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).

Completed

• Conditions: Dementia With Lewy Body Disease
• Interventions: Drug: Donepezil Hydrochloride

• Registration Number: NCT02448784
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-20
• Study First Submitted: 2015-05-14
• Study First Submitted QC: 2015-05-15
• Study First Posted: 2015-05-19
• Status Verified: 2017-01
• Primary Completion: 2017-03-30
• Study Completion: 2017-03-30
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 591

Inclusion Criteria

1. Naive participants diagnosed as DLB

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with DLB	Donepezil Hydrochloride	Participants with DLB who will receive donepezil hydrochloride per approved label.

Primary Outcome Measures

Name	Time	Method
Mean Mini-Mental State Examination (MMSE) score	At Week 52
Mean Revised Hasegawa's Dementia Scale (HDS-R) score	At Week 52

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs) /adverse drug reactions (ADRs)	From Week 0 to Week 52