A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
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.
Timeline
- Start
- 2023-02-28
- Primary completion
- 2024-05-16
- Completion
- 2027-05
Outcome
Met primary endpoint
paper Modified titration met the 24-week primary outcome with 94% probability of achieving ≥ 20% RRR versus the standard arm. PMID 40172303 ↗
release “today announced positive results from the TRAILBLAZER-ALZ 6 Phase 3b study, showing a reduction in amyloid-related imaging abnormalities with edema/effusion (ARIA-E) at the 24-week primary endpoint” lilly.com ↗
release “The results at 24 weeks showed the once-monthly modified titration described below met the predefined study success criteria” lilly.com ↗
Publications
- Wang H, Nery ESM, Ardayfio P, Khanna R, Svaldi DO, Shcherbinin S, Xu W, Andersen SW, Hauck PM, Brooks DA, Collins EC, Salloway S, Mintun MA, Sims JR. The effect of modified donanemab titration on amyloid-related imaging abnormalities with edema/effusions and amyloid reduction: 18-month results from TRAILBLAZER-ALZ 6. J Prev Alzheimers Dis. 2025 Sep;12(8):100266. doi: 10.1016/j.tjpad.2025.100266. Epub 2025 Jul 5.
- Wang H, Serap Monkul Nery E, Ardayfio P, Khanna R, Otero Svaldi D, Gueorguieva I, Shcherbinin S, Andersen SW, Hauck PM, Engle SE, Brooks DA, Collins EC, Fox NC, Greenberg SM, Salloway S, Mintun MA, Sims JR. Modified titration of donanemab reduces ARIA risk and maintains amyloid reduction. Alzheimers Dement. 2025 Apr;21(4):e70062. doi: 10.1002/alz.70062.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Donanemab | Monoclonal antibody | 1400 mg | Intravenous |
| Background | Dexamethasone | Small molecule | — | Intravenous |