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Anti-amyloid therapy eligibility in a longitudinal brain-donor cohort with post mortem confirmation
Monjurul Haque1, Keeley J Brookes2, Beili Shao1,3
1Department of Neurology Nottingham University Hospitals NHS Trust Nottingham UK.
Introduction:
Anti-amyloid therapies (AATs) for Alzheimer's disease (AD) demonstrate modest benefit in trials, but real-world eligibility remains uncertain. Requirements including biomarker confirmation and safety exclusions may limit access.
Methods:
Using the Brains for Dementia Research cohort, we linked longitudinal cognitive data with post mortem neuropathology to estimate trial-like AAT eligibility. Early stage was defined using harmonized cognitive thresholds. AD pathology required Thal amyloid phase ≥3 and Braak stage ≥IV. Exclusions were applied hierarchically: (1) vascular neuropathology, (2) anticoagulant use, and (3) apolipoprotein E (APOE) ε4/ε4 homozygosity.
Results:
Of 1230 participants, 945 had sufficient data; 232 had early, pathology-confirmed AD. Vascular pathology excluded 70.7%, anticoagulant use 19.1%, and APOE ε4/ε4 homozygosity 3.6% of remaining cases. Overall, 53 individuals (4.3% of those screened) were eligible. Eligibility declined with age and was driven primarily by vascular comorbidity.
Discussion:
Using a conservative pathology-anchored framework, only a small proportion of this older brain-donor cohort met trial-like eligibility criteria.
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