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Participation in Alzheimer’s and Related 

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Convened by 

October 2018 
TOGETHER WE MAKE THE DIFFERENCE

 

TABLE OF CONTENTS 

Foreword ....................................................................................................................................................... 1
 

Acknowledgments ......................................................................................................................................... 2
 

Introduction................................................................................................................................................... 

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3
 

Why a National Strategy—And Why Now? 3
 

Challenges to Research Participation 4
 

Emphasis on Inclusion and Diversity 5
 

Collaborating to Develop a National Strategy 6
 

From Recommendations to Implementation 7
 

Goal 1: Increase Awareness and Engagement 9
 

1. Identify diverse audiences needing tailored messages and best locations and modes of outreach at the
	

national and community levels........................................................................................................................ 

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10
	

2. Develop and disseminate culturally and linguistically appropriate content for outreach and awareness 12
	

Goal 2: Build and Improve Research Infrastructure 13
 

1. Leverage and improve existing registry infrastructure 14
	

2. Develop and adapt information technologies to support recruitment 15
	

3. Structure staffing and organizational incentives to support and reward successful recruitment and
	

retention of diverse participants 15
	

4. Support study site capacity building 17
	

5. Improve efficiency and effectiveness of screening 18
	

6. Facilitate collaborative networks of study sites .............................................................................................. 

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18
	

Goal 3: Engage Local Communities and Support Participants 19
 

1. Develop equitable and sustainable community partnerships to build trust and a sense of shared
	

ownership of the research mission 20
	

2. Promote health and science literacy in the community with a focus on cognitive health 21
	

3. Expand trial design to encourage participation of larger and more diverse communities 22
	

4. Facilitate participation of diverse individuals and families by providing support and implementing
	

audience-specific recruitment and retention strategies 23
	

5. Identify and prioritize available funding and/or resources to develop community partnerships and
	

support participants 24
	

Goal 4: Develop an Applied Science of Recruitment..................................................................................... 

...................................................................................................................................... 

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25
 

1. Develop baseline measures and evaluate and optimize effectiveness of outreach and
	

recruitment strategies 26
	

2. Create, disseminate, and continuously improve evidence-based recruitment resources 27
	

References 28
 
TOGETHER WE MAKE THE DIFFERENCE

FOREWORD 

October 19, 2018 

Spurred by the growing threat of Alzheimer’s disease and related dementias to our loved ones and families, 

as well as our health and economic systems, Americans have taken notice. The National Plan to Address 

Alzheimer’s Disease, in place since 2012, drives our efforts. Importantly, lawmakers have supported that 

mission with major increases in funding for research toward treatment and prevention. The scientific 

community is galvanized. We are tackling Alzheimer’s and related dementias on an unprecedented scale, 

moving forward with innovative approaches and new discoveries that will need to be tested as expeditiously 

and comprehensively as possible. 

This document focuses on one area of urgency—the pressing need for increased and diverse participation in 

research studies as these scientific opportunities emerge. Additional studies on new approaches will require 

greater numbers of people from across the disease spectrum, including healthy and preclinical individuals, 

and must ensure representation from racial, ethnic, and socioeconomic groups who may be differentially 

affected by dementia. 

Here, I present to you Together We Make a Difference: National Strategy for Recruitment and Participation in 

Alzheimer’s and Related Dementias Clinical Research. This National Strategy is the product of extensive and 

in-depth discussions over nearly 2 years, convened by the National Institute on Aging at the National Institutes 

of Health (NIH) and facilitated by the Alzheimer’s Association, to bring together experts, including patients 

and caregivers, on this issue. Crowd-sourcing outreach invited and brought in comments, too, from the public 

more broadly. We thank all for their time and insights. They provided important data and experience on why 

people join studies as well as the obstacles and barriers for doing so, how to address concerns, and what it will 

take to engage broad segments of the public to join in Alzheimer’s and related dementias research. 

What’s needed, they conclude, is concerted national action to create awareness and to support study 

participation. The National Strategy offered here outlines concrete steps that each of us—from researchers, 

funders, and participants to families and clinicians, employers and media, national and community-based 

organizations—can take to effect change. Some measures can be taken by individuals and organizations on 

their own and others through collaboration and coordination. This will require attention by both the public 

and private sectors. 

For our part, we at the NIA/NIH will continue to emphasize the need for careful consideration of recruitment 

in Alzheimer’s and related dementias studies, to support and disseminate research on effective strategies for 

study participation, and to conduct further and targeted outreach and information to increase awareness. And 

we will continue to take a leadership role in implementation of this National Strategy, working with all of you 

as we follow the guideposts provided by this document. 

I look forward to expanding and intensifying our efforts to engage the public in Alzheimer’s and related 

dementias trials and studies. Together, I believe we can move research more quickly and more inclusively 

toward our ultimate treatment and prevention goals. 

Richard J. Hodes, M.D. 

Director, National Institute on Aging 

National Institutes of Health 

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TOGETHER WE MAKE THE DIFFERENCE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACKNOWLEDGMENTS 

With a broad stakeholder and community 

undertaking in mind, the NIA, with facilitation by 

the Alzheimer’s Association, sought expertise and 

insights from a collaborative of government, private, 

academic, and industry stakeholders, as well as from 

individuals, caregivers, and study participants in 

development of the National Strategy. We are deeply 

grateful to the experts, stakeholders, and community 

members who contributed to this endeavor and 

look forward to continuing our work together to 

implement this framework. 

Steering Committee 

•	 Paul Aisen, M.D., Alzheimer's Therapeutic 

Research Institute, University of Southern 

California 

•	 Vicky Cahan, NIA/NIH 

•	 Maria Carrillo, Ph.D., Alzheimer's Association 

•	 Meryl Comer, Geoffrey Beene Foundation 

•	 Susan De Santi, Ph.D., Piramal Imaging 

•	 John Dwyer, J.D., Global Alzheimer's Platform 

Foundation 

•	 Jessica Langbaum, Ph.D., Banner Alzheimer’s 

Institute 

•	 Laurie Ryan, Ph.D., NIA/NIH 

•	 Nina Silverberg, Ph.D., NIA/NIH 

•	 Heather Snyder, Ph.D., Alzheimer's Association 

•	 Eliezer Masliah, M.D., NIA/NIH 

•	 George Vradenburg, J.D., USAgainstAlzheimer's 

Working Groups 

National Efforts 

•	 Jason Karlawish, M.D., Penn Memory Center at 

the University of Pennsylvania, Chair 

•	 Malaz A. Boustani, M.D., MPH, Sandra Eskenazi 

Center for Brain Care Innovation, Indiana 

University 

•	 Vicky Cahan, NIA/NIH 

•	 Maria Carrillo, Ph.D., Alzheimer's Association 

•	 Joshua Chodosh, M.D., MSHS, FACP, New York 

University School of Medicine 

•	 Josh Grill, Ph.D., University of California, Irvine, 

Alzheimer’s Disease Center 

•	 Amy Jordan, Ph.D., Annenberg School for 

Communication, University of Pennsylvania 

•	 Rachel L. Nosheny, Ph.D., Brain Health Registry, 

University of California, San Francisco 

•	 Itzhak Yanovitzky, Ph.D., Rutgers University 

Capacity Building 

•	 Pierre Tariot, M.D., Banner Alzheimer’s Institute, 

Chair 

•	 Jeffrey Burns, M.D., M.S., University of Kansas, 

Alzheimer’s Disease Center 

•	 Keith Fargo, Ph.D., Alzheimer's Association 

•	 Lynn Hughes, B.Med.Sci., Ph.D., PMP, QuintilesIMS 

•	 Jamie Roberts, MPH, MA, CCRP, Duke University 

•	 Laurie Ryan, Ph.D., NIA/NIH 

•	 Stephen Salloway, M.D., M.S., Brown University 

Medical School 

•	 Chris Van Dyck, M.D., Yale University, Alzheimer’s 

Disease Center 

Local, Diverse Efforts 

•	 Laura Baker, Ph.D., Wake Forest University, 

Alzheimer’s Disease Center, Chair 

•	 Debra Buchwald, M.D., Washington State 

University 

•	 Debra Clark-Jones, Dioko Strategies 

•	 Gina Green-Harris, M.B.A., University of Wisconsin 

School of Medicine and Public Health 

•	 Jonathan Jackson, Ph.D., Massachusetts General 

Hospital 

•	 Olivia Mastry, J.D., MPH, ACT on Alzheimer’s 

•	 Stephanie Monroe, J.D., 

AfricanAmericansAgainstAlzheimer’s Network 

•	 Jason Resendez, LatinosAgainstAlzheimer's 

Network 

•	 Nina Silverberg, Ph.D., NIA/NIH 

•	 Heather Snyder, Ph.D., Alzheimer's Association 

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TOGETHER WE MAKE THE DIFFERENCE

INTRODUCTION 

Why a National Strategy—And Why Now? 

As many as 5.5 million Americans ages 65 and older are estimated to be living with Alzheimer’s disease, the 

most common form of dementia, and many more under age 65 also have the disease (Hebert et al., 2013). 

