Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The Global Statistical Test Combined Information on Change From Baseline on a Battery of Standardized Executive Function Tests
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of a drug called atomoxetine for the treatment of cognitive impairment for Parkinson 's disease. Atomoxetine (ATM) is an approved drug currently on the market for the treatment of attention deficit. It works to increase the amount of norepinephrine (a chemical in the brain that helps keep us awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration (FDA) to be used in the treatment of PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of idiopathic PD according to the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria
- •Male or female subjects aged between 35 and 75 years, inclusive at the time of consent
- •Hoehn & Yahr Stage I-IV
- •Diagnosis of PD mild cognitive impairment (MCI), Montreal Cognitive Assessment (MoCa) score 21-25
- •Stable concomitant medications for 60 days
排除标准
- •Secondary parkinsonism or atypical parkinsonism, Prior Deep Brain Stimulation (DBS) or other brain surgery
- •PD Dementia; MoCA score <21
- •Presence of Psychosis, pregnancy, suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) type 4 or 5 in past 3 months.
- •Current treatment with anticholinergics, monoamine oxidase (MAO) inhibitors or neuroleptics (including quetiapine)
- •Serious cardiac abnormalities, Narrow angle glaucoma, Pheochromocytoma, Bipolar Disorder
- •Liver Function Tests (LFTs) >1.5 X upper limit of normal value
研究组 & 干预措施
Atomoxetine
The study drug target dose is Atomoxetine (ATM) 80 milligram (mg) per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily.
干预措施: Atomoxetine (Drug)
Placebo
Patients in the placebo arm will follow the same titration schedule as those in the active arm. Patients will titrate up to target dose by starting 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose to 80mg daily.
干预措施: Placebo (Drug)
结局指标
主要结局
The Global Statistical Test Combined Information on Change From Baseline on a Battery of Standardized Executive Function Tests
时间窗: change from baseline and 10 weeks
Patients were ranked on each outcome and ranks were summed. The mean summed-ranks were compared by treatment group by a global statistical test (GST). Higher scores indicate better performance. The total summed-ranks range from 7 - 210 (7 outcomes x N=30).
次要结局
- Change in D-KEFS: Inhibition-Switching Time(change from baseline and 10 weeks)
- Change in WAIS-IV: Digit Span(change from baseline and 10 weeks)
- Change in PASAT(change from baseline and 10 weeks)
- Change in NAB: Part D(change from baseline and 10 weeks)
- Change in D-KEFS: Number-Letter Switching Time(change from baseline and 10 weeks)
- Change in NAB: Part A(change from baseline and 10 weeks)
- Change in D-KEFS: Inhibition Time(change from baseline and 10 weeks)
研究者
Vanessa Hinson
Director, Movement Disorders Program
Medical University of South Carolina