Clinical Trial

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

Active, Not Recruiting Phase 3

Summary

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA. Approximately 375 additional participants will be enrolled in addendum 2. Addendum 3 includes a subset of participants from the main study to receive a single dose. The study will last approximately 91 weeks and include up to 26 visits in the main study.

Protocol Amendment History 21 amendments

This ClinicalTrials.gov record has been amended 21 times since 2023-02-13; most recent amendment 2026-05-22.

Status change: Recruiting → Active, Not Recruiting 2024-07-23

Status change: Not Yet Recruiting → Recruiting 2023-03-24

Trial Details

NCT Number	NCT05738486
Lead Sponsor	Eli Lilly and Company
Conditions	Alzheimer's Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders
Enrollment	1,175 participants
Start Date	2023-02-28
Primary Completion	2024-05-16 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2026-06-18