Alzheimer’s disease is the sixth leading cause of death in the United States (Murphy et al., 2013). Estimates 

suggest more than 1 million individuals in the United States have related dementias, such as frontotemporal, 

Lewy body, vascular, and mixed dementias (Knopman & Roberts, 2011; Plassman et al., 2007; Zweig & Galvin, 

2014). Age is the primary risk factor for dementia, and as the U.S. population ages, the number of people with 

Alzheimer’s disease is expected to triple by 2050 if no effective preventive strategies or treatments are found 

(Hebert et al., 2013). The human and financial costs to people with Alzheimer’s disease, their families, and 

society are among the highest of any disease (Hurd et al., 2013). 

Recognizing the urgency of ramping up Alzheimer’s research and care, the National Alzheimer’s Project 

Act1 (NAPA) was signed into law in 2011 and resulted in the first National Plan to Address Alzheimer’s 

Disease (National Plan) in 2012.2 The National Plan’s primary research goal is to prevent and effectively 

treat Alzheimer’s disease and related dementias—such as frontotemporal, Lewy body, vascular, and mixed 

dementias—by 2025. 

This ambitious goal demands new strategies to overcome obstacles to research and discovery. 

Increased public and private investments have identified many potential therapeutic targets, and 

pharmaceutical interventions to hit those targets are quickly being developed and tested in clinical trials. 

Population studies enable researchers to characterize the trajectory of dementia in different sub-groups, better 

understand the risk factors for dementia, and identify the best approaches to clinical and long-term care. 

1

 See https://aspe.hhs.gov/national-alzheimers-project-act. 

2

 See https://aspe.hhs.gov/report/national-plan-address-alzheimers-disease-2017-update. 

3 
TOGETHER WE MAKE THE DIFFERENCE

 

We have learned a great deal. A cadre of volunteers, 

who have contributed everything from their time to 

their DNA, has been critical to this progress, and the 

nation is grateful for their participation in research. But 

to build on progress thus far, and to reach our goals 

as quickly as possible, even more volunteers will be 

needed. Expanded scientific opportunities require a 

concerted national effort to bring a range of individuals 

and organizations into the research endeavor so that— 

TOGETHER—we can make a difference. 

However, difficulties with recruitment and retention 

across a broad range of biomedical clinical trials 

mean that many fall short of recruitment and 

retention goals (Institute of Medicine, 2012). In 

Alzheimer’s disease research, despite best efforts, 

many study sites are slow to meet volunteer 

recruitment targets, delaying the time to complete 

studies and increasing research costs. Some sites 

never reach their targets (Grill & Galvin, 2014; 

Karlawish et al., 2008). 

The challenge is daunting. Currently, nearly 200 U.S.-

based Alzheimer’s disease clinical trials seek more than 

270,000 participants.3 It is estimated that researchers 

will need to screen roughly 10 people to identify 1 

eligible participant (Watson et al., 2014). Participation 

of diverse volunteers—such as by age, race, ethnicity, 

sex, education, socioeconomic status, geographic 

location, comorbidities, and cognitive status—for 

a variety of clinical research studies has become a 

leading challenge in Alzheimer’s and related dementias 

research today (Carr et al., 2010; Vellas et al., 2012). 

Challenges to Research Participation 

Inadequate recruitment and retention skew 

demographic representation, limit generalizability, 

and reduce statistical power of clinical trials (VanEpps 

et al., 2016). In addition to the common challenges 

facing all clinical trials (Institute of Medicine, 2012), 

studies examining Alzheimer’s disease research have 

identified unique barriers to participation. 

Strict Eligibility Criteria 

Many older adults are ineligible to participate in 

Alzheimer’s disease research because of stringent, 

though often necessary, study criteria. Fewer than 

one-third of Alzheimer’s disease patients are trial 

eligible, according to one estimate (Grill & Galvin, 

2014). Studies may exclude individuals because 

of age, use of certain prescription medications, or 

medical or psychiatric comorbidities, or because 

they are unable or unwilling to undergo required 

procedures (Grill & Karlawish, 2010). 

Need for Cognitively Unimpaired Volunteers 

Evidence suggests that brain pathology begins at 

least 10 years before the onset of Alzheimer’s disease 

symptoms. Prevention trials that test interventions in 

at-risk individuals require participation of cognitively 

unimpaired adults who are willing to undergo gene 

and biomarker screening (Watson et al., 2014). 

Lack of Capacity, Awareness, and Resources 

Among Primary Care Physicians 

Primary care physicians typically manage multiple 

chronic conditions in older adult patients and may 

not always perform adequate diagnostic assessments 

of Alzheimer’s disease. Brief screening in primary 

care settings offers promise, but more research is 

needed (McCarten et al., 2012). Physicians may 

not suspect cognitive impairment in patients who 

might qualify for clinical studies unless they conduct 

screening, be unaware of local research participation 

opportunities, or have concerns about referring older 

adult patients to clinical studies (Watson et al., 2014). 

Participant Burden 

Many studies require concurrent participation of 

a study partner (e.g., spouse, partner, adult child, 

or caregiver) who can provide informed consent, 

report on cognitive changes in the participant, 

assure compliance with study procedures, and 

be available to assist with managing study risks. 

Study partners often are spouses, but an increasing 

3 ClinicalTrials.gov, accessed 10/15/2018, https://clinicaltrials.gov/ct2/

results?recrs=abf&type=Intr&cond=alzheimer&cntry=US. 

4 
TOGETHER WE MAKE THE DIFFERENCE

number of older adults have no spouse or live alone. 

Participants with dementia and non-spouse study 

partners drop out of studies more often than those 

with spouses (Grill et al., 2013). 

Prospective research volunteers and study partners 

may be reluctant to participate in studies involving 

time-consuming or invasive procedures, such as 

lumbar puncture or brain imaging with radioactive 

materials. These and other procedures, such as 

cognitive testing, sometimes require significant 

time and repeat visits, or may be part of screening 

even before acceptance into a clinical trial, 

deterring volunteers and their study partners from 

participating (Grill & Karlawish, 2010; Watson et al., 

2014). Travel inconvenience can be a disincentive to 

volunteer for participants and their study partners 

(Karlawish et al., 2008). 

Emphasis on Inclusion and Diversity 

Clinical trials often seek participants with similar 

characteristics such as the same stage of disease, 

comorbidities, prescription medications, and age 

range because a homogenous trial population 

increases confidence that any research results 

showing effectiveness of a treatment are due to the 

treatment and not other factors. However, building 

an evidence base for clinical care that benefits the 

entire population and does not perpetuate health 

disparities demands diversity in clinical research 

participants (Stronks et al., 2013). Diversity is 

considered broadly to include heterogeneity of age, 

race, ethnicity, sex, education, socioeconomic status, 

geographic location, comorbidities, and cognitive 

status. Representativeness in biomedical clinical 

research remains a challenge, despite its critical 

importance and some past efforts to improve it. 

Clinical evidence that reflects population diversity 

is critical for Alzheimer’s and related dementias 

studies. Evidence suggests, for example, that African 

Americans have greater risk of Alzheimer’s disease 

than non-Hispanic whites, and there may also be 

differences in risk factors and disease manifestation 

(Barnes & Bennett, 2014). Higher rates of dementia 

are also found in Latino populations compared 

to non-Hispanic whites, and understanding these 

differences is further complicated by diversity within 

the Latino population (Vega et al., 2017). These 

high-risk populations are less likely to be recruited 

to participate in Alzheimer’s disease and other 

clinical trials (Oh et al., 2015; Romero et al., 2014), 

although studies show minority groups are as likely 

to participate as non-minority groups if offered the 

opportunity. Recruitment of underrepresented and 

underserved populations faces several challenges, 

including “differing access to care and therapy, gaps 

in the knowledge of Alzheimer’s disease among 

certain rural and ethnic groups, differences in 

perceived risk for Alzheimer’s disease, and longstanding (and well-founded) skepticism toward 

research” (Grill & Galvin, 2014). 

Research, including important qualitative and 

practical experience of researchers focused on these 

issues, has demonstrated potential for communitybased strategies to address the diversity challenge, 

including the use of satellite clinic locations, hiring of 

study staff that reflect the makeup of the population, 

community-specific outreach efforts and social 

marketing, and partnerships between researchers 

and local organizations. These and other promising 

approaches need to be further explored, studied, 

and implemented where they demonstrate success 

in recruiting from underrepresented populations. 

More work is needed to expand and strengthen the 

evidence base for effective strategies to increase 

minority participation in Alzheimer’s and related 

dementias clinical trials (Grill & Galvin, 2014). 

Barriers to participation often differ culturally as well 

as regionally, making it challenging to design universal 

recruitment strategies that adequately address 

community-specific barriers. Consequently, the status 

quo for Alzheimer’s and related dementias clinical 

research systematically favors the enrollment of a 

shrinking, increasingly less representative segment of 

the U.S. population. Because of its critical importance, 

attention to improving diverse representation in 

Alzheimer’s and related dementias clinical research is 

emphasized throughout this National Strategy. 

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TOGETHER WE MAKE THE DIFFERENCE

 

Collaborating to Develop a 

National Strategy 

As early as 2012, the National Institute on Aging 

(NIA) at the NIH began to solicit input on how to 

enhance participation in Alzheimer’s research.4

In 2016, the NIA launched the current effort to 

outline practical, proactive approaches to help study 

sites and researchers recruit and retain adequate 

numbers of volunteers for specific studies, resulting 

in this National Strategy for Recruitment and 

Participation in Alzheimer’s Disease Clinical Research 

(National Strategy). 

