Dementia, Lewy Body, Lewy Body Disease
Conditions
Keywords
DLB, Dementia with Lewy bodies, Lewy Body Disease, Dementia, E2020, Donepezil, Aricept
Brief summary
The purpose of this study is to confirm the efficacy of Aricept in patients with dementia with Lewy bodies (DLB).
Interventions
DRUGE2020
E2020 tablets will be orally administered once daily after breakfast
DRUGPlacebo
Matching placebo tablets will be orally administered once daily after breakfast
Sponsors
Eisai Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus) | Up to 12 weeks | 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. |
Countries
Japan
Outcome results
None listed