Alzheimer’s Trials Need Rethinking to Broaden Participation, Expert Says
Increasing cultural and ethnic diversity in Alzheimer’s clinical trials is a must — but it’s going to take a complete rethinking of the way these studies are recruited, conducted, and analyzed, said a Fordham University psychology professor speaking at an Alzheimer’s conference.
Monica Rivera-Mindt, speaking at the Clinical Trials in Alzheimer’s Disease meeting in Boston, said that the good news is that trialists are keying into this challenge and new empirical data prove that community engagement from study leaders does increase the enrollment of groups that have traditionally shied away from participation.
“We’re at such an exciting inflection point in our field,” said Rivera-Mindt also an assistant clinical professor of neurology at the Icahn School of Medicine at Mount Sinai. “It’s a historic moment. But if we don’t make room for everyone to benefit, especially those who are differentially impacted by dementia, what are the long-term consequences going to be, ethically? Scientifically? Socially?”
According to the Alzheimer’s Association, whites comprise most of the more than 5 million diagnosed Alzheimer’s patients in the U.S., but the disease is twice as common in Blacks and about 1.5 times as common in Hispanics. These groups are less likely to get a diagnosis, and much less likely to be included in clinical trials of the disease. Less than 5 percent of Alzheimer’s disease clinical trials comprise Blacks or Hispanics, according to a 2022 study.
That means disease-modifying drugs are being tested in almost exclusively white populations, despite these differences. And that needs to change, said Rivera-Mindt. The change begins with improving cultural competence in clinical trials planning and leadership but will have to extend far beyond just a philosophical overhaul, she said. Recruiters will need to leave “the ivory tower” and establish long-term, trustworthy physical presences in targeted communities.
“The studies and projects that have successfully explored this are those where the leaders are modeling this kind of thinking. This isn’t something that can be marginalized to study coordinators. It has to start at the top and permeate the whole research project.”
Traditionally, clinical trials have adopted a “conquistador” approach, she said. “By that I mean going into a community and getting the gold — which is the data — and then going back to the ivory tower and using it to a specific end, instead of moving as a partner in communities.”
Building these relationships isn’t quick; the successful partnerships will require trialists to rethink their typical study timeframe. “We typically work in five-year cycles. It’s go fast, get the data and get out. This isn’t going to work here.”
The good news is that emerging evidence supports this kind of research, she said. Her own recent work, now under peer review, found that including a diversity task force in the recruiting arm of an Alzheimer’s neuroimaging trial increased the enrollment of underrepresented people by more than 200 percent. The goal, she said, is for at least half the study cohort to comprise these groups.
Some proven methods to encourage diverse cohorts include compensation for enrollment and retention, culturally tailored educational materials, blog posts pertaining to brain health in the target community, social media groups for enrollees, and videos that feature investigators and community peers explaining the importance of recruiting minority populations.
“We know that there has been profound under-inclusion of minoritized underrepresented populations,” Rivera-Mindt said. “We can do better. We must do better.”