Phase 2RecruitingAge-related condition
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology
- Sponsor
- Eli Lilly and Company (Industry)
- Enrolment
- 350 planned
- Conditions
- Cognitive Dysfunction; Lewy Body Disease; Synucleinopathies; Amyloid
- Interventions
- Donanemab; Placebo
- Ages
- adults, older adults
- Registry
- NCT07589595
Full record on ClinicalTrials.gov
From the registry
The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.
Primary outcomes
- Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)
History
Primary completion expected
Last registry update
Started
Registered