ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease

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).

Interventions

• Blood Brain Barrier (BBB) Disruption · DEVICE

  Focal Ultrasound (FUS) involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct targets to induce BBB disruption.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (10)

• 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, Morgantown, West Virginia · ACTIVE_NOT_RECRUITING