The National Strategy enumerates ways we might 

increase the number of study participants and 

support the success of clinical research—through 

not only federal agency action, but also the 

engagement of all individuals and organizations 

interested in eradicating Alzheimer’s and related 

dementias. With extensive stakeholder and 

community involvement, the NIA, with facilitation by 

the Alzheimer’s Association, convened experts and 

collected insights from government, academic, and 

industry stakeholders, as well as from individuals, 

caregivers, study participants, and members of the 

public.5 A Steering Committee and topical working 

groups developed the initial draft of the National 

Strategy. The NIA then sought broad public input on 

components of the draft strategy as well as any new 

ideas for recruitment and retention. This endeavor 

sought a range of perspectives to encourage fresh 

thinking and new energy to address the challenges 

and opportunities of clinical research participation. 

The approaches outlined here include both those 

formally demonstrated in research and those 

brought to it by years of field experience by those 

who have shared what they know works—and what 

does not—to engage a variety of audiences. 

These efforts resulted in four National Strategy goals. 

Goal 1: Increase Awareness and Engagement 

Increasing awareness and engagement can empower 

people from diverse communities to participate 

in clinical research, including individuals with 

Alzheimer’s and related dementias, their family 

members and caregivers, and healthy adults. To 

improve public understanding of the role and 

importance of clinical trials, education and outreach 

should capitalize on existing resources to provide 

basic information about brain health, Alzheimer’s 

and related dementias symptoms and risk factors, 

diagnosis, and treatment options. Multiple sectors 

have a role in increasing awareness and engagement, 

including federal and state governments, national 

advocacy organizations, community-based 

organizations, and research study sites. 

Goal 2: Build and Improve Research Infrastructure 

Building capacity and improving infrastructure 

of research study sites, registries, and referral 

networks is vital to recruiting and retaining more 

and more diverse qualified study participants. The 

federal government, the national and local medical 

community, study sites, and their host institutions all 

have a role in improving the Alzheimer’s and related 

dementias clinical trial research infrastructure. 

Goal 3: Engage Local Communities and 

Support Participants 

Sustained local engagement is needed to increase 

recruitment and retention of heterogeneous 

participants in Alzheimer’s and related dementias 

research. Community-based efforts must focus on 

developing equitable and sustainable partnerships 

and promoting health and science literacy of all 

community members. Researchers and study sites, 

local organizations, and people with and without 

dementia and their families have important roles in 

engaging potential participants where they live. 

4

 See, for example, https://grants.nih.gov/grants/guide/notice-files/NOT-AG-12-017.html. 

5 See https://www.nia.nih.gov/research/recruitment-strategy. 

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TOGETHER WE MAKE THE DIFFERENCE

 

 

 

Goal 4: Develop an Applied Science of Recruitment 

Investing in and prioritizing research to study the 

effectiveness of recruitment and retention strategies, 

support program evaluation, and disseminate best 

practices is critical to developing an applied science 

of recruitment. Public and private research funding 

agencies, academic institutions, and researchers have 

an important role in evaluating the effectiveness 

of their own strategies, making transparent their 

research methodology, and sharing results without 

undue delay. Federal agencies and national advocacy 

organizations can help develop, collect, and widely 

disseminate research-based best practices. 

From Recommendations to Implementation 

This National Strategy comes at an important time 

in the ongoing partnership between scientists 

and the public to find more effective ways to 

prevent, diagnose, and treat Alzheimer’s and 

related dementias. There is now an unprecedented 

opportunity to build on scientific knowledge and 

to accelerate and expand the research effort. It is 

incumbent on all of us to leverage our different 

missions, interests, and resources. Some agencies, 

organizations, and communities are already ramping 

up efforts, and this National Strategy describes ways 

more can contribute. 

At the NIH, this effort is already under way. New tools 

and policies are allowing scientific and review staff 

to perform more targeted consideration of study 

recruitment plans and their potential effectiveness 

in applications for clinical research funding. The NIA 

awarded the Global Alzheimer’s Platform Trial-Ready 

Cohort for the Preclinical/Prodromal Alzheimer’s 

Disease (GAP TRC-PAD) project, which will build 

a new study-ready cohort and a next-generation 

clinical trials infrastructure with a particular focus on 

enlisting participants at presymptomatic stages of 

Alzheimer’s.6 The recently funded Alzheimer’s Clinical 

Trial Consortium (ACTC) focuses on recruitment, 

including establishing a new minority outreach and 

recruitment team, which will use evidence-based 

recruitment strategies to support both central 

and local partnerships with diverse communities.7

The NIA is organizing a repository to collect and 

disseminate best practices in Alzheimer’s and related 

dementias clinical studies recruitment. Released 

in April 2018, NIA funding opportunity PAR-18-749 

will provide up to $3 million in fiscal year 2019 

to support collaborative network teams to target 

gaps in recruitment and retention methods and 

outcomes, as well as to establish the community 

infrastructure needed to accelerate studies.8 Looking 

ahead, the NIH will continue to use the National 

Strategy to identify opportunities to accelerate and 

expand its efforts, including new collaborations and 

partnerships at the national and community levels. 

While the NIH can support and incentivize improved 

recruitment and retention in several ways, the 

success of this National Strategy rests on the 

contributions of diverse stakeholders, including but 

not limited to the following: 

Federal agencies, including those involved in 

funding, regulating, guiding, or using outcomes from 

research, can signal study participation as a national 

priority. Depending on the mission, this might include 

attention in funding opportunity announcements 

or procedures, shaping application submission 

and review requirements, working directly with 

investigators in cooperative agreements, collecting 

and disseminating evidence-based resources in a 

central location, supporting evaluation efforts and 

compilation of the evidence base, and providing a 

national voice to communicate the importance of 

6 See https://projectreporter.nih.gov/project_info_description.cfm?aid=9471301&icde=40471034 for project

information.

7 See https://projectreporter.nih.gov/project_info_description.cfm?aid=9422266&icde=

40471148&ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC&pball= for project information.

8 See https://grants.nih.gov/grants/guide/pa-files/PAR-18-749.html for full announcement.

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TOGETHER WE MAKE THE DIFFERENCE

 

study participation to a variety of audiences, including 

national and regional traditional and social media. 

National organizations, including advocacy and 

funding entities and their local affiliates, can organize 

national, regional, and local awareness campaigns, 

build and maintain relationships with other 

stakeholder groups, create and adapt materials and 

resources for study site use, collect and disseminate 

evidence-based resources in a central location, 

support or conduct community needs assessments 

and evaluations, and provide a national voice to 

communicate and reinforce priorities. 

Researchers and clinical research study sites and 

their host institutions can plan and budget for the 

priorities outlined in the National Strategy, prioritize 

and implement improvements in study site capacity 

to support diverse recruitment and participation, 

develop and sustain local-level community 

partnerships, build trust, involve members of the 

community in the research enterprise, develop 

and maintain referral networks with primary care 

providers and other study sites, and implement trial 

designs and organizational incentive structures that 

maximize diverse participation. 

Health care providers and provider organizations 

can engage in ongoing conversation with local and 

regional researchers and study sites, consider their 

role in screening, educating, and referring potential 

participants in Alzheimer’s and related dementias 

clinical research, and provide input on community 

advisory boards or as invited members of study 

teams on ways to leverage primary care provider 

relationships with potential participants. 

Local community-based organizations providing 

services to people with dementia and their families 

and caregivers can participate in community advisory 

boards, build relationships with researchers and 

study sites, host community events or offer locations 

for study outreach, and become involved in the 

research enterprise. 

People with or concerned about dementia, 

caregivers, and families can share their experiences 

with others, ask primary care physicians for screening 

or referrals to clinical research opportunities, 

participate in clinical research, become peer mentors 

for others considering research participation, provide 

input and feedback to researchers and study sites, 

and help study sites build community partnerships. 

Pharmaceutical and biotech companies can 

collaborate with federal agencies and national 

advocacy organizations, leverage their relationships 

with health care providers and payers, build and 

improve study site capacity, broker local-level 

relationships between industry-funded researchers 

and the communities in which they operate, 

incentivize study sites to focus on underrepresented 

patient populations, and ensure that study endpoints 

are meaningful for participants and families as well 

as for researchers and regulators. 

Health care payers and insurers can engage 

potential clinical research participants, cover and 

implement Alzheimer’s and related dementias 

screening and referral procedures, and engage in 

ongoing conversations with other stakeholders 

about the importance of protecting beneficiaries 

participating in clinical research from reduction or 

loss of benefits. 

The opportunities to advance our scientific 

understanding of prevention and treatment of 

Alzheimer’s and related dementias have never 

been greater. Capitalizing on these opportunities 

requires participation and partnership of everyone 

who is willing and able to volunteer for research 

and meaningful support of these volunteers. There 

are multiple opportunities for all stakeholders to 

contribute to achieving each of the four goals. 

