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

Lewy Body Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345213
• Other study ID #: E2020-J081-419
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2015
• Est. completion date: March 26, 2018

Study information

• Verified date: December 2017
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 26, 2018
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Dementia, Lewy Body
• Lewy Body Disease

Intervention

Drug:
• E2020
E2020 tablets will be orally administered once daily after breakfast
• Placebo
Matching placebo tablets will be orally administered once daily after breakfast

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	Up to 12 weeks