Journal article
Donanemab in Early Symptomatic Alzheimer Disease The TRAILBLAZER-ALZ 2 Randomized Clinical Trial
John R Sims, Jennifer A Zimmer, Cynthia D Evans, Ming Lu, Paul Ardayfio, JonDavid Sparks, Alette M Wessels, Sergey Shcherbinin, Hong Wang, Emel Serap Monkul Nery, Emily C Collins, Paul Solomon, Stephen Salloway, Liana G Apostolova, Oskar Hansson, Craig Ritchie, Dawn A Brooks, Mark Mintun, Daniel M Skovronsky
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | AMER MEDICAL ASSOC | Published : 2023
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 rand..
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Funding Acknowledgements
This work was funded by Eli Lilly and Company.