MR-Guided Focused Ultrasound Trial for Alzheimer’s Disease

Broward Health is participating in a clinical trial, in partnership with Insightec, to evaluate the safety and efficacy of the Exablate Model 4000 Type 2.0/2.1 System as a tool to disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer’s disease. This innovative clinical trial uses a non-invasive MR-guided focused ultrasound (MRgFUS) technology to target specific areas in the brain. Focused ultrasound has been shown to be capable of disrupting the blood-brain barrier through a non-invasive technique allowing for a temporary opening where the amyloid plaque burden may be reduced.

The Blood-Brain Barrier clinical trial is open, and we currently are enrolling patients diagnosed with Alzheimer’s who meet the inclusion/exclusion criteria.

Alzheimer’s disease affects an estimated 5.8 million people in the United States1 caused by a buildup of proteins in the brain. Most of the current research for Alzheimer’s disease revolves around two proteins, Beta-amyloid, or plaques and Tau proteins, or tangles, affecting:

  • When Beta-amyloid proteins cluster together, it may have a toxic effect on neurons.
  • When tau proteins change shape, they become neurofibrillary tangles which can disrupt the transport system becoming toxic to cells.

Clinical Trial with Innovative Technology

Patient undergoing an MRI

Broward Health is one of only a few hospitals in the United States authorized to conduct this Phase of the Alzheimer’s clinical trial to evaluate the safety and efficacy of the Exablate Model 4000 Type 2.0/2.1 System from Insightec as a tool to disrupt the blood-brain barrier (BBB) in patients with probable Alzheimer’s disease.

Broward Health is currently enrolling eligible patients in the clinical trial. Qualifications for patients include:

  • Male or Female, ages 50-85
  • Probable Alzheimer’s disease consistent with NIA/AA criteria (McKhann, Alzheimer & Dementia 2011)
  • Modified Hachinski Ischemia Scale (MHIS) score of <=4
  • Mini Mental State Exam (MMSE) scores 18 – 26
  • Short form Geriatric Depression Scale score <=6
  • If receiving concurrent treatment with an AChEI and/or memantine, has been on the medication for at least three months with a stable dose for at least 3 months prior to the first Exablate BBB procedure
  • Amyloid PET scan2 consistent with the presence of β-amyloid
  • Able to communicate sensations during the Exablate MRIGFUS procedure
  • Able to attend all study visits (i.e., life expectancy of 1 or more years)
  • Has a delegated LAR to sign informed consent

Additional inclusion and exclusions for qualifications may apply.


  1. Center for Disease Control. Alzheimer’s Disease and Related Dementias. 2020.
  2. Some studies may be completed as part of the clinical trial.

For questions about Broward Health’s new clinical study for the treatment of Alzheimer’s Disease, please contact our contact study coordinators at 954.786.6736.