Trials / Active Not Recruiting
Active Not RecruitingNCT05026866
A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)
A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,996 (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 55 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Donanemab | Administered intravenously |
| DRUG | Placebo | Administered intravenously |
Timeline
- Start date
- 2021-08-27
- Primary completion
- 2027-11-01
- Completion
- 2027-11-01
- First posted
- 2021-08-30
- Last updated
- 2026-01-21
Locations
216 sites across 3 countries: United States, Japan, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05026866. Inclusion in this directory is not an endorsement.