A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Proof-of-Concept, Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease

Eisai Clinical Trials

A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Proof-of-Concept, Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Subjects With Mild Cognitive Impairment Due to Alzheimer’s Disease (Prodromal Alzheimer’s Disease) and Mild to Moderate Dementia Due to Alzheimer’s Disease

Protocol # E2609-G000-202

Study Overview

Study Compound: E2609

Drug Name: elenbecestat

Registry #: NCT02322021

Trial Period: Nov 2014 - Dec 2019

Indication: Alzheimer's disease

Primary Endpoint:
1. Core Phase: Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to 21 months]

2. Core Phase: Number of Participants With Serious Adverse Events (SAEs) [Time Frame: Up to 21 months]

3. Core Phase: Number of Participants With Treatment Emergent Markedly Abnormal Laboratory Safety Test Values [Time Frame: Up to 21 months]

Population
Males and females 50 Years to 85 Years (Adult, Older Adult)
Study Status
Terminated
Study Phase
Phase 2
Countries
United States

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

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