- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02448784
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).
July 10, 2018 updated by: Eisai Co., Ltd.
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.
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
591
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Naive participants diagnosed as Dementia with Lewy bodies and administrated Aricept (donepezil hydrochloride)
Description
Inclusion Criteria:
1. Naive participants diagnosed as DLB
Exclusion Criteria:
- Participants with a history of donepezil hydrochloride product administration in the past
- Participants who have already been registered in this surveillance
- Participants with a history of hypersensitivity to any ingredients of donepezil hydrochloride or piperidine derivatives
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Participants with DLB
Participants with DLB who will receive donepezil hydrochloride per approved label.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean Mini-Mental State Examination (MMSE) score
Time Frame: At Week 12
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At Week 12
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Mean Mini-Mental State Examination (MMSE) score
Time Frame: At Week 24
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At Week 24
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Mean Mini-Mental State Examination (MMSE) score
Time Frame: At Week 52
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At Week 52
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Mean Revised Hasegawa's Dementia Scale (HDS-R) score
Time Frame: At Week 12
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At Week 12
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Mean Revised Hasegawa's Dementia Scale (HDS-R) score
Time Frame: At Week 24
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At Week 24
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Mean Revised Hasegawa's Dementia Scale (HDS-R) score
Time Frame: At Week 52
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At Week 52
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Number of participants with adverse events (AEs) /adverse drug reactions (ADRs)
Time Frame: From Week 0 to Week 52
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From Week 0 to Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kazuhiro Omata, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
- Study Director: Syoya Yamakawa, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2015
Primary Completion (Actual)
March 30, 2017
Study Completion (Actual)
March 30, 2017
Study Registration Dates
First Submitted
May 14, 2015
First Submitted That Met QC Criteria
May 15, 2015
First Posted (Estimate)
May 19, 2015
Study Record Updates
Last Update Posted (Actual)
July 11, 2018
Last Update Submitted That Met QC Criteria
July 10, 2018
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Dementia
- Lewy Body Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- ART09T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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