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

NCT03671889 · InSightec
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Official title
Assessment of Safety and Efficacy of ExAblate Blood-Brain Barrier Disruption for the Treatment of Patients With Probable Alzheimer's Disease
About this study
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.
Eligibility criteria
Inclusion Criteria: 1. Male or Female between 50-85 years of age 2. Probable Alzheimer's Disease (AD) 3. 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 4. Able to communicate sensations during the ExAblate MRgFUS procedure 5. Ambulatory Exclusion Criteria: 1. MRI Findings 2. Presence of unknown or MR unsafe devices anywhere in the body 3. Significant cardiac disease or unstable hemodynamic status 4. Relative contraindications to ultrasound contrast agent or PET amyloid tracer 5. History of a bleeding disorder 6. History of liver disease 7. Known cerebral or systemic vasculopathy 8. Significant depression and at potential risk of suicide 9. Any contraindications to MRI scanning 10. Any contraindication to lumbar puncture for collection of cerebral spinal fluid 11. Untreated, uncontrolled sleep apnea 12. History of seizure disorder or epilepsy 13. Severely Impaired renal function 14. 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 15. Chronic pulmonary disorders 16. Positive human immunodeficiency virus (HIV) 17. Known apolipoprotein E allele (ApoE4) homozygosity
Study design
Enrollment target: 50 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2018-09-28
Estimated completion: 2030-01
Last updated: 2026-01-09
Interventions
Device: Blood Brain Barrier (BBB) Disruption
Primary outcomes
  • Device and procedure related adverse events (5 years)
Sponsor
InSightec · industry
All locations (10)
Delray Medical Center & Florida Atlantic UniversityRecruiting
Delray Beach, Florida, United States
Broward Health Medical Center & The University of FloridaRecruiting
Fort Lauderdale, Florida, United States
University of Florida Health ShandsRecruiting
Gainesville, Florida, United States
Baptist Health South Florida & Florida International UniversityRecruiting
Miami, Florida, United States
Advent HealthRecruiting
Orlando, Florida, United States
Tampa General HospitalRecruiting
Tampa, Florida, United States
Weill Cornell MedicineActive Not Recruiting
New York, New York, United States
The Ohio State University -Wexner Medical CenterActive Not Recruiting
Columbus, Ohio, United States
University of Texas Southwestern Medical CenterActive Not Recruiting
Dallas, Texas, United States
West Virginia University Rockefeller Neuroscience CenterActive Not Recruiting
Morgantown, West Virginia, United States
ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease · TrialPath