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

Eisai Korea Inc.2,231 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

2,231

Conditions

Alzheimer's Disease

Interventions

AriceptDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (13)

Unnamed facility

Busan, South Korea

Unnamed facility

Chungcheongbuk-do, South Korea

Unnamed facility

Chungcheongnam-do, South Korea

Unnamed facility

Daegu, South Korea

Outcomes

Primary Outcomes

Safety and tolerability due to an increase of Aricept in patients with Alzheimer's disease.

The aspects of adverse events between those who have increased Aricept dosage from 5mg to 10mg and those who have increased Aricept dosage from 10mg to 23mg will be compared. The subjects will be observed at least more than 12 weeks after Aricept administration. The patients who have obtained safety information through a visit after Aricept administration at least once will be selected as the subjects who can be assessed under the status of use.

Time frame: Up to 12 Weeks

Data from ClinicalTrials.gov

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