, the public-private partnerships, are 

certainly a major part of the answer in this fiscal environment. So 

we have all said several times that this is about to bankrupt our 

country and many other aging countries around the world and 

there aren’t unlimited funds either to put into any one particular 

disease. And maybe we need to look at an innovative science and 

an innovative way of answering some of these questions that have 

come up. 

So the FDA is going to be faced with a lot of the new science arriving in different ways. Part of what we have been working together with them was to put a process in place to translate this 

science, not just, let us say, from the test tube to the rat, but all 

the way through to a new medication at the very end. In other 

words, to make a process available to be able to gather the evidentiary information. 

The FDA doesn’t have but a few handful of staff that we deal 

with on a very regular basis and, as I mentioned, are indeed a part 

of our consortium; and the Europeans, in fact, are in a similar situation. So what I was referring to is basically stretching the dollar 

and the people that we have. Part of what we are doing and seek 

to do more of is in fact build an in-kind work, and there is a lot 

you can do with that. There is a lot of scientists, just like there was 

a lot of data, who have been siloed, be it within government—I 

used to be at NIH—or within companies. 

Once a trial has failed, that data is essentially put on the shelf 

somewhere. Definitely with the kind of tools we are talking about, 

those data can be re-examined, at the very least, and perhaps there 

will be some pearls in there. But they also can be mined for the 

learnings that are there and shared. That is public and belongs to 

all of us. 

So what we put together are these various methods to do that. 

It is, I would say, an innovative tool to get people to give up their 

silo thinking, look at a precompetitive space for companies and 

even for academics, that they actually don’t own the data that they 


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have generated, that it belongs to the people. And if we can set it 

up that way, have it as a database, for example, as I mentioned, 

but also the other tools, then that is freed for the best minds in 

the world to attack and that is actually a very efficient way of 

doing that. 

Mr. ENGEL. Thank you for pointing that out. It certainly is a 

shame if research is put on the shelf and no one else can get to 

it or look at it. This has to be a collaborative effort, obviously, and 

thank you for pointing that out. 

I would like to ask a question of Mr. Hall and Mr. Johns. As I 

am sure you are aware, the Patient Protection and Affordable Care 

Act, which is referred to as health care reform, that we just passed 

here, we were doing this for as you know almost 2 years. There 

was a provision in there that improves access to home and community based care for patients. We know that these services greatly 

improve the quality of life for Alzheimer’s patients. 

Health care reform, as we know, strengthens the long-term care 

system for chronic and other long-term neurological conditions both 

by eliminating the arbitrary caps on treatment, which we did—that 

was one of the crowning glories of this bill—and by expanding coverage to include preexisting conditions, which is the second pillar 

that is so important in this bill. 

In an effort to improve upon existing programs that positively 

impact Alzheimer’s patients and help you provide services, can you 

give us some insight as to how these provisions will improve your 

ability to provide services for Alzheimer’s patients and their families? And can you also address what other Federal programs exist 

to help you deliver services to more patients? 

Mr. JOHNS. Well, I personally think that all of our constituents 

are in a position, especially, as I mentioned previously, that 70 percent or more of people are cared for at home. All of our constituents 

who are in a position to be at home need additional assistance. As 

we see how all this unfolds, we will learn better exactly how it can 

best serve the individuals who are in those situations. So we certainly always have high hopes for what would help to be a better 

care at home. 

Because we know, as I mentioned a little bit earlier, that we do 

not have the capability to really accommodate all the folks who 

would ultimately perhaps need to go to long-term care. So additional ways to find ability to handle people at home is critical to 

the entirety of the Alzheimer’s constituency. 

Mr. HALL. Additionally, I think we all agree that the longer we 

can prolong institutionalization the better it is for the Federal 

budget, for sure. But families do need an enormous amount of support. The conversation we have had here around research is pivotal. There is no doubt we need to find a cure as quickly as possible, and any amount of money that we can put towards this disease would be an enormous win at this point. But the reality is 

that a cure does not seem to be coming anytime soon, and so it 

does rely on care, and it does rely on those families. So any type 

of provision that supports individuals with the disease and cares 

for them and provides for them the greatest quality of life for the 

longest period of time is great. 


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But also, too, we are recognizing the support that is truly needed 

for caregivers across the country at this point, at this juncture 

where we are in relationship to a cure is really the critical step. 

It is what we need to do. 

Mr. ENGEL. Thank you. Thank you, Mr. Chairman. 

Mr. GINGREY. Mr. Chairman, just very quickly—and I know the 

afternoon is getting long, and I appreciate our witnesses who have 

done a wonderful job. I guess I would direct this to Mr. Hall. Can 

you talk about the benefits of early detection as it relates to both 

the financial realities that patients face and for making end-of-life 

decisions? 

Mr. HALL. Sure. The Alzheimer’s Foundation of America hosts 

and is the initiator of National Memory Screening Day, and the 

reason that we do that is really just to sort of educate the public 

as a whole and then to allow individuals to participate in memory 

screenings across the country. That isn’t a diagnosis for Alzheimer’s, but rather is looking to see if there is an indication of I 

guess the most common manifestation of Alzheimer’s disease, 

which is memory problems. That initiative to us is really important 

because of the fact that it points to a possible early diagnosis of 

this disease. It is really critical because our experience at the Alzheimer’s Foundation of America is that our phone calls, our e-mails 

in the volume that we receive, every single one of those families 

is in crisis and chaos. So they are really scrambling now to figure 

out what does Alzheimer’sdisease care look like? What am I now 

responsible for as a family? What is required of me legally, financially? What is required of my time? 

Early diagnosis in our interpretation is really important because, 

one, I think some of the treatments that are available right now 

are able too offset the progression of the symptoms of the disease 

and therefore the person enjoys—the person with the disease enjoys a higher quality of life for a longer period of time. 

And I have to tell you, traveling the country—and I am sure 

Harry could say the same thing—We have not met one single family anywhere that hasn’t said that all they wanted was one more 

good day with their loved one who is in the grips of Alzheimer’s 

disease. If we can prolong one more day, I think that is a win. That 

is what we have right now. 

But, additionally, planning in this situation is enormous, educating, empowering the family unit so that they understand. It is 

generally one in four individuals caring for every person with Alzheimer’s disease. But also then enabling organizations to surround 

those families, to hold their hands, to walk with them on the journey and support them, to connect those families at the point of diagnosis with those necessary resources, instilling hope, which is 

probably the greatest missing link in Alzheimer’s disease. 

At least by surrounding a family with hope you are doing just 

that. You are giving them a lifeline, and you are letting them know 

that they are not going to be alone in the process. That takes care 

of an enormous emotional toil for a family, which is probably the 

biggest piece of the picture. 

And then if you are able to bring in other resources of financial 

planning and legal planning and what all this looks like as far as 


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care in the future, those are enormous wins in alleviating the burden, the stress, depression for caregivers. 

Mr. GINGREY. Thank you. 

Mr. PALLONE. Thank you. That concludes our questions, but I 

just want to thank you all of you. It is obvious from listening to 

the questions and your testimony how important this is both now 

and in the future. We do plan to move the one bill that passed the 

Senate on the House floor next week; and, of course, the larger bill 

will have to wait for another time. But this is—I just want to stress 

how important really and how we really plan to prioritize this. So 

thanks a lot. 

Let me mention that you may get additional questions from the 

members to answer in writing. The members are supposed to submit those within the next 10 days or so, but you may get those and 

the clerk will notify you of that. 

But, without objection, this meeting of the subcommittee is adjourned. 

[Whereupon, at 3:21 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 


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Statement of the Honorable Anna G. Eshoo 

Energy and Commerce Committee, Health Subcommittee 

Hearing on Alzheimer's Disease 

December 9, 2010 

Thank you Mr. Chainnan, for calling this hearing on the ongoing challenges 

of Alzheimer's Disease and the critical health care needs of an aging 

population. 

Alzheimer's is a disease all of us know too well. Everyone's had a relative, 

a friend, a co-worker, or even an acquaintance who's been stricken with this 

frustrating and painful disease. An Alzheimer's diagnosis can be a long 

process and lacks a simple test, even as patients lose their memory and 

ability to connect with others. The causes of Alzheimer's are not well 

understood and treatments are limited. The annual cost of care in our 

country for Alzheimer's patients will reach $172 billion this year. 

That's why I'm proud to be a cosponsor of Mr. Markey's Alzheimer's 

Breakthrough Act, which focuses attention and research at the NIH and CDC 

on early detection, diagnosis and prevention of Alzheimer's and its potential 

precursors. It will also help us take a close look at interventions designed to 

help caregivers and improve patient outcomes. 
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Alzheimer's is not a "Democratic Disease" or a "Republican Disease". It's a 

disease that can affect anyone, from any walk oflife. With the cost of caring 

for Alzheimer's patients expected to rise to $1 trillion in 2050, I think we 

can all see that continuing to fund Alzheimer's research makes common 

sense and fiscal sense. 

Thank you again, Mr. Chairman, for holding this hearing, and I look forward 

to hearing from our witnesses. 
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The Honorable Joe Barton 

Alzheimer's Disease: The Ongoing Challenges 

Subcommittee on Health 

December 9,2010 

Thank you, Mr. Chairman, for holding this hearing today. 

Alzheimer's is a tragic disease affecting millions of 

Americans and their families and friends. We all must face the 

reality of death, but Alzheimer's disease forces families and 

friends to watch as loved ones, once independent and vivacious, 

suffer personality changes, loss of independence, and severe 

memory loss, such that they view those close to them as 

strangers. 

As difficult as it must be to watch a loved one struggle with 

this disease, those afflicted with Alzheimer's face an inevitable 

1 
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and irreversible process in which they lose many of those things 

that define them as the person they have become. 

While Alzheimer's can affect people as young as in their 

30s, most patients are over 60 years old. As this population will 

double over the next 25 years to around 72 million, the number 

of people with Alzheimer's will also increase dramatically. 

As with other diseases, which also affect large numbers of 

people and cause profound suffering for patients, families, and 

friends, we want to do whatever we can to eliminate them or 

mitigate their impact on people's lives. When Congress 

reauthorized the NIH in 2006, Congress decided to put the 

question of which diseases to fund in to the hands of the experts. 

2 
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While it makes the most sense to let experts determine the 

best use of scarce resource for research, Congress still has an 

important role to play in fighting Alzheimer's and other 

diseases. Specifically, identifying laws and regulations that can 

be eliminated or streamlined to ensure new research findings are 

used to develop new treatments and diagnostic tests quickly and 

safely. 

Over the past 2 years, about 10% of the funds for 

Alzheimer's research carne from the 2009 stimulus bill. The 

stimulus was designed to be spent within 2 years. I hope Dr. 

Morrison-Bogorad's testimony can also describe not only the 

type of research funded by the stimulus, but what the long term 

implications of that research could be for Alzheimer's disease. 

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I would also be interested to hear about the opportunity 

costs of the stimulus grants for Alzheimer's disease. Would we 

have been better served investing those resources in traditional 

NIH grants rather than the 2 years grants funded by the 

stimulus? 

Thank you Mr. Chairman and I yield back. 

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Rep. Joseph R. Pitts 

Opening Statement 

Energy and Commerce Committee Subcommittee on Health 

Hearing - "Alzheimer's Disease: The Ongoing Challenges" 

December 9, 2010 

• Thank you, Mr. Chairman. 

• While estimates vary, as many as S.3 million Americans may have Alzheimer's 

disease. 

• According to Alzheimer's Association estimates from a few years ago, nearly 

SOO,OOO people in my home state of Pennsylvania are currently living with 

Alzheimer's disease and related dementias. 

• And, an additional 24,000 Pennsylvanians have early onset Alzheimer's. 

• Alzheimer's disease is one of the top ten leading causes of death in the United 

States. Among American adults, it is the 7th leading cause of death. 

• It is the Sth leading cause of death among American adults aged 6S and older. 

• It is degenerative and irreversible. And there is no cure. 

• The FDA has approved a handful of medications to treat Alzheimer's, but none 

of them stops the disease itself. Instead, they help delay or prevent symptoms 

from becoming worse for a limited amount of time. 

• This time period, however short, allows those with Alzheimer's to live with 

dignity and independence for as long as possible. 

• Millions of Americans, including friends, family members, and health care 

professionals, serve as devoted caregivers to those suffering from Alzheimer's, 

often at great personal cost to themselves. 

• And their efforts should be recognized. 
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• I am proud to be a cosponsor of Mr. Markey's bill, H.R. 4689, the National 

Alzheimer's Project Act, which seeks to coordinate the federal government's 

efforts to study, treat, and prevent this disease. 

• I look forward to the testimony of our witnesses and their opinions on this bill 

and others that have been introduced in the III th Congress. 

• Thank you, and I yield back my time. 

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Congressman Marsha Blackburn 

Opening Statement for Energy and Commerce 

Health Subcommittee Hearing 

"Alzheimer's Disease: The Ongoing Challenges" 

December 9, 2010 

I would like to thank the Chairman for holding this hearing 

today and welcome our witnesses. 

Alzheimer's disease is a devastating illness that affects 

millions and is of grave concern as the nation's population ages 

and lives longer. This is an issue particularly important to me 

because Tennessee is home to nearly 850,000 residents over the 

age of65. 

