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CTAD 2023 | Plasma p-tau217: a cost-effective and practical surrogate biomarker for clinical trials

Pamela Lukasewicz Ferreira, PhD, University of Pittsburgh, Pittsburgh, PA, presents insights from a study exploring plasma phosphorylated-tau217 (p-tau217) as a surrogate biomarker in clinical trials, assessing its cost-effectiveness relative to tau-PET. All 188 individuals had Aβ-PET at baseline and the cohort was divided into preclinical Alzheimer’s disease (cognitively unimpaired) and symptomatic individuals (cognitively impaired). Longitudinal rate of change in plasma p-tau217 was relatively high in both groups, giving an effect size of 0.71 and 0.84 in the cognitively unimpaired and cognitively impaired groups, respectively. It was calculated that around 1000 participants per arm would be required for a clinical trial testing a 25% drug effect on biomarker reduction. Regarding cost, the use of p-tau217 as a surrogate would be cheaper than tau-PET, both for cognitively unimpaired and cognitively impaired groups. Overall, plasma p-tau217 appears to be more cost-effective, convenient, and readily available, enabling data collection at more time points compared to tau-PET. This enhances the understanding of treatment effects and strengthens the validity of study outcomes. This interview took place at the Clinical Trials on Alzheimer’s Disease (CTAD) congress 2023 in Boston.

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