Istradefylline for Parkinson Disease Cognitive Impairment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in executive function - Card Sort test
研究概览
简要总结
The purpose of this research study is to determine whether istradefylline improves cognition in individuals with Parkinson disease with cognitive impairment.
详细描述
Istradefylline has been approved by the U. S. Food and Drug Administration (FDA) to reduce "off" episodes in Parkinson disease. The period when levodopa has a positive effect on Parkinson's symptoms is called on-time. Once the medication stops working, a so called "off" episode starts, where symptoms recur. Usual care for treatment of Parkinson disease with cognitive impairment is use of cognition enhancing medications also called cholinesterase inhibitors. In this study, participants will receive usual care, and in addition, they will be asked to take istradefylline daily for 26 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet criteria for probable Parkinson disease dementia or PD-MCI (mild cognitive impairment)
- •Age greater than 50
- •Hoehn and Yahr stage < 4 in "on" state
- •Currently taking carbidopa/levodopa
- •Antiparkinsonian medications stable for at least 4 weeks prior to baseline visit
- •Cholinesterase inhibitor dose stable for 8 weeks prior to baseline visit
排除标准
- •Meet criteria for dementia with Lewy bodies, including dementia onset prior to or within 1 year of parkinsonism onset
- •Presence of troublesome dyskinesias
- •Pregnancy or possibility of becoming pregnant during the study period.
- •Moderate or severe hepatic impairment
- •dementia too severe to complete study measures or to adhere to medication schedule
研究组 & 干预措施
Usual care plus istradefylline
Participants will receive usual care, and in addition, will be asked to take istradefylline daily for 26 weeks.
干预措施: Istradefylline medication (Drug)
结局指标
主要结局
Change in executive function - Card Sort test
时间窗: Baseline to 26 weeks
Executive function will be assessed using the Card Sort Test from the NIH Toolbox Cognition Battery. Participants will be assessed at baseline, 4 weeks, 14 weeks, and 26 weeks
次要结局
- Change in neurocognitive outcomes(Baseline to 26 weeks)
- Change in recall(Baseline to 26 weeks)
- Change in oral fluency(Baseline to 26 weeks)
- Change in executive function - Trail Making Test(Baseline to 26 weeks)
- Change in cognitive status(Baseline to 26 weeks)
- Change in higher cortical functions(Baseline to 26 weeks)