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

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

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

Conditions
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Dementia, Lewy Body, Lewy Body Disease

Intervention / Treatment
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* Drug: E2020
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E2020<br>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. | Drug: E2020<br>* E2020 tablets will be orally administered once daily after breakfast<br>|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* Matching placebo tablets will be orally administered once daily after breakfast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DLB, Dementia with Lewy bodies, Lewy Body Disease, Dementia, E2020, Donepezil, Aricept