Abstract Details

Title TRAILBLAZER-ALZ 2: A Phase 3 Study to Assess Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer’s Disease

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) P18 - Poster Session 18 (5:30 PM-6:30 PM)

Poster/Presentation
Number 3-005

Background

Donanemab is an antibody that targets N3pG, a modified form of amyloid-β (Aβ). TRAILBLAZER-ALZ (NCT03367403) was a phase 2 study of 272 individuals with early symptomatic Alzheimer’s disease (AD) with elevated amyloid plaque levels and intermediate tau levels on positron-emission tomography (PET). In TRAILBLAZER-ALZ, donanemab resulted in a 32% slowing of disease progression at 76 weeks on the Integrated Alzheimer’s disease Rating Scale (iADRS, composite measure of cognition and function) with a reduction of 85 centiloids in amyloid plaque level.

Objective We present baseline characteristics of TRAILBLAZER-ALZ 2 (NCT04437511), a global phase 3 study designed to assess the treatment effects of donanemab on disease progression in individuals with early symptomatic AD.

Design/Methods TRAILBLAZER-ALZ 2 is a randomized, placebo-controlled, double-blind study with a planned enrolment of ~1500 participants. The study population comprises individuals 60-85 years of age, with mild cognitive impairment or mild dementia due to AD, and the presence of both brain amyloid plaque and tau pathology (intermediate or high level). The primary analysis will test the intermediate tau pathology population. Participants were randomized 1:1 to placebo every 4 weeks (Q4W) or to donanemab 700mg IV Q4W for 3 doses and then 1400mg IV Q4W, with a potential blinded dose reduction to placebo based on amyloid plaque clearance at 24 and 52 weeks. The primary endpoint is change from baseline to 76 weeks on the iADRS; secondary endpoints include changes in other cognitive assessments, amyloid PET, tau PET, and volumetric MRI.

Results Available enrollment and baseline findings will be presented.

Conclusions Available enrollment and baseline findings will be presented.

Authors/Disclosures
Jennifer Zimmer, MD PRESENTER	Dr. Zimmer has received personal compensation for serving as an employee of Eli Lilly & Company. Dr. Zimmer has stock in Eli Lilly & Company.
	No disclosure on file
Cynthia Evans (Eli Lilly & Company)	No disclosure on file
Ming Lu	No disclosure on file
John R. Sims, MD (Eli Lilly)	Dr. Sims has received personal compensation for serving as an employee of Eli Lilly and Company. Dr. Sims has stock in Eli Lilly and Company.
Dawn Brooks (Eli Lilly and Company)	No disclosure on file
Mark A. Mintun, MD	Dr. Mintun has received personal compensation for serving as an employee of Eli Lilly & Co.