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).

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02448784

Enrollment

591

Registered

2015-05-19

Start date

2015-04-20

Completion date

2017-03-30

Last updated

2018-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia With Lewy Body Disease

Keywords

Donepezil Hydrochloride, ARICEPT, Dementia, Lewy bodies, Dementia with Lewy bodies, Post-marketing surveillance

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.

Interventions

DRUGDonepezil Hydrochloride

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mean Mini-Mental State Examination (MMSE) score	At Week 12
Mean Revised Hasegawa's Dementia Scale (HDS-R) score	At Week 12

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026