I have personally stood behind the organizations and 

researchers who are striving to make changes to the treatment and 

barriers-to-care for those affected. In 2007, I worked with my 

Committee colleagues - Mr. Engel and Mr. Hall, as well as Ms. 

Giffords - to establish the Critical Path Public/Private Partnerships 
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at FDA to improve the process for developing safe medical 

products, accelerate innovation, and enhance safety. Since the 

successful passage of this amendment to the FDA Amendments 

Act of 2007, such partnerships have successfully facilitated 

collaborations between the FDA and scientists to enhance the safe 

development of treatments for Alzheimer's disease. 

With the increasing number of people living with 

Alzheimer's, research must delve further into the causes of this 

disease; a better understanding of the disease will result in 

improved treatments and outcomes. I commend the work of the 

Critical Path Initiative and the National Institute of Aging (NIA), 

within the National Institute for Health, which have the potential to 

garner the greatest researchers and scientists to do just that. 

Support for both the Initiative and NIA are critical to 

curtailing the continued progression of Alzheimer's, which is 

quickly becoming one of the costliest and most devastating chronic 
67 


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conditions of the baby boomer generation. Currently, 5.1 million 

Americans live with Alzheimer's. The incidence of the disease 

continues to rise, and I am sure everyone in this room knows 

someone affected. It is time to solve this problem before the 

projected 13.5 million potentially-afflicted becomes a reality. 

I look forward to hearing testimony from today's witnesses. 

Thank you Mr. Chairman and I yield back the balance of my time. 
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Evidence for Neurocognitive Plasticity in At-Risk Older 

Adults: 

1\!ichelle C. Carlson.l Kirk l. Erickson." Arthur E Kramer'; :llichelle W. Vos,,' >Jalalie Boiea, i :ltkhdle 

Mielke." Syh'ia :I!cGill, 5 Geurg:e 'tv. Rebok, t Teresa Seeman," and Linda P. Fried' 

prevulcnce of one of the most 

conditions. Alzheimer's 

to rise fourfold. to 8.6 million, oyer the next 50 

health crisis. Healthy 

memory and fUl1ctional uifHcnlties ,md serve ;:111 importanl target fur preventive interventions:. 

To dnk. i11tk is- known about thct:ffkacy of Clumnunityi).wed 

exe('uiiye: function, 

\Ve now dC$cribe a ncw model designed to enhance physicaL soda!. activity ~U1d how 

and exerdsc of c.\ccuth·c func~ 

1275 
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1276 CARLSON ET AL 

grade with literacy and lihrnry functions (17). A pilot r.mdomized trial of this program in Baltimore demonstrated 

program-specific benefits in children's academic achievement 

(18) and in the physical (17) and cognitive health (8) of 

senior volunteers. Specifically. we found that those at greatest 

risk for executive deficils showed subslmltial and clinically 

me,aningfuJ improvements in ~h-ese and other functiuns 

because of participating in EC. Our promjsing short-term 

findings among individuals at risk for cognitive icnpairment 

suggest !hat they have sufficient neaIDCognttlve resen'es or 

I'iasticity to heneflt immediately and substantially from this 

type of high-icnpaet activity intervention. 

Wc ncxt sought 10 find preliminary evidence of brain 

plasticity in age~vulnerabie executive functions ,w1I.:mg 

these cognitively at-risk older adults through a functional 

magnetic resonance imaging (fMRI) pilot study of EC in 

eight volunteers and nine matched controls (see Tahle O. 

We describe Tesulls of Ihis pilol sllldy "fEe, a program tilat 

provides an ideal environment in which to lest the potential 

for a multimndal activity intervention to influence cognitive and brain health. Additionally, practical goals were 

to determine whether the use of fMRI would be feasible 

in jlll1'\icipants wbo do not typically comprise volullteer 

samples fnr interventiou. 

Panicipal1ls 

All prospective volunteers Ultended information sessions 

to describe the He program and participation reqUirements, 

if interested. Eligibility crHeria included (a) being 60 years of 

age or older; (b) English spea!dng; (oj agreeing to conmlit to 

at least I year; (d) agreeing to participate a(least 15 hlwk 

for the full school year; (el meeting minimum criteria for 

cognitive functioning necessary to function successfuny in 

a school setting via an education-sensitive, two-step process 

using tho: Mini-Mental State Examination (MMSEll J 9) 

score = 24 or higher or if scoring 20··23. wilh a higb school 

education or less. and successful completion of the Tool 

Milking Test (Thin (20) wilhinll!e time allmted (420 51'''' 

on<1s). The TMT served as a measure of mental flexibililY, a 

skill presumed key ~, adaptability in the schools; (I) minimum fifth grade level rending Htemcy; (g) clearance on the 

Baltimore city public school's I.'rimillal bi1!.:kground check; 

and (h) completing a 2-week tntirting 10 participate in EC. 

In eddition. to participate in this fMRI pilot study. participant, al;o had 10 (a) be free of a pacemaker or olher ferrous 

melal object' iu the body, (b) have no history of brain callcer or brain aneurism or stmke in the prior year, and (c) be 

right-hand dominant to avoid possible confounds due to 

hHeraHty in lefl-handed individuals, They W1.~re- then 

scheduled for a separate I-hour tMRI visil at the I'M Kirby 

Center at lohns Hopkins, This study was approved by the 

Johns Hopkins IRB. and each p~lrtidpant gave infvl111ed. 

written consent All paIticipam, received a ,50 hOllOl'aJium 

for each fMRl visit. . 

PaIticipants were AfTieat! American. 80% of whom had. 

high ~cho,Jl t::ducation UJ'Jd mnrgll1aUy normal globat l.:ognitive sc(}re~ on the MMSE (average:; 24.5). Half were troined 

and iutegrated will! existing teatns of experienced EC volunteers in two elementary schools. and half were wait-liSted 

for enrollme.nt the following academic year. 

buerVf!ntioH 

This multi modal EC activilY program is described in 

detail elsewhere (21). It was designed to bolster memory 

and executive funt .. 1.ions by exercising working memory skills: 

via reading comprehension activities with >..'hitdrenj inlileracy 

and library support, cooperative problem-solving skills with 

teanJ members, students. and teacbers, and through program 

activities that operated along multiple dimensions of cognilive ability and by exercising mental flexibility through the 

need to shift across EC roles. 

All volunteers were trained on the following modules 

and provided wilh it corresponding tool book covcdng the 

following: 

General Uleracy Support; provides a literacy support 

guide to IFJin adults who are reading with aud to childr.u. It 

aids lldults in assessing children's CU!Ten! reading levels!(J 

guide level-appropriate book selection, build vocabulary 

and comprehension, and ask question. about the book. 