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TOGETHER WE MAKE THE DIFFERENCE

GOAL 1: INCREASE AWARENESS AND ENGAGEMENT 

A first step in motivating individuals with Alzheimer’s and related dementias, their families and caregivers, 

healthy adults, health professionals, businesses, and the general public to participate in research or support 

the research enterprise is simply awareness. National, state, and local level awareness campaigns targeted at 

diverse audiences are needed to better inform the public about Alzheimer’s and related dementias symptoms 

and risk factors, diagnosis and treatment options, opportunities for participation in clinical research, and the 

importance of clinical research in combating the disease. 

Target audiences should include potential research study participants ranging in cognitive and functional 

status, from healthy volunteers to people with dementia; caregivers and families; health care providers 

including primary care physicians, specialists, and nurses; business and other community leaders; health care 

organizations and system providers; insurers and payers; advocacy organizations; professional associations; 

and other disease associations for common comorbidities (e.g., American Heart Association, American 

Diabetes Association). Audience segmentation—dividing a large target audience into smaller and relatively 

homogenous groups that are expected to respond similarly to a communication, influence, or incentive—can 

help to strategically assess when to approach a group based on its readiness for action, ease of access, or 

match to program needs. With these approaches, outreach strategies can be tailored to effectively engage 

each target audience. 

Efforts by multiple stakeholders are already under way to address many of these strategic priorities. For 

example, the NIA plans to solicit feedback from health care providers and provider organizations about 

their knowledge of, interest in, and barriers to talking to patients about or referring them to clinical studies 

generally and specifically for dementia. 

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Strategic Priorities 

1. Identify Diverse Audiences Needing Tailored 

Messages and Best Locations and Modes of 

Outreach at the National and Community Levels. 

A.	Identify key audiences that are instrumental to

improving participation in Alzheimer’s research.

•	 Identify target audiences for nationwide, 

regional, and community messaging, including 

primary audiences of potential participants, 

as well as secondary groups and influencers, 

such as caregivers, clinicians, and national 

professional and advocacy organizations. 

•	 Determine current knowledge and 

predispositions of target audiences regarding 

participation in research studies, segmenting 

audiences into smaller groups according to 

interests, needs, and demographics to address 

what volunteers might have in common. This 

can be informed by current best practices, 

reported research findings, or new research. 

•	 Assess the feasibility of successfully engaging 

specific audience segments through messaging 

and collaboration at the national, regional, and 

local levels. This should be approached with 

short, intermediate, and long-term goals in mind 

to fashion and implement effective outreach. 

B.	Determine the specific action or actions to be

requested of each audience segment.

•	 Ascertain, along with the research community, 

the range of actions being requested of each 

audience, clearly establishing who is being 

asked to do what, and by when. Different 

types of studies and classes of research will 

require different types of participants in terms 

of age, disease and disease stage, gender, 

underrepresentation in research, physical 

location, and other criteria. 

•	 Apply formative research, including such 

techniques as behavioral mapping and 

behavioral analysis, to identify major factors, 

including barriers and facilitators, to help 

determine the likelihood that particular 

audiences will engage in behaviors involved in 

joining research. 

C.	 Study and address beliefs, attitudes, and social

norms among diverse communities to enhance

messaging and support successful recruitment

actions at the study level.

•	 Identify salient beliefs, attitudes, values, and 

perceived behavioral norms and/or incentives 

(monetary and non-monetary) likely to affect 

whether people in diverse audiences are 

motivated to join in research. 

•	 Identify major barriers to participation in 

research in each audience segment, especially 

among underrepresented groups. 

•	 Include individuals from the audiences of interest 

in the design of outreach materials and strategies. 

•	 To better engage presymptomatic or 

asymptomatic participants in prevention and 

other trials, consider framing outreach and 

recruitment messaging in terms of brain health 

rather than focusing on a deficit model of 

Alzheimer’s disease. 

•	 Leverage targeted advertising and popular 

social media platforms to engage families and 

communities about Alzheimer’s and other 

dementias, particularly to address common 

myths and community-specific concerns and 

fears. 

D. Conduct outreach to health care providers, including

primary care physicians,specialists, and nurses.

•	 Gather information from health care providers 

or provider organizations about their knowledge, 

interest, needs, and barriers to talking to patients 

about or referring them to clinical studies, 

generally and specifically for dementia. 

•	 Provide information to health care providers 

about the value of research referral as a clinical 

best practice. Consider multiple ways to engage 

clinicians, such as training, providing cognitive 

screening tools, and establishing learning 

communities through social media. 

•	 Increase health care provider awareness of 

specific research opportunities at local centers 

and provide them with access to research 

experts at study sites. 

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•	 Provide educational opportunities about 

Alzheimer’s and related dementias clinical research 

opportunities and referral practices to health care 

providers through national programming (e.g., 

Continuing Medical Education credits). 

•	 Provide updates to primary care providers on 

their patients enrolled in studies through regular 

communication or electronic health records. 

E.	 Conduct outreach to health care plans and

other insurers.

•	 Encourage health care systems, payers, and 

insurers to use clinical trial awareness initiatives, 

evidence-based brain health resources, and 

partnerships as an incentive and benefit for their 

beneficiaries/clients and subscribers. 

•	 Engage the Centers for Medicare & Medicaid 

Services (CMS) as a partner, examining 

approaches such as including opportunities to 

participate in clinical studies as part of the Star 

Rating program ranking certain plans and drug 

coverage. 

•	 Express the importance of not penalizing
	

beneficiaries for their participation in
	

clinical research. Coverage should not be
	

compromised, lessened, or lost for clinical
	

research participants.
	

F.	 Conduct outreach to national employer and

employee organizations and workforce agencies

at the federal, state, and local levels.

•	 Discuss with employers and employee 

leadership how organizational policies can 

support and increase participation in clinical 

studies, including by providing paid time 

off for employees who might become study 

participants or study partners. 

•	 Ensure protections against discrimination for 

employees who participate in clinical studies or 

serve as study partners in age-related cognitive 

function, cognitive impairment, or dementia 

studies. 

G.	Adopt a wide range of grassroots strategies

to raise awareness of the importance of

participation in clinical research among potential

participants, their family members, and

members of the community.

•	 Identify and use a variety of locations for 

outreach, including physician office waiting 

rooms, pharmacies, senior centers, over-55 

residential communities, nursing homes and 

assisted living facilities, adult day care centers, 

community-based organizations (e.g., Lions 

club, Rotaries, veterans’ groups, institutions 

of faith), Alzheimer’s and related dementias 

caregiver support groups, hospitals, health fairs, 

and other community events. 

•	 Identify and use a wide range of modes of 

outreach depending on target audience 

and effectiveness, including print media, 

radio, brochures, posters, TV/Public 

Service Announcements, emails, face-toface community events, social media, and 

computerized screen kiosks in public areas. 

Ensure inclusion of local and segment-specific 

media outlets (e.g., minority-owned or -focused 

media outlets and publications, local television 

stations, rural newspapers or radio shows). 

•	 Identify and engage, at the national and local 

levels, key influencers to deliver outreach 

messages, such as current or former trial 

participants, people with Alzheimer’s and 

related dementias or their family members, 

caregivers, trusted advisors in the community, 

or local or national celebrities. 

•	 Leverage a broad spectrum of social media and 

other interactive communication technologies, 

particularly for hard-to-reach rural or isolated 

populations. 

•	 With great care for protecting privacy and 

obtaining appropriate consent, explore the 

possibility of partnering with social media 

companies to apply machine learning 

algorithms to identify potential participants and 

family members for outreach. 

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•	 Include in outreach materials the availability 

and benefits of registries. 

•	 Consider innovative strategies such as “share on 

Twitter/Facebook” buttons at www.clinicaltrials. 

gov records or an appropriately moderated 

“Yelp” website for clinical trials and study sites. 

2. Develop and Disseminate Culturally and 

Linguistically Appropriate Content for 

Outreach and Awareness. 

A. Develop or adapt content in plain language

for outreach materialsto address common

information needs and basic concerns of potential

participantsthat describesthe following:

•	 The impact of Alzheimer’s and related 

dementias nationally, in different geographic 

regions, and among sub-group populations. 

Explain that deaths due to complications 

of Alzheimer’s disease are underreported 

because it is often not recorded as the official 

cause of death. 

•	 What a clinical trial is, what participants in clinical 

trials can expect, and why some necessary 

features of a clinical trial seem counterintuitive 

from the participant perspective (e.g., “clinical 

trials 101” for the lay reader). 

•	 The scientific goals of clinical trials in 

Alzheimer’s and related dementias generally, 

goals of specific recruiting studies, and the 

realistic potential for scientific advances. 

•	 The potential risks and benefits, both to
	

the participant and for public health, of
	

participating in a clinical trial.
	

B.	 Ensure that materials, tools, and content are

available in languages used in the community.

•	 Use centralized translation services to ensure 

that all outreach materials are available in 

all languages used across the range of target 

communities. 

•	 Provide opportunities for local community 

members to review and modify or approve 

translations based on local-level linguistic norms. 

C.	 Adapt information to address concerns

of specific racial/ethnic, geographic,

or linguistic communities.

•	 Using information from community needs
	

assessments and input from community
	

partners, identify best-fit modalities and
	

communications channels for delivering
	

messages to each target community.
	

