ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease
Recruiting · NCT03671889 · Interventional (participants receive a specific treatment) · Lead sponsor: InSightec
View the official record on ClinicalTrials.gov →Interventions studied
Blood Brain Barrier (BBB) Disruption
What this trial is about
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).
Who can take part
Age range
50 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- MRI Findings
- Presence of unknown or MR unsafe devices anywhere in the body
- Significant cardiac disease or unstable hemodynamic status
- Relative contraindications to ultrasound contrast agent or PET amyloid tracer
- History of a bleeding disorder
- History of liver disease
- Known cerebral or systemic vasculopathy
- Significant depression and at potential risk of suicide
- Any contraindications to MRI scanning
- Any contraindication to lumbar puncture for collection of cerebral spinal fluid
- Untreated, uncontrolled sleep apnea
- History of seizure disorder or epilepsy
- Severely Impaired renal function
- 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
- Chronic pulmonary disorders
- Positive human immunodeficiency virus (HIV)
- Known apolipoprotein E allele (ApoE4) homozygosity
Where it is running
10 locations listed across 5 US states.
- Delray Medical Center & Florida Atlantic University - Delray Beach, Florida, United States
- Broward Health Medical Center & The University of Florida - Fort Lauderdale, Florida, United States
- University of Florida Health Shands - Gainesville, Florida, United States
- Baptist Health South Florida & Florida International University - Miami, Florida, United States
- Advent Health - Orlando, Florida, United States
- Tampa General Hospital - Tampa, Florida, United States
- Weill Cornell Medicine - New York, New York, United States
- The Ohio State University -Wexner Medical Center - Columbus, Ohio, United States
- University of Texas Southwestern Medical Center - Dallas, Texas, United States
- West Virginia University Rockefeller Neuroscience Center - Morgantown, West Virginia, United States