Seeking optimal repeated fluid biomarker assessments to enhance precision and statistical power in clinical trials: SLIM method.

ABSTRACT:

Introduction

Plasma biomarkers are increasingly used as surrogate outcomes in clinical trials for Alzheimer's disease and related dementias (ADRD) due to their non-invasive nature. In early-phase trials designed to evaluate mechanisms of action and biological efficacy, assessing pre-post changes in plasma biomarkers within the same individuals - using a single-arm placebo lead-in design - offers a potentially cost-effective alternative to parallel-group designs by minimizing between-subject variability. However, plasma biomarkers are also subject to within-individual variability, which can obscure true treatment effects.

Methods

One strategy to address this limitation is to collect repeated measures during each study period. This approach can improve measurement precision, e

SUBMITTER: Dodge HH 

PROVIDER: S-EPMC12541280 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature