A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)
Overview
- Phase
- Phase 4
- Intervention
- E2020
- Conditions
- Dementia, Lewy Body
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 160
- Primary Endpoint
- Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to confirm the efficacy of Aricept in patients with dementia with Lewy bodies (DLB).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: E2020
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus)
Time Frame: 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".