Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease

NCT01251718 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 894

Last updated 2023-07-24

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Shoya Yamakawa · Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-01
Primary Completion
2015-10-14
Completion
2016-02-18

Countries

  • Japan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01251718 on ClinicalTrials.gov