Alzheimer’s Association Calls for Diversity in Clinical Trial Participation
Access to health care and the opportunity to achieve optimal health should not depend on where people live, their socioeconomic status, or their race and ethnicity, but as the COVID-19 pandemic has shown, that is not always the case.
COVID-related disparities served to shine a light on other areas of health disparities as well, including clinical trial diversity. In the case of Alzheimer’s disease, for example, difficulties recruiting traditionally underrepresented groups has a significant impact on researchers’ ability to develop therapeutics and care models that work for people of all ethnic and racial backgrounds.
The Alzheimer’s Association seeks to change that paradigm, with several initiatives designed to address obstacles, reach out to underserved communities and make clinical trial recruitment more equitable across diverse populations.
Carl Hill, Alzheimer’s Association
“Scientific discoveries should translate into improved health outcomes for all people, in all communities,” said Carl V. Hill, PhD, MPH, Chief Equity, Diversity and Inclusion Officer, Alzheimer’s Association. “Without representative participation in trials, it is impossible to get a complete understanding of how treatments will be safe and effective for everyone.”
Benefits of Clinical Trial Participation
In addition to accelerating progress toward treatments, prevention and a cure for Alzheimer’s, participating in clinical trials can translate into tangible benefits for individual patients, according to Dr. Hill. He noted that people involved in clinical trials tend to do somewhat better than people in a similar stage of their disease who are not enrolled in clinical trials, regardless of whether the experimental treatment works.
“Patients can get access to potential treatments before they are widely available,” he explained. “They can take advantage of expert medical care at leading academic medical centers, often free of charge. Plus, they can take a more active role in their own health care through general health checkups that are often a regular component of trials.”
To help those living with Alzheimer’s find a clinical trial for Alzheimer’s and other dementia, the Alzheimer’s Association launched TrialMatch, a free matching service to a continuously updated list of more than 700 studies, including drug and non-drug trials. Studies can be flagged with languages in which they are available, and users can filter studies by their preferred language.
Obstacles to Clinical Trial Participation
Dr. Hill pointed to several obstacles keeping racial and ethnic minorities from being well represented in clinical trials, some of which have their genesis in long-standing mistrust of medical research.
“Black communities, for example, have passed-down memories of the heinous Tuskegee syphilis trial, forced sterilizations, and Baltimore’s 1930s redlining initiative, the latter of which impacted health care access and outcomes for generations,” he said. “Researchers and the health care system as a whole must therefore work on building trust before they can start to convince African Americans of the benefits of trial participation.”
Even when unwarranted, fears over racism or discrimination from doctors and medical staff prompt some racial and ethnic minorities to delay seeking Alzheimer’s care. A 2021 study found that more than one-third of Black Americans (36%), two-fifths of Native Americans (40%), and nearly one-fifth of Hispanic Americans (18%) and Asian Americans (19%) believes discrimination would be a barrier to receiving care. They are also less confident that they have access to health professionals who understand their ethnic and racial background and experiences, supporting the need for more diverse representation among health care providers.
Still other challenges to participating in Alzheimer’s clinical trials are logistical in nature, including access to transportation, distance from clinical trial locations and ability to take time off from work or family duties.
“Researchers should receive funding from NIH and other sources to better understand how these local, logistical obstacles make it difficult to apply a one-size-fits-all solution,” Dr. Hill said. “They also need to re-evaluate trial exclusion criteria, which have the potential to restrict the participation of those disproportionately affected by Alzheimer’s or another dementia, like Latinos and African Americans.”
Outreach Builds Awareness and Recruitment
The Alzheimer’s Association is leading two major clinical trials with a strong focus on diverse participation. The New Ideas study is recruiting 2,000 Latinos and 2,000 Blacks to investigate the impact of brain amyloid PET scan on clinical care outcomes, including diagnosis and treatment. The U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) study is a two-year clinical trial studying the effects of multi-component lifestyle interventions on risk of cognitive decline in a diverse population.
“Together, these studies should provide valuable insight into how a patient’s knowledge of their Alzheimer’s hallmarks and risk factors affect how they manage their health,” Dr. Hill said. “Will they take better care of their cardiovascular health? Will they go see their doctor more frequently? Research shows that when people can get their hypertension under control, progression from mild cognitive impairment to severe dementia slows down.”
The two trials are actively recruiting, and the Alzheimer’s Association is conducting community-based outreach through its 70+ chapters across the country, as well as through strategic partnerships with more than 20 national and countless local organizations, to get the word out in culturally relevant and appropriate formats.
Noting that partnerships at a national level translate into more effective community engagement, Dr. Hill said the Alzheimer’s Association is working with the African Methodist Episcopal (AME) Church on a five-year program to disseminate free Alzheimer’s and dementia-related information, resources and referrals to its two million members. It also is working with the National Association of Hispanic Nurses to develop culturally responsible and language appropriate content. A complete list of the Association’s national partners can be viewed here.
“People are more likely to participate in clinical trials if they are invited by a trusted individual from their community,” added Dr. Hill.
A Critical Moment
Later this month, the Alzheimer’s Association will host its International Conference, the most influential international meeting dedicated to advancing dementia science. This year, the Conference will have a special focus on health disparities and health equity, with a daylong workshop Addressing Dementia Risk Through Social Determinants of Health, co-sponsored with the CDC. The workshop will bring researchers and practitioners to increase understanding of how the conditions in which people live, learn, work and play affect dementia risks and outcomes.
“This is an exciting time in health equity research, but issues remain complex,” Dr. Hill concluded. “We are at a critical moment in which more intentional inclusion in Alzheimer’s and dementia research can help to change the course of a devastating disease and benefit generations to come.”