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

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

Sponsors

Lead sponsor: Eisai Co., Ltd.

Source Eisai Inc.
Brief Summary

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

Overall Status Completed
Start Date March 1, 2015
Completion Date March 26, 2018
Primary Completion Date May 15, 2017
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus) Up to 12 weeks
Enrollment 160
Condition
Intervention

Intervention type: Drug

Intervention name: E2020

Description: E2020 tablets will be orally administered once daily after breakfast

Arm group label: E2020

Intervention type: Drug

Intervention name: Placebo

Description: Matching placebo tablets will be orally administered once daily after breakfast

Arm group label: Placebo

Eligibility

Criteria:

Inclusion Criteria

1. Patients diagnosed with probable DLB according to the diagnostic criteria for DLB

2. Patients having caregivers throughout the study who submit written consent to cooperate with this study, can routinely stay with patients at least 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance, and escort the patients on required visits to study institution

3. Clinical Dementia Rating (CDR) score is greater than or equal to 0.5

4. Mini-Mental State Examination (MMSE) score is greater than or equal to 10 and less than or equal to 26

Exclusion Criteria

1. Patients diagnosed with Parkinson's disease with dementia (PDD)

2. Patients who have received anti-dementia drug therapy within 12 weeks before the start of the observation period

3. Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency

4. Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than or equal to IV)

5. Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/minute at screening test

Gender: All

Minimum age: 50 Years

Maximum age: 99 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Megumi Ohdake Study Director Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
Location
facility
Location Countries

Japan

Verification Date

December 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: E2020

Arm group type: Experimental

Description: 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.

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov