Recruiting

ExAblate

Sponsor:

InSightec

Code:

NCT03671889

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Blood Brain Barrier (BBB) Disruption

Study Details

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).

Conditions

Alzheimer Disease

Study ID

NCT03671889

Start date

Sep 28, 2018

Status verified date

Jan, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Blood Brain Barrier (BBB) Disruption

ExAblate Model 4000 Type 2.0 System

Interventions

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.

Primary outcome measure

  • Device and procedure related adverse events [ Time Frame: 5 years ]

Central Contacts and Locations

Locations

Delray Medical Center & Florida Atlantic University

Recruiting

Delray Beach, Florida, United States, 33484

Contacts

Principal Investigator:

Lloyd Zucker, MD, FAANS

Broward Health Medical Center & The University of Florida

Recruiting

Fort Lauderdale, Florida, United States, 33316

Contacts

Principal Investigator:

Shaye Moskowitz, MD PhD

University of Florida Health Shands

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Principal Investigator:

Justin Hilliard, MD

Baptist Health South Florida & Florida International University

Recruiting

Miami, Florida, United States, 33176

Contacts

Principal Investigator:

Michael W. McDermott, MD

Advent Health

Recruiting

Orlando, Florida, United States, 34747

Contacts

Principal Investigator:

Valeria Baldivieso, MD

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33612

Contacts

Shalini Raj Nampally

8138218513snampally@tgh.org

Principal Investigator:

Yarema Bezchlibnyk, MD

More Information

Sponsor

InSightec

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by InSightec on 2026-01-09.