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

E2020
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 50 Years and older (Adult, Older Adult)

  • Completed

  • Phase 3

  • Japan

Clinical Trial Documents

Clinical Study Report Synopsis

No download available

Plain Language Protocol Synopsis (PLPS)

No download available

Plain Language Summary of Results (PLS)

No download available

Publication reference citation

Mori E, Ikeda M, Nagai R, Matsuo K, Nakagawa M, Kosaka K. Long-term donepezil use for dementia with Lewy bodies: results from an open-label extension of Phase III trial. Alzheimers Res Ther. 2015 Feb 3;7(1):5. doi: 10.1186/s13195-014-0081-2. eCollection 2015.

Ikeda M, Mori E, Matsuo K, Nakagawa M, Kosaka K. Donepezil for dementia with Lewy bodies: a randomized, placebo-controlled, confirmatory phase III trial. Alzheimers Res Ther. 2015 Feb 3;7(1):4. doi: 10.1186/s13195-014-0083-0. eCollection 2015.

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 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