Blood Brain Barrier (BBB) Disruption: Focal Ultrasound (FUS) involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct targets to induce BBB disruption.
Study 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).
Eligibility
Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
1. Male or Female between 50-85 years of age
2. Probable Alzheimer's Disease (AD)
3. 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
4. Able to communicate sensations during the ExAblate MRgFUS procedure
5. Ambulatory
Exclusion Criteria:
1. MRI Findings
2. Presence of unknown or MR unsafe devices anywhere in the body
3. Significant cardiac disease or unstable hemodynamic status
4. Relative contraindications to ultrasound contrast agent or PET amyloid tracer
5. History of a bleeding disorder
6. History of liver disease
7. Known cerebral or systemic vasculopathy
8. Significant depression and at potential risk of suicide
9. Any contraindications to MRI scanning
10. Any contraindication to lumbar puncture for collection of cerebral spinal fluid
11. Untreated, uncontrolled sleep apnea
12. History of seizure disorder or epilepsy
13. Severely Impaired renal function
14. 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
15. Chronic pulmonary disorders
16. Positive human immunodeficiency virus (HIV)
17. Known apolipoprotein E allele (ApoE4) homozygosity
Primary outcome measure(s)
Device and procedure related adverse events — 5 years Rate of adverse events following each treatment through end of study
Trial sites (10)
Facility
City
Region
Status
Delray Medical Center & Florida Atlantic University
Delray Beach
Florida
Recruiting
Broward Health Medical Center & The University of Florida
Fort Lauderdale
Florida
Recruiting
University of Florida Health Shands
Gainesville
Florida
Recruiting
Baptist Health South Florida & Florida International University
Miami
Florida
Recruiting
Advent Health
Orlando
Florida
Recruiting
Tampa General Hospital
Tampa
Florida
Recruiting
Weill Cornell Medicine
New York
New York
Active Not Recruiting
The Ohio State University -Wexner Medical Center
Columbus
Ohio
Active Not Recruiting
University of Texas Southwestern Medical Center
Dallas
Texas
Active Not Recruiting
West Virginia University Rockefeller Neuroscience Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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