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In April 2022, the US Food and Drug Administration, based in Silver Spring, Maryland,
instituted guidelines recommending that trials reflect the diversity of people who will use the
drug — but this doesn’t always happen. The lack of diversity is particularly acute for Alzheimer’s
disease. This is because participants in trials testing monoclonal antibody drugs such as
lecanemab and donanemab must have sufficient levels of the sticky amyloid protein that
accumulates in the brains of people with Alzheimer’s.
At the AAIC, neurologist Doris Molina-Henry, at the University of Southern California in
Los Angeles, presented a study which found that having low amyloid levels made people of
colour two to four times less likely than their white counterparts to qualify for an ongoing trial
testing whether lecanemab could prevent Alzheimer's. A study3 presented at the 2022 AAIC
meeting found similar trends in data from nearly 11,000 people in the early stages of Alzheimer’s
who underwent positron emission tomography (PET) scans to determine whether they could
participate in four separate Alzheimer’s trials run by Eisai, a bio-pharmaceutical company based
in Tokyo.
Qualifying for the latest donanemab trial was even more difficult, says Lilly’s senior
medical director, John Sims, because the company was screening for both amyloid and tau,
another Alzheimer’s-related protein. Only one in 8 Black and one in 17 Hispanic volunteers
qualified, he says, compared with one in 4 white applicants.
“The field really needs to understand why this keeps happening,” says Alzheimer’s
researcher Joshua Grill at the University of California, Irvine. It is unclear why people of colour
would have lower amyloid or tau levels than their white counterparts with the same amount of
cognitive impairment. Grill speculates that dementia in people of colour might often be caused by
other conditions such as vascular disorders or inflammation. External factors such as education
levels and stress could also contribute to dementia risk, and some evidence suggests that certain
genetic variants involved in Alzheimer’s risk differ between people of European and African
ancestry4,5.
Amyloid levels are not the only reason that Alzheimer’s trials lack racial diversity, says
Reisa Sperling, a neurologist at Harvard University in Cambridge, Massachusetts. People of
colour are less likely than white people to live near hospitals with PET scanners that are used to
determine whether a drug is working, and recruitment campaigns typically target white
communities. People of colour also face higher rates of disorders that disqualify them from trials,
such as cardiovascular disease and lupus. “We need to look at all our inclusion and exclusion
criteria: which are necessary and which are contributing to disparities in who we bring in,”
Sperling says.
doi: https://doi.org/10.1038/d41586-023-02464-1
References
van Dyck, C. H. et al. NEJM. 388, 9–21 (2023).
Sims, J. R. et al. JAMA. https://doi.org/10.1001/jama.2023.13239 (2023).
Grill, J. et al. Alzheimers. Dement. 18, e069198 (2022).
Le Guen, Y. et al. JAMA https://doi.org/10.1001/jama.2023.0268 (2023).
Naslavsky, M.S. et al. Mol Psychiatry 27, 4800–4808 (2022).