•	 Ensure that community-specific concerns are 

learned and addressed respectfully. 

•	 Communicate that minority groups have a 

right to be represented in clinical trials funded 

by taxpayer dollars and explain how their 

representation improves generalizability of 

scientific knowledge and the future potential 

impact on preventing, slowing, or treating 

Alzheimer’s and related dementias. 

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TOGETHER WE MAKE THE DIFFERENCE

GOAL 2: BUILD AND IMPROVE RESEARCH INFRASTRUCTURE 

Increasing enrollment and participant diversity in Alzheimer’s and related dementias studies requires further 

development of study recruitment infrastructure. To build capacity, institutions and research sites can create 

more volunteer opportunities; collaborate with peers at the local, regional, and national levels; and contribute 

to the growing evidence base for effective recruitment strategies. Aligning staffing and organizational 

incentives with recruitment and retention goals, training staff to better serve their target populations, and 

investing in appropriate facilities and collaborative study site networks will all improve site capacity to recruit 

and retain research participants needed to conduct studies. 

One straightforward approach to improving the rate and quality of clinical research enrollment is to increase 

the number of trial sites and their ability to enroll qualified volunteers (Grill & Karlawish, 2010). In addition, 

participant registries—repositories of individuals who have agreed to learn about new studies for which they 

might be eligible—are powerful and increasingly used tools to improve study recruitment. A variety of registry 

models and methodologies are currently being implemented, and registry sponsors report varying levels of 

success in converting enrollees into participants in clinical trials. Several improvements, such as linking individual 

registries in a unified network, may enhance the effectiveness of registries as enrollment tools. Registry designs 

and methods also need to be evaluated and optimized for specific audience segments and enrollment goals. 

A variety of existing and emerging information technologies also have potential to support study recruitment. 

These range from enhancing electronic health record systems and other point-of-care tools to developing mobile 

apps for data collection and adapting customer relationship management software to improve recruitment 

efficiency. These sophisticated but often easy-to-use technologies may, for example, help researchers keep track 

of information, understand participant behavior, and connect with prospective volunteers and physicians. 

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Strategic Priorities 

1. Leverage and Improve Existing Registry 

Infrastructure. 

A.	Create larger registries by linking existing

individual programs in a national network.

•	 Develop a national recruiting network by 

linking existing registries, cohort programs, and 

other appropriately consented data sharing 

mechanisms. 

•	 Engage large organizations with data on many 

potential participants, such as large integrated 

health systems. 

•	 Bring together leadership of registries through 

meetings, focus groups, case studies, and guided 

interviews to develop a registry linkage plan. 

•	 Produce lists of studies for which registered 

individuals are eligible based on information 

obtained from participants and mining of 

publicly available information, including actively 

recruiting studies listed in ClinicalTrials.gov. 

Ensure that smaller, local trials are included as 

options in larger registries. 

•	 Reach participants at the local level through 

affiliated local or regional registries. Explore 

the use of local crowdsourcing methods to 

populate local registries. Consider technical and 

Institutional Review Board architectures that 

will optimize registry linkages. 

B.	Improve the effectiveness of registries by

studying current best practices.

•	 Assess current performance of registries, 

including in the context of successful recruitment 

for small studies, large multisite trials, and 

national surveys. Consider the relative 

advantages of distinct registry characteristics, 

such as geographic reach, breadth of disease 

focus, and mode of participation. 

•	 Identify best practices for recruiting and 

retaining registry volunteers. Assess the 

usefulness of social media, crowdsourcing, 

and online disease forums that may facilitate 

interest in registry participation. 

•	 Examine the factors that motivate, facilitate, 

or hinder participation in registries and 

subsequent enrollment in research studies. 

Study how cognitive and functional status, 

demographic features, and other characteristics 

influence registry participation. 

C.	 Improve registries’ ability to match participants

with appropriate trials.

•	 Clearly list inclusion and exclusion criteria for all 

available trials in lay language. 

•	 Highlight trials that are actively recruiting. If 

displaying information about trials that are 

closed to new participants, clearly label trials as 

closed to accrual. 

•	 Develop more effective processes for matching 

willing volunteers to specific studies in need of 

participants. 

D.	Expand registries to include family groups and

participants of all ages.

•	 Recruit family members of people with
	

dementia to join registries.
	

•	 Target family members of all ages to participate 

in observational studies to explore genetic links 

to Alzheimer’s disease and prevention studies 

focusing on preclinical Alzheimer’s disease. 

E.	 Facilitate follow-up and notify participants of

new opportunities.

•	 Send regular newsletter updates to registry 

participants notifying them of new trials 

enrolling in their area, local events, and 

research progress. 

•	 Use registries to create a system to follow up 

with participants who have joined studies for 

further opportunities. For participants who have 

contributed data to past studies, leverage their 

contributions for additional studies or analyses. 

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2. Develop and Adapt Information Technologies 

to Support Recruitment. 

A.	Leverage electronic health records and other

point-of-care tools to identify and inform

potential Alzheimer’s and related dementias

trial participants.

•	 Create customized referral links and alerts to 

providers through electronic health records 

indicating trials for which the patient may 

be eligible. With appropriate consent, use 

electronic health records to produce lists of 

potential Alzheimer’s and related dementias 

trial participants. 

•	 Explore opportunities to link electronic health 

records to registries, including by allowing 

interested participants and their family 

members to share their electronic health 

records with researchers. 

•	 Use personal health record portals to support 

direct, interactive messaging between 

providers, current and potential future research 

participants, and their family members. 

•	 Install kiosks in primary care provider waiting 

rooms to deliver information about Alzheimer’s 

and related dementias research studies and 

recruitment, while ensuring appropriate privacy 

protections. 

•	 Embed new software tools into research site 

workflows and train staff to use them effectively. 

B.	Apply existing technologies in innovative ways to

support recruitment efforts.

•	 Develop a lifestyle tracking mobile app for 

participants of all ages that would engage 

participants, provide relevant information for 

public health, and send passively collected data 

to researchers for identification of potential trial 

participants. 

•	 Explore ways to incorporate sensory
	

technologies, fitness trackers, augmented
	

reality, and machine-learning algorithms to
	

collect and analyze data. Use an app to facilitate 

study enrollment by checking eligibility criteria, 

obtaining consent, submitting research data, 

and disseminating study results. 

•	 Use client relationship management software 

to improve research site efficiency by managing 

and coordinating relationships with research 

participants, their health care providers, study 

partners, and other stakeholders. 

•	 Facilitate study referrals from self-organized 

online communities such as disease forums. 

•	 Explore partnerships between the 

pharmaceutical industry and private genetic 

testing organizations to enable volunteers to be 

invited to participate in clinical research based 

on their genetic profile.9 

C.	 Maintain privacy protections in all new

information technology applications.

•	 Ensure data security, privacy protections, and 

anonymity of participant data, especially for 

smaller studies conducted at a local level that 

may not have access to sophisticated security 

tools and in which participant identification may 

be a greater concern. 

3. Structure Staffing and Organizational Incentives 

to Support and Reward Successful Recruitment 

and Retention of Diverse Participants. 

A.	Incentivize physicians and their practices to

screen for and treat Alzheimer’s and related

dementias and refer patients to clinical trials.

•	 Consult primary care practices to determine 

how best to integrate research recruitment into 

the practice environment without disrupting 

the flow of clinical care. 

•	 Provide logistical or monetary incentives to 

providers who screen and refer patients to 

clinical trials or explore ways to reimburse 

discussions of clinical trial participation as a 

component of care consultation. 

9 See, for example, https://www.gsk.com/en-gb/media/press-releases/gsk-and-23andme-sign-agreement-toleverage-genetic-insights-for-the-development-of-novel-medicines/. 

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•	 Leverage existing point-of-care tools to identify 

potential research subjects and obtain consent 

for enrollment in research studies. 

•	 Work with partners (e.g., National Quality Forum, 

CMS) to make facilitating research recruitment a 

care quality criterion within ongoing, alternative 

payment models for primary care providers. 

B.	 Set ambitious and realistic recruitment targets

based on a community needs assessment, and

reward success.

•	 Set realistic site- or region-specific recruitment 

targets with input from community partners 

and enforce accountability metrics to ensure 

demographic inclusion goals are met. 

•	 Collect available CMS data on Alzheimer’s 

disease prevalence by county and census tract 

data on race, ethnicity, education, religion, and 

geographic distribution to inform local targeting 

and recruitment goals. 

•	 Identify and use publicly available qualitative 

reports and community health assessments 

(e.g., from hospitals, universities) to 

complement CMS and census data.10 

Recruitment Targets Success Indicators 

1.		Consistent pace of enrollment into the studies 

2. Diversity of study population 

3. Consistent number of referrals from current 

participants 

4. Number of new participants 

5. Retention of participants from underserved 

populations 

6. Number of projects that achieved 

recruitment goals 

7. Number of new collaborative partnerships 

and/or projects 

8. Number of satellite recruitment sites 

•	 Use existing online surveys or other tools to 

complete a community needs assessment in 

collaboration with community partners and 

use the results to develop realistic goals for 

recruitment and to obtain buy-in from local 

partners for accomplishing recruitment goals. 

•	 Financially reward sites that meet or exceed 

their recruitment targets. 

•	 Use data transparency to reward recruitment 

and retention of diverse participants. 

•	 Provide incentives, such as additional funding, 

training, or access to resources, to grantees 

who meet recruitment targets specified in grant 

applications. 

C.	 Incentivize academic institutions and publicly

funded researchers to prioritize recruitment of

diverse populations.

•	 Foster institutional environments that 

incentivize and prioritize recruitment, such 

as by communicating the importance of 

clinical trials to academic leaders, rewarding 

successful recruitment with financial 

incentives and co-authorship of research 

studies, and creating tenure-track career paths 

for recruitment professionals. 

•	 Provide funding for outreach support modules 

for publicly funded clinical trials. 

•	 Make diversity of researchers, key personnel, 

and study staff a consideration for clinical trial 

grant funding decisions. 

D.	Incentivize study site staff to actively recruit

diverse study participants.

•	 Foster an environment that incentivizes and 

prioritizes diverse recruitment, enrollment, 

and retention in high-quality clinical trials and 

studies in academic settings. 

•	 Provide viable career paths and opportunities 

for professional advancement for all staff in the 

recruitment workforce. 

10 For example, https://www.kcoi.com/wp-content/uploads/2017/03/CHNA_2016.pdf. 

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E.	 Develop and implement process improvements

that enhance trial recruitment.

•	 Develop site and system business processes 

that support a robust, efficient clinical research 

infrastructure (e.g., stable funding models that 

do not rely on per-subject recruitment revenue, 

use of existing clinical data for new studies, and 

centralized management of multisite studies). 

•	 Develop nimble staffing models that respond to 

fluctuations in recruitment needs and minimize 

staff burden and risk of burnout during periods of 

heavy enrollment. 

4. Support Study Site Capacity Building. 

A.	Invest in facilities to accommodate greater

enrollment.

•	 Ensure that sites have adequate physical space, 

equipment, and support services such as pharmacy, 

laboratory, radiology, and information technology. 

B.	 Train study site staff to foster more effective

recruitment efforts.

•	 In collaboration with community advisory boards, 

create clear institutional or site-level guidelines 

and training programs focused on differentiating 

recruitment from coercion. 

•	 Improve the health literacy skills of research teams 

so that they can effectively communicate trial 

information and results to potential and current 

participants. 

•	 Identify ways to expose study staff to the realities 

of life with dementia in the target community. 

•	 Educate recruitment staff on available community 

data and assessment tools to help understand 

community priorities and possible recruitment 

incentives. 

C.	 Recruit and retain a diverse and

skilled workforce.

•	 Develop a staffing strategy that is appropriate to 

the project’s outreach and recruitment goals for 

its target populations. 

•	 Develop guidelines to recruit and retain a diverse 

and inclusive professional workforce at all levels 

of the research team. Ensure that researchers, 

research teams, and study site personnel are 

representative of the target population. 

•	 Build the cost of full-time recruitment staff (e.g., 

outreach specialist, patient navigator) into grant 

application budgets. 

•	 Retain a customer service team to respond rapidly 

to prospective volunteers. 

•	 Leverage staffing resources from other 

departments or community partners that align 

with the target community. 

•	 Hire at each site or cluster of sites a recruiter or 

recruitment team that includes backgrounds in 

public health marketing and outreach, as well 

as those with skills in recruiting families who are 

experiencing cognitive decline in a loved one. 

Develop employment descriptions that capture 

relevant experience with targeted communities 

and specialized skills. 

•	 Support site-level efforts to retain experienced 

coordinators, raters, regulatory staff, and clinical 

researchers to ensure efficient and high-quality 

conduct of studies. Offer job flexibility and 

benefits to allow a broader range of individuals 

to serve as study staff. These may include access 

to child or adult care, access to transportation 

or telecommuting options, health benefits, and 

flexible schedules. 

•	 Invest in recruitment training and mentorship 

programs to ensure the development of the next 

generation of researchers. 

D.	Assess and reduce workforce implicit bias.

•	 Assess and quantify implicit bias in academic and 

community research sites. Disseminate results of 

the assessment to relevant stakeholders and use 

these measures to track improvements over time. 

•	 Train study site staff and research teams to 

recognize implicit bias and implement evidencebased interventions to reduce implicit bias at the 

individual or group level. 

•	 Leverage existing resources for cultural 

competency training among study site staff. 

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•	 Engage and be accountable to community partners 

for reduction of implicit bias in study sites. 

•	 Include individuals living with dementia on study 

staff, advisory boards, and local engagement teams. 

5. Improve Efficiency and Effectiveness of Screening. 

•	 Streamline required enrollment and informed 

consent forms to apply across sites, studies, and 

purposes, including coverage for all disease stages 

and trial interventions. 

•	 Run multiple, complementary studies at a site 

so that screening efforts are not specific to 

one trial and can offer more than one research 

participation option for many volunteers. Allow 

sites to use funding from a single sponsor to help 

support recruitment efforts for multiple studies. 

•	 Establish a community screening center or offer 

a financial incentive to sites that prescreen for 

studies beyond their own investigations. 

•	 Combine outreach and screening efforts, such as 

by providing screening for trial opportunities at 

community outreach events. 

•	 Offer cognitive impairment screening for everyone 

at the time of Medicare eligibility to record a 

baseline. 

•	 Explore the feasibility of placing brain imaging 

scanners in convenient locations and returning 

results to local sites so that researchers can 

identify suitable study candidates. 

•	 Identify potential study participants at risk earlier 

in the disease process through collecting a variety 

of evidence types, such as genetic, biomarker, 

clinical, and demographic data. 

6. Facilitate Collaborative Networks of Study Sites. 

•	 Incentivize study sites to form recruitment networks 

in which a site can easily refer a participant to a 

study being conducted at a different site if a more 

appropriate opportunity exists elsewhere. 

•	 Encourage local clinicians to participate in referral 

networks by providing financial incentives, 

professional recognition, and exposure to the 

research community. 

•	 Use recruitment networks to disseminate 

information about specific research opportunities. 

•	 Seek financial support for a practice-based 

research network from the Clinical Translational 

Science Institute and other funding entities. 

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TOGETHER WE MAKE THE DIFFERENCE

GOAL 3: ENGAGE LOCAL COMMUNITIES AND SUPPORT PARTICIPANTS 

To improve the representativeness of participants—in the broadest sense—we must focus on inclusivity and 

diversity in age, race/ethnicity, language, sex, education, socioeconomic status, comorbidities, concomitant 

treatments, geographic region, and cognitive status by engaging with communities and supporting people 

with dementia and their families in their efforts to participate. Although more research is needed to 

strengthen the evidence base for best practices, the most promising efforts for improving recruitment and 

retention of diverse participants focus on building community relationships and addressing specific locallevel barriers (Grill & Galvin, 2014). 

Diversifying participant representation, including with at-risk sub-groups, addresses two important public 

health goals: (1) increase the generalizability of the evidence generated to benefit the overall population 

and (2) mitigate health disparities that are perpetuated by differential access to care and effectiveness of 

treatments in underrepresented groups. 

Research participation involves a relationship between the research scientist and the participant. People 

volunteer because they trust the research system, expect potential benefits to themselves or to others, and 

judge the research risks and burdens to be reasonable. Lessons from marketing, behavioral economics, and 

other social sciences should be employed to better develop, test, share, and customize strategies to enhance 

these local relationships with heterogeneous populations. All community engagement efforts should strive 

to provide participants with individualized and genuine attention and demonstrate commitment to ongoing 

communication and cooperation. 

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Strategic Priorities 

1. Develop Equitable and Sustainable Community 

Partnerships to Build Trust and a Sense of 

Shared Ownership of the Research Mission. 

A. Identify specific community-based organizations,

supportservice organizations, and local

stakeholders with whom to develop relationships.

•	 Expand community partnerships beyond
	

traditional networks.
	

•	 Identify and meet with representatives of 

support services, particularly for vulnerable 

populations (e.g., social services, clinical services, 

behavioral health, assisted living facilities, faith 

groups, caregiver support groups, Area Agency 

on Aging offices, city offices on aging, local 

chapters of AARP, those living with dementia). 

•	 Engage students in professional training 

programs (e.g., medicine, nursing, social work, 

public health, home health). 

•	 Identify key stakeholder collaborators to 

identify geographical areas of focus and to 

assist in engagement of targeted communities. 

•	 Develop an effective and sustained 

communication strategy to support bidirectional 

flow of information with community partners. 

B.	 Create and/or participate in community

advisory boards.

•	 Develop diverse local community advisory 

boards to help monitor recruitment efforts of 

each research center. Include representation 

from primary care and specialist providers, 

patients, and caregivers. 

•	 Work with advisory boards to ensure ongoing 

community presence and responsiveness to 

community needs. 

C.	 Implement varied grassroots strategies to

build meaningful and sustainable community

relationships.

•	 Work with community partners to prioritize 

needs and develop a responsive outreach and 

recruitment program that features the voices of 

people with dementia living in the community. 

•	 Develop and maintain a calendar of community 

events for outreach activities and share the 

information with outreach partners, and attend 

community events: 

As guests to learn more about the 

community, its population, and its leaders. 

