Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial.

ABSTRACT:

Importance

There are limited efficacious treatments for Alzheimer disease.

Objective

To assess efficacy and adverse events of donanemab, an antibody designed to clear brain amyloid plaque.

Design, setting, and participants

Multicenter (277 medical research centers/hospitals in 8 countries), randomized, double-blind, placebo-controlled, 18-month phase 3 trial that enrolled 1736 participants with early symptomatic Alzheimer disease (mild cognitive impairment/mild dementia) with amyloid and low/medium or high tau pathology based on positron emission tomography imaging from June 2020 to November 2021 (last patient visit for primary outcome in April 2023).

Interventions

Participants were randomized in a 1:1 ratio to receive donanemab (n = 860) or placebo (n = 876) i

SUBMITTER: Sims JR 

PROVIDER: S-EPMC10352931 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature