Remote Ischemic Conditioning of the Human Brain in Dementia Patients (RICBDE): Protocol for a Crossover Non-pharmaceutical Intervention Study
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 主要终点
- Measurements to Assess General Cognitive Function
研究概览
简要总结
The study investigates the incidence of remote ischemic conditioning in mild cognitive impairment and dementia patients
详细描述
The investigators will study the potential neuroprotection of ischemia/reperfusion (I/R) of a peripheral organ or tissue against cerebral I/R injury in people with mild cognitive impairment as well as early and middle stage dementia.
This crossover study will be held with individuals suffering from peripheral arteriopathy that can cause intermittent claudication after structured exercise, thus inducing extensive transient leg's ischemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of mild cognitive impairment
- •Clinical diagnosis of mild dementia
- •Clinical diagnosis of moderate dementia
- •Peripheral arteriopathy
排除标准
- •Clinical diagnosis of severe dementia
- •Not being able to follow the exercise program for more than two days for any reason
结局指标
主要结局
Measurements to Assess General Cognitive Function
时间窗: Baseline, 1 and 6 months
Change in Mini Mental State Examination (minimum value 10 - maximum value 30, higher scores mean a better outcome)
Neuropsychological Assessment
时间窗: Baseline, 1 and 6 months
Change Test (higher scores mean a better outcome)
Changes in Functional Cognitive State
时间窗: Baseline, 1 and 6 months
Global Deterioration Scale (values 1-7, higher scores mean a worse outcome)
次要结局
- NeuroImaging(baseline, 1 month, 6 months)
- Electroencephalography recording(Baseline, 1 month, 6 months)
- Neurophysiology(Baseline, 1 month, 12 months)
研究者
Magda Tsolaki
Professor
Aristotle University Of Thessaloniki