Trials / Recruiting
RecruitingNCT07169578
A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 50 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Trontinemab | Participants will receive IV trontinemab. |
| OTHER | Placebo | Participants will receive IV placebo. |
Timeline
- Start date
- 2025-09-17
- Primary completion
- 2028-06-07
- Completion
- 2028-06-07
- First posted
- 2025-09-12
- Last updated
- 2026-04-03
Locations
134 sites across 12 countries: United States, Brazil, Canada, China, France, Germany, Italy, Japan, Poland, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07169578. Inclusion in this directory is not an endorsement.