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.

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).

Sponsors

Lead sponsor: Eisai Co., Ltd.

Source Eisai Inc.
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.

Overall Status Completed
Start Date April 20, 2015
Completion Date March 30, 2017
Primary Completion Date March 30, 2017
Study Type Observational
Primary Outcome
Measure Time Frame
Mean Mini-Mental State Examination (MMSE) score At Week 12
Mean Mini-Mental State Examination (MMSE) score At Week 24
Mean Mini-Mental State Examination (MMSE) score At Week 52
Mean Revised Hasegawa's Dementia Scale (HDS-R) score At Week 12
Mean Revised Hasegawa's Dementia Scale (HDS-R) score At Week 24
Mean Revised Hasegawa's Dementia Scale (HDS-R) score At Week 52
Secondary Outcome
Measure Time Frame
Number of participants with adverse events (AEs) /adverse drug reactions (ADRs) From Week 0 to Week 52
Enrollment 591
Condition
Intervention

Intervention type: Drug

Intervention name: Donepezil Hydrochloride

Description: 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.

Arm group label: Participants with DLB

Other name: Aricept

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Location
facility
Location Countries

Japan

Verification Date

January 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Participants with DLB

Description: Participants with DLB who will receive donepezil hydrochloride per approved label.

Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov