This trial is active, not recruiting.

Condition alzheimer's disease
Treatment donepezil hydrochloride
Phase phase 4
Sponsor Eisai Co., Ltd.
Start date June 2010
End date September 2015
Trial size 10000 participants
Trial identifier NCT01129596, ART05T


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
donepezil hydrochloride
This is a multicenter, open-labeled, practice-based, post-marketing surveillance study. Therefore, dosing is not specified.

Primary Outcomes

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)

Eligibility Criteria

Male or female participants of any age.

Inclusion criteria: Patients diagnosed with Alzheimer's Disease by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Patients diagnosed with mild or moderate Alzheimer's Disease, applicable to FAST score 4 or 5. Exclusion criteria: Patients with history of hypersensitivity to component of Aricept or piperidine derivative. Patients registered for this survey before.

Additional Information

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-
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Eisai Inc..