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).
This is a prospective, multi-center, single-arm study to evaluate the safety and efficacy of BBB disruption using the ExAblate Model 4000 Type 2.0 (220 kHz) system. Patients with diagnosis of Probable Alzheimer's Disease may qualify for a clinical trial to have three serial ExAblate BBB disruption procedures in specific areas in the brain. This study will be conducted at up to 8 sites in the United States and will enroll up to 30 patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
50
Focal Ultrasound (FUS) involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct targets to induce BBB disruption.
Delray Medical Center & Florida Atlantic University
Delray Beach, Florida, United States
RECRUITINGBroward Health Medical Center & The University of Florida
Fort Lauderdale, Florida, United States
Device and procedure related adverse events
Rate of adverse events following each treatment through end of study
Time frame: 5 years
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University of Florida Health Shands
Gainesville, Florida, United States
RECRUITINGBaptist Health South Florida & Florida International University
Miami, Florida, United States
RECRUITINGAdvent Health
Orlando, Florida, United States
RECRUITINGTampa General Hospital
Tampa, Florida, United States
RECRUITINGWeill Cornell Medicine
New York, New York, United States
ACTIVE_NOT_RECRUITINGThe Ohio State University -Wexner Medical Center
Columbus, Ohio, United States
ACTIVE_NOT_RECRUITINGUniversity of Texas Southwestern Medical Center
Dallas, Texas, United States
ACTIVE_NOT_RECRUITINGWest Virginia University Rockefeller Neuroscience Center
Morgantown, West Virginia, United States
ACTIVE_NOT_RECRUITING