NIH grant will make next phase of AD trial more diverse, says UCSF
The US NIH has given the Northern California Institute for Research and Education $147 million to make Alzheimer’s disease trials more diverse.
The grant will be used to drive efforts to recruit more Black, Latinx, Asian and American Indian participants in clinical trials examining candidate therapies according to UCSF.
Project leader Michael Weiner, a professor of radiology, medicine and neurology at UCSF and the principal investigator of the Alzheimer’s Disease Neuroimaging Initiative (ADNI) - explaining clinical trial diversity is a major challenge for developers.
“Clinical trial recruitment has traditionally always struggled to enroll participants of color. Up until about two years ago, only 10% to 11% of our participants were non-white.
“But if we are to understand Alzheimer’s disease, we must study participants who represent the North American population” he said.
Site network
The ADNI is a public-private partnerships funded in part by the National Institutes of Health’s National Institute on Aging to study the neurodegenerative disorder. It operates a 60-site research network in the US and Canada.
The new funding will support “ADNI4,” the latest stage of a project begun in 2004 that set out to identify and validate the imaging, genetic and biochemical biomarkers in the early detection and tracking of Alzheimer’s disease.
According to UCSF the grant will let researchers expand their participant pool from more than 1,000 to about 1,500 people, at least half of whom will come from underrepresented populations.
Weiner said “in ADNI4, researchers will focus on recruiting ethnoculturally diverse participants by using a community-engaged approach with recruiters in communities, digital marketing, and social media campaigns.
“Some 50 percent to 60 percent of new enrollees will be from underrepresented groups, such as Black, Latinx, Asian, Pacific Islander, American Indian, as well as people with a high school education or less.”
Melanie Miller, senior program manager at ADNI, expanded on this, adding that “through a web-based portal, ADNI4 will screen up to 20,000 participants using digital cognitive tests including a novel voice-based assessment tool.
“One in five of these participants will be further screened using remote collection of blood samples for amyloid and tau, and those participants with cognitive assessments suggesting higher risk for MCI, or those with amyloid positivity, will be referred to their local ADNI site.”
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