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RecruitingNCT03671889Updated Jan 9, 2026

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

An interventional study of Blood Brain Barrier (BBB) Disruption in Alzheimer Disease, sponsored by InSightec. Recruiting at 10 sites in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by InSightec · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Started Sep 2018; still recruiting 8 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
50 Years to 85 Years
Sex
All
01

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).

Read the 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.

02

Conditions studied

  • Alzheimer Disease

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Keywords

  • Alzheimer Disease
  • Alzheimer Syndrome
  • Magnetic Resonance guided Focal Ultrasound (MRgFUS)
  • Blood-Brain Barrier
  • ExAblate
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 50 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

InSightec is the lead sponsor of 84 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Blood Brain Barrier (BBB) Disruption

    ExAblate Model 4000 Type 2.0 System

    Device: Blood Brain Barrier (BBB) Disruption

Interventions

  • DeviceBlood 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.

    Also known as: ExAblate Neuro

06

What researchers measure

Primary outcomes

  1. Device and procedure related adverse events

    Rate of adverse events following each treatment through end of study

    Time frame: 5 years

Other outcomes

  1. BBB Disruption and Closure

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

    Time frame: Immediately after the end of each ExAblate treatment and 24 hours post treatment

07

Study locations

6 of 10 sites recruiting
  • Delray Medical Center & Florida Atlantic University
    Delray Beach, Florida 33484, United States
    • Jenny Zucker, MS · Contact · JennyZucker712@gmail.com · 561-825-1505
    • Lloyd Zucker, MD, FAANS · Principal investigator
    Recruiting
  • Broward Health Medical Center & The University of Florida
    Fort Lauderdale, Florida 33316, United States
    Recruiting
  • University of Florida Health Shands
    Gainesville, Florida 32608, United States
    Recruiting
  • Baptist Health South Florida & Florida International University
    Miami, Florida 33176, United States
    Recruiting
  • Advent Health
    Orlando, Florida 34747, United States
    Recruiting
  • Tampa General Hospital
    Tampa, Florida 33612, United States
    • Shalini Raj Nampally · Contact · snampally@tgh.org · 8138218513
    • Yarema Bezchlibnyk, MD · Principal investigator
    Recruiting
  • Weill Cornell Medicine
    New York, New York 10065, United States
    Active, not recruiting
  • The Ohio State University -Wexner Medical Center
    Columbus, Ohio 43210, United States
    Active, not recruiting
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
    Active, not recruiting
  • West Virginia University Rockefeller Neuroscience Center
    Morgantown, West Virginia 26506, United States
    Active, not recruiting
08

References and documents

Publications

  • 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. PubMed 37328855 ↗
  • 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. PubMed 36334289 ↗
  • 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. PubMed 34815790 ↗
  • 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. PubMed 33399511 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03671889
Lead sponsor
InSightec
Responsible party
Sponsor
First posted
Sep 14, 2018
Start date
Sep 28, 2018
Primary completion
Jan 2028 (estimated)
Completion
Jan 2030 (estimated)
Last update
Jan 9, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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