A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients
- Registration Number
- NCT02158910
- Lead Sponsor
- Eisai Korea Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2231
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Aricept Group 1 Aricept Subjects starting at 5 mg Aricept and increasing their dose to 10 mg Aricept Aricept Group 2 Aricept Subject starting at 10 mg Aricept and increasing their dose to 23 mg Aricept
- Primary Outcome Measures
Name Time Method Safety and tolerability due to an increase of Aricept in patients with Alzheimer's disease. Up to 12 Weeks 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.
- Secondary Outcome Measures
Name Time Method