ExAblate Blood-Brain Barrier Disruption for Alzheimer's Disease
This study is testing a device called the ExAblate Model 4000 Type 2.0 System. It uses focused ultrasound (FUS) to temporarily open the blood-brain barrier (BBB) in specific areas of the brain. The blood-brain barrier is a protective layer that normally prevents substances from entering the brain. Researchers want to see if opening it is safe and effective for people with probable Alzheimer's Disease (AD). You might be able to join if you are 50-85 years old, have probable AD, and can communicate during the procedure. The main goal is to track any device or procedure-related side effects over 5 years. The current recruitment status is unclear.
- Study design
- This is a single-arm study, meaning all participants receive the intervention. It aims to enroll up to 30 participants across up to 8 sites in the United States.
- What's involved
- Participants will undergo three ExAblate BBB disruption procedures in specific brain areas. You will need to communicate sensations during the procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 5 years to monitor for device and procedure-related adverse events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease
At a glance
Conditions
Where it's being run
10 sites across 5 statesWho to contact
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What this trial measures
- Device and procedure related adverse events5 years
Rate of adverse events following each treatment through end of study