NCT04437511 · Phase 3 · ACTIVE NOT RECRUITING
A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
This Phase 3 trial tested donanemab, an anti-amyloid antibody drug, against placebo in people with early Alzheimer's disease. Researchers measured how well it slowed cognitive and functional decline. Phase 3 means this was a large, late-stage test of effectiveness and safety before any regulatory approval decision. An open-label safety cohort and a 3-year follow-up extension were also added after the main study.
You may qualify if
- Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
- MMSE score of 20 to 28 (inclusive) at baseline
- Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort
- Meet 18F florbetapir PET scan (central read) criteria
- Have a study partner who will provide written informed consent to participate
You're excluded if
- Contraindication to MRI or PET scans
- Current treatment with immunoglobulin G (IgG) therapy
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-08-29