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

Recruiting now · Not applicable

Conditions studied: Alzheimer Disease

In brief

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).

Key facts

Study ID

NCT03671889

Run by

InSightec

People needed

50

Starts

2018-09-28

Expected to finish

2030-01-01

Last updated by the study team

2026-01-09

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Delray Medical Center & Florida Atlantic University — Delray Beach, Florida, United States (enrolling)
• Broward Health Medical Center & The University of Florida — Fort Lauderdale, Florida, United States (enrolling)
• University of Florida Health Shands — Gainesville, Florida, United States (enrolling)
• Baptist Health South Florida & Florida International University — Miami, Florida, United States (enrolling)
• Advent Health — Orlando, Florida, United States (enrolling)
• Tampa General Hospital — Tampa, Florida, United States (enrolling)
• 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

Full record on ClinicalTrials.gov

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