Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-
The purpose of this study is to investigate the following about donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease in clinical practice: cognitive function, Functional Assessment Staging (FAST) score, adverse events/adverse drug reactions, and patient background.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-|
- The transition of clinical condition is evaluated comparing the result of HDS-R,MMSE with the time of study initiation [ Time Frame: 48 months(12 weeks and every 6 months) ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Drug: donepezil hydrochloride
This is a multicenter, open-labeled, practice-based, post-marketing surveillance study. Therefore, dosing is not specified.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01129596
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|Study Director:||Kenta Sumitomo||Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.|