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).
NCT ID: NCT02448784
Last Updated: 2018-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
591 participants
OBSERVATIONAL
2015-04-20
2017-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with DLB
Participants with DLB who will receive donepezil hydrochloride per approved label.
Donepezil 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.
Interventions
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Donepezil 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Kazuhiro Omata
Role: STUDY_DIRECTOR
Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
Syoya Yamakawa
Role: STUDY_DIRECTOR
Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
Locations
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Tokyo, , Japan
Countries
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Other Identifiers
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ART09T
Identifier Type: -
Identifier Source: org_study_id
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