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

Sex: All

Ages: 60 Years – 85 Years

Healthy volunteers: No

Phase: PHASE3

Enrollment: 1736

Sponsor: Eli Lilly and Company

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. Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up.

Eligibility 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04437511). StuddyBuddy aggregates publicly available trial information.