A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)

Eisai

Status and phase: Completed; Phase 2

Conditions: Dementia With Lewy Bodies (DLB)

Treatments: Drug: 5 mg Donepezil hydrochloride; Drug: Placebo; Drug: 10 mg Donepezil hydrochloride; Drug: 3 mg Donepezil hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00543855

E2020-J081-431

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of E2020 in patients with Dementia with Lewy Bodies (DLB).

Enrollment: 167 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients diagnosed as probable Dementia With Lewy Bodies (DLB) according to the diagnostic criteria for DLB.

Participants having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with participants 3 days a week (at least 4 hours a day), provide participants' information necessary for this study, assist treatment compliance, and escort participants on required visits to study institution.

Exclusion criteria

Participants with past experience of donepezil (Aricept) therapy at the same study institution.

Participants treated with donepezil in 3 months immediately before starting the observation period.

Participants with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsia, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or experience of brain surgery causing unsolved deficiency.

Participants with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.

Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion

Participants with severe extrapyramidal disorders (Hoehn & Yahr staging score is ≥IV)

Participants whose systolic blood pressure is <90 mmHg or pulse rate is <50 beats/min.

Participants suspected to have a complication of vascular dementia based upon neurological findings.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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167 participants in 4 patient groups, including a placebo group

3 mg Donepezil hydrochloride

Experimental group

Treatment:

Drug: 3 mg Donepezil hydrochloride

5 mg Donepezil hydrochloride

Experimental group

Treatment:

Drug: 5 mg Donepezil hydrochloride

10 mg Donepezil hydrochloride

Experimental group

Treatment:

Drug: 10 mg Donepezil hydrochloride

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo