journal articles
TOP FIVE ALZHEIMER DISEASE TRIAL ELIGIBILITY CRITERIA FAVOR MEN COMPARED TO WOMEN IN A CLINIC-BASED COHORT
Lieza G. Exalto, Siti S. Syaziyah, Xiaotian T Fang, Niels D. Prins, Sietske A.M. Sikkes, Wiesje M. van der Flier, Everard G.B. Vijverberg, Yvonne M.F. Lim
BACKGROUND: Less women participate in Alzheimer Disease (AD) trials compared to their estimated representation in the global dementia population.
OBJECTIVES: We aimed to apply five most commonly used eligibility criteria to a real-world memory clinic population to compare male and female eligibility according to these criteria.
DESIGN: Observational.
SETTING: Memory clinic setting.
PARTICIPANTS: Consecutive patients (2000–2024) from Amsterdam Dementia Cohort with a diagnosis of mild cognitive impairment (MCI) or AD (n = 3835).
MEASUREMENTS: Free-text eligibility criteria of n = 608 phase II and III AD drug trials were downloaded from ClinicalTrials.gov (March 28, 2025). A machine-learning model was trained and validated to extract all eligibility criteria. Next the criteria were applied on observational real world data from on memory clinic diagnostic work-up.
RESULTS: Top 5 most common AD clinical trial eligibility criteria were 1) no other central nervous system disorder related to cognitive impairment (84%), 2) participation of a caregiver (72%), 3) MMSE (66%, range 20–30), 4) no comorbidities, specifically vascular and mental health (62%), 5) no contra-indications for study procedures such as lumbar puncture, MRI and PET (59%). Applying the abovementioned criteria results in 33% of men and 23% of women remaining eligible (p<.001). Main reason for non-eligibility is caretaker absence (applicable for 20% of men and 38% of women) and low MMSE (32% of man and 54% of women).
CONCLISION: Based on five commonly used eligibility criteria of AD clinical trials, women in our clinic-based cohort are less eligible for participation in AD drug trials than men. This discrepancy was mainly attributed to lack of caregiver presence and lower MMSE at presentation. These results provide clues for trial design to facilitate more equal inclusion of women.
CITATION:
Lieza G. Exalto ; Siti S. Syaziyah ; Xiaotian T Fang ; Niels D. Prins ; Sietske A.M. Sikkes ; Wiesje M. van der Flier ; Everard G.B. Vijverberg ; Yvonne M.F. Lim (2025): Top five Alzheimer Disease trial eligibility criteria favor men compared to women in a clinic-based cohort. The Journal of Prevention of Alzheimer’s Disease (JPAD). https://doi.org/10.1016/j.tjpad.2026.100580