A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients

NCT ID: NCT02158910

Last Updated: 2017-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2231 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-06-30

Brief Summary

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The purpose of the study is for investigation and collection of Aricept safety information with a dose increase on Alzheimer's disease patients.

Detailed Description

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This is an observational study to systematically investigate domestic patients with Alzheimer's disease to figure out the safety under a situation of the use of Donepezil HCl 23mg. Additionally, if the dose of Donepezil HCl increase, there is need to examine the safety of Donepezil HCl 23mg in depth for patients with Alzheimer's disease by comparing aspects of occurring adverse events by the type of Donepezil HCl increase.

Conditions

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Alzheimer's Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Aricept Group 1

Subjects starting at 5 mg Aricept and increasing their dose to 10 mg Aricept

Aricept

Intervention Type DRUG

5 mg Aricept increasing dose to 10 mg Aricept, or 10 mg Aricept increasing dose to 23 mg Aricept

Aricept Group 2

Subject starting at 10 mg Aricept and increasing their dose to 23 mg Aricept

Aricept

Intervention Type DRUG

5 mg Aricept increasing dose to 10 mg Aricept, or 10 mg Aricept increasing dose to 23 mg Aricept

Interventions

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Aricept

5 mg Aricept increasing dose to 10 mg Aricept, or 10 mg Aricept increasing dose to 23 mg Aricept

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients who admitted the reading and using of his/her biographical and medical data by word
2. Patients who maintained Aricept dosage for at least 3 months before involved in the study

Exclusion Criteria

1. Hypersensitivity to the active substance or to any of the excipients
2. Breast feeding
3. Pregnancy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Korea Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Busan, , South Korea

Site Status

Chungcheongbuk-do, , South Korea

Site Status

Chungcheongnam-do, , South Korea

Site Status

Daegu, , South Korea

Site Status

Gangwon-do, , South Korea

Site Status

Gwangju, , South Korea

Site Status

Gyeonggji-do, , South Korea

Site Status

Gyeongsangbuk-do, , South Korea

Site Status

Gyeongsangnam-do, , South Korea

Site Status

Jeju-do, , South Korea

Site Status

Jeollabuk-do, , South Korea

Site Status

Jeollanam-do, , South Korea

Site Status

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ART-M082-601

Identifier Type: -

Identifier Source: org_study_id

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