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

Eisai Clinical Trials

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

Protocol # E2814-G000-202

Study Overview

Study Compound: E2814

Drug Name: N/A

Registry #: NCT06602258, jRCT2031240393

Trial Period: Sep 2024 -

Indication: Alzheimer's disease

Primary Endpoint: 1. Change From Baseline in Cerebrospinal Fluid Microtubule-binding Region-tau-243 (CSF MTBR-tau-243) up to 18 Months [Time Frame: Baseline up to 18 months]

Population
Males and females 50 Years to 80 Years (Adult, Older Adult)
Study Status
Active, not recruiting
Study Phase
Phase 2
Countries
Japan, United States See moreSee less

Clinical Trial Documents

Clinical Study Report Synopsis

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Plain Language Protocol Synopsis (PLPS)

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Plain Language Summary of Results (PLS)

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Publication reference citation

Data Sharing

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CSDR Sharing is not available for this study.

CSDR	Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR