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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03671889
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
InSightec

Study Description
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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
Alzheimer Disease Device: Blood Brain Barrier (BBB) Disruption Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : September 28, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: ExAblate Neuro


Outcome Measures
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Primary Outcome Measures :
  1. Device and procedure related adverse events [ Time Frame: 5 years ]
    Rate of adverse events following each treatment through end of study


Other Outcome Measures:
  1. BBB Disruption and Closure [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671889


Locations
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United States, Florida
Delray Medical Center & Florida Atlantic University Recruiting
Delray Beach, Florida, United States, 33484
Contact: Jenny Zucker, MS    561-235-3767    JennyZucker712@gmail.com   
Principal Investigator: Lloyd Zucker, MD, FAANS         
Broward Health Medical Center & The University of Florida Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Celena Bodie    954-786-6736    cbodie@browardhealth.org   
Principal Investigator: Shaye Moskowitz, MD PhD         
Baptist Health South Florida & Florida International University Recruiting
Miami, Florida, United States, 33176
Contact: Margarita Mederos    786-596-1845    Margarita.mederos@BaptistHealth.net   
Principal Investigator: Michael W. McDermott, MD         
United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Rachael Olovyannikov    212-746-7373    rao4005@med.cornell.edu   
Principal Investigator: Michael Kaplitt, M.D., PhD         
United States, Ohio
The Ohio State University -Wexner Medical Center Active, not recruiting
Columbus, Ohio, United States, 43210
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Elaine Most, MS    636-634-0478    elaine.most@utsouthwestern.edu   
Principal Investigator: Bhavya R Shah, MD         
United States, West Virginia
West Virginia University Rockefeller Neuroscience Center Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Kiley Everson, RN, BSN    304-293-9146    kiley.everson@hsc.wvu.edu   
Principal Investigator: Ali R Rezai, MD         
Sponsors and Collaborators
InSightec
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT03671889    
Other Study ID Numbers: AL002
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by InSightec:
Alzheimer Disease
Alzheimer Syndrome
Magnetic Resonance guided Focal Ultrasound (MRgFUS)
Blood-Brain Barrier
ExAblate
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders