Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease Characterized by Postural Instability and Gait Disturbance
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Positron emission tomography using 18F-flurodeoxyglucose
研究概览
简要总结
Cholinergic deficiency in the brain can be related to gait and balance problems in Parkinson disease (PD). Recent clinical trials suggested a beneficial role of acetylcholinesterase inhibitors (AchEI) on gait in PD. In this study, the investigators are planning to study the influence of AchEI on a brain network for gait and balance in PD. As gait problem is prominent in postural instability and gait disturbance (PIGD) subtype, this study will focus on the patients with PIGD phenotype.
详细描述
PD patients with PIGD subtype will be included.
- Assessment:
- Overall features of PD are assessed by Unified Parkinson Disease Rating Scale (UPDRS). Non-motor features including cognition will be assessed by standard scales. Gait and balance will be assessed by gait analysis system, which measures physiological parameters of gait such as velocity, variability and center of pressure. Positron emission tomography using 18F-fluorodeoxyglucose (FDG PET) will be done to brain activities related to gait and balance.
- Clinical evaluation will be done at the baseline, 4th, 8th and 12th week
- Gait analysis and FDG PET will be done at the baseline and 12th week
- Drug dosage
- For the first 4 weeks, 5 mg/day
- Then, 10 mg/day for 8 weeks
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson disease diagnosed by United Kingdom Parkinson's disease Society Brain Bank Criteria
- •Postural instability and gait disturbance phenotype
- •Hoehn and Yahr stage ≤ 3
- •Mini-Mental status examination ≥ 24
排除标准
- •Significant motor complication affecting daily activities
- •Drugs related to acetylcholine metabolism
研究组 & 干预措施
Donepezil
dosage: 5mg, 10mg frequency: once a day duration: 12 weeks
干预措施: Donepezil (Drug)
Placebos
dosage: 5mg, 10mg frequency: once a day duration: 12 weeks
干预措施: Placebos (Drug)
结局指标
主要结局
Positron emission tomography using 18F-flurodeoxyglucose
时间窗: Metabolic change from Baseline at 12 weeks
次要结局
- Time-Up and Go(Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week)
- Unified Parkinson disease rating scale (UPDRS)(Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week)
- Gait analysis(Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week)
- Montreal Cognitive Assessment(Baseline assessment/ Follow-up assessment at 12th week)
研究者
Tae-Beom Ahn
Professor
Kyung Hee University Hospital