NCT02166827终止不适用
Effects of a NeuroAD System, for the Treatment of Alzheimer Disease: a Randomized, Double-blinded, Placebo-controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Neuronix Ltd
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Efficacy
研究概览
简要总结
To evaluate the long-term efficacy of the NeuroAD system
详细描述
To evaluate the long-term efficacy of the NeuroAD system in improvement of mild- to moderate Alzheimer patients' cognitive function
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 60-90 years
- •Patients diagnosed with mild or moderate stage of Alzheimer's Disease, according to the DSM-IV criteria
- •MMSE score 18 to 26
- •Physical clearance for study participation as evaluated by the clinician
- •Spouse, family member or professional caregiver agree and capable of taking care for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication)
- •Informed consent by the patient or by legally authorized person if appointed
排除标准
- •CDR 0, 0.5 or 3
- •Severe agitation
- •Mental retardation
- •History of Epileptic Seizures or Epilepsy
- •Contraindication for performing MRI scanning
- •Contraindication for receiving TMS treatment according to a TMS questionnaire
- •Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
- •Cardiac pacemakers
- •Implanted medication pumps
- •Intracardiac lines
- •Significant heart disease
- •Currently taking medication that lower the seizure threshold
结局指标
主要结局
Efficacy
时间窗: 3 Months
Change from Baseline to 3 months in ADAS-Cog score and CGI-C. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive. CGI-C: Clinical Global Impression of Change
次要结局
- Efficacy(9 Months)
研究者
研究点 (2)
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