Eisai Clinical Trials

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

E2020-J081-341

Study Overview

donepezil
NCT01278407
Feb 2011 - Apr 2013
Dementia With Lewy Bodies
1. Change From Baseline in Mini-Mental State Examination (MMSE) Score [ Time Frame: Week 12 for Confirmatory Phase ]

2. Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score [ Time Frame: Week 12 for Confirmatory Phase ]

  • Males and females (age 50 years and over)

  • Completed

  • Phase 3

  • Japan

Results

CSR Synopsis

No download available

Lay Summary

No download available

Publication reference citation

Ikeda M et al. Donepezil for dementia with Lewy bodies: a randomized, placebo-controlled, confirmatory phase III Trial. Alzheimer’s research & therapy 2015; 7.1: 4. DOI: http://dx.doi.org/10.1186/s13195-014-0083-0

Extension study:
Mori E et al. Long-term donepezil use for dementia with Lewy bodies: results from an open-label extension of Phase III trial. Alzheimer’s research & therapy 2015; 7.1: 5. DOI: http://dx.doi.org/10.1186/s13195-014-0081-2

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.

Redacted documents are available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR