Association Endorses ENACT Act to Improve Clinical Trial Diversity

The Alzheimer’s Association and its advocacy affiliate, the Alzheimer’s Impact Movement (AIM), are backing recently introduced bipartisan legislation to support equity in Alzheimer’s disease clinical trials.

The Equity in Neuroscience and Alzheimer’s Clinical Trials (ENACT) Act of 2021 (H.R. 3085/S. 1548) would amend the Public Health Service Act to improve the diversity of participants in clinical trials, which is important in treatment development, advocates say.

“Alzheimer’s and other dementia disproportionately affect older Black and Hispanic-Americans compared to older whites,” said Carl V. Hill, PhD, the association’s chief diversity, equity, and inclusion officer, in a press release. “Yet too often the clinical trial staff and participants have not included sufficient numbers of Black, Hispanic, Asian, and native Americans.”

“There is an urgent need for our nation to do more to encourage and ensure diversity in clinical trial participation, and the ENACT Act is an important step to addressing this shortcoming in our pursuit of health equity.”

The legislation would heighten diversity in clinical studies by enhancing education and outreach to underrepresented segments, fostering diversity among clinical trial staff, and removing or easing barriers to trial participation.

“To ensure future treatments and means of prevention are effective in all populations, Alzheimer’s and dementia trials must reflect the U.S. population,” said Robert Egge, chief public policy officer of the Alzheimer’s Association and AIM executive director. “We are grateful to the bill’s sponsors for their leadership introducing legislation that prioritizes research.”

Not only does clinical trial underrepresentation hamper the ability of scientists to understand health disparities, it also limits their awareness of how a treatment or diagnostic may affect populations most likely to need the therapies.

“While much progress has been made in understanding Alzheimer’s-related brain changes and their impact on a person’s symptoms, we know more work remains,” said Maria Carrillo, PhD, the association’s chief science officer. “Of critical need, we must design future trials to be reflective of all communities impacted. It is only when measures outlined in the ENACT Act are implemented across the research field will we improve health equity.”

Specifically, the legislation would provide funding for the National Institute on Aging (NIA) to increase the number of Alzheimer’s Disease Research Centers (ADRCs) in areas where there are higher concentrations of underserved populations.

In addition, the measure would help fund efforts by ADRCs and resource centers for minority aging research to improve outreach and education to such populations as well as to physicians. The aim is to underline the importance of clinical trial participation, make trial opportunities known, and emphasize the disparate impact of Alzheimer’s.

The act would also direct the NIA to improve the diversity of scientists conducting Alzheimer’s and other dementia-related studies, so that they better reflect populations they hope to enroll.

Sen. Susan Collins (R-Maine) was one of the legislators to introduce the measure, which has been referred to the House Committee on Energy and Commerce. She called Alzheimer’s one of the greatest and most under-recognized public health threats.

“Millions of Americans and thousands of Mainers are living with the disease, which imposes a devastating human and financial cost,” she said. “Hispanics and African-Americans are disproportionately affected by Alzheimer’s, yet they are underrepresented in current research.”