A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)
NCT ID: NCT02345213
Last Updated: 2019-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
160 participants
INTERVENTIONAL
2015-03-01
2018-03-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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E2020
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
E2020 tablets will be orally administered once daily after breakfast
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.
Placebo
Matching placebo tablets will be orally administered once daily after breakfast
Interventions
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E2020
E2020 tablets will be orally administered once daily after breakfast
Placebo
Matching placebo tablets will be orally administered once daily after breakfast
Eligibility Criteria
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Inclusion Criteria
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
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
50 Years
99 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Megumi Ohdake
Role: STUDY_DIRECTOR
Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
Locations
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Saitama, , Japan
Countries
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Other Identifiers
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E2020-J081-419
Identifier Type: -
Identifier Source: org_study_id
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