Actively Recruiting
ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease
Led by InSightec · Updated on 2026-01-09
50
Participants Needed
10
Research Sites
587 weeks
Total Duration
On this page
AI-Summary
What this Trial 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).
CONDITIONS
Official Title
ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Delray Medical Center & Florida Atlantic University
Delray Beach, Florida, United States, 33484
Actively Recruiting
2
Broward Health Medical Center & The University of Florida
Fort Lauderdale, Florida, United States, 33316
Actively Recruiting
3
University of Florida Health Shands
Gainesville, Florida, United States, 32608
Actively Recruiting
4
Baptist Health South Florida & Florida International University
Miami, Florida, United States, 33176
Actively Recruiting
5
Advent Health
Orlando, Florida, United States, 34747
Actively Recruiting
6
Tampa General Hospital
Tampa, Florida, United States, 33612
Actively Recruiting
7
Weill Cornell Medicine
New York, New York, United States, 10065
Active, Not Recruiting
8
The Ohio State University -Wexner Medical Center
Columbus, Ohio, United States, 43210
Active, Not Recruiting
9
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Active, Not Recruiting
10
West Virginia University Rockefeller Neuroscience Center
Morgantown, West Virginia, United States, 26506
Active, Not Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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