RecruitingNot ApplicableNCT03671889

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

Assessment of Safety and Efficacy of ExAblate Blood-Brain Barrier Disruption for the Treatment of Patients With Probable Alzheimer's Disease


Sponsor

InSightec

Enrollment

50 participants

Start Date

Sep 28, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a non-invasive procedure that uses focused ultrasound waves (guided by MRI) to temporarily open the brain's natural protective barrier — the blood-brain barrier — in Alzheimer's patients, allowing medications to better reach brain tissue. **You may be eligible if...** - You are between 50 and 85 years old - You have been diagnosed with probable Alzheimer's disease - If you take Alzheimer's medication, you have been on a stable dose for at least 3 months - You are mobile (ambulatory) and able to communicate during the procedure **You may NOT be eligible if...** - Your MRI shows certain abnormalities (like significant bleeding, large strokes, or structural problems) that make the procedure risky - You have metal implants in your body that are unsafe in MRI (e.g., certain pacemakers, cochlear implants, or aneurysm clips) - You have a history of brain surgery or significant neurological conditions beyond Alzheimer's - You are unable to tolerate the procedure (e.g., severe claustrophobia) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBlood 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.


Locations(10)

Delray Medical Center & Florida Atlantic University

Delray Beach, Florida, United States

Broward Health Medical Center & The University of Florida

Fort Lauderdale, Florida, United States

University of Florida Health Shands

Gainesville, Florida, United States

Baptist Health South Florida & Florida International University

Miami, Florida, United States

Advent Health

Orlando, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

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

View Full Details on ClinicalTrials.gov

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NCT03671889


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