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

InSightec · NCT03671889

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 50–85 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
50
US sites recruiting
6
Study start
September 28, 2018
Record last updated
January 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Blood Brain Barrier (BBB) Disruption

Conditions: Alzheimer Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Male or Female between 50-85 years of age
  • Probable Alzheimer's Disease (AD)
  • 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
  • Able to communicate sensations during the ExAblate MRgFUS procedure
  • Ambulatory

Exclusion Criteria

  • MRI Findings
  • Presence of unknown or MR unsafe devices anywhere in the body
  • Significant cardiac disease or unstable hemodynamic status
  • Relative contraindications to ultrasound contrast agent or PET amyloid tracer
  • History of a bleeding disorder
  • History of liver disease
  • Known cerebral or systemic vasculopathy
  • Significant depression and at potential risk of suicide
  • Any contraindications to MRI scanning
  • Any contraindication to lumbar puncture for collection of cerebral spinal fluid
  • Untreated, uncontrolled sleep apnea
  • History of seizure disorder or epilepsy
  • Severely Impaired renal function
  • 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
  • Chronic pulmonary disorders
  • Positive human immunodeficiency virus (HIV)
  • Known apolipoprotein E allele (ApoE4) homozygosity

Recruiting US locations

  • Delray Medical Center & Florida Atlantic University

    Delray Beach, FL 33484

    Site contact: Jenny Zucker, MS · 561-825-1505 · JennyZucker712@gmail.com

  • Broward Health Medical Center & The University of Florida

    Fort Lauderdale, FL 33316

    Site contact: Joan Osborne, EdD · 954-355-5563 · BHResearch@browardhealth.org

  • University of Florida Health Shands

    Gainesville, FL 32608

    Site contact: Phuong Deleyrolle · 352-273-5529 · phuong.deleyrolle@neurosurgery.ufl.edu

  • Baptist Health South Florida & Florida International University

    Miami, FL 33176

    Site contact: Margarita Mederos · 786-596-1845 · Margarita.mederos@BaptistHealth.net

  • Advent Health

    Orlando, FL 34747

    Site contact: Bhumi Patel · 407-609-4598 · Bhumi.patel4@AdventHealth.com

  • Tampa General Hospital

    Tampa, FL 33612

    Site contact: Shalini Raj Nampally · 8138218513 · snampally@tgh.org

All neurology studies in Florida →
ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of… (NCT03671889) | Bored Studies