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

Last updated: October 4, 2024
Sponsor: InSightec
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Blood Brain Barrier (BBB) Disruption

Clinical Study ID

NCT03671889
AL002
  • Ages 50-85
  • All Genders

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 Criteria

Inclusion

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

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-approveduse 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

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Blood Brain Barrier (BBB) Disruption
Phase:
Study Start date:
September 28, 2018
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Delray Medical Center & Florida Atlantic University

    Delray Beach, Florida 33484
    United States

    Active - Recruiting

  • Broward Health Medical Center & The University of Florida

    Fort Lauderdale, Florida 33316
    United States

    Active - Recruiting

  • Univerisyt of Florida Health Shands

    Gainesville, Florida 32608
    United States

    Active - Recruiting

  • University of Florida Health Shands

    Gainesville, Florida 32608
    United States

    Active - Recruiting

  • Baptist Health South Florida & Florida International University

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Advent Health

    Orlando, Florida 34747
    United States

    Active - Recruiting

  • Tampa General Hospital

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Site Not Available

  • The Ohio State University -Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • West Virginia University Rockefeller Neuroscience Center

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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