Phase 3Active, not recruiting
A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (Clarity AD)
A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease
- Sponsor
- Eisai Inc. (Industry)
- Enrolment
- 1,906 enrolled
- Conditions
- Early Alzheimer's Disease
- Interventions
- Lecanemab IV; Placebo; Lecanemab SC
- Ages
- adults, older adults
- Registry
- NCT03887455
From the registry
This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase. Extension Phase Part B will continue dosing with lecanemab in countries where lecanemab may not be commercially available.
Primary outcomes
- Core Study: Change from Baseline in the CDR-SB at 18 Months
- Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
- Extension Phase: Change from Core Study Baseline in CDR-SB
- Extension Phase Part B: Number of Participants Exposed to Lecanemab