Eisai Clinical Trials

Double-blind Study of E2020 in Patients With Dementia With Lewy Bodies – Phase II

E2020-J081-431

Study Overview

E2020
donepezil
NCT00543855
Nov 2007 - Feb 2010
Dementia With Lewy Bodies
1. Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and every 4 weeks up to 12 weeks ]

2. Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and every 4 weeks up to 12 weeks ]

3. Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and week 12 ]

4. Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and Week 12 ]

  • Males and females (age 50 years and over)

  • Completed

  • Phase 2

  • Japan

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.

Redacted documents are available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR