Delray Medical Center is the first hospital in Florida to treat an Alzheimer's disease patient using non-invasive focused ultrasound technology as part of a groundbreaking study being conducted in collaboration with Florida Atlantic University's Institute for Human Health and Disease Intervention (I-Health).
In the FDA-approved clinical trial, focused ultrasound technology is used to disrupt the blood-brain barrier in participating Alzheimer's patients. Alzheimer's may be caused by a buildup of certain proteins in the brain. Precisely guided by magnetic-resonance imaging, ultrasound waves are directed at specific areas of the patient's brain to create a temporary opening in the blood-brain barrier where the protein buildup may be reduced. The Delray Medical Center patient enrolled in the clinical trial received the first of three treatments at the hospital on Feb. 15.
"Delray Medical Center is proud and excited to be a leader in this effort to determine the safety and efficacy of this potentially revolutionary treatment for Alzheimer's patients," said Lloyd Zucker, M.D., FAANS, a board-certified neurosurgeon and medical director of neurosurgery at Delray Medical Center. "The study will help determine whether the use of this non-invasive focused ultrasound technology can lead to cognitive improvement in patients with Alzheimer's disease."
An estimated 6.5 million Americans ages 65 and older are living with Alzheimer's disease, which is the sixth leading cause of death for those age 65 and above in the U.S., according to the Alzheimer's Association. Florida has the second highest incidence of Alzheimer's in the country, with an estimated 580,000 cases.
By establishing the Florida Alzheimer's Center of Excellence last year, Florida Gov. Ron DeSantis has placed Alzheimer's disease as a priority health issue in Florida, which will benefit the more than 580,000 people now living with Alzheimer's as well as their families. We are excited to collaborate with Delray Medical Center, Insightec and others on this groundbreaking technology that will create the next generation of patient care for Alzheimer's disease and other neurodegenerative disorders."
Stacy Volnick, FAU President
FAU's Gregg Fields, Ph.D., executive director of I-Health and a professor of chemistry and biochemistry in FAU's Charles E. Schmidt College of Science, is the program director for the project.
"Drug passage through the blood-brain barrier is perhaps one of the greatest challenges in neurology," said Fields. "The treatment of the first patient in Florida with the non-invasive focused ultrasound technology represents a significant advancement for potential drug delivery and treatment of Alzheimer's disease and other neurological disorders. In tandem, we are also working on non-invasive, blood-based monitoring to determine if treatments are effective."
The clinical trial, called ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease, is designed to evaluate the safety and efficacy of Insightec's ExAblate Model 4000 Type 2.0 System as a tool for disrupting the blood-brain barrier in probable Alzheimer's patients.
"Insightec is committed to working with our partners to help drive innovation," said Maurice Ferre, M.D., chairman and CEO from Insightec. "By providing our medical technologies to hospitals and universities across the state of Florida, we are building a cross-sector network with advanced capabilities to accelerate research for potential treatment solutions for brain diseases."
The study, part of Florida's Brain State initiative, is being conducted at up to eight sites in the country. Patients who meet the specific study criteria receive three focused ultrasound treatments, two weeks apart, and will be followed for five years after the final procedure.
"Today marks a historic milestone in the fight against Alzheimer's as we begin trials in Florida using Insightec's cutting-edge focused ultrasound technology," said Jonathan Weiss, chairman of the Alzheimer's Disease Advisory Committee and vice president of strategic innovation at Insightec. "Thanks to Gov. DeSantis' visionary leadership, the Florida legislature's support, and the unprecedented partnership between Florida's academic powerhouses, health systems and private industry, we are proud to launch this pioneering research program aimed at treating and ultimately finding a cure for Alzheimer's. This achievement signals a new era in medical research, offering hope to millions of patients and families affected by this devastating disease."
The Insightec technology has already been shown to be effective in treating patients with Parkinson's disease and essential tremor, a neurological disorder that causes involuntary trembling of the head and hands, preventing people with the condition from performing simple tasks, such as drinking from a glass or tying shoelaces.
"I have spent a great deal of my career working and hoping for advancements in Alzheimer's research, so I am incredibly excited for what this means for the hundreds of thousands of Floridians living with Alzheimer's and their caregivers," said Michelle Branham, Department of Elder Affairs secretary. "Our governor has been a steadfast supporter of the Brain State program and continues to champion Alzheimer's initiatives and increasing budget recommendations to ensure Florida remains a leader in research, support and treatment. This successful treatment is a historical and pivotal moment for our state and its commitment to a fortified structure to support Alzheimer's and other dementias. I am very proud to be a partner in the Brain State Program."