The Effect of Deep Brain Stimulation on Memory Network and Neurological Function of Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)
研究概览
简要总结
Background: Deep brain stimulation (DBS) is used to modulate the activity of dysfunctional brain circuits. The safety and preliminary efficacy of nucleus basalis of Meynert (NBM)-DBS in Alzheimer's disease (AD) is proved in a recent phase 1 clinical trial, yet, the mechanism still unknown.
Objective: 1. To compare the brain structure and functional circuits between a) AD patients with optimal drug treatment (ODT) plus NBM-DBS, b) AD with ODT and c) normal age-and sex-matched control. 2. To evaluate the clinical effectiveness of NBM-DBS in AD patients 60-75 year-old. 3. To evaluate the abnormal functional circuitry response to acute and chronic NBM-DBS in AD.
Methods: A total of 30 subjects (10 subjects of AD with ODT plus NBM-DBS; 10 subjects of AD with ODT and 10 subjects of normal age-and sex-matched subjects) will be enrolled in this prospective, with normal control, Phase II study. Study tools will include clinical rating batteries, structure and functional imaging of magnetic resonance (MR) and positron emission tomography (PET), and electroencephalogram (EEG).
Expected Results: NBM-DBS will be proved to be an safe and effective treatment modality in AD patients 60-75 year-old. Through multi-modal images and EEG analysis, the possible action mechanisms of NBM-DBS on memory circuit will be discussed. The study results may shed a light on this helpless neurodegenerative disease of dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For groups (AD with/ without DBS)
- •Confirmed Alzheimer's dementia diagnosis
- •Regular medications taking for at least 3 months
- •Clinical Dementia Rating: 0.5 - 2
- •Mini Mental Status Examination: ≦ 26
- •Amyloid PET: positive
- •Informed consent signed by patients or families
- •For normal control group
- •No cognitive impairment (Mini Mental Status Examination)
- •Amyloid PET: negative
- •Informed consent signed by patients and families
排除标准
- •For groups (AD with/ without DBS)
- •Structural lesions identified by Magnetic resonance imaging (ex: stroke, brain surgery)
- •Other neurodegenerative/ neuropsychiatric diseases
- •Systemic medical diseases with cognitive impairment (ex: anemia, thyroid disease)
- •Can't have regular follow-up visit
- •For normal control group
- •Structural lesions identified by Magnetic resonance imaging (ex: stroke, brain surgery)
- •Dementia/ neurodegenerative/ neuropsychiatric diseases
- •Systemic medical diseases with cognitive impairment (ex: anemia, thyroid disease)
- •Can't have regular follow-up visit
研究组 & 干预措施
AD with DBS
Alzheimer's disease subjects with optimal medication therapy and with DBS treatment
干预措施: Deep brain stimulation (Device)
AD with DBS
Alzheimer's disease subjects with optimal medication therapy and with DBS treatment
干预措施: Best medical treatment for Alzheimer's disease (Drug)
AD without DBS
Alzheimer's disease subjects with optimal medication therapy and without DBS treatment
干预措施: Best medical treatment for Alzheimer's disease (Drug)
结局指标
主要结局
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)
时间窗: One year
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale; Total scores range from 0-70. Higher scores (≥ 18) indicate worse cognitive function. It consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities.
次要结局
未报告次要终点