Trials / Active Not Recruiting
Active Not RecruitingNCT05738486
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,175 (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 60 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA. Approximately 375 additional participants will be enrolled per addendum. The study will last approximately 91 weeks and include up to 26 visits in the main study.
Conditions
- Alzheimer's Disease
- Dementia
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Neurocognitive Disorders
- Mental Disorders
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Donanemab | Administered IV |
| DRUG | Placebo | Administered IV |
| DRUG | Dexamethasone | Administered IV |
Timeline
- Start date
- 2023-02-28
- Primary completion
- 2024-05-16
- Completion
- 2027-05-01
- First posted
- 2023-02-22
- Last updated
- 2025-11-14
- Results posted
- 2025-11-14
Locations
49 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05738486. Inclusion in this directory is not an endorsement.