Library Sllpport: supports: library functions! including 

shelving or cataloguing books, reopening and helping staff 

school libraries, helping children pick books they will enand reading tolwill! children. all uuder the guidance of 

C"riflicl Resolution. entitled "Partners in PIa}''' (18): 

le,",he.~ children _'oullict resolution Il!l'ough play in a supervised recc" program. V(,lunteers are !!"dined in how to lead, 

set gouIs. and playa varielY of bOIl! quiet group activity 

games. and board games. 

Outcome Measure: Flanker Task 

This selective allenlinn task measures one's ability to 

rapidly determine the direction of a central target (arrow) 
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UFESTYlE ACTlVlTYl"YD B1VllN PLASTICITY 1277 

INCONGRUENT 

anatomic.1 image was also collected. .trippe'll of aU nonbrsin 

tissue (12), and 5ubsequoody used fOf image registrattt.m. 

The functional :l'vfRI data were preprt'Ii.'cssed using FSL 

version 4.0 (23). Images we,,: slice-time and motion corre<'te4 using a rigid-body algorithm (24), k:mporally ltltered 

with a l'landpas5 filter cutoff at 30 se(..'Onds and 1 sec\.md, and 

spatially smoothed with a 7-mm FWHlvI3D Gaussiill1 kemel. 

Residual noise from excessive head motion was isolated 

and corrected using MfLODlC, an independent corllpolletlts 

analysis used in FSL. Residual moth)!) al1ifal.:t:S eHch 

wne in:>4"1't:iC',u t{'t participant were signal filtered from her respective time 

course before the fir:;t-level analysis (25). 

while effectively inhibiting distracting infom'ation that 

flanks the may conflict with the larget respOllS. 

(c.g'1 target points left, whereas flanking arrows 

point right). Each trial consisted of visual prest:nl<ition of a 

central target arrow flanked on either side by two arrows 

using a magnetic resonalKc imaging (1\'fRl)~!l'afe back pmN 

je.ction system, !f Ibe center arrow pointed right, participants 

were ill5tmcted to press the button in their right h,md; jf the 

center arrow painted left. prutic:ipanL' 

'"vere 

emphasized. Task difficulty was manipulated aero" trials 

by varying the direction of the flankers. which wen: elmer 

and »<») Of congruent ««« and 

with me central arrow. In me congruent c()ndition, 

tlanking arrows reinforced !he target n:spouse. In the incongruent condition. ftanken conflicted with the target response. 

The magnitude of interference from flankers WHS manipulated by cue size on eacl! trial (small and large), which was 

composed of a red drde that was either drawn only around 

the ccmral target (small) or around hOftl tru'llC! lind flankers 

(large; see Figure I). The '111all cue helped focus attelluon on 

the Illrget and minimize the impact of dist1llCung Il~nkers, 

whereas lhe large cue provided no information. 

Th"se task lnrutipuiatiol1s yielded four conditions (small 

circle incongruent. small cirele -congr.ueflt. large circle jn~ 

congruent, and large drde congruent), which were each presented 40 times for a total of 160 trials in a rapid event· related 

paradigm. Each stimulus was displayed for 2 ,,,,"'and, on , 

black background in the middle of the screen. Baseline con· 

~i$ied of a 3~second presentation of a central fixation crO&.ll: 

fotlmved by a40% interstimulm. jitter optinllze,d by optse,q2 

(http://surfer.nmr.mgh.harvard.edulnptseqi), 

JrfRI Pamnwters and Preprocessing 

AU MRI dal<i wen: collected un a 3.0T Phillips scanner 

(Best, the Netherlands). The functional MRI protocol 

employed a fast echo-planar imaging sC(juence with hlood 

oxygenation leYel-dependent contrast aequiring 2'() slices 

in sequence at a sampling rate of 1000 milliseconds. In 

addition, for each subject a high-resolution Tl-weighted 

[)maAna(rs;s 

A repeated measures analysis of variance (ANOV.'\1 w.s 

run Oll all behavioral data (response times [RT,J and 

accuracy) with time (baseline. postintervcntion) and condition (congruent large cue~ congruent small cue, incongruent 

large cue, and incongruent smail "cue) as withln~~mhjc('ts 

factors and group (control and treatment) as a hetwe-co w 

Sllbjects facfor. 

The neuroimaging data Were convolved using a doublegamma function with temporal deriv8tiYt:!s it; an event~ 

related analysis. Eaoh 00lldl1,on was added separately to 

the genera! linear mode1. For each l"'rticipant •• parameter 

estimate was t~akulated nt each vQxel 3C-fOSS each ()f the 

four (.'Ontiiliol1s. Contrasts of the flanker task conditions 

were calculated at this level and then forwarded to a higherlevel. gruup-wise analysis ill which a mixed-effects AKOVA 

carried OUL An regbtration IDatrkes to a &landnrd~ 

spa~e template (M(mtreal Neurological Institute) were 

calculated on the individllal level an{) then rub,equently 

[0 the estiwlltcs and variance c;,-limates 

ill group level analyses. These a"alyses 

were conducted separately at each time point. 1'0 minimize 

statistical constraint., associated with conducting multiple 

comparison!'., we dc/lued regions. of interest (ROh) based 

on main eifects of congruent,), (incongruent> congruent 

collapsed actuss cue size) at baseline: the Ulltenor dngulate 

cortex (ACe) and left and right dorsal and ventral prefi"onl<il 

cortex (dPFC and vPFC, resp,,".:tivety). These ROb were 

similar to activated regions 10nnd in previous studies of the 

flanker task (26). The main aim ofthls studY was {o examine 

thetffects of the EC intervention; therefo;c, we uscd these 

regions to analyze the follow-up session so that our exploration of the data was re;trkted to well-defined and 

theoretically important regions. Data were extracted from 

these regions and analyzed via 11 repealed measures an.clvsis 

illSPSS ,ersion 14.0 for Mac (Chicago, IL) to assess eff::Cts 

and intemctions of group, time, and condition. \Ve first 

assessed whether the intervention group exhibited a greater 

change in activation than the contro!s over the 6-month in~ 

tcrval (Time x Oroup interaction). Second, we determined 

whether such intervention .. spedtlc change in activity would 
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1278 CARLSON Ef AT. 

be selective to the .... "1 difficult !lanker condition (inccngrucnt) compared willl Ille easier congruent conditions (Time X 

Group x C audition inlc'l1lCtion). 

Analysis of the neuroimaging data w"" carried out u.ing 

FEAT (FMRI El<peI1 Analysis '1001) vernion 5.1 part of Fl>1._. 

Group level analyse. were carried cuI using FLAME. All 

Z-.latistic imagel! were !breshoJded using clusters determined by Z> 3.1 and a corrected duster significance threshold of p z .01. 

