Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Factors That Affect Aricept Medication Persistence Rate and the Safety and Efficacy in Patients With Alzheimer's Disease in Clinical Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02162264

Enrollment

8662

Registered

2014-06-12

Start date

2013-06-01

Completion date

2016-07-22

Last updated

2018-09-07

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

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease, donepezil hydrochloride

Brief summary

To investigate the factors that affect Aricept medication persistence rate and the safety and efficacy in patients with Alzheimer's Disease in clinical practice

Interventions

DRUGDonepezil 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

Patients diagnosed with Alzheimer's Disease and administered Aricept for the first time.

Exclusion criteria

Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.

Design outcomes

Primary

Measure	Time frame
Change From Baseline in the Mini-Mental State Examination (MMSE) Score	Baseline, Month 3, Month 6, and Month 12

Secondary

Measure	Time frame
Investigations on adverse events and adverse drug reactions	Baseline and Month 12

Countries

Japan

Outcome results

None listed

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