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

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Donepezil Hydrochloride

• Registration Number: NCT02162264
• Lead Sponsor: Eisai Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-01
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-12
• Primary Completion: 2015-05-30
• Study Completion: 2016-07-22
• Status Verified: 2017-01
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8662

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
E2020	Donepezil Hydrochloride	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Investigations on adverse events and adverse drug reactions	Baseline and Month 12