A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,231
- 主要终点
- Safety and tolerability due to an increase of Aricept in patients with Alzheimer's disease.
研究概览
简要总结
The purpose of the study is for investigation and collection of Aricept safety information with a dose increase on Alzheimer's disease patients.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Aricept Group 1
Subjects starting at 5 mg Aricept and increasing their dose to 10 mg Aricept
干预措施: Aricept (Drug)
Aricept Group 2
Subject starting at 10 mg Aricept and increasing their dose to 23 mg Aricept
干预措施: Aricept (Drug)
结局指标
主要结局
Safety and tolerability due to an increase of Aricept in patients with Alzheimer's disease.
时间窗: 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.
次要结局
未报告次要终点