NCT02253043Unknown不适用
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog)
研究概览
简要总结
Purpose: The purpose of this clinical study is to verify the long term effectiveness and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with cognitive, behavioral, and functional disability of Alzheimer's disease.
详细描述
Other: Deep Brain Stimulation Implanted device Subjects will then be instructed to apply PINS Deep Brain Stimulation Device for 12 month.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is aged 40 to 80 years old;
- •Subject with AD diagnosed according to the criteria for probable AD as defined by the National Institute of Neurological Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA);
- •Subject have received the diagnosis of AD within the past 2 years;
- •Subject have a CDR of 0.5 or 1.0;
- •Score between 20 and 28 on the Mini Mental State Examination
- •have been taking a stable dose of cholinesterase inhibitors for a minimum of 6 months.
排除标准
- •Patients with hearing impairment;
- •Failures of important organs and in severe conditions
- •Be reluctant or disabled to receive neuropsychological assessments;
- •Participate in other clinical trial;
- •Has a life expectancy of < 1 year.
- •The investigator and/or enrollment review committee, would preclude participation in the study.
结局指标
主要结局
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog)
时间窗: 12 month
Change from Baseline
次要结局
- Clinical Dementia Rating Scale(12 month)
研究者
研究点 (2)
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