drugset / Trial / NCT05108922
A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)
RandomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to compare donanemab to aducanumab on brain amyloid plaque clearance in participants with early symptomatic Alzheimer's Disease (AD).
Timeline
- Start
- 2021-11-16
- Primary completion
- 2022-09-09
- Completion
- 2023-09-19
Outcome
Met primary endpoint
registry analysis (superiority test); Aducanumab vs Donanemab; p <0.001; Odds Ratio (OR) 29.26 (95% CI 5.30 to 100.0); Regression, Logistic NCT05108922 ↗
registry analysis (superiority test); Aducanumab vs Donanemab; p = 0.008; Odds Ratio (OR) 15.18 (95% CI 2.04 to 100.0); Regression, Logistic NCT05108922 ↗
release “donanemab met all primary and secondary endpoints for the 6-month primary outcome analysis in the Phase 3 TRAILBLAZER-ALZ 4 study” lilly.com ↗
Publications
- Ardayfio P, Mullins GR, Khanna R, Zimmer JA, Wang H, Nery ESM, Evans CD, Piela P, Battioui C, Lauzon S, Anglin G, Ng HW, Jayaraman AR, Agada N, Natalie CR, Brooks DA, Sims JR. Infusion-related reactions in donanemab-treated participants with early symptomatic Alzheimer's disease. Alzheimers Dement (N Y). 2026 Mar 8;12(1):e70229. doi: 10.1002/trc2.70229. eCollection 2026 Jan-Mar.
- Salloway S, Pain A, Lee E, Papka M, Ferguson MB, Wang H, Hu H, Lu M, Oru E, Ardayfio PA, Hoban DB, Collins EC, Brooks DA, Sims JR. TRAILBLAZER-ALZ 4: A phase 3 trial comparing donanemab with aducanumab on amyloid plaque clearance in early, symptomatic Alzheimer's disease. Alzheimers Dement. 2025 May;21(5):e70293. doi: 10.1002/alz.70293.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aducanumab | Monoclonal antibody | — | Intravenous |
| Subject | Donanemab | Monoclonal antibody | 1400 mg | Intravenous |