Effects of Cholinergic Augmentation on Measures of Balance and Gait
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Delta of the Variability of Stride Time While Walking
研究概览
简要总结
This study will compare the effects of placebo and donepezil, a drug that helps conserve concentrations of the neurotransmitter, acetylcholine, on measures of balance and gait in subjects with Parkinson's disease (PD). This study is a double-blind, placebo controlled, cross-over randomized clinical trial. Short-latency afferent inhibition (SAI), a physiological index of cholinergic function will be measured to determine if the deficits in balance and gait correlate with abnormalities of the SAI and if SAI is altered by donepezil as a measure of drug efficacy. Cognitive tests like the Attention Network Test (ANT) will be administered to determine if changes in gait and balance are mediated by changes in attention.
The results of this study will be the most direct test of the hypothesized role of cholinergic neurons and the neurotransmitter, acetylcholine in terms of gait and balance. The study is exploratory because it is not known whether donepezil will affect gait, balance or attention, nor which measures of gait, balance or attention will be sensitive to drug manipulation. The study's immediate goal is to determine the potential utility of cholinergic manipulation as a strategy for preventing or treating balance and gait dysfunction in PD. The findings of this trial are intended to lead to more sharply focused questions about the role of cholinergic neurons in balance and gait and eventually to Phase II B trials to determine clinical utility of cholinergic manipulation to prevent falls and improve mobility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 years old or older
- •Diagnosis of idiopathic Parkinson's disease
- •Stand unassisted (without use of an assistance device) and walk continuously for at least 2 minutes.
排除标准
- •musculoskeletal disorders that affect standing and walking
- •Uncorrected vision disturbance
- •Vestibular problems
- •Major depression
- •Hallucinations or other psychiatric disturbances
- •Tachycardia
- •Bradycardia
- •Arrhythmias
- •Peptic ulcer disease
- •Use of anticholinergics
- •Use of cholinesterase inhibitors
- •Use of bladder antispasmodics
- •Use of tricyclic antidepressants
研究组 & 干预措施
Donepezil
Donepezil 5 mg per day for week 1-3 or 12-14. 10 mg/day for weeks 4-6 or 14-18, if tolerated.
干预措施: Donepezil (Drug)
Placebo
Placebo 5 mg per day for week 1-3 or 12-14. 10 mg/day for weeks 4-6 or 14-18, if tolerated.
干预措施: Donepezil (Drug)
结局指标
主要结局
Delta of the Variability of Stride Time While Walking
时间窗: Six weeks
Variability in stride time time and an increase with dual tasking is another marker for increased fall risk in Parkinson's disease. Stride time variability was measured with inertial sensors attached to both feet. The delta for each phase is reported \[post-donepezil - pre-donepezil for the donepezil phase, and post-placebo - pre-placebo for the placebo phase\].
Delta Medio-lateral Postural Sway Range (Foam)
时间窗: Six weeks
Increased body sway while standing may be markers for increased risk of falling in Parkinson's disease. Sway was measured with an inertial sensor attached to the waist. Participants did this task on a foam pad. We reported the delta in the donepezil and placebo phases \[post-donepezil - pre-donepezil for the donepezil phase, and post-placebo - pre-placebo for the placebo phase\].
次要结局
- Short-latency Afferent Inhibition is a Marker of Cortical Cholinergic Activity(Six weeks)
- Attention Network Test(Six weeks)
研究者
John G. Nutt
M.D.
Oregon Health and Science University