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