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May 3, 2017

An initial safety study in the application of INSIGHTEC’s MR-guided focused ultrasound to open the Blood-Brain Barrier (BBB) in Alzheimer’s patients has been initiated at Sunnybrook Health Sciences Centre in Toronto, Canada.


The feasibility study is being done under the direction of Nir Lipsman, MD, PhD using INSIGHTEC’s Exablate Neuro low frequency MR-guided focused ultrasound system.   The first three patients with early stage Alzheimer’s disease have undergone focused ultrasound to temporarily open the Blood-Brain Barrier (BBB).


 “Our goal with this Phase 1 trial is to investigate whether we can successfully and safely open the BBB in people with mild stage Alzheimer’s disease using the non-invasive method of MRI-guided focused ultrasound,” says Dr. Nir Lipsman, principal investigator of the trial and a neurosurgeon at Sunnybrook Health Sciences Centre.


Based on previous work in animal models, it is believed that opening the BBB with focused ultrasound may allow the body’s endogenous immune system cells to cross into brain tissue and increase plaque clearance from the brain. This may, in turn, improve behavioral and cognition measurements.  Attacking the disease early, before significant progression has occurred, may have important implications for preventing the disease or slowing its progress. 


“Ground-breaking research with our focused ultrasound continues to push the boundaries of medical technology to change people’s lives,” said Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board. “Alzheimer’s disease impacts so many lives in devastating ways.  Our hope is that this study will serve as the foundation to provide a non-invasive approach for treating early stage Alzheimer patients around the world.”


In addition to safety parameters, the study will be a first look at the effect of opening the BBB on plaque concentrations, as measured by PET scans, and on behavioral and cognitive measures.


A total of six patients with diagnosed mild Alzheimer’s disease will be treated under this protocol. Opening of the BBB will be confirmed using contrast enhanced MR imaging.  Clinical measurements and safety will be evaluated 30 days post-treatment.  Patients who continue to qualify may undergo a second treatment of a slightly larger area in the same region of the brain and followed up for an additional 60 days for safety and preliminary effectiveness.  

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