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

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

Protocol # E2609-G000-301

Study Overview

Study Compound: E2609

Drug Name: elenbecestat

Registry #: NCT02956486, 2016-003928-23

Trial Period: Oct 2016 - Jan 2020

Indication: Alzheimer's disease

Primary Endpoint:
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]

Population
Males and females 50 Years to 85 Years (Adult, Older Adult)
Study Status
Terminated
Study Phase
Phase 3
Countries
Argentina, Australia, Austria, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Mexico, Poland, Portugal, Russian Federation, Singapore, Slovakia (Slovak Republic), South Africa, Spain, Taiwan, United Kingdom, United States See moreSee less

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Bullich S, Mueller A, De Santi S, Koglin N, Krause S, Kaplow J, Kanekiyo M, Roe-Vellve N, Perrotin A, Jovalekic A, Scott D, Gee M, Stephens A, Irizarry M. Evaluation of tau deposition using 18F-PI-2620 PET in MCI and early AD subjects-a MissionAD tau sub-study. Alzheimers Res Ther. 2022 Jul 27;14(1):105. doi: 10.1186/s13195-022-01048-x.

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

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