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

NCT00543855 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2013-03-08

Study results available
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Summary

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

Conditions

  • Dementia With Lewy Bodies (DLB)

Interventions

DRUG

3 mg Donepezil hydrochloride

Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

DRUG

5 mg Donepezil hydrochloride

Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks). Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).

DRUG

10 mg Donepezil hydrochloride

Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks). Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks). Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks).

DRUG

Placebo

Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Masaki Nakagawa · Neurosciences Clinical Development Section, Japan / Asia Clinical Research, Product Creation Unit, Eisai Product Creation System.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Japan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00543855 on ClinicalTrials.gov