ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease
NCT ID: NCT03671889
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2018-09-28
2030-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
DEVICE_FEASIBILITY
NONE
Study Groups
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Blood Brain Barrier (BBB) Disruption
ExAblate Model 4000 Type 2.0 System
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
50 Years
85 Years
ALL
No
Sponsors
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InSightec
INDUSTRY
Responsible Party
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Locations
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Delray Medical Center & Florida Atlantic University
Delray Beach, Florida, United States
Broward Health Medical Center & The University of Florida
Fort Lauderdale, Florida, United States
University of Florida Health Shands
Gainesville, Florida, United States
Baptist Health South Florida & Florida International University
Miami, Florida, United States
Advent Health
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Weill Cornell Medicine
New York, New York, United States
The Ohio State University -Wexner Medical Center
Columbus, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
West Virginia University Rockefeller Neuroscience Center
Morgantown, West Virginia, United States
Countries
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Facility Contacts
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References
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Mehta RI, Carpenter JS, Mehta RI, Haut MW, Wang P, Ranjan M, Najib U, D'Haese PF, Rezai AR. Ultrasound-mediated blood-brain barrier opening uncovers an intracerebral perivenous fluid network in persons with Alzheimer's disease. Fluids Barriers CNS. 2023 Jun 16;20(1):46. doi: 10.1186/s12987-023-00447-y.
Rezai AR, Ranjan M, Haut MW, Carpenter J, D'Haese PF, Mehta RI, Najib U, Wang P, Claassen DO, Chazen JL, Krishna V, Deib G, Zibly Z, Hodder SL, Wilhelmsen KC, Finomore V, Konrad PE, Kaplitt M; Alzheimer's Disease Neuroimaging Initiative. Focused ultrasound-mediated blood-brain barrier opening in Alzheimer's disease: long-term safety, imaging, and cognitive outcomes. J Neurosurg. 2022 Nov 4;139(1):275-283. doi: 10.3171/2022.9.JNS221565. Print 2023 Jul 1.
Mathew AS, Gorick CM, Price RJ. Multiple regression analysis of a comprehensive transcriptomic data assembly elucidates mechanically- and biochemically-driven responses to focused ultrasound blood-brain barrier disruption. Theranostics. 2021 Oct 11;11(20):9847-9858. doi: 10.7150/thno.65064. eCollection 2021.
Mehta RI, Carpenter JS, Mehta RI, Haut MW, Ranjan M, Najib U, Lockman P, Wang P, D'haese PF, Rezai AR. Blood-Brain Barrier Opening with MRI-guided Focused Ultrasound Elicits Meningeal Venous Permeability in Humans with Early Alzheimer Disease. Radiology. 2021 Mar;298(3):654-662. doi: 10.1148/radiol.2021200643. Epub 2021 Jan 5.
Other Identifiers
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AL002
Identifier Type: -
Identifier Source: org_study_id
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