Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease
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.
Interventions
DRUGAricept
5 mg Aricept increasing dose to 10 mg Aricept, or 10 mg Aricept increasing dose to 23 mg Aricept
Sponsors
Eisai Korea Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed