A Phase IIa Study to Evaluate the Safety and Efficacy of Blood-Brain Barrier (BBB) Opening Using Transcranial MR-Guided Focused Ultrasound in Patients With 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
- 30
- 试验地点
- 2
- 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 open the blood-brain barrier (BBB) in patients with probable Alzheimer's Disease (AD).
详细描述
This study is a prospective, open label, single-arm, non-randomized, phase IIa trial to evaluate the feasibility, safety and efficacy of repeated, BBB opening using the ExAblate® Model 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 a single center in Canada 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
- Single Group
- 主要目的
- Treatment
- 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
结局指标
主要结局
Device and procedure related adverse events
时间窗: 6 months
Rate of adverse events following each treatment through end of study
次要结局
- Change in Alzheimer's Disease Assessment Scale-Cognition(Baseline and 6 months)
- Change in Amyloid Tracer uptake(Baseline and Day 8 following the third treatment)
- BBB Disruption and Closure(Immediately after the end of each ExAblate treatment and 24 hours after each treatment)