A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)
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|ClinicalTrials.gov Identifier: NCT02345213|
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : January 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dementia, Lewy Body Lewy Body Disease||Drug: E2020 Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)|
|Actual Study Start Date :||March 1, 2015|
|Actual Primary Completion Date :||May 15, 2017|
|Actual Study Completion Date :||March 26, 2018|
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.
E2020 tablets will be orally administered once daily after breakfast
Placebo Comparator: 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.
Matching placebo tablets will be orally administered once daily after breakfast
- 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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345213
|Study Director:||Megumi Ohdake||Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.|