Donanemab in preclinical Alzheimer's disease: Screening and baseline data from TRAILBLAZER-ALZ 3.

ABSTRACT:

Introduction

TRAILBLAZER-ALZ 3 is investigating donanemab in preclinical Alzheimer's disease (AD).

Methods

This double-blind, placebo-controlled trial used a plasma phosphorylated tau-217 (p-tau217) assay to detect AD pathology for eligibility and a decentralized design to enhance screening and enrollment. After nine monthly infusions, clinical assessments continue every 6 months with a time-to-event primary outcome. A sub-study will evaluate longitudinal changes in amyloid and tau positron emission tomography (PET).

Results

Participants 55-80 years of age were screened (N = 63,124). Plasma p-tau217-eligible participants were enrolled (N = 2196), with Clinical Dementia Rating (CDR) scale-Global score (CDR-GS) of 0 (n = 1202) and 0.5 (n = 664). Plasma p-tau217 eligibil

SUBMITTER: Yaari R 

PROVIDER: S-EPMC12439032 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature