Assessment of Safety and Efficacy of ExAblate Blood-Brain Barrier Disruption for the Treatment of Patients With Probable Alzheimer's Disease
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Delray Medical Center & Florida Atlantic University
RECRUITING
Delray Beach
Broward Health Medical Center & The University of Florida
RECRUITING
Fort Lauderdale
University of Florida Health Shands
RECRUITING
Gainesville
Baptist Health South Florida & Florida International University
RECRUITING
Miami
Advent Health
RECRUITING
Orlando
Tampa General Hospital
RECRUITING
Tampa
New York
Weill Cornell Medicine
ACTIVE_NOT_RECRUITING
New York
Ohio
The Ohio State University -Wexner Medical Center
ACTIVE_NOT_RECRUITING
Columbus
Texas
University of Texas Southwestern Medical Center
ACTIVE_NOT_RECRUITING
Dallas
West Virginia
West Virginia University Rockefeller Neuroscience Center
ACTIVE_NOT_RECRUITING
Morgantown
Time Frame
Start Date: 2018-09-28
Estimated Completion Date: 2030-01
Participants
Target number of participants: 50
Treatments
Experimental: Blood Brain Barrier (BBB) Disruption
ExAblate Model 4000 Type 2.0 System
Related Therapeutic Areas
Sponsors
Leads: InSightec