NCT03352739Unknown不适用
A Randomized Controlled Study of 12 Months to Evaluate the Safety and Efficacy of Deep Brain Stimulation(DBS) to the Fornix & Meynert Nucleus(NbM) in Patients With Mild to Moderate Alzheimer's Disease(AD)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Cognitive outcome
研究概览
简要总结
The primary goal of this study is to evaluate the efficacy and safety of the DBS to the fornix/NbM among patients who are diagnosed as AD according to a series of evaluations including cerebrospinal fluid (CSF) biomarkers and molecular imaging examinations; The secondary goal is to compare the efficacy among the two treatment groups of different targets.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with informed consent;
- •45-75 years of age;
- •At least 6 years of education;
- •AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines (McKhann et al., 2011);
- •Clinical Dementia Rating Scale (CDR): 1.0-2.0;
- •Positive findings with amyloid PET imaging;
- •Stable prescription of donepezil (5mg, qd) for at least 3 months, and without any intentions to modify the dosage during the observation period.
排除标准
- •Fazekas scale>2;
- •Neuropsychiatric inventory (NPI) total score ≥10, or any subdomain≥4；
- •Modified Hachinski ischemic score>4；
- •Young Mania Rating Scale>11(Young, Biggs, Ziegler, & Meyer, 1978);
- •Any suicidal tendencies in recent 2 years;
- •Cornell Scale for Depression and Dementia>10;
- •Familial AD;
- •Abnormal brain structural magnetic resonance imaging (MRI) scan, including hydrocephalus, stroke, structural lesions, etc. that would potentially confound the outcome;
- •Surgical history of the central nervous system;
- •Severe cardiovascular/pulmonary disorders.
结局指标
主要结局
Cognitive outcome
时间窗: 12 months (from 1 month to 13 month after implantation)
Cognitive function measured by Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 13-items version). ADAS-cog 13 scale range: 0-80; (Higher value represents a worse outcome)
次要结局
- Neuroplasticity outcome(12 months (from 1 month to 13 month after implantation))
- Cognitive outcome(12 months (from 1 month to 13 month after implantation))
- Safety outcome(12 months (from 1 month to 13 month after implantation))
- Functional outcome(12 months (from 1 month to 13 month after implantation))
研究者
研究点 (2)
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