NCT01256905撤回不适用
Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- EGI netstation software (Electrical Geodesics Inc.) and a custom made software that runs on the Matlab platform (The Mathworks)
研究概览
简要总结
The purpose of this study is to evaluate if a drug commonly used to treat excessive day-time sleepiness, called armodafinil (Nuvigil), is also effective in improving the impairment in the attention commonly reported by patients with more advanced Parkinson's disease (PD) and Lewy body disease (LBD).
详细描述
The main aims of this study are:
- To investigate whether in PDD and DLB th specific disturbances in the basal ganglia thalamocortical network, measured through the Electroencephalography (EEG) frequency analysis, are ameliorated by armodafinil.
Our main hypothesis is that armodafinil can restore the attention and improve cognitive disturbances in PDD and DLB, through a specific effect on striatal-thalamo-cortical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established criteria for diagnosis of PDD (Parkinsons Disease) {Emre M et al. Mov Disord 2007;22:1689-707} and DLB (Lewy Bodies Disease) {McKeith et al. Neurology 2005;65:1863-72}
- •Mini Mental State Examination (MMSE) score between <24; and/or Dementia Rating
- •Scale-2 (DRS-2) score <134;
- •Clinical Assessment of Fluctuation (CAF)>4;
- •Stable anti-parkinsonian medication in the 4 weeks preceding the study
排除标准
- •Use of cognitive enhancers (Donepezil, Rivastigmine, Galantamine, Modafinil, Memantine) in the last 4 weeks:
- •Concomitant use of any medication contraindicated with modafinil/armodafinil; History of alcohol and substances abuse. Use of medications known to alter the normal EEG activity in humans during the study period (i.e. clonazepam) History of psychiatric disorders, other than depression and psychiatric complication of PDD and DLB
研究组 & 干预措施
Armodafinil
Experimental
干预措施: Armodafinil (Drug)
结局指标
主要结局
EGI netstation software (Electrical Geodesics Inc.) and a custom made software that runs on the Matlab platform (The Mathworks)
时间窗: 2 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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