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Clinical Trials in the USA / NCT03671889
Recruiting Not applicable

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

NCT03671889 · tracked via the Priya Life Science USA tracker
Sponsor
InSightec
Phase
Not applicable
Started
2018-09-28
Last updated
2026-01-09

Condition(s) studied

Alzheimer Disease

Investigational drug(s) / intervention(s)

Blood Brain Barrier (BBB) Disruption

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.

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).

Eligibility

Sex
ALL
Min age
50 Years
Max age
85 Years
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: 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

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Delray Medical Center & Florida Atlantic University Delray Beach Florida Recruiting
Broward Health Medical Center & The University of Florida Fort Lauderdale Florida Recruiting
University of Florida Health Shands Gainesville Florida Recruiting
Baptist Health South Florida & Florida International University Miami Florida Recruiting
Advent Health Orlando Florida Recruiting
Tampa General Hospital Tampa Florida Recruiting
Weill Cornell Medicine New York New York Active Not Recruiting
The Ohio State University -Wexner Medical Center Columbus Ohio Active Not Recruiting
University of Texas Southwestern Medical Center Dallas Texas Active Not Recruiting
West Virginia University Rockefeller Neuroscience Center Morgantown West Virginia Active Not Recruiting

More InSightec trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03671889 on ClinicalTrials.gov ↗ ← All trials in the USA