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

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: donepezil hydrochloride

• Registration Number: NCT01251718
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-01
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-02
• Primary Completion: 2015-10-14
• Study Completion: 2016-02-18
• Status Verified: 2017-01
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 894

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Donepezil Hydrochloride	donepezil hydrochloride	-

Primary Outcome Measures

Name	Time	Method
ADAS-Jcog (test of cognitive function)	36 month (12 weeks and every 6 months)

Secondary Outcome Measures

Name	Time	Method
Adverse events/adverse drug reactions	36 months