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Drug Development.

Lieza G Exalto1,2, Siti S Syaziyah3, Xiaotian T Fang1

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|December 25, 2025
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Women are less likely to be eligible for Alzheimer

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Area of Science:

  • Neurology
  • Clinical Trials
  • Medical Research

Background:

  • Alzheimer's Disease (AD) drug trials often lack female participation relative to the global dementia population.
  • Industry stakeholders aim for inclusive trials, focusing on engagement and recruitment.
  • This study investigates how trial design, specifically eligibility criteria, impacts sex-based participation rates.

Purpose of the Study:

  • To analyze the influence of common Alzheimer's Disease clinical trial eligibility criteria on the proportion of men and women eligible for participation.
  • To identify specific criteria that disproportionately affect women's eligibility in AD trials.

Main Methods:

  • Extracted eligibility criteria from 563 Phase II and III AD drug trials registered on clinicaltrials.gov.
  • Manually annotated 113 trials based on the top 5 most common inclusion criteria.
  • Applied these criteria sequentially to a cohort of men and women diagnosed with AD or Mild Cognitive Impairment (MCI) at Alzheimer Center Amsterdam.

Main Results:

  • The top 5 criteria included: no other central nervous system (CNS) disorder, caregiver participation, Mini-Mental State Examination (MMSE) score range (24-30), no contraindications for study procedures, and age range (55-85).
  • Applying these criteria sequentially to 3835 patients (48% women), eligibility decreased significantly for women.
  • Final eligibility was 31% for men and 16% for women, primarily due to lower MMSE scores and lack of caregiver availability in women.

Conclusions:

  • Commonly used eligibility criteria in Alzheimer's Disease clinical trials result in lower eligibility rates for women compared to men.
  • Lower MMSE scores at presentation and reduced caregiver availability appear to be key factors contributing to this discrepancy.
  • Trial designs should consider these factors to promote more equitable inclusion of women in AD drug trials.