RESULTS 

As shown in Table 1. hoth groups were malched on all 

soclodemographic variablcs. Participant. were African AmenelUl. with low income. low education level •• and an average 

MMSE score of 25, • score lower than typically observed in 

""fuuteer munptes. Only one participant, in the inlerventioo 

group. dropped out prior to fo!low-up due to personal health 

",,",ons. No adverse events were reported in tbe intervention or control arms, and the fMRI protocol was welllQlermcd at bascline and f01l0\\'-up. 

Response Dtua 

TIle control group and intervention group did no! reliably 

differ for any eonditi,," .t the baseline assessment (.Il 

p > .05). Furthennore, at haseline, RTs were slower for ilIe 

incongruent condition oompared willi llie congruent coucti· 

lioll (F (I, 15) = 21.27; p <: .(01) and for large cues compared 

with ,mall cues (F(1.15)= 25.33; p <: .001), as expected. 

At baseline, both gwupn showed improved performance on 

the incongruent condition when a small cue Wit.~ avaHahk 

but shOWed no similar benefit of cue size on llie oongment 

condition (FH.IS) ~ 19.52;p <: .0(1). 

In pre--post compru;so.s, RTs were analyzed u",ng rcpeilled 

measures ANOVA< with interveutioo stalUS as a between-

,ubjects factor. time (baseline, postinlcTVention) as a withinsubjects factor, and cue size (small circle and large circle) as 

a within-snbjects f'actor. Percent Interferen", «(incongruent 

RT - congruent RT)/eongruent RD x 100) Was cakulated 

to adjust for general slowing effects related to aging (denominator) and served as the primary dependent variable, 

We obiicrved a significant Time x Group interaction 

(F(I,13) = 5.28;p'" .(4) in interference scores such Ihal the 

intervention group showed a greater reduction in interference over the II-month interval compared with malclled 

coutrol& (see Figure 2). The pen:cnt rcdilCtion in interference 

WWi equivalent across large and small. cue sires. Similarly, 

the Time" Group" Cue-size imCl"llction was not "'t.'lliticanl 

(1"(1,13)", 1.80:p < .20). 

Accurncy rates did not reliably differ between the <"(mho) 

and the intervention groups .t baseline (.11 p > .(5). At baseline. aC\.'Ur~C)' 'was wor$e for the inc.ou,brnlenl condition com'" 

pared with the congrueot condition (F (1.15) = 6.32: p <: .02) 

and marginally worse for large cues compared with smiill 

cues (F (1,15) = 2.59; p <: .06). In addition, the small cue 

I 101-----_.......--.....] ............... 

g 

i~ 4r-----------------

:: 

improved accuracy more for Ibe incongruent condition than 

tile congmentcollditiOll (F (1,15) = 4.52;p <: .(5). No other 

milln effects or i"""""nons were signillcant (aU p > .(5). 

Repeated measures ANOVAs were also conducted to 

examine accurncy rnle' by inlo .. ventloll slams aad task dilli-

''Ulty (congruent vs incongruent). Tune (hlr&line ruJd P',stlnlerventlon) and cue size (small chel. lUItllarge circle) were also 

witl1ill·sul*,~ factors. Compared with RT lneasurcs, there 

Groupinlerru::ti()!1(F(I,13)= L28; 

p <: .28). there was a significant TIme x Group" 

Omgruency interaction If (1,13) '" 5.77; p < .03). Post hoc 

comparisons revealed that this three-way !ll!emCtion was due 

\0 a greater interventlon-specifie improvemellt in .tcurlU."y in 

the incongruent conditions (p '" .05) that was independent of 

cue size(F(l,13)=l.!60;p<: .16), 

Neumimaging 

Resu!!lI"", (itst presented for b"""tine within- ruJd betweengroup comparisons alld then for intervention-related changes 

over lime. Consistent wi!b prior fMRl studies using the 

!loom task, we observed significant increases in activity in 

regions associated with the attention.1 network, including 

the left and right aon;a1lateraJ prefrontal cortex, the ventral 

Intern! prefrontal cortex, and !be ACC (26). These regions 

sbowed elevated levels of activity for the incongruent condition compared with the congruent condition (collopsed 

across cue size) that met a voxe!-wise threshold of p < .01 

lUlU a duster-wise !bresbold of p <: .05. PIior studies have 

rJ(lensively described these effects ill relalion to cognitive 

tlmctio!l, and age-related decline allowulg Ibis study to focus 

on how the Be inlcTVention may impact 00 ~ing efficiency nad plasticity in these regions. At baseline, holb interventio!l and control groups showed comparable levels of 

activity across all three ROIs. the ACC.left ventral prefrontal 

cortex (vLPFC), and left dorsal prefroulal cortex (dLPFC). 

The effect~ of the interventi<lI1 are highlighfed sub.'equemly. 
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liFESTYlE ACTfVfTY AND BRAiN PlASTleD}" 1279 

in activity over the 

follow-up (see 3), There were no !"temelion, with 

congruency or cue size, suggwing dmt intervClltion-spedllc 

gains in L'leACC were independent of congruency condition 

OJ' ~uc size {)f that tl'K~re was insufllcicnt power, 

Similar analyses of tile left dLPFC (duster size = 27114 

rom') also revealed a ,ignificanl Time x Group interaction 

(F(l,13)= 5.l6;p< ,()4) with the intervention group showing 

in activity over time (Figure 2), As 

ACC, there were no signilicllllt interacti0ns with 

congruency OfClle size. Theleft vLPFC (cluster size = 1576 

cubic mm) showed a similar Time x Group interaction 

(F (I,H) = 8.99; p < .01) with those in the imcrvclllion 

grollp showing a significant increase in activity at follow-up. 

Again, neilher congmcm:y nl)f cue size interacted with 

time or indicating that the intervention group ::J1owed 

increases across clI conditions (Figure 2). 

No regions showed an inten'ention-related decrease in 

activity. The right prefronta! regit)ns. although at·tive at 
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1180 

baseline for both groups, did not shew significant cbanges 

in activation that met threshold. However~ there wus a non~ 

in Ihe light dOfSalprejrOl1lal activity for 

incongruent oondllion for both the intervention and the 

control groups (p < . 16). 

Pre-post comparisons of each group', ability to IUter 

contlicting dis!:ractcrs (incongruent RT -c<mgruen( RT) for 

small and large CUes are presented in Figure 3 and show 

Ee-intervention-specific improvements in the ability to 

~e1e~tively attend during the most attentiDn demanding task 

conditions (in<;()ngruem). COl1""pondillg fMRI group comparisons similarly showed increased activity in attenli<lnal 

control regIons of the ?FC (middle and inferior frontal re,~ 

gions bilaterally) and the parieM regions, suggesting more 

efficient filtering or inhibiting of target infonnation from 

distraetil1u (Figure 3). 

