Assessment of Safety and Efficacy of ExAblate Blood-Brain Barrier Disruption for the Treatment of Patients With Probable Alzheimer's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Blood Brain Barrier (BBB) Disruption
- Conditions
- Alzheimer Disease
- Sponsor
- InSightec
- Enrollment
- 50
- Locations
- 19
- Primary Endpoint
- Device and procedure related adverse events
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Blood Brain Barrier (BBB) Disruption
ExAblate Model 4000 Type 2.0 System
Intervention: Blood Brain Barrier (BBB) Disruption
Outcomes
Primary Outcomes
Device and procedure related adverse events
Time Frame: 5 years
Rate of adverse events following each treatment through end of study