Population enrichment is becoming increasingly recognized as a key element of Alzheimer’s disease (AD) clinical trials, in order to reduce required sample sizes and improve the chances of detecting a treatment effect. Amyloid-β (Aβ) pathology and the APOEε4 genotype have been shown to accelerate tau accumulation, however assessing both APOEε4 carriership and Aβ positivity as a strategy to enrich AD clinical trials has not yet been investigated. João Pedro Ferrari-Souza, MD-PhD student, University of Pittsburgh, Pittsburgh, PA, and his team investigated whether using both APOEε4 and Aβ positivity could reduce the sample size needed for clinical trials testing a 25% reduction in tau-PET accumulation. In total, 63 cognitively impaired individuals (Clinical Dementia Rating ≥ 0.5) from the McGill Translational Biomarkers in Aging and Dementia (TRIAD) cohort were studied. It was shown that to detect a 25% drug effect, using Aβ positivity plus APOEε4 carriership would require a sample size of 64% less than using Aβ positivity alone. In the future, Mr Ferrari-Souza wants to investigate whether these results are replicable in other cohorts and with other tau-PET tracers or measures of tau pathology such as plasma p-tau. This interview took place at the Clinical Trials on Alzheimer’s Disease congress 2022 in San Francisco.
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