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

Part of paid clinical trials in Delray Beach, Florida.

Sponsor
InSightec
Study ID
NCT03671889
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Blood Brain Barrier (BBB) Disruption — DEVICE
    Focal Ultrasound (FUS) involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct targets to induce BBB disruption.

Study Details

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).

Key Dates

Start date
Sep 28, 2018
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Blood Brain Barrier (BBB) Disruption
    ExAblate Model 4000 Type 2.0 System

Primary Outcome Measure

Device and procedure related adverse events [ Time Frame: 5 years ]

Locations (10)

FacilityCityStateZIPSite coordinators
Delray Medical Center & Florida Atlantic UniversityDelray BeachFlorida33484
Jenny Zucker, MS
[email protected]
561-825-1505
Lloyd Zucker, MD, FAANS (PRINCIPAL_INVESTIGATOR)
Broward Health Medical Center & The University of FloridaFort LauderdaleFlorida33316
Joan Osborne, EdD
[email protected]
954-355-5563
Celena Bodie
[email protected]/
654-786-6736
Shaye Moskowitz, MD PhD (PRINCIPAL_INVESTIGATOR)
University of Florida Health ShandsGainesvilleFlorida32608
Phuong Deleyrolle
[email protected]
352-273-5529
Victoria Hope
[email protected]
352-273-9000
Justin Hilliard, MD (PRINCIPAL_INVESTIGATOR)
Baptist Health South Florida & Florida International UniversityMiamiFlorida33176
Margarita Mederos
[email protected]
786-596-1845
Michael W. McDermott, MD (PRINCIPAL_INVESTIGATOR)
Advent HealthOrlandoFlorida34747
Bhumi Patel
[email protected]
407-609-4598
Valeria Baldivieso, MD (PRINCIPAL_INVESTIGATOR)
Tampa General HospitalTampaFlorida33612
Shalini Raj Nampally
[email protected]
8138218513
Yarema Bezchlibnyk, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065-
The Ohio State University -Wexner Medical CenterColumbusOhio43210-
University of Texas Southwestern Medical CenterDallasTexas75390-
West Virginia University Rockefeller Neuroscience CenterMorgantownWest Virginia26506-

Find similar trials in Delray Beach, FL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Delray Medical Center & Florida Atlantic University· Delray Beach, FLBroward Health Medical Center & The University of Florida· Fort Lauderdale, FLUniversity of Florida Health Shands· Gainesville, FLBaptist Health South Florida & Florida International University· Miami, FLAdvent Health· Orlando, FLTampa General Hospital· Tampa, FL

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