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

Eisai

Status and phase: Completed; Phase 4

Conditions: Dementia, Lewy Body; Lewy Body Disease

Treatments: Drug: Placebo; Drug: E2020

Study type: Interventional

Funder types: Industry

Identifiers

NCT02345213

E2020-J081-419

Details and patient eligibility

About

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

Enrollment: 160 patients

Sex: All

Ages: 50 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups, including a placebo group

E2020

Experimental group

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:

Drug: E2020

Placebo

Placebo Comparator group

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.

Treatment:

Drug: Placebo