Chicago, July 23, 2018 - Increased public and private investments in Alzheimer's disease research have brought about a proliferation of potential therapeutic targets. Drugs and other interventions to hit those targets are moving into clinical trials. Other studies are helping us better understand risks for dementia and examining best approaches to clinical and long-term care. Yet engagement and participation has not kept pace with the acceleration of research and great need for volunteers.
The impact of low participation impedes progress toward generating study results, keeping potentially effective therapies achingly further away from people with and at risk for dementia, and their caregivers.
With the growing global epidemic of Alzheimer's disease and other dementias, and the recent string of negative clinical trial results, the urgency to correct this situation has never been greater.
At the Alzheimer's Association International Conference (AAIC) 2018, representatives of the National Institutes on Aging (NIA) at the National Institutes of Health (NIH) reported progress on the National Strategy for Recruitment and Participation in Alzheimer's Disease Clinical Research, the effort convened to outline practical, proactive approaches to help study sites and researchers recruit and retain volunteers for Alzheimer's and other dementia research studies.
To devise the strategy, the NIA, with facilitation by the Alzheimer's Association, brought together experts and collected insights from a collaborative of government, private, academic, and industry stakeholders, as well as from individuals with Alzheimer's and other dementias, caregivers, and study participants.
"Perhaps most fundamental is the need to understand, in a careful and sensitive way, what motivates and facilitates -- or impedes -- participation by individuals from diverse communities in Alzheimer's and other dementias research," said Marie A. Bernard, MD, geriatrician and Deputy Director of the NIA.
"The national strategy focuses on the fact that all recruitment and participation is local, and that it is a shared responsibility with shared benefits. Fighting Alzheimer's disease and related dementias depends on us all," Bernard said.
"People with dementia, caregivers, and a wide variety of other volunteers are needed today to help advance Alzheimer's research," said Heather Snyder, PhD, Alzheimer's Association Senior Director of Medical and Scientific Operations. "By participating in clinical research, you can help to accelerate progress and provide valuable insights into potential treatments and preventions, successful caregiving, and better understanding and managing our Alzheimer's risk."
National Strategy Development: A Collaborative Effort
The new National Strategy -- currently a work in progress -- is an outgrowth of the National Plan to Address Alzheimer's Disease, which calls for expanded research aimed at preventing and treating Alzheimer's disease. Specific actions outlined in the National Plan seek to (1) increase enrollment in clinical trials and other clinical research through community, national, and international outreach, and (2) monitor and identify strategies to diversify enrollment in Alzheimer's disease studies.
Challenges to Recruitment
Studies examining Alzheimer's disease research participation have identified a number of ways participation might be limited:
- Lack of eligibility. Many older adults are ineligible to take part in Alzheimer's and related dementias research because of stringent, though often necessary, study criteria. In fact, studies show that only 10 to 27 percent of Alzheimer's disease patients are trial eligible. (Grill & Galvin, 2014)
- Lack of capacity, awareness, and resources among primary care physicians. Primary care physicians may be unaware of research-participation opportunities or have concerns about referring elderly patients to clinical studies. (Watson et al., 2014)
- Study partner requirements. Many studies require concurrent participation of a study partner-- typically a spouse, partner, or adult child.
- Use of invasive and time-consuming procedures. Prospective research volunteers and study partners may be reluctant to participate in studies involving procedures perceived as invasive, such as lumbar puncture or brain imaging with radioactive materials. (Grill & Karlawish, 2010; Watson et al., 2014)
- Need for cognitively unimpaired volunteers. Trials testing interventions in people who are at risk of the disease require participation of cognitively unimpaired adults who are willing to undergo gene and biomarker screening. (Watson et al., 2014)
"Fundamentally, the decision to enroll in research involves people weighing the benefits and the risks, upsides and downsides, of choosing to participate. It is critical that we find better ways to facilitate the decision to enroll, by credibly emphasizing the benefits and upsides of participation and appropriately putting the risks and downsides of research studies in context," Bernard said. "This will involve understanding and responding to the physical, fiscal and psychological barriers to enrollment and devising innovative and feasible tactics to incentivize or encourage potential decision-makers."
Strategies Address Multiple Perspectives
The National Strategy is built upon the foundation that all recruitment and participation is local, with studies taking place mostly in communities where people live. The National Strategy encompasses:
- Increasing Awareness and Engagement with broad policies and activities at the national and community levels that can identify and support strategies for successful recruitment and retention.
- Engaging Local Communities and Supporting Participants to identify and implement best practices to build trusting relationships within and across communities and individuals toward the shared goals of making a difference for people and families affected by Alzheimer's and related dementias.