To give presentations to introduce the 

researchers and study purpose to the 

community and solicit feedback on proposed 

recruitment strategies to the local community. 

To provide opportunities for attendees to ask 

questions and sign up to receive more details 

about actively recruiting studies. 

To provide educational materials about 

clinical trials research and the option to be 

added to a registry or referral database. 

•	 Support and train local community
	

spokespeople to discuss clinical trials and
	

research within communities.
	

•	 Use personal stories on dementia, caregiving, 

and research in creative ways (e.g., hosted online 

webinars, hosted home-based support groups, 

social media, emails lists, newsletters). Featured 

faces and voices should be inclusive and local. 

•	 Foster conversation opportunities between 

potential participants and their trusted advisors, 

including health care providers, support service 

providers, and community leaders. 

•	 Directly and honestly address community
	

concerns and barriers to participation.
	

D.	Develop community-based referral

and recruitment partners.

•	 Explore opportunities to work with 

community-based organizations and support 

service providers as referral and recruitment 

partners with a view toward leveraging existing 

networks to reach vulnerable populations. 

•	 Support institutional and community-wide
	

coordination among research groups and
	

clinical/social services, including ensuring
	

that study sites are fully accessible to local
	

communities.
	

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i

i

•	 Work with local Aging Resource Centers, 

Councils on Aging, Area Agencies on Aging, 

Veterans Administration health providers, 

and state medical societies to develop referral 

network processes. 

2. Promote Health and Science Literacy in the 

Community with a Focus on Cognitive Health. 

A.	Enhance study site capacity to serve as a

community resource for cognitive health literacy.

•	 Consider the value of educational programs 

targeting different community needs. Sites may 

not need to develop programs on their own 

but can utilize and customize resources from 

a national recruitment repository of materials 

and best practices. 

•	 Ensure that study site staff engage with 

potential participants in the community to build 

trust before discussing research. 

•	 Ensure that messaging is culturally and 

linguistically appropriate for targeted audiences 

because similar language may be interpreted 

differently in unique demographic groups. 

• Onsite opportunities might: 

Offer educational programming on dementia 

at study sites that includes cognitive health 

education, the range of modifiable and nonmodifiable risk factors, benefits and risks of 

participating in clinical trials, background 

information on Alzheimer’s and related 

dementias and how it is different from other 

neurodegenerative diseases, the importance 

of early screening, and medication that may 

slow symptom progression. 

Offer tours of research study site(s) after 

introducing concepts of research into the 

community. 

Host support groups (e.g., for people with 

dementia, family members, and caregivers) to 

disseminate information and discuss concerns. 

Offer study participants, families, and 

caregivers free onsite education and 

counseling to support lifestyle changes that 

can lower risk of dementia, enhance care, 

and improve quality of life. 

• Educational materials 

Use or adapt existing sources of culturally 

and linguistically appropriate educational 

materials about cognitive health. 

Access and contribute to national repositories 

of educational materials that can provide 

nformation and training on dementia-related 

and clinical trial topics to local participants and 

nfluencers (e.g., health care providers, health 

educators, research navigators, communitybased service organizations, faith-based 

organizations, family members).11 

Ensure technology-based education materials 

are user- and mobile-friendly. 

• Multimedia approaches 

Create short vignettes on brain health, 

dementia, caregiving, and clinical research 

in creative ways (e.g., online webinars, 

home-based support groups, social media). 

Featured faces and voices should be inclusive 

and local where possible, with time allocated 

for questions and answers. 

Present at educational events for professional 

health providers and integrate cognitive 

health education into existing Continuing 

Medical Education (CME)–based training, 

particularly for primary care physicians in 

community health centers. 

Conduct culturally and linguistically 

appropriate information sessions at 

community events for mixed-age audiences 

to increase cognitive health literacy and 

awareness of research opportunities (e.g., 

lunch and learn series, lay presentations, 

memory screening events, town halls). 

11 For example, the NIA Recruitment Resource repository, Dementia Friendly America, and Being Patient.

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B.	 Train community partners and clinical research

participants and/or their caregivers to be

educational resources for local communities.

•	 Train and support a bureau of speakers to 

provide community education and training for 

the public and health care providers. 

•	 Develop a peer mentor training program for 

selected clinical research participants and care 

partners to become recruiters and advocates 

for their study site. 

•	 Create formal and informal opportunities for 

community-based advocates and champions to 

liaise with the public (e.g., community events, 

health campaigns). 

Sample Training Program Topics 

1. Basic facts about Alzheimer’s and related 

dementias
	

2. Clinical trials 101 

3. Overview of recruiting for local trials 

4. Advantages of participating in clinical research 

5. Responses to common reasons people say 

they do not want to participate 

6. Developing a personal story 

7. Media training 

3. Expand Trial Design to Encourage Participation 

of Larger and More Diverse Communities. 

A.	Broaden inclusion criteria to increase

heterogeneous participation.

•	 Relax exclusion and inclusion criteria to permit 

increased diversity in participant characteristics, 

and thus less restricted access to research, such as 

expanding design to include participants who are 

taking other medications 

asymptomatic 

younger than 65 

unable to bring a study partner 

at any stage of disease 

healthy, but have a genetic history of 

Alzheimer’s disease (e.g., for prevention trials) 

•	 Consider whether a study partner is required 

for healthy, preclinical, and asymptomatic 

participants. 

•	 For individuals who fail to meet entry criteria 

for a study, offer other research opportunities 

so that there are no closed doors to those 

who express an interest in research. For 

example, redirect a healthy volunteer with 

genetic risk of Alzheimer’s to a prevention trial 

opportunity or a person who does not want 

to take experimental medication to a nonpharmacological intervention trial. 

B.	 Expand access to treatments for which

effectiveness is demonstrated.

•	 Increase the experimental drug-to-placebo arm 

ratio so a larger proportion of patients receives 

the investigational compound. 

•	 Encourage commercial pharmacological 

sponsors to use pooled data from their 

historical controls in Phase III trials so that all 

patients in the next generation of Alzheimer's 

trials have access to the investigational drug. 

•	 Reform structure of open label restrictions so 

participants in the placebo arm get access to 

an effective treatment and are not restricted in 

future studies. 

•	 If it is determined early on that the treatment 

protocol works well with minimal risk to patient, 

make it available to the control group as well. 

C.	 Leverage ongoing studies for other indications.

•	 Collect a consistent minimum dataset from all 

participants of all trials that can be used across 

studies in a combined sample. 

D.	Involve people with dementia and their families

and caregivers, local clinicians, and members of

community-based organizations in planning the

research design.

•	 Involve populations of interest in the design 

of the trial to help address issues such as 

disclosure of plaque or genetic status, number 

of screening steps before enrollment, open 

label status, etc. 

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•	 Seek input from health care providers or
	

provider organizations when planning new
	

research studies.
	

•	 Add local clinicians to site study staff to promote 

familiarity and community partnership. 

4. Facilitate Participation of Diverse Individuals 

and Families by Providing Support and 

Implementing Audience-Specific Recruitment 

and Retention Strategies. 

A.	Compensate and recognize participants for their

contributions to research.

•	 Develop, test, and implement a variety of 

feasible, culturally appropriate, and valuedriven incentives, such as compensation for lost 

time or wages at work, charitable donations, 

gift cards, cost savings services, transportation 

and parking reimbursements, lotteries, 

educational programming, and support group 

opportunities. Evaluation should examine both 

positive and negative implications of incentive 

strategies on participation behaviors. 

•	 Identify and address the scientific, ethical, 

regulatory, and compliance challenges to 

implementing incentives and recruitment 

strategies for a given audience. A menu of 

agreed-upon compensation and incentive 

opportunities could be developed as more is 

learned about these approaches. 

•	 Identify goals for maintaining participant
	

relationships.
	

•	 Host at least annual events summarizing
	

research and publicly recognizing research
	

participants and their families.
	

B.	 Consider whether/how to provide study results

to participants.12 

•	 Make some or all the test results administered 

for the trial available to the trial participant and 

their spouse/care partner. 

Consider Ethical Issues Related to 

Offering Incentives 

1. The potential for recruitment to become 

coercive, particularly for participants with 

cognitive impairment 

2. The need for incentives to be culturally 

appropriate and value-driven, and to not 

exclude participants based on literacy or 

language 

3. The risk of offering incentives that only 

appeal to limited subpopulations 

4. The potential to unintentionally deter 

participation among the immigrant 

community (e.g., by collecting Social 

Security numbers) 

•	 Consider offering individualized research 

feedback at the end of the study (or at regular 

intervals), such as z-scored cognitive data, so 

that participants may understand how they 

have performed. 

•	 Provide general health tracking tools during and 

after completion of research studies to further 

engage participants and bolster retention and 

referral for future study participants. 

C.	 Reduce participant burden.

•	 Explore opportunities to send study staff to 

where the participants are, such as residential 

settings, community-based settings, satellite 

locations, in mobile units, online, and via 

telemedicine, rather than requiring participants 

to always travel to a central location. 

•	 Provide, coordinate, or reimburse costs of
	

transportation.
	

•	 Simplify and reduce length of research consent 

process, screening and enrollment paperwork, 

and research protocols. 

