A Six-month, Open Labeled, Multi-centered, Observational Study for the Tolerability of Exelon Patch (Rivastigmine) for Patients With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 19
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The investigators plan to see what factors can influence the durability of Exelon patch treatment in Korean patients with Alzheimer's disease.
Based on these results, the investigators will find the ways to maximize the effect and durability of Exelon patch on Korean patients with Alzheimer's disease.
After finishing this study, the investigators are going to present the study results at the international and national academic meetings or conferences.
Also the investigators expect that they can publish the result in a journal of in the field of neurology or dementia till the winter of 2010.
详细描述
A once-daily Exelon patch has recently been developed to reduce the GI side effect of rivastigmine and make application easier by once a day.
Thinking the patch as the first-line drug, it should be proven as safe for a long time. The safety and clinical effect of Exelon patch was tested in many studies.
However, most of studies have been conducted on Western countries and the study period was not more than a year.
There are only few data on Exelon patch related to other ethnic such as Asian patients with Alzheimer's disease.
Especially, there are many different environmental factors between Western and Asia countries, such as habitual or climate factors, skin type and behavioral styles which may be influenced on patch durability.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 51 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Probable AD by NINCDS-ADRDA and DSM-IV
- •Male and female aged from 51 to 85 years old
- •Magnetic resonance imaging or computed tomographic scan within 12 months consistent with a diagnosis of probable AD
- •Patients who approved to release of personal information
排除标准
- •Patient with any active pulmonary, gastrointestinal, renal, hepatic (severe hepatic function impaired patients), endocrine, or cardiovascular disease, clinically significant laboratory abnormalities, or any medical condition which would prohibit them from completing the study
- •Any patients suspicious of drug addiction or alcohol addiction for the past 10 years
- •Any other patients to be decided to be inappropriate for the study by the investigators
结局指标
主要结局
Number of participants with adverse events
时间窗: 24 weeks
number of participants with skin irritation or other adverse events
次要结局
- Factors for the disuse of Rivastigmine patch(24 weeks)
研究者
SangYun Kim
Department of Neurology, Seoul National University College of Medicine, Seoul National University Bundang Hospital
Seoul National University Hospital