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

Sponsor
InSightec (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03671889
Collaborator
(none)
30
Enrollment
7
Locations
1
Arm
74.1
Anticipated Duration (Months)
4.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Device: Blood Brain Barrier (BBB) Disruption
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
Subjects who meet study eligibility will undergo treatment procedures in groups by staged volumes.Subjects who meet study eligibility will undergo treatment procedures in groups by staged volumes.
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Assessment of Safety and Efficacy of ExAblate Blood-Brain Barrier Disruption for the Treatment of Patients With Probable Alzheimer's Disease
Actual Study Start Date :
Sep 28, 2018
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Blood Brain Barrier (BBB) Disruption

ExAblate Model 4000 Type 2.0 System

Device: 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.
Other Names:
  • ExAblate Neuro

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Device and procedure related adverse events [5 years]

      Rate of adverse events following each treatment through end of study

    Other Outcome Measures

    1. BBB Disruption and Closure [Immediately after the end of each ExAblate treatment and 24 hours post treatment]

      MR images post-procedure to verify that the BBB was disrupted and subsequently closed within 24 hours.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Delray Medical Center & Florida Atlantic University Delray Beach Florida United States 33484
    2 Broward Health Medical Center & The University of Florida Fort Lauderdale Florida United States 33316
    3 Baptist Health South Florida & Florida International University Miami Florida United States 33176
    4 Weill Cornell Medicine New York New York United States 10065
    5 The Ohio State University -Wexner Medical Center Columbus Ohio United States 43210
    6 University of Texas Southwestern Medical Center Dallas Texas United States 75390
    7 West Virginia University Rockefeller Neuroscience Center Morgantown West Virginia United States 26506

    Sponsors and Collaborators

    • InSightec

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    InSightec
    ClinicalTrials.gov Identifier:
    NCT03671889
    Other Study ID Numbers:
    • AL002
    First Posted:
    Sep 14, 2018
    Last Update Posted:
    Jul 13, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by InSightec
    Alzheimer Disease
    Alzheimer Syndrome
    Magnetic Resonance guided Focal Ultrasound (MRgFUS)
    Blood-Brain Barrier
    ExAblate
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Jul 13, 2022