Trials / Active Not Recruiting
Active Not RecruitingNCT06602258
A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease
A Phase 2, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Study to Evaluate Safety, Tolerability, and Biomarker Efficacy of E2814 With Concurrent Lecanemab Treatment in Subjects With Early Alzheimer's Disease
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- 50 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to determine the dose response of E2814, when concurrently administered with lecanemab, on the change from baseline at 6 months in cerebrospinal fluid (CSF) microtubule-binding region (MTBR)-tau-243 in participants with early Alzheimer's disease (AD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E2814 | E2814 IV infusion. |
| DRUG | Lecanemab | Lecanemab SC injection. |
| DRUG | Placebo | Placebo IV infusion. |
Timeline
- Start date
- 2024-09-30
- Primary completion
- 2026-12-03
- Completion
- 2027-08-18
- First posted
- 2024-09-19
- Last updated
- 2026-02-11
Locations
26 sites across 2 countries: United States, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06602258. Inclusion in this directory is not an endorsement.