drugset / Trial / NCT05026866

A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)

NCT05026866

Phase 3 Active not recruiting 2996 enrolled Eli Lilly and Company
RandomizedParallel-groupDouble-blindTreatment

Summary

The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD) over up to 332 weeks. Approximately 800 additional participants will be enrolled in the 12-month Addendum 7 to assess safety of a different titration regimen.

Timeline

Start
2021-08-27
Primary completion
2027-11
Completion
2027-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Donanemab Monoclonal antibody Intravenous

Indications