Neuroimaging and Fluid Biomarker Data from Sunnybrook’s Ongoing Alzheimer’s Study Published


Key Points

  • Researchers recently published new data from an ongoing Alzheimer’s disease clinical trial using focused ultrasound to disrupt the blood-brain barrier (BBB).
  • The data show that BBB disruption is safe across multiple areas of the brain and at expanded volumes.
  • Although the treatment reduced the amyloid deposits in the brain, no improvement of the Alzheimer’s decline was observed.

Blood-Brain Barrier Opening of the Default Mode Network in Alzheimer’s Disease with Magnetic Resonance–Guided Focused Ultrasound

A collaborative group of international researchers based at Sunnybrook Research Institute recently published neuroimaging and fluid biomarker data from Sunnybrook’s ongoing study using MR-guided focused ultrasound (MRgFUS) to disrupt the blood-brain barrier (BBB) in participants with Alzheimer’s disease (AD).

The team has been seeking to expand the reach of the technique throughout the various regions of the brain (including the regions controlling memory) and to increase the volume and number of BBB disruptions in each area. This update on the first nine patients enrolled in an ongoing clinical trial (NCT03739905) shows that this type of expansion for BBB disruption is safe. These safety data are crucial, especially to the broader medical community, because the BBB is an important physiologic structure, and even temporary disruption of it needs to be shown to be without adverse events. Furthermore, MRgFUS did reduce the amyloid deposits in the brain, although no amelioration of the AD decline was observed.

“Our results show that we can now continue expanding the parameters for our trial, both clinically and technically,” said Nir Lipsman, MD, PhD, the study’s principal investigator and director of Sunnybrook’s Harquail Centre for Neuromodulation. “We hope to comprehensively measure key outcomes, including amyloid and tau levels before and after each treatment and, critically, to enhance the delivery of promising therapeutics across the BBB.”

The discussion of the manuscript also notes: “These results set the stage for larger trials pairing MRgFUS with promising AD therapeutics for which the BBB is an important obstacle. Intravenous immunoglobulin, for example, may be a promising and ready candidate as it has been shown to synergistically promote neurogenesis and modulate the inflammatory milieu with [focused ultrasound] in animal models.”

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