Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01129596

Enrollment

10238

Registered

2010-05-24

Start date

2010-06-10

Completion date

2016-06-23

Last updated

2018-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

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.

Interventions

DRUGdonepezil hydrochloride

This is a multicenter, open-labeled, practice-based, post-marketing surveillance study. Therefore, dosing is not specified.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The transition of clinical condition is evaluated comparing the result of HDS-R,MMSE with the time of study initiation	48 months(12 weeks and every 6 months)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026