Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Attention Network Effects
研究概览
简要总结
The purpose of this study is to determine the relationship between attention and quality of life and how rivastigmine and atomoxetine alter attention in non-demented persons with Parkinson's disease (PD).
详细描述
Cognitive dysfunction can occur in early stage of Parkinson's disease (PD) and increases as PD progresses. Attention deficits in PD patients with dementia strongly predict the impairment of their daily living activities.
Previous studies have shown that atomoxetine improves PD executive dysfunction and rivastigmine improves attention deficits in PD patients with dementia without worsening the motor symptoms.
The aim of this study is to examine the effect of atomoxetine and rivastigmine on attention and quality of life in PD patients without disabling cognitive impairment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Parkinson's disease
- •Respond to levodopa therapy
排除标准
- •Psychiatric disorders including anxiety disorders, dissociative disorders, mood disorders, schizophrenia and related disorders, or ADD/ADHD
- •Any clinically unstable disease such as cancer, HIV/AIDS, heart condition, liver disease, kidney or renal failure or others that might require hospitalization
- •Evidence for another neurological disease (history of seizures, Alzheimer disease, multiple sclerosis or other movement disorders);
- •Currently using any of the study drugs;
- •Colorblindness
研究组 & 干预措施
Placebo
sugar pill
干预措施: Placebo (Other)
atomoxetine
Strattera 10-30 mg b.i.d.
干预措施: Strattera (Drug)
rivastigimine
Exelon 1.5-4.5 mg b.i.d.
干预措施: Exelon (Drug)
结局指标
主要结局
Attention Network Effects
时间窗: 6 weeks
次要结局
- Depression(6 weeks)
- Daytime Sleepiness(6 weeks)
- Quality of Life(6 weeks)
- Fatigue(6 weeks)
- Stroop Color Word Test(6 weeks)
研究者
Jau-Shin Lou
Associate Professor
Oregon Health and Science University