Leveraging recent advances in plasma biomarkers to optimize early proof of concept trials in Alzheimer's disease.

ABSTRACT:

Introduction

The importance of biomarkers as a primary outcome or as supportive evidence of clinical effect is rising as the field shifts toward disease-modifying treatments and earlier intervention, because they have lower variability and can indicate disease progression earlier than clinical outcomes. This study assessed the performance of plasma pTau 181 and 217 as a predictive biomarker and potential primary endpoint in early-phase Alzheimer's disease (AD) trials.

Methods

Summary data from recent monoclonal antibody (mAb) trials including plasma pTau 181 and 217 were analyzed to evaluate associations between plasma pTau 181/217 and clinical outcomes. The suitability of plasma pTau 181/217 as a surrogate endpoint for internal decision making was assessed using Prentice cr

SUBMITTER: Duncan GB 

PROVIDER: S-EPMC12645156 | biostudies-literature | 2025 Oct-Dec

REPOSITORIES: biostudies-literature