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Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease
Post-marketing Surveillance of Donepezil Hydrochloride- Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease
Lead sponsor
Asset
Donepezil
Listed sites
106
Recruiting sites
-
Enrollment
894
actual
Study population
Alzheimer’s disease
Key I/E criterion
•Age ≥18
Primary endpoint
•ADAS-Jcog
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Patients diagnosed as Alzheimer's Disease by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
Patients diagnosed as mild or moderate Alzheimer's Disease, applicable to Functional Assessment Staging (FAST) score 4 or 5
Exclusion criteria
Patients who used Aricept within 3 months prior to dosing.
Patients registered this survey before.
Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.
Endpoints (2)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
1 endpointADAS-Jcog (test of cognitive function)
Time frame:36 month (12 weeks and every 6 months)
descriptive
Safety / tolerability / PK
1 endpointAdverse events/adverse drug reactions
Time frame:36 months
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.