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ACTIVE NOT RECRUITING
NCT06602258
PHASE2

A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease

Sponsor: Eisai Inc.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2024-09-30

Completion Date

2027-08-18

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

DRUG

E2814

E2814 IV infusion.

DRUG

Lecanemab

Lecanemab SC injection.

DRUG

Placebo

Placebo IV infusion.

Locations (26)

Banner Sun Health Research

Phoenix, Arizona, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Bradenton Research Center

Bradenton, Florida, United States

K2 Medical Research

Clermont, Florida, United States

Advanced Clinical Research Network

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Alzheimer's Research and Treatment Center-Stuart

Stuart, Florida, United States

Axiom Brain Health

Tampa, Florida, United States

Charter Research

The Villages, Florida, United States

Alzheimer's Research and Treatment Center

Wellington, Florida, United States

Columbus Memory Center, PC

Columbus, Georgia, United States

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Washington University School of Medicine

St Louis, Missouri, United States

Abington Neurological Associates LTD

Abington, Pennsylvania, United States

Neurology Clinic, P.C.

Cordova, Tennessee, United States

Kerwin Memory Center

Dallas, Texas, United States

National Clinical Research-Richmond, Inc

Richmond, Virginia, United States

National Center for Geriatrics and Gerontology

Ōbu, Aichi-ken, Japan

National Hospital Organization Hiroshima-Nishi Medical Center

Ōtake, Hiroshima, Japan

Keimei Memorial Hospital

Honjō, Miyazaki, Japan

Rijikai Medical Corporation Katayama Medical Clinic

Kurashiki, Okayama-ken, Japan

Tokyo Medical University Hospital

Shinjuku, Tokyo, Japan

Keio University Hospital

Shinjuku, Tokyo, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Yamagata Tokushukai Hospital

Yamagata, Japan