DlSCXSSION 

This pilot study provides proof of concept for the feasibil· 

ity and utility of neumimaging to begin to unden;tand how n 

multimodal activity program in the community gets ullder 

the skill to improve executive functions and supporting brain 

regions. Thes\.~ at~risk individuals exhibited measurable bruin 

plasticity in direct to such environmental enrichment,providing <:Viden,,, of fui. program's potential 

to reverse cognitive and corresponding neural declines with 

nge.lndividuals exhibiteduse--dependent neumi plasticity by 

exerei,;ing and reactivating skills that may have been relati\'Cly unused for years oreven decedes. This finding is best 

captured by a personal observation [rom one of the \,o[unteers, who stated tbat "it [Experience Corps] rem"",,,j the 

cobwebs from my brain." Additionally, these previously 

sedentary at-risk participants were amenable [() the fMRI 

environment ou repeated exams, as demonstrated by 100% 

retention, and fuose enrolled in the pn:>gram met the intensive senice requirements; which Jed to un{lrecedented doses 

over a relutive1y sh0l1-expo5ure period. 

The results replicate and build on the previous pilot trial 

ofEC and cognition, and on an fMRI trial of physical activity in older ednlt,. First. we replicated the impact of EC on 

executive functions using a semitive measure that focuses 

on the age-vulnerable abilily to inhibit distraction in one's 

environment. Indeed, the present finding suggests genenui.7UtiOll of EC imptoyement" oyer different measures of executive function. These improvements extended to IXlrrcspt,nding 

increases in the activity of supporting prefrontal cortical 

-:ubstrale.;;, furthc-r repUcate seminal findings on the neuro~ 

cognitive henefit of physical activity (26--28), The patterns 

of increa.~ed functional activity here differed slightly from 

me exercise fiudings in two ways. First, we observed ECrelated increases iu the ACC during the executive function 

task. whereas fue exercise intervention led to decreased acrivation in this region. The ACe has been implicated in the 

efficient filtering or inhibiting of conflicting information 

prior to generation of a motor response. Although hoth 

studies demonstrate.d improved inhibitory efficiency (speed), 

Be parHcipants started with kl\vcr baseline inhibitory 

ability than those in the exercise intervention. Thus, as in 

a prior pilot trial of EC (21), these individuals were at 

elevate-d risk for executive "pfunetion and likely exened 

more effon to successfully develop inhibitory skills, 

which may be reflected by increased ACC activity. Second. 

we observeil the !atetalized increases in left prefrontal 

I.!ortical t/(tlvity in the EC sampJe while the exercise inler~ 

vcotion observed the right prefrontal cortical incre.ases. 

These laterality differences may be due to the nature of 

Be \'olunteer activities, which rely heavily on verbal 

COHlffiuoicat1on and mediation strategies, and may thus: 

elicit greater improvements in regions associated with 

NInmunication, such as the left prefrontal and temporomedial curtice:;. The:-t! hypoth~st!s require f!;!plication in a 

larger sample. 

Although the functional significance of the laterality 

differences is uudcRr, greater unilateral activation of cortical regions follo\\,tng the EC intervention t::ontributes to 

discussions in the functiooal neuroimaging literature (11;29) 

()n the nature of brain plasticity, reserve, and compellsatory 

function, \Ve have determine whether (hese changes 

were accompanied by slrUemral changes and chang"', in 

supporting white matter tracl5 that facilitate rapid and ellkiem 

romtnl1nietttion across 

The in'lpilcatlous. of findings to the assessment of 

postretirement lifestyle activity are tbat a broader nlilge 

of cognitive activities embedded within social settings may 

confer gre~t cognitive and brain benefits for older adults. 

Recent epidemiological evider.ce in twill pmrs suggest, fuat 

socially engaging cognitive activities in midlife and early 

late-life may redu,-. lisk ferr AD and dementia decades later 

(30) Jlnd may be indicative of an enriched environment, 

which enhnnces the proliferation of new brain celts and 

promotes brain repair in animal models (31-33). The implication!;. oJ !h<!,~ findings to the assessment of postretirement 

lifcstyle activity are that a broader range of cognitive activities may confer great cognitive benefit~ for older adults and 

may further comer neurocngnitivc protectit1n. 

Cognitive activity embedded within social settings may 

further increase task noveltYt int.eractive problem~solvillg 

skills. and motivations to sustain these activities, In addition~ 

tiH!se actl\'ities are gen~rative in giving meaning and purpose 

to one~s life {volunteering,. civic organizations, assisting 

others), which Illay make them more rewarding and personally enriching than highly stimulating activities performed 

alone (34). As a reSUlt, individuals Illay place more value on 

these activities beyond their immediate personal benefit and 

may sustain interest longer (35). This important developmentalnccd to be gCi1etative could provide- an 1 mportant 

,'ehicle for e.nnancing and sustaining behaviors important 

to successful aging, narnely remaining actJve-·socially, 

physically. and cognilivdy (4). 
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UFESTYLEAC1TViTYAND BRAIN PLASTICiTY 12111 

Umillltions of this pilot study indude the small sample 

site necessarily restricted to women (doe to gender differCI1ces in brain morphology), which limns genernli1.abilily but 

provides proof of concept for the potential of well·validated 

parametric fMRl tasks, such as this, to sensitively detect 

program-related functional brain changes in a larger randOlnized study of men l1lld wOInCl1. Second. although the 

sumple represemed an important and Mien uuder-studied 

segment of the aging adoll population. we have yet to dotermine whether Ihis program enhances or main!cins cognition 

amoog more ethnically and socioecooomically diverse individuals. Finally. this stedy design does not allow us to definitively discern whether the etrecl$ of this intervention on 

cDgnition function were mediated primarily by cognitive and 

physical pathways, respectively, or wheth<.'T benefits represent 

the synergy <Jf increased activity in all dolllllins. Understanding the mediating source may not be as critical as the observation that a mull;ple palbway approach sel in the community 

was associated with Jtigh doses, gnod relentioo. and short-

\el1n effects spunning many abilities in lbe most at risk. 

These finding,' olTer next-level que'tions about the .bili!y of this program. lUld others like it, to reset one's trajectory of cognitive decline with age, partlcularly among 

Ibose at elevated risk for dementia by virtue of impoverisbed environments over tile life course, a. marked by 

low or pOOl' quality (36) educationlllld low inCOIIlC. These 

individuals require furtber follow-up ill order to deter· 

mine Ihe potential ond boundaries of plasticity in a dosedepcndem manner. Questions include whether a l()Wet 

weekly exposure may confer equivalent benefits and whether 

continua:! exposure wooIIl lead to accruing benefits, perbaps in other brain regions interacting with lit"", prefi:ootal 

circuit." snch .. parahippocampallllld hippocampal regions 

that support some memory functions. Furthen:nore, it will 

be key to determine whether .hlll'Henn benefi IS will be sustained after program exl"""'" is discontinued. Overall, 

these pilot findings hold promise for enhlll1cing functional 

reserve and neural pia,-ticity among those at great risk. 

