This trial is active, not recruiting.

Condition alzheimer's disease
Treatment donepezil hydrochloride
Sponsor Eisai Co., Ltd.
Start date October 2010
End date September 2015
Trial size 1000 participants
Trial identifier NCT01251718, ART06T


To investigate the clinical safety and effectiveness of donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
donepezil hydrochloride
Initial dose of 3 mg orally once daily. After 1-2 weeks, dosage increased to 5 mg orally once daily. After 4 or more weeks, dosage increased to 10 mg orally once daily for patients with severe dementia of Alzheimer's type. Dose reduced appropriately according to patient's symptoms.

Primary Outcomes

ADAS-Jcog (test of cognitive function)
time frame: 36 month (12 weeks and every 6 months)

Secondary Outcomes

Adverse events/adverse drug reactions
time frame: 36 months

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Post-marketing Surveillance of Donepezil Hydrochloride- Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Eisai Inc..