Assessment of Safety and Efficacy of ExAblate Blood-Brain Barrier Disruption for the Treatment of Patients With Probable Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- InSightec
- 入组人数
- 50
- 试验地点
- 19
- 主要终点
- Device and procedure related adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the ExAblate Model 4000 Type 2.0 System as a tool to disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).
详细描述
This is a prospective, multi-center, single-arm study to evaluate the safety and efficacy of BBB disruption using the ExAblate Model 4000 Type 2.0 (220 kHz) system. Patients with diagnosis of Probable Alzheimer's Disease may qualify for a clinical trial to have three serial ExAblate BBB disruption procedures in specific areas in the brain. This study will be conducted at up to 8 sites in the United States and will enroll up to 30 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female between 50-85 years of age
- •Probable Alzheimer's Disease (AD)
- •If taking concurrent Alzheimer's medication, has been on the medication for at least 2 months with a stable dose for at least 3 months
- •Able to communicate sensations during the ExAblate MRgFUS procedure
排除标准
- •MRI Findings
- •Presence of unknown or MR unsafe devices anywhere in the body
- •Significant cardiac disease or unstable hemodynamic status
- •Relative contraindications to ultrasound contrast agent or PET amyloid tracer
- •History of a bleeding disorder
- •History of liver disease
- •Known cerebral or systemic vasculopathy
- •Significant depression and at potential risk of suicide
- •Any contraindications to MRI scanning
- •Any contraindication to lumbar puncture for collection of cerebral spinal fluid
- •Untreated, uncontrolled sleep apnea
- •History of seizure disorder or epilepsy
- •Severely Impaired renal function
- •Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research
- •Chronic pulmonary disorders
- •Positive human immunodeficiency virus (HIV)
- •Known apolipoprotein E allele (ApoE4) homozygosity
研究组 & 干预措施
Blood Brain Barrier (BBB) Disruption
ExAblate Model 4000 Type 2.0 System
干预措施: Blood Brain Barrier (BBB) Disruption (Device)
结局指标
主要结局
Device and procedure related adverse events
时间窗: 5 years
Rate of adverse events following each treatment through end of study
次要结局
未报告次要终点