Disrupting the blood-brain barrier to treat Alzheimer's disease
Assessment of Safety and Efficacy of ExAblate Blood-Brain Barrier Disruption for the Treatment of Patients With Probable Alzheimer's Disease
This study is testing a new method to temporarily open the blood-brain barrier in people with Alzheimer's disease to see if it can help their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | InSightec Industry-sponsored |
| Locations | 10 sites (Delray Beach, Florida and 9 other locations) |
| Trial ID | NCT03671889 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of the ExAblate Model 4000 Type 2.0 System to disrupt the blood-brain barrier in patients diagnosed with probable Alzheimer's Disease. It is a prospective, multi-center, single-arm study that will involve three serial procedures targeting specific brain areas. The trial aims to enroll up to 30 patients across multiple sites in the United States, assessing both the safety of the intervention and its potential therapeutic effects.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 50-85 with a diagnosis of probable Alzheimer's Disease who can communicate sensations during the procedure.
Not a fit: Patients with significant cardiac disease, severe renal impairment, or contraindications to MRI or lumbar puncture may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel method to enhance drug delivery for Alzheimer's treatment, potentially improving patient outcomes.
How similar studies have performed: While the approach of using focused ultrasound to disrupt the blood-brain barrier is innovative, similar studies have shown promise in other neurological conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Delray Beach, Florida and 9 other locations
- Delray Medical Center & Florida Atlantic University — Delray Beach, Florida, United States (Recruiting)
- Broward Health Medical Center & The University of Florida — Fort Lauderdale, Florida, United States (Recruiting)
- University of Florida Health Shands — Gainesville, Florida, United States (Recruiting)
- Baptist Health South Florida & Florida International University — Miami, Florida, United States (Recruiting)
- Advent Health — Orlando, Florida, United States (Recruiting)
- Tampa General Hospital — Tampa, Florida, United States (Recruiting)
- Weill Cornell Medicine — New York, New York, United States (Active_not_recruiting)
- The Ohio State University -Wexner Medical Center — Columbus, Ohio, United States (Active_not_recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Active_not_recruiting)
- West Virginia University Rockefeller Neuroscience Center — Morgantown, West Virginia, United States (Active_not_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.