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Drug Development.

Martine Meyer1, David Henley2, Jennifer Bogert3

  • 1Johnson & Johnson, San Diego, CA, USA.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 25, 2025
PubMed
Summary
This summary is machine-generated.

Screen failure rates in Alzheimer's disease trials are high, particularly for Black/African American participants. Understanding these differences is key to improving diversity in clinical trials for Alzheimer's disease (AD).

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Area of Science:

  • Neurology
  • Clinical Trials
  • Alzheimer's Disease Research

Background:

  • Recruiting diverse participants in Alzheimer's disease (AD) clinical trials is crucial.
  • This study examines screen failure (SF) rates and reasons across different races in the posdinemab Phase 2b Auτonomy study.

Purpose of the Study:

  • To analyze preliminary screen failure (SF) data across racial groups in an early symptomatic Alzheimer's disease (AD) trial.
  • To identify reasons for SF to improve recruitment strategies for diverse populations.

Main Methods:

  • Screen failure (SF) participants from the Auτonomy study were identified.
  • SF rates and reasons were evaluated across racial categories: White, Black/African American, and Asian.

Main Results:

  • An overall screen failure (SF) rate of 79.6% was observed in 2563 participants.
  • Numerically higher SF rates were seen in Black/African American (86.4%) and White (80.5%) populations compared to Asian (73.3%).
  • The primary SF reason across these groups was not meeting the criterion for elevated plasma p217tau concentration, followed by not meeting early AD clinical criteria, which was higher in Black/African Americans.

Conclusions:

  • Black/African American participants showed numerically higher screen failure (SF) rates.
  • Higher SF in Black/African Americans was linked to early AD clinical criteria, though numbers were limited.
  • Further analysis of SF data across AD trials is needed to understand racial differences and inform diverse recruitment.