Individuals of Hispanic/Latino or African descent vs White individuals are at a higher risk for developing Alzheimer disease and related dementias. However, they are routinely underrepresented in clinical trials.
In 2021, the FDA fast-tracked aducanumab (Aduhelm®) for approval as a treatment for Alzheimer’s, the first new FDA-approved treatment for the disease in over 20 years of research and development. The multinational clinical trials were designed to evaluate the efficacy and safety of aducanumab, however, the population included extraordinarily low proportions of patients with African (0.6%) or Hispanic/Latino (3.2%) ancestry.
Researchers published a systematic review of the literature in 2022 and included 101 clinical trials for Alzheimer’s in their final analysis. They reported that trial participants consisted predominantly White individuals (median percentage, 94.7%). When analyzing temporal trends, this percentage did not increase or decrease significantly between 2001 and 2019.8
Clinical investigators continue to struggle with increasing diversity in AD clinical trials, begging the question of why?
See “Diversity Challenges in Clinical Trials of Alzheimer Disease and Related Dementias” (June 14, 2024)
