NCT03671889 · InSightec
ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease
What this study is about
The purpose of this study is to evaluate the safety and effectiveness 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).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
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
Where
- Delray Beach, Florida
- Fort Lauderdale, Florida
- Gainesville, Florida
- Miami, Florida
- Orlando, Florida
- Tampa, Florida
- New York, New York
- Columbus, Ohio
- Dallas, Texas
- Morgantown, West Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 9, 2026 · Source of record for eligibility and locations