Reporting and Representation of Participant Demographic Information in Completed Alzheimer’s Disease Clinical Trials


Communities of color in the United States, particularly Black and Latino persons, are disproportionately affected by Alzheimer’s disease and related dementias (AD/ADRD), with higher all-cause dementia incidence and prevalence. Despite this unequal burden, they are often underrepresented in research and clinical trials. Differences in AD/ADRD symptoms, behaviors, and thereby response to therapeutics in persons from underrepresented racial and ethnic groups may further compromise the external validity of research findings and reinforce treatment disparities. Low representation in clinical trials may also reinforce mistrust of the medical system generally and of tested treatments specifically, compromise fairness for minoritized participants and their communities, lessen biomedical knowledge among diverse populations, and widen treatment disparities.

The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have made concerted efforts to increase diversity in clinical trials. To date, relatively few studies assess reporting of participant race and ethnicity in clinical trials. Due to data availability, analyses of diversity in clinical trials tend to focus on FDA-approved drugs. Since clinical trial failure rates are notoriously high for AD therapeutics, this approach limits our understanding of diversity in AD clinical trials. To address this issue, we analyzed demographic reporting and representation of participants in completed AD clinical trials registered at, irrespective of approval status.

The full study can be viewed at Journal of the American Geriatrics Society.

This work is part of the Clinical Trial Recruitment Lab (CTRL)’s efforts to disseminate findings and share best practices to increase access to Alzheimer’s clinical trials and expand diversity in clinical trials. The work was supported by an award from the American Heart Association as part of the Alzheimer’s Trial Recruitment Innovation Lab (ATRIL), a collaboration between the USC Schaeffer Center, the USC Alzheimer’s Therapeutic Research Institute, and Howard University.

Arellanes, I., Mirsafian, L., Wang, Y., & Jacobson, M. (2024). Reporting and representation of participant demographic information in completed Alzheimer’s disease clinical trials. Journal of the American Geriatrics Society.

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