Trials / Recruiting
RecruitingNCT05508789
A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,500 (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 60 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.
Detailed description
TRAILBLAZER-ALZ 5 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) and the presence of AD pathology.
Conditions
- Alzheimer Disease
- Dementia
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Tauopathies
- Neurodegenerative Diseases
- Neurocognitive Disorders
- Mental Disorders
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Donanemab | Administered IV |
| DRUG | Placebo | Administered IV |
Timeline
- Start date
- 2022-10-10
- Primary completion
- 2028-05-01
- Completion
- 2028-07-01
- First posted
- 2022-08-19
- Last updated
- 2026-03-27
Locations
141 sites across 8 countries: Argentina, Australia, China, Poland, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05508789. Inclusion in this directory is not an endorsement.