PL'NtlrNO 

This work W$ supported in part by the Research Career Development 

eNo!' <Jf!he OJd« Aroefi.:ans. lndependencc Cenier (f'3i)wAG02t334) and it 

gift from g, B. Becbtel 

AOCNO\\'T.1mGN1\Nr 

We would Ukt ro thmk Mr. Vijay Vamm for editing an eadicr drJlft of 

lhisarticl=. 

C~Nt:XE .. -..:CE 

AJdreSt. ('(m:$$pondenc~ to Michelle C. Carlson.. PhD, Dt-pmment of 

Mental Heru.t.h. Center on Aging and Health, Jdms Hopkins Bloomberg School of Pubtk 11eallh. 2024 FAlI! __ to Sui .. 2·700, B.t6m""" 

MD-lllOS. Email: mcarlsj)n(g.jh~ph.. 

R£.11i,;nNct!s 

I. Ilrook"",'Y'" R. Joh",,," E, Zi<gl<:Nl",hmn K. Arrlj:hi IllI!. Fo,.. 

casting the glohal !Y"m1en of AWleimer's diM'::m:. Aft/lf'tmeF':; mrd 

Dementia. 2n07:3f.~}:186-191, 

2. Fratigllcmt I..., PJ:iHard~:aQf0 S. \Vinblad B. An ac!h'c Rnd sociaRy 

inWSfaWd Ufestyle in l~ fife might P:0iCI.-'1 ugaliJSt oomemia.waJ 

Neuml.2004;3(6):343-353. 

3. $tudcnski S. Carb:QnMC. FUU, HI Greenough WT'l Kramer A. Rcl'lok 

OW. From bedside tQ be:mh: does menw..and physicalactiviQ' pm-

.mote cognitive Vitali£), in _ life? Sci Aging Knowledge Erwirtm. 

2006:2006(lQ),pal. 

4, Carlson Me.. Fried LP, Xue Qt. Band~cIt-<Rodle K~2'.eF Sf-, Brandl 

1. A~~lChl!k'fl hetwr.¢u ~ecntive attemkm :and phJ$ical fun~1:ion:J! 

p{'lfw:uumc.e in camrmmity,dwJI;Hing mder women. J Oeromol Ii 

Psychol Sci $()C Sci. 1999;54(5);SUl-S:ml. 

5. GOlr'by J. Kaye K. 8axrer J. _I)- SM. flamman RF. E=Ul:lr,. 

oognith>e Wiluies 0Uld funttiooal SIat11!, among ¢(lmmuuity~d\,"'clling 

aJder perwm in rhe San L* Valley Heakh :utd Asing Study. JAm 

Go"''''· S«'. 1998:46(5);590-596. 

(t. John!»tI JK. Lw LY, Yat'f¢ K. 'E~CCUttve functi(.'ln. more than global 

;;':(l,gmfiop; prediC'\s funclional decHnt- and mortality in eJderly women 

JGel'rm1tJ1A Bio! SI.:iMed Sci. 2007t62(lZ)}:!1 34,.....ll4-1 . 

.,. RoyaU DR,. Palmer R, Chiodo LK.l'i:"Jk Ml C'KC(.'Utl,,'l! control medial.c$ 

memory'$, i$$OC!300n with eha.ng~ in my."Ulntmtallll.1;hirles of d~Uy 

JivlojJ.: the: Freed,.ml HQuse Study_) ~4.m Geria1r SM.. 2005:S3(1): 

tt-l7. 

8. Carlson Me. Xuc Ql .... Zbou J. fried U~ Execlltive declme lind 

dysfunction precedes declin!!$ in d'11: Women's Health 

a!1d Aging Study H. J Gemntu A !1iol 2(1{)9:Mn): 

1 I{H 17. 

9, Kempen Gl. van Hcuvclen MJ* \'an Sofid~re:n E, v~n dea BrInk RH, 

Kooijms:n AC. Onncl 1. The reladoo.wp {If functional lbMatrol.l$ to 

disability and me ~ingetre"''tIGf ps,Y1:ho1ogieal ~ iD com-

~"8{)lder_S"'SeiMeJ.lm;43(9):1161-lm. 

to. Dulaney CL. R~)gOl1> WA Mod:umirom!- underlying reduction in 

Stroop interferenc~ with ptaCU\i-C fot young and old adwlS" J Exp 

Ps;.'dm[l,.earn M~m ('(wn;. Mat 1994a0{2}:470-484, 

11. Buckner R.I.. Memory lmd e:I;ecutive t\lnl;tion in It!,\!in£ and AD. 

j~ltiplt facton. that ea.t1W: ~lim: sud ~f\-'e factors that coropemate 

N£U.ron.l004;44{l)~!95-·20K. 

f2, Rat N. Aging of the brain and its hnpllt.'t till c~ peri"ormaoc.:!: 

Intqrsrlon of ~ and ftmmional finding!.. In: Craft F and Salth~')1lse T. ed~" lImJdbook af Aging and CogJJition, New Jersey 

_:2000;1-90. 

B. Re,~niclc SM. pr.lm DL, KI'3Ut MA. 7..<mtkrman AS. Da\'l'l:t:~iko$ C. 

Longitudinal ID:lgnetic f¢$nnllllCC imaging studies of older. ",aula: a 

shrinking brain. J Neurr;sd. 2005;23(8):3195-3301. 

14. Gllll11ing~Di"oo R--f, Rat: N. NeDfOMatQmir.ai Cot~ of se'er:ted 

exccUtn'c functiu..'l5 in middJc..aged and older adults; it pJ:OIij1CCU\-'e 

MIll SIUdy. ,v<uml'.ryciwlogi4. 2003:41(14):J929-1941. 

1 S. Schooler C. MulMu MS. Oatts O. The comimung .:-ffccts or "5UbstanH 

tively compk't w!lrk un rhe inTclleeru.al functioning of oider worh>r!i.. 

I'sycIoolllyiny, 1999;14(3),483-·506. 

ifi Fri~ LP, Fr~~tm;m )1, FJldres TE. ·Wll.!iik n. r·htildJng c,ornmunlti1::' 

that.prum01c !.ucc('ssful aging, WtJ,St J Me.i. 199/:161(4)::216-219. 

17. Fried [..P, Carlson Me, Freedman M. et al. A 'OI:ial model for health 

promotion for .an aging popubition: illitM evidenre on the Expe:rj. 

enueorp. modd.J Urban Hl!I1hh. 2004;81(l);64-78. 

