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Sunnybrook researchers demonstrate safe and non-invasive way to open blood-brain barrier in patients with Alzheimer’s disease

July 25, 2018

First peer-reviewed published report to show the safety and feasibility in Phase 1 trial

Sunnybrook researchers have demonstrated that focused ultrasound can be used to safely open the blood-brain barrier (BBB) in patients with Alzheimer’s disease in the first peer-reviewed published report of its kind.

The study, “Blood-Brain Barrier Opening in Alzheimer’s Disease Using MR-guided Focused Ultrasound,” has been published in Nature Communications. Sunnybrook researchers will be presenting their findings at the Alzheimer’s Association International Conference (AAIC) in Chicago today.

“This is a critical first step,” says Dr. Nir Lipsman, lead author and Director of the Harquail Centre for Neuromodulation at Sunnybrook Health Sciences Centre. “By successfully, safely and reversibly opening the blood-brain barrier in patients with early to moderate Alzheimer’s disease, we can support the continued investigation of focused ultrasound as a potential novel treatment, and further study the delivery of therapies that otherwise cannot access the brain.”

The BBB surrounds the small blood vessels of the brain to protect it from toxins and infectious agents. It also prevents drug therapies from entering, which could be effective in treating disease. In this Phase 1 trial, the focused ultrasound technology used low frequency ultrasound waves to non-invasively open the BBB in a small area of the frontal lobe in patients with mild stage Alzheimer’s disease. No drug therapies were administered as the trial investigated safety and feasibility.

“While it is still early in development, in the future focused ultrasound may provide a non-invasive, effective way of delivering large molecules such as antibodies or even stem cells directly to the brain to help patients with Alzheimer’s,” says Dr. Sandra Black, study co-principal investigator and internationally renowned Professor of Medicine (Neurology) at Sunnybrook Health Sciences Centre and the University of Toronto. “We are pioneering exciting potential innovative treatment options for patients.”

Alzheimer’s is the most common neurodegenerative disorder, which over time robs people of memory and thinking ability. Over 6.4 million people in North America and at least 44 million people worldwide, are living with Alzheimer’s or another dementia.

In 2015, Sunnybrook researchers safely opened the BBB to test the delivery of chemotherapy directly to a patient’s brain tumour. This recent study is the first peer-reviewed, published report showing the safety and feasibility of breaching the BBB in patients with Alzheimer’s. Philanthropic investment has been a major catalyst behind Sunnybrook’s advances in focused ultrasound technology and research.

Dr. Kullervo Hynynen, Director of Physical Sciences at Sunnybrook Research Institute, worked with INSIGHTEC®, a global medical technology innovator of incisionless surgery, for almost two decades to develop the technology.

“Sunnybrook continues their ground-breaking research using INSIGHTEC’s focused ultrasound now to explore treatments for Alzheimer’s disease,” says Maurice R. Ferré MD, INSIGHTEC’S CEO and Chairman of the Board of Directors. “Research aimed at opening the blood-brain barrier holds promise to advance treatment options to help millions of patients in the future.”

The next phase of the trial will investigate the safety and efficacy of using focused ultrasound to breach the BBB in a larger group of patients with Alzheimer’s. Phase 2a will begin this fall.

“Sunnybrook has been recognized as a Center of Excellence in focused ultrasound, and their pioneers have made history once again by using focused ultrasound to safely breach the blood-brain barrier in patients with Alzheimer’s disease,” says Dr. Neal F. Kassell, Chairman of the Focused Ultrasound Foundation which funded the trial. “This is an important first step that widens the horizon of possibility for focused ultrasound to become a treatment option for any neurological disorders.”

For more information about focused ultrasound at Sunnybrook Health Sciences Centre, visit


Media Contact:

Jennifer Palisoc
Sunnybrook Health Sciences Centre

About the Focused Ultrasound Foundation

The Focused Ultrasound Foundation was created to improve the lives of millions of people worldwide by accelerating the development of focused ultrasound, an early-stage, noninvasive, therapeutic technology with the potential to transform the treatment of many serious medical disorders. The Foundation works to clear the path to global adoption by coordinating and funding research, fostering collaboration, and building awareness among patients and professionals. It is dedicated to ensuring that focused ultrasound finds its place as a mainstream therapy for a range of conditions within years, not decades. Since its establishment in 2006, the Foundation has become the largest non-governmental source of funding for focused ultrasound research. More information can be found at


INSIGHTEC® is a global medical technology innovator transforming patient lives through incisionless brain surgery with MR-guided focused ultrasound. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. INSIGHTEC is headquartered in Haifa, Israel, and Miami, with offices in Dallas, Tokyo and Shanghai.

About Sunnybrook

Sunnybrook Health Sciences Centre is inventing the future of health care for the 1.2 million patients the hospital cares for each year through the dedication of its more than 10,000 staff and volunteers. An internationally recognized leader in research and education and a full affiliation with the University of Toronto distinguishes Sunnybrook as one of Canada’s premier academic health sciences centres. Sunnybrook specializes in caring for high-risk pregnancies, critically-ill newborns and adults, offering specialized rehabilitation and treating and preventing cancer, cardiovascular disease, neurological and psychiatric disorders, orthopaedic and arthritic conditions and traumatic injuries. The Hospital also has a unique and national leading program for the care of Canada’s war veterans.