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)
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 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.
研究组 & 干预措施
DBS of the NbM, power on
干预措施: DBS of the NbM, power on (Device)
Control group
The patients are going to prescribe stable dosage of donepezil during observation period without surgical interference.
DBS of the fornix, power off
干预措施: DBS of the fornix, power off (Device)
DBS of the NbM, power off
干预措施: DBS of the NbM, power off (Device)
DBS of the fornix, power on
干预措施: DBS of the fornix, power on (Device)
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))