18, Rebok OW, carlson Me. GJau TA. etat Smm-!erm imptu,'1 ofExJ..* 

rience Corps participation em children and M!hool$: !e$.ults from a 

pilot. randomiz.('.d trial. J lJrPtJll Health. 2O:J4;Sl{ 1}:79-93. 

19, Foi!ltein MP, FoIfilein SE\ McHugh PR. "MlnlHmcl\Hd stEne'''" .A 

practicul mciln:4 for grading d~ tQgllitive sta!e 01 pali~flts for tnt 

olinician. J PSJchiatricRes. 1915;12(3):189-19!t 

20. Reitan RM, Validity of the Tro.il Making Test as on JndiC4t(\f of 

"""""' btoin <bffill§e.1'mept. M"wr Skills. 1953:8(4):271-276. 

21. Carlson Me, Saczynski JS, Reook OW. rt at. Ex:ploring the efi'ttts 

of l1Il "I:\'eryday'" activity PfO&l'am cn c:xc..:;:UU\·c function and rnem-

«y in older adults: Experience Corps. Gemutowgrsr. 2008;48(6); 

793-·801. 
75 


tjames on DSK6SPTVN1PROD with HEARINGInsert graphic folio 81 here 78139A.046

1282 CARLSON ET tlL 

22. Smim SM. Fmil robust auro~~d brain CX~HOft Hum Brain Map}? 

2(102:17(3):143 .. ·155. 

23. Strum SM. Jenkhlson M. Woolricb MW, et at Au'!anccs in functio»al 

ami """wm] MR image analysis and ~"" as FSL Nc_ 

image. 2004;21(.uppll): S208-5219. 

2·t Jenkift$l)l'! M. Smith S. A gh,bsl o!,timlsation mt.'thtlu for rolmSt 

affine rcgis.trnuon of brain images. Mea Image Ana}, 20!Jl;5(2); 

143-156. 

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modeling fur gt{lUp analysis in f<"'MRL Neun>im11gc. 200;.\;20(2): 

lOS2-H163. 

26. Col",_ SJ, Knuner AF, Eru:kson Kl. .. aI. Canli""ll$"ul.ur 6 ... ,.. 

crutie:al plasticity,llnd aging. Fmc Ntul:kad Sci USA, 2004;101(9;; 

3316-3321, 

17. CQkmnbe SJ. Enekson KI, St-.alf PE, CI at l'\ewbic \!Xi!xise; training 

incre~$es. bnun VQluIDI; in ating humans. J Gt'mmlJ/ A .Rlm Sd Met! 

Sci. 2006;61(11):1166-1170. 

1ft K~ A. Erkkson KJ, CQlcombe SJ. r&8(:r{;'i~, togliitiou::and the 

aging brain., J Appi Physicl, 2006;lOl{4Xl237-t:4:l. 

29'. Cubeza R. Hemispheric (iJymmmy red®tirut in 0100.( adults: ~ 

ilAROLD .nodeLI',}"lwl A!<ini. 20()2:17(l):85··l00. 

JU, Carlsim MC'. Helm! MJ. Ste«en$ DC. Burlre JR, PoU .. "'(f GG. 

Pla.<;.sman BI... MldJite actiVity predk!$ risk of dem\mIla in ohler mll~e 

twlnpairs,<!l:;lJ~imerl DrlMttl. 2008;4(5):314--33-1, 

31. Gould E, BeyU. A, T .... pat 1'. R~"" A. S_ 'fl. t..rnil1g ",lila..", 

adult neurrrgene$is in the hippO(ampal forma:tlon. Not NeUTQ,..,;i. 

1999,2(3):160-265. 

n. ~[R"'ugb Wr. Cohen Nl.lUiIl,Yra Tht New net:ll"()fi$ in old br.;tim~ 

learning to ~'Utvi:vc-i Nat NellJV1ci. 1999:2(3);20J-20$, 

33 ..... an Przag H. Kempermann 0 1 G8,ge F. RUMing inercM't'..t> cdt prolif~:tii()n .and neurogencsis in the adult moU:ie dentate gyrus, Nut 

Nf!'.t1t'>8r.l,1999;J{3.):266-170. 

;;4, Carlson Met Seeman T. Fried LP. Importance of ~rati\'i(y for 

healthy aging alderwomen, Agmg (Mtlfl#fI), 2000~12{2):B.2--140, 

J;5, Erikson EH. Idemiry and life Cycle: Sflier:fed Paper,~. New Yo:,k: 

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2(1O;;18(4):213 .. 211. 

Ree«Md February Z. 2009 

,4,('Cepll".J July 16, 2009 

D«ision. F,diror: Exigi Ferructi.l!d.D. PhD 
76 


tjames on DSK6SPTVN1PROD with HEARINGInsert graphic folio 82 here 78139A.047

CORP s* 

Preliminary Research Shows Promise of Behavioral Interventions in 

Improving Cognitive Ability for Older Americans 

Unitt'fl States House of ReprescntlltiYes 

Committee on Energy and Commerce 

Subcommittt'e on Health 

December 9, 2010 

In a study published in the Dec~mber 2009 issue of the Joul'I1al oj' (ierol1lologl': Medical Sciences, 

volunteer activity in the Baltimore Corps program-a program in which older Americans 

tutor young children in reading--was to improve cognitive and brain functions in older 1V0men at 

risk for cognitive impairment Researchers, led by Michelle C, Carlson, PhD" Associate Professor in the 

Johns Hopkins Bloomberg School OfPllblic Health and Associate Director oflhe Johns Hopkins Center 

on Aging and Health, conducted this six-month case-control study in 17 older adults lIsing brain 

fUllctional magnetic resonance imaging (fMRl). 

The research provide, evidence that behavioral interventiolls, like Experience Corps, designed 10 

prolllote health and function through volunteer activity lllay improve the brain's plasticity, or the abiliry 

to bounce back, in key regions that support executive 111l1ction - cognitive abilities a;;socialed with 

planning and one's life, These afe the same areas critical to maintaining independent 

functioJl in areas are significantly affected by aging related diseuses including 

The Experience Corps f.l.1RI pilot study enrolled 17 women aged 65 and older, half of whom were 

trained and integrated withiJl existing Experience Corps programs in local Baltimore CiTY schools n'om 

January-June, and half of whom were evaluated and wait-listed to enroll in the Experience Corps the 

lnl10wing academic year. Pat1icipants underwent brain scans at baseline and six-months later. The 

fMRl analyses revealed that Experience Corps volunteers showed a 54% improvement in executive 

function beyond baseline compared to the control subjects, This is a huge effect by any intervention 

standard, 

"The resnlts of this study hold promise for enhancing and maintaining brain reserve and health in later 

life," said Dr. Carlson. who is now leading a much larger, multi-year study to confirmlhcse preliminary 

findings, 

Brain arCllS associated with improved executive function among Expedcnce Corps volunteers. 

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