A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)

Phase 4

Completed

• Conditions: Dementia, Lewy Body; Lewy Body Disease
• Interventions: Drug: E2020; Drug: Placebo

• Registration Number: NCT02345213
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The purpose of this study is to confirm the efficacy of Aricept in patients with dementia with Lewy bodies (DLB).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-19
• Study First Posted: 2015-01-26
• Study Start: 2015-03-01
• Primary Completion: 2017-05-15
• Status Verified: 2017-12
• Study Completion: 2018-03-26
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E2020	E2020	Treatment period: Weeks 1-2 E2020 3 mg, Weeks 3-6 E2020 5 mg, Weeks 7-12 E2020 10 mg. Extension period: Weeks 1-6 E2020 10 mg, After Week 7 up to week 60 E2020 10 mg.
Placebo	Placebo	Treatment period: Weeks 1-12 placebo Extension period: Weeks 1-2 E2020 3 mg, Weeks 3-6 E2020 5 mg, After Week 7 up to week 60 E2020 10 mg.

Primary Outcome Measures

Name	Time	Method
Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus)	Up to 12 weeks	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".