NCT03671889 · RECRUITING
ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease
This study tests whether a focused-ultrasound device, guided by MRI, can safely and temporarily open the blood-brain barrier in people with probable Alzheimer's disease. The barrier is the brain's protective filter. Researchers are looking at safety and early effects. It has no phase label, which is common for device studies. It is not proven or approved.
You may qualify if
- 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
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-01-09