Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
125 participants
INTERVENTIONAL
2013-09-30
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intensive adherence instruction
Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure
Intensive adherence instruction
Instruction with educational brochure
Control
The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.
Control
Instruction as per usual practice
Interventions
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Intensive adherence instruction
Instruction with educational brochure
Control
Instruction as per usual practice
Eligibility Criteria
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Inclusion Criteria
* Written informed consent will be obtained from subject (if possible) or from the subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities.
* Patients having caregivers who submit written consent for cooperative involvement in this study, can provide patients' information necessary for this study, assist treatment compliance, and escort patients on required visits to study institution.
* Outpatients in their own home.
Exclusion Criteria
* Known hypersensitivity to donepezil or piperidine derivatives.
* Involvement in any other investigational drug clinical trail during the preceding 12 weeks.
ALL
No
Sponsors
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Mirai Iryo Research Center, Inc.
OTHER
Responsible Party
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Tetsumasa Kamei
Hospital Director
Principal Investigators
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Tetsumasa Kamei
Role: PRINCIPAL_INVESTIGATOR
Shonan Fujisawa Tokushukai Hospital
Locations
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Shonan Fujisawa Tokushukai Hospital
Fujisawa, Kanagawa, Japan
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ART-2013-01
Identifier Type: -
Identifier Source: org_study_id
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