Baptist Health, FIU’s Herbert Wertheim College of Medicine Partner in New Clinical Trial That Could Revolutionize Care for Alzheimer’s Patients

A pivotal new clinical trial for patients with Alzheimer’s disease is underway and recruiting participants. Baptist Health Miami Neuroscience Institute and Florida International University’s Herbert Wertheim College of Medicine are collaborating on the study that utilizes low-intensity, focused ultrasound – LiFU – to disrupt the “blood-brain barrier” that can cause memory and cognition problems in patients who have, or may have, Alzheimer’s disease.

The blood-brain barrier blocks foreign or toxic substances -- and some medications -- from entering the brain. The investigational study will focus on how LiFU can provide a safe way to bypass the barrier and improve the delivery of drugs. Since the treatment is minimally invasive, no incisions are needed.

The study, named ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer’s Disease, could revolutionize care for those suffering from Alzheimer’s, said co-principal investigator Michael McDermott, M.D., neurosurgeon and chief medical executive of Miami Neuroscience Institute, and professor and chief of the Division of Neuroscience at the Herbert Wertheim College of Medicine.

Michael McDermott, M.D., a neurosurgeon and the chief medical executive of Baptist Health Miami Neuroscience Institute.

 

“The technology is very exciting, especially because there is no cure for Alzheimer’s and only a few drug treatments that temporarily treat symptoms,” said Dr. McDermott said. “It’s non-invasive for patients and we hope it will lead to cognitive improvement.”

The FDA (U.S. Food & Drug Administration)-approved clinical trial, which is currently enrolling patients, is part of Florida’s Brain State initiative, which funds and brings together hospitals, state universities and institutions in Florida. Alzheimer’s disease is the sixth leading cause of death for those age 65 and older in the U.S., according to the Alzheimer’s Association. Florida has the second highest incidence of Alzheimer’s with nearly 600,000 cases.

High intensity ultrasound technology has already proven to be a game changer for patients who cannot perform common tasks such as holding a cup of water without spilling, shaving safely or writing legibly due to essential tremor. For essential tremor, high-intensity focused ultrasound (HiFU) waves are targeted to hit the area of abnormal circuitry in \the brain. In one sitting, patients see immediate improvement.

Geriatric psychiatrist and the LiFU study’s co-principal investigator, Patricia Junquera, M.D., hopes to see similar results with the low-intensity ultrasound. “We expect to see improvement days after the procedure,” said Dr. Junquera, the associate professor and vice chair of clinical services for the Department of Psychiatry and Behavioral Health at FIU’s College of Medicine.  “Any improvement we see is going to be huge because patients with Alzheimer’s typically cannot make any new memories or manage functions of daily living.”

Who can participate in the LiFU clinical trial?

Patients who:
• Are male or female, age 50-85.
• Have probable Alzheimer’s disease consistent with NIA/AA criteria.
• Have been on a stable dose of Alzheimer’s medication for three months.

What can participants expect if they’re chosen for the study? Participants will have to provide a medical history and undergo a physical exam and cognitive assessments. They will also be required to have blood work and various imaging tests to ensure it is safe for them to participate.

Once approved, study participants will undergo up to three procedures — about 14 days apart. Each procedure may take up to four hours. After the  last procedure, there will be 10 follow-up visits, and then one every year for five years.

If you are interested in participating, please call 305-348-9499. For more information, visit ClinicalTrials.gov (NCT03671889).