Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies (DLB).

Eisai Co., Ltd.591 enrolled

Overview

To investigate long term safety (especially about Parkinsonism) and efficacy of donepezil hydrochloride in clinical practice as well as its proper use information in participants with DLB.

Study Type

OBSERVATIONAL

Enrollment

591

Conditions

Dementia With Lewy Body Disease

Interventions

Donepezil HydrochlorideDRUG

Initial dose for oral use is 3 mg once daily. The dose is increased to 5 mg after 1-2 weeks. Following at least 4 weeks of dosing at 5 mg, the dose is increased to 10 mg. The dose may be decreased to 5 mg depending on the symptoms of the participant.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1\. Naive participants diagnosed as DLB Exclusion Criteria: 1. Participants with a history of donepezil hydrochloride product administration in the past 2. Participants who have already been registered in this surveillance 3. Participants with a history of hypersensitivity to any ingredients of donepezil hydrochloride or piperidine derivatives

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

Mean Mini-Mental State Examination (MMSE) score

Time frame: At Week 12

Mean Mini-Mental State Examination (MMSE) score

Time frame: At Week 24

Mean Mini-Mental State Examination (MMSE) score

Time frame: At Week 52

Mean Revised Hasegawa's Dementia Scale (HDS-R) score

Time frame: At Week 12

Mean Revised Hasegawa's Dementia Scale (HDS-R) score

Time frame: At Week 24

Mean Revised Hasegawa's Dementia Scale (HDS-R) score

Time frame: At Week 52

Secondary Outcomes

Number of participants with adverse events (AEs) /adverse drug reactions (ADRs)

Time frame: From Week 0 to Week 52

Data from ClinicalTrials.gov

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