People of color want to participate in Alzheimer's research. The NIA has a new tool to make it happen

The newly approved Alzheimer's disease drug Aduhelm was tested in mostly white individuals, and yet the disease disproportionately impacts people of color. The National Institute on Aging wants to change that with a new tool to help researchers and clinicians raise awareness and participation in their trials for the disease. 

The launch of the tool, called Outreach Pro, is coupled with a report from the Wisconsin Alzheimer's Disease Research Center that found 85% of respondents were more willing to volunteer for a clinical trial if invited to participate. The respondents were a mix of white, African American, Latino and American Indians.

The report also found that 83% of respondents want to contribute to the goal of research and 74% said having a family member with Alzheimer's would encourage them to volunteer in trials. 

In the survey, respondents also said they were significantly more likely to volunteer for a trial if asked by a person of the same race. These groups were more concerned than white counterparts about disruption to work and family responsibilities and availability of transportation and childcare, according to the results presented Thursday at the 2021 Alzheimer's Association International Conference in Denver.

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Alzheimer's and other dementias disproportionately affect people of color. Older Black Americans are nearly twice as likely to have the neurodegenerative disease or other dementias and Hispanic Americans are about 1.5 times as likely compared to older white Americans, according to data from the Alzheimer's Association. 

These results point to the importance of trust and familiarity, said Carl Hill, Ph.D., chief diversity, equity and inclusion officer for the Alzheimer's Association in an interview with Fierce Biotech. The survey also highlights the importance of understanding research literacy and why clinical trials are critical, he said.

"It really aligns with one of the overarching themes of our work in equity and that’s participatory engagement, so really working with members of a community or community-based organizations to align with the research project and to get on board so that when we recruit in communities, we do that together," Hill said. 

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Outreach Pro includes resources to customize websites, handouts, videos, social media outreach and other forms of engagement to connect with underrepresented groups. Initially available in English and Spanish for African American and Hispanic/Latino communities, the NIA is also working on developing materials in multiple languages this fall for Asian Americans and Pacific Islanders, and next year for American Indian and Alaska Native groups. 

Hill was previously director of the NIA's office of special populations, which he said tries to provide researchers with grants and resources to boost recruitment. Now, Outreach Pro is available to the public, and Hill hopes the NIA's public-facing mission will make biotechs, Big Pharmas and others in the industry aware of the tool. The NIA is part of the U.S National Institutes of Health.

"It’s not a one-size-fits-all, so researchers will tailor these materials to these communities, but it’s a really important start to give researchers these resources so that they can do more with being innovative in recruitment of underrepresented populations," Hill said. 

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Biogen has been asked to conduct a phase 4 clinical trial to confirm Aduhelm's benefit to maintain its approval with the FDA. 

In Emerge, one of Biogen's phase 3 trials for Aduhelm, nearly 80% of patients were white. And, in another treatment Biogen has in the works with Ionis Pharmaceuticals that's in an earlier stage, 100% of patients in a phase 1b trial were white. 

Asked if there's any concerns the new confirmatory trial will also be majority white, Hill said he hopes a more diverse group will be sought out.

"This is a great opportunity for this momentum to inform that next phase," he said. "So we're hopeful that it influences their next steps."

Also at the conference Thursday, the NIA said commonly used exclusion criteria in active NIA-funded Alzheimer's and related dementia trials may "inadvertently exclude African American and Hispanic participants." Of 235 active trials, 60% of them had at least one exclusion category that disproportionately affects these populations.

“It’s a call to action," Hill said of the data. The tool is a great first step, but Hill wants to see more done to boost resources and attention for recruiting diverse patients to address disparities. 

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Going forward, the Alzheimer's Association wants to form more national partnerships to add to recent ones inked with the Black Nurses Rock and the Omega Psi Phi Fraternity. The association is also focused on connecting potential Alzheimer's clinical study participants to its trial matching service, Hill said.