12 A recent consensus study report titled Returning Individual Research Results to Participants (National Academies

of Sciences, Engineering, and Medicine, 2018) recommends that investigators and their institutions routinely

consider whether and how to return research results in specific studies through an informed decision-making

process, which is consistent with stakeholder and public feedback NIA received for the National Strategy.

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•	 Provide a study volunteer for participants who 

cannot go to the study site with a care partner. 

•	 Provide opportunities to participate on 

evenings and weekends to accommodate 

participants and caregivers in the workforce. 

D.	Improve study staff-participant communication,

coordination of care, and support for participants

while providing participants with individualized

and genuine attention and demonstrating a

commitment to ongoing communication.

•	 Develop or leverage existing data management 

systems to track correspondence and support 

ongoing relationships with current, past, and 

potential research participants. 

•	 Enlist a research navigator, ideally from the 

targeted community, to assist with recruitment, 

and shepherd participants through all phases 

of consent, screening, enrollment, and research 

protocol(s). 

•	 Ensure that feedback is provided to anyone who 

submits interest in a trial and share submissions 

with other trials to ensure that studies do not 

miss the chance for a viable candidate. 

•	 Provide a patient advocate, peer mentor, or 

resource person who can answer questions 

and provide guidance to potential and enrolled 

participants throughout the process. 

•	 Identify goals for the participant relationship 

maintenance program (e.g., monthly contact 

to show continued appreciation) and related 

strategies (e.g., luncheons, personal notes, 

newsletters). 

E.	 Consider and address stigma and negative

consequences for study volunteers.

•	 Volunteering for a trial and being labeled with a 

dementia diagnosis can result in stigma and have 

implications for employment, health insurance 

coverage, capacity to make important decisions, 

establishing a power of attorney, ability to drive, 

and loss of independence. Develop policies to 

mitigate potential negative consequences for 

those diagnosed with dementia. 

Study Site Approaches to Providing

Individualized and Genuine Attention 

1. Train study staff in soft skills and cultural 

competence. 

2. Ensure adequate staffing to provide 

individualized attention and care. 

3. Foster a culture of commitment to 

participant support and engagement. 

4. Respond promptly to any inquiries from 

participants or potential participants. 

5. Solicit feedback from participants and 

implement changes to address concerns. 

5. Identify and Prioritize Available Funding and/or 

Resources to Develop Community Partnerships 

and Support Participants. 

•	 Identify available resources to support the work 

of community-based organizations and study 

sites as they develop partnerships, sustain the 

work of community advisory boards, build 

referral networks, implement recruitment 

plans, and implement recommendations. 

•	 Ensure when feasible that a budget and plan 

exist to expand a site’s capacity to serve the 

community as a cognitive health resource. 

•	 Include a community engagement outreach 

plan in site recruitment proposals with a focus 

on sustaining partnerships for other future 

recruitment efforts. 

24 
TOGETHER WE MAKE THE DIFFERENCE

GOAL 4: DEVELOP AN APPLIED SCIENCE OF RECRUITMENT 

Scientific research on clinical trial recruitment effectiveness is limited, particularly for Alzheimer’s and 

related dementias (Tarrant et al., 2017). Yet, as efforts to improve recruitment and retention expand, it is 

crucial that these efforts be systematically applied, monitored, and evaluated so that they can be optimized. 

Existing literature on best practices in Alzheimer’s and related dementias clinical trials recruitment must 

be translated into practical implementation steps for study sites. Evaluation results should be transparent 

so that others may learn from them. Past recruitment efforts have benefited from robust, scalable, and 

generalizable approaches for improving local research participation, but implementation success has varied 

across locations. Superseding past performance will require an improved ability to adapt recruitment and 

retention strategies to specific communities by accurately characterizing them (e.g., by using U.S. Census 

data) and fostering relationships with the communities. 

Building an applied science of recruitment entails developing and testing strategies before they are widely 

implemented and incentivizing researchers to consult the evidence base when designing recruitment and 

retention strategies for new studies. By systematically varying different aspects of a recruitment strategy 

(e.g., incentives or approaches to initial outreach), investigators can monitor objective success indicators 

across contexts. Target communities can be engaged proactively to integrate site-specific knowledge into 

each strategy. Investigators should be encouraged and incentivized to report on their specific approaches and 

outcomes to help build a shared evidence base that can inform efforts at different study sites. Methods are 

needed to track the effectiveness of newly implemented strategies and to increase reporting transparency. 

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Strategic Priorities 

1. Develop Baseline Measures and Evaluate 

and Optimize Effectiveness of Outreach 

and Recruitment Strategies. 

A.	Summarize community baseline data.

•	 Determine the factors that influence different 

communities and how they vary (e.g., 

cultural norms, community voices, attitudes, 

values, incentives), perhaps with the help 

of community advisory boards and/or other 

community organization partnerships. 

•	 Use available data sources (e.g., U.S. Census) to 

assess target community needs, and integrate 

these data with qualitative reports to identify 

and proactively recruit individuals with low 

health-seeking behavior. 

B.	 Evaluate and optimize outreach

and recruitment strategies.

•	 Use available literature and evidence-based 

resources to design evaluations and define 

metrics to measure outreach effectiveness. 

•	 Identify target audiences (e.g., people with 

dementia, family members, caregivers, 

experienced/novice participants, specific ethnic/ 

racial populations) and evaluate outreach and 

recruitment strategies for each subgroup. 

•	 Track engagement on social media, websites, 

and hotlines, and at community events. 

•	 Establish a monitoring and reporting capability 

as part of any recruitment initiative to monitor 

the performance of both national- and locallevel strategies. 

•	 Apply existing techniques such as behavioral 

mapping and behavioral analysis to identify 

factors that facilitate or inhibit recruitment and 

predict retention probabilities. 

•	 Assess the potential to use social networks and 

platforms such as discussion forums to prerecruit participants by educating them about 

clinical trials. 

•	 Assess how clinicians decide when to refer 

patients to clinical studies and use this knowledge 

to encourage maximal eligible referrals. 

•	 Involve members of the target audiences in 

evaluation efforts. 

•	 Consider engaging an external program
	

evaluator and/or marketing consultant to
	

evaluate practices and inform alternate or
	

improved strategies.
	

•	 Use evaluation results to inform improvements 

to outreach and recruitment strategies. 

C.	 Evaluate registries.

•	 Characterize current national registry efforts 

and identify strengths and weaknesses. 

•	 Understand what variables motivate people to 

enroll and remain in registries. 

•	 Measure the effectiveness of different registry 

models and use this knowledge to improve the 

utility of Alzheimer’s and related dementias 

registries for recruitment. 

D.	Evaluate data collection methods.

•	 Test ways to conduct clinical research within 

target communities and away from centralized 

clinical sites to reduce participation burden. 

•	 Assess how participants use technology via the 

Internet of Things and use that information to 

personalize research and optimize engagement. 

E.	 Develop tools to measure recruitment feasibility.

•	 Develop tools to assess the barriers to 

participation for specific populations and use 

the assessment data to inform recruitment 

strategies for those populations. 

•	 Develop methods to assess study protocols 

and trial designs for recruitment and retention 

barriers, both generally and for specific 

populations. 

•	 Develop and use metrics to measure levels of 

trust between researchers and members of the 

community. 

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TOGETHER WE MAKE THE DIFFERENCE

 

 

	 	 	

 

 

	 	 	 	

 

 

 

 

 

 

 

 

•	 Build virtual reality models or simulations that 

model behaviors of participants, study partners, 

clinicians, researchers, and others to vary and 

test recruitment strategies before deploying 

them in the field. 

2. Create, Disseminate, and Continuously Improve 

Evidence-Based Recruitment Resources. 

A.	Summarize existing recruitment literature.

•	 Study existing research on clinical trials 

recruitment and retention strategies, 

particularly for underrepresented populations, 

and summarize evidence-based techniques. 

•	 Disseminate existing research knowledge to 

investigators and study sites. 

B.	 Create and disseminate best practices.

•	 Bring together trialists and research funders, 

facilitated by additional experts such as 

industrial engineers and implementation 

scientists, to discuss recruitment practices. 

•	 Analyze past recruitment efforts and create 

a publicly available online living textbook of 

strategies and population-specific efficacy data. 

Update the textbook with each new effort and 

incentivize investigators to consult the evidence 

base to inform their study design. 

•	 Conduct focus groups to learn what factors are 

likely to influence participation of specific groups 

and create strategies to leverage those factors. 

•	 Share evaluation results with outreach partners. 

•	 Build a national repository (and/or local-level 

repositories) of outreach content, materials, 

strategies, and evaluation results from which 

others can learn. 

•	 Learn from past and ongoing efforts in other 

disease areas. 

C.	 Promote transparency.

•	 Encourage investigators and sponsors to report 

on screening, randomization, and retention rates 

to add to the evidence base on best practices. 

•	 Involve populations of interest in trial design to 

help address issues affecting retention such as 

number of screening steps before enrollment, 

disclosure of biomarker or genetic results, and 

other study procedures. 

•	 Create an open discussion forum to help evaluate 

past and current recruiting approaches, gather 

new ideas, and help define criteria for success. 

27 
TOGETHER WE MAKE THE DIFFERENCE

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Convened by 

October 2018