A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)

Phase 2

Completed

• Conditions: Dementia With Lewy Bodies (DLB)
• Interventions: Drug: 3 mg Donepezil hydrochloride; Drug: 5 mg Donepezil hydrochloride; Drug: 10 mg Donepezil hydrochloride; Drug: Placebo

• Registration Number: NCT00543855
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of E2020 in patients with Dementia with Lewy Bodies (DLB).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-04
• Study First Submitted QC: 2007-10-12
• Study First Posted: 2007-10-15
• Study Start: 2007-11
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Results First Submitted: 2013-01-16
• Results First Submitted QC: 2013-01-16
• Results First Posted: 2013-02-18
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-05
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 mg Donepezil hydrochloride	3 mg Donepezil hydrochloride	-
5 mg Donepezil hydrochloride	5 mg Donepezil hydrochloride	-
10 mg Donepezil hydrochloride	10 mg Donepezil hydrochloride	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)	Baseline and every 4 weeks up to 12 weeks	MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)	Baseline and every 4 weeks up to 12 weeks	NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from "0" to "120," higher score indicated "worse neuropsychiatric outcomes." Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)	Baseline and week 12	CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from "markedly improved" to "markedly worse". Percentage of participants in each category were reported. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)	Baseline and Week 12	J-ZBI is a Japanese version instrument to measure and assess the level of burden experienced by the principal caregivers of participants with dementia.; ZBI contains 22 items, in which each statement is scored by the caregiver using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total score derived from sub-scores; total ranged from 0-88. Higher scores indicate greater burden. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.