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NCT03671889NARecruiting

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

InSightec

Start Date

9/28/2018

Completion Date

1/1/2030

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.

Eligibility Criteria

Age Range: 50 years to 85 years

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

Interventions

DEVICE

Blood Brain Barrier (BBB) Disruption

Interested in This Trial?

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Conditions

Alzheimer Disease

Locations

Delray Medical Center & Florida Atlantic University

Delray Beach, Florida 33484

United States

Broward Health Medical Center & The University of Florida

Fort Lauderdale, Florida 33316

United States

University of Florida Health Shands

Gainesville, Florida 32608

United States

Baptist Health South Florida & Florida International University

Miami, Florida 33176

United States

Advent Health

Orlando, Florida 34747

United States

Tampa General Hospital

Tampa, Florida 33612

United States

Weill Cornell Medicine

New York, New York 10065

United States

The Ohio State University -Wexner Medical Center

Columbus, Ohio 43210

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

West Virginia University Rockefeller Neuroscience Center

Morgantown, West Virginia 26506

United States