- Building and Improving Infrastructure aimed at changing the way study sites and multisite networks do business, so they can be most effectively structured and staffed for the number and types of clinical studies being undertaken.
- Developing a Science of Recruitment focused on supporting investigators, in collaboration with communities, to develop and test innovative strategies and build an evidence base of effective participant recruitment and retention methods.
Community-Based Outreach Increases African American Participation in Alzheimer's Research at Indiana University
At AAIC 2018, Mary Guerriero Austrom, PhD, Associate Dean for Diversity Affairs and Wesley P. Martin Professor of Alzheimer Disease Education at Indiana University School of Medicine (IUSM), reported on a pilot project that used a collaborative research model to work with a Community Advisory Board (CAB) at the Indiana Alzheimer Disease Center (IADC) and the Alzheimer's Association, Greater Indiana Chapter.
The CAB represents a dozen leaders from the minority communities in Central Indiana -- predominantly from the African American community -- and include pastors, retired volunteers, an elder law attorney, and representatives from the State and County Boards of Health.
Austrom and colleagues engaged the CAB to help with messaging about Alzheimer's research, and created a research recruitment video specifically for minority communities. They identified locations and designed outreach activities where they could work within targeted minority communities.
The Alzheimer's Association collaborated at community outreach and educational events, and partnered with IADC to increase participants in Alzheimer's Association TrialMatch® -- a free, easy-to-use clinical studies matching service that connects people with Alzheimer's, caregivers and healthy volunteers with currently recruiting research studies.
Over the course of the pilot study, community-based outreach resulted in 185 African American, 68 White, and 67 other and unspecified referrals to the IADC. Prior to this research, the minority percentage at the IADC was 8.8%. Today it is 19%, which the researchers consider a resounding success. In addition, they added 300 African American volunteers to the TrialMatch database.
"Collaborating with the community as equal partners is essential. The addition of dedicated staff from the minority community was key to our success," Austrom said. "Working together, we reached out to the African American community in central Indiana to provide education about dementia and Alzheimer's disease, what research is, the importance of diverse populations engaging in research, and finally, asking for the community to volunteer for research at IUSM and register for the Alzheimer's Association TrialMatch program."
Culturally Diverse Participant Registry at Duke Facilitates Recruitment of African Americans
It is well documented that lack of immediate access to a "research-ready" cohort of volunteers results in significant delays in the pace of Alzheimer's research. The Duke Alzheimer's Prevention Registry (ADPR) was established in 2009 with a goal of providing a research-ready, readily accessed cohort of diverse individuals age 55+ to support clinical trials focused on Alzheimer's prevention and treatment strategies.
At AAIC 2018, the Duke ADPR reported that it currently has 4,300 members, of whom 27% are African American and 73% are female. Twenty-one (21) studies of various types are supported through the registry.
"We have enhanced our ability to quickly identify appropriate participants for specific studies by collecting additional information on a subset of 1,400 individuals," said Shelytia Cocroft, PhD, a Postdoctoral Fellow at the Center for Study of Aging and Human Development at Duke University's Medical Center. "This includes cognitive testing, self-reported memory problems, brief medical history, medications, family history of dementia and genotyping of Alzheimer's risk genes. This subgroup has proportionally fewer African Americans (14%) than the overall registry."
Cocroft noted that the ADPR is broadly representative of the local community demographics; its success in increasing participation and sustaining involvement in the registry is rooted in several factors:
- Culturally competent recruitment with staff who are sensitive to the community background, and educational materials that are appropriate to the cultural context.
- Dedicated coordinator time to ensure timely responses to member inquiries.
- Regular communication of research opportunities and findings.
- Coordination of requests to members regarding enrolling studies based on their interests and eligibility.
"Recruitment and retention of healthy research volunteers from diverse backgrounds is a national priority in the effort to prevent and treat Alzheimer's disease and other dementias," Cocroft said. "Key to retaining participation are regular communications about a broad portfolio of studies. Establishing trust and nurturing community-centric relationships is also vital to the recruitment and retention of underserved groups in clinical research."
The Alzheimer's Association International Conference® (AAIC®)
The Alzheimer's Association International Conference (AAIC) is the world's largest gathering of researchers from around the world focused on Alzheimer's and other dementias. As a part of the Alzheimer's Association's research program, AAIC serves as a catalyst for generating new knowledge about dementia and fostering a vital, collegial research community. AAIC 2018 home page: alz.org/aaic
AAIC 2018 newsroom: alz.org/aaic/press
About the Alzheimer's Association:
The Alzheimer's Association is the leading voluntary health organization in Alzheimer's care, support and research. Our mission 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 of dementia through the promotion of brain health. Our vision is a world without Alzheimer's. Visit alz.org or call 800.272.3900.