Eisai Clinical Trials

A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study With an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer’s Disease

E2609-G000-302

Study Overview

E2609
elenbecestat
NCT02956486, EU CTR 2016-004128-42
Dec 2016 - Jan 2020
Alzheimer's disease
1. Core Phase: Change From Baseline up to Month 24 in the Clinical Dementia Rating-sum of Boxes (CDR-SB) Score [ Time Frame: Baseline (Day 1: before first dose in the core phase) up to Month 24 of the core phase ]

2. Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From first dose of study drug up to approximately 6 months (including 1 month follow up) for the extension phase ]

  • Males and females (age 50 years to 85 years)

  • Terminated

  • Phase 3

  • Bulgaria, Czechia, France, Germany, Greece, Japan, Korea, Republic of, Poland, Portugal, Russian Federation, Slovakia (Slovak Republic), Spain, United States See more

Results

CSR Synopsis

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Lay Summary

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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