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

Primary Purpose

Dementia, Lewy Body, Lewy Body Disease

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
E2020
Placebo
Sponsored by
Eisai Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia, Lewy Body focused on measuring DLB, Dementia with Lewy bodies, Lewy Body Disease, Dementia, E2020, Donepezil, Aricept

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

E2020

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus)
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".

Secondary Outcome Measures

Full Information

First Posted
January 19, 2015
Last Updated
January 7, 2019
Sponsor
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02345213
Brief Title
A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)
Official Title
A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
May 15, 2017 (Actual)
Study Completion Date
March 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Lewy Body, Lewy Body Disease
Keywords
DLB, Dementia with Lewy bodies, Lewy Body Disease, Dementia, E2020, Donepezil, Aricept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E2020
Arm Type
Experimental
Arm 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 Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
E2020
Intervention Description
E2020 tablets will be orally administered once daily after breakfast
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets will be orally administered once daily after breakfast
Primary Outcome Measure Information:
Title
Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus)
Description
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".
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients diagnosed with probable DLB according to the diagnostic criteria for DLB 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 Clinical Dementia Rating (CDR) score is greater than or equal to 0.5 Mini-Mental State Examination (MMSE) score is greater than or equal to 10 and less than or equal to 26 Exclusion Criteria Patients diagnosed with Parkinson's disease with dementia (PDD) Patients who have received anti-dementia drug therapy within 12 weeks before the start of the observation period 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 Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than or equal to IV) Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/minute at screening test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megumi Ohdake
Organizational Affiliation
Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Saitama
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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