The NIH’s National Institutes on Aging (NIA) and the Alzheimer’s Association brought together various experts and stakeholders to create the National Strategy for Recruitment and Participation in Alzheimer’s Disease Clinical Research.
According to the Alzheimer’s Association, Alzheimer’s disease (AD) is the sixth-leading cause of death in Americans. Between 2010 and 2015, deaths from AD increased 123 percent. The National Institute of Health (NIH) sponsors in whole or in part, approximately 140 active clinical trials into AD. The Alzheimer’s Association indicates their database has more than 250 studies ongoing.
The problem? There aren’t enough people participating in the trials.
This became enough of a concern that the NIH’s National Institute on Aging and the Alzheimer’s Association brought together various experts and stakeholders to create the National Strategy for Recruitment and Participation in Alzheimer’s Disease Clinical Research. This effort will launch this fall. “We anticipate a finished product that will give helpful strategies for recruitment at local, regional, and national levels to other governmental agencies, medical providers, people with Alzheimer’s, and caregivers,” stated Marie Bernard, geriatrician and deputy director of the NIH. “Everyone needs to be more informed and aware of the challenges and opportunities of recruitment.”
Alzheimer’s disease clinical trials pose specific challenges based on varying age requirements and cognitive abilities. Some patients need to be healthy and cognitively unimpaired, while others often involve severely impaired individuals. Clinical Informatics News points out, “While people in cognitive decline require a partner to assist with tasks such as driving and reporting, potential volunteers with no impairment often don’t enroll in AD trials due to a lack of awareness or the stigma of AD.”
The National Strategy is part of the National Plan to Address Alzheimer’s Disease. The research goal of the plan is to prevent and treat Alzheimer’s disease by 2025, a daunting and ambitious goal only seven years away. The NIA states, “Specific actions outlined in the National Plan related to recruitment 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 increase enrollment of diverse populations in Alzheimer’s disease studies. With development of a National Strategy, the community will also seek to develop ways to track activities and monitor progress.”
Noting that primary physicians are often the access point for involvement in clinical trials, the National Strategy is also working to expand that role to other community leaders. “For example,” Clinical Informatics News writes, “outreach must start with the tribal elders in Native American reservations and with church elders in African-American communities.”
Bernard told Clinical Informatics News, “Researchers must take into consideration the context. They must know the community, work in it and become a part of it. There are differences from site to site; researchers must be cognizant of the nuances within different sites. We must focus on the fact that there needs to be diversity in studies.”
As an example, Indiana University developed a community-based outreach program to increase African-American involvement in clinical trials. It works with a Community Advisory Board made up of clergy, retired volunteers, an elder law attorney, and representatives from the State and County Boards of Health.
The Alzheimer’s Association created TrialMatch in 2010, a matching service on its website that is free and matches healthy individuals to trials and AD patients to caregivers.
Other examples include the Duke Alzheimer’s Disease Prevention Registry (ADPR), and the Banner Alzheimer’s Institute’s GeneMatch program.
The National Strategy also focuses on improving infrastructure, including sufficient staffing to conduct an 18 to 24-month clinical trial. The NIH also has developed $3 million funding opportunity, Examining Diversity Recruitment and Retention in Aging Research, to study the science of Alzheimer’s disease recruitment.
Heather Snyder, Senior Director of Medical and Scientific Operations for the Alzheimer’s Association told Clinical Informatics News, “This is not a one-and-done sort of thing. It must be monitored to see what needs to be tweaked and to further enhance it.”
