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

Description

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).

Conditions

Alzheimer Disease

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Study Overview

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Study Details

Study overview

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).

Assessment of Safety and Efficacy of ExAblate Blood-Brain Barrier Disruption for the Treatment of Patients With Probable Alzheimer's Disease

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

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

Delray Beach

Delray Medical Center & Florida Atlantic University, Delray Beach, Florida, United States, 33484

Fort Lauderdale

Broward Health Medical Center & The University of Florida, Fort Lauderdale, Florida, United States, 33316

Gainesville

University of Florida Health Shands, Gainesville, Florida, United States, 32608

Miami

Baptist Health South Florida & Florida International University, Miami, Florida, United States, 33176

Orlando

Advent Health, Orlando, Florida, United States, 34747

Tampa

Tampa General Hospital, Tampa, Florida, United States, 33612

New York

Weill Cornell Medicine, New York, New York, United States, 10065

Columbus

The Ohio State University -Wexner Medical Center, Columbus, Ohio, United States, 43210

Dallas

University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75390

Morgantown

West Virginia University Rockefeller Neuroscience Center, Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

50 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

InSightec,

Study Record Dates

2025-12