Investigator Initiated Study: Galantamine CR Potential Enhancement of Attentional and Executive Function in Non-Demented Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Improvement on cognitive measures
研究概览
简要总结
The aim of the study is to determine whether galantamine stabilizes or improves thinking abilities in individuals with Parkinson's disease. Individuals included in the study have minor complaints about thinking such as problems with concentration or memory but do not have dementia. This medication has been shown to have a positive effect on stabilizing memory in individuals with Alzheimer's disease. It is FDA approved for use in elderly individuals with Alzheimer's disease. It is hypothesized that galantamine will stabilize or improve executive and attentional functions in individuals with Parkinson's.
详细描述
While several cholinesterase inhibitors have effectiveness in Alzheimer's disease (AD), galantamine is unique since it has a dual mode of action: inhibition of acetylcholinesterase and modulation of nicotinic acetylcholine receptors.As Parkinson's disease (PD) impacts frontal systems, executive cognition rather than memory function (mediated by medial temporal) would be the targeted area for potential improvement. This single center, double blind, placebo controlled study compares a group of PD patients treated with galantamine to a group of PD patients who are not treated with this medication on a series of cognitive tasks that examine attention and executive control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Idiopathic Parkinson's Disease
排除标准
- •dementia, depression, cardiac disease, gastrointestinal disease
结局指标
主要结局
Improvement on cognitive measures
时间窗: 16 weeks
次要结局
- No worsening of PD symptoms(16 weeks)