Eligibility Rates among Racially and Ethnically Diverse US Participants in Phase 2 and Phase 3 Placebo-Controlled, Double-Blind, Randomized Trials of Lecanemab and Elenbecestat in Early Alzheimer Disease

Abstract

Objective

Many factors contribute to inadequate diversity in Alzheimer disease (AD) clinical trials. We evaluated eligibility rates among racial and ethnic groups at US sites in large global multisite trials in early AD.

Methods

Using screening data from 4 randomized, double-blind, placebo-controlled clinical trials in early AD, we assessed rates of eligibility among racial and ethnic groups controlling for other demographic covariates. Each trial incorporated positron emission tomography and/or cerebrospinal fluid to evaluate brain amyloid pathology, as well as typical eligibility criteria used in early AD trials.

Results

Across the trials, 10,804 US participants were screened: 193 (2%) were of Hispanic ethnicity and Black race, 2,624 (25%) were of Hispanic ethnicity and White race, 118 (1%) were of non-Hispanic ethnicity (NH) and Asian race, 696 (7%) were of NH ethnicity and Black race, and 7,017 (65%) were of NH ethnicity and White race. Data from 156 participants who did not fit into these categories were excluded. Accounting for age, sex, and trial and using NH White participants as a reference group, we observed higher probabilities of ineligibility for amyloid biomarker criteria among Hispanic Black (odds ratio [OR] = 3.20, 95% confidence interval [CI] = 2.11–4.88), Hispanic White (OR = 4.15, 95% CI = 3.58–4.83), NH Asian (OR = 2.35, 95% CI = 1.23–4.55), and NH Black (OR = 3.75, 95% CI = 2.80–5.06) participants.

Interpretation

Differential eligibility may contribute to underrepresentation of some minoritized racial and ethnic groups in early AD trials. Amyloid biomarker eligibility is a requirement to confirm the diagnosis of AD and for treatment with amyloid-lowering drugs and differed among racial and ethnic groups. ANN NEUROL 2023

The full study can be viewed at Annals of Neurology.

Grill, J. D., Flournoy, C., Dhadda, S., Ernstrom, K., Sperling, R., Henry, D. M., … & Raman, R. (2023). Eligibility rates among racially and ethnically diverse US participants in Phase 2 and Phase 3 placebo‐controlled, double‐blind, randomized trials of lecanemab and elenbecestat in early Alzheimer’s disease. Annals of Neurology.