A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

• Status: Recruiting
• Trial end date: 2023-12-19
• Target enrollment: 0
• Participant gender: All

Summary

The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease.

Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Contraindication to MRI or PET scans

• Current treatment with immunoglobulin G (IgG) therapy