MIAMI, FL., —Neurologists and researchers with theUniversity of Miami Miller School of Medicine and UHealth—the University of Miami Health System have begun screening study participants for a new, national Alzheimer’s disease (AD) clinical study to evaluate the potential benefits of an investigational medicine for people with mild-to-moderate AD.
The Phase 2 study, called T2 Protect AD, is evaluating the investigational drug troriluzole (BHV-4157), which may have the potential to protect against, slow down, and eventually improve memory and thinking problems that increase as Alzheimer’s disease progresses. Troriluzole is a drug that modulates glutamate, protecting against neuron loss. Glutamate problems in the brain can lead to brain cell dysfunction and disease, including Alzheimer’s disease.
“We are hoping this drug truly makes a difference in slowing progression of this illness,” said Bernard S. Baumel, M.D., assistant professor of neurology; interim chief of the Cognitive Disorder Division; director of Memory Disorders Clinical Trials. “It’s a unique compound that takes a different approach than most recent drugs. Riluzole has shown efficacy in ALS patients, and the prodrug now offers the possibility of helping those with Alzheimer’s, and with fewer side effects.”
Doctors at UM’s Memory Program are now seeking eligible participants for the T2 Protect AD study. To enroll in T2 Protect AD, participants must be between age 50 and 85, diagnosed with mild-to-moderate Alzheimer’s disease, and already being treated with Alzheimer’s medications for at least three months. Participants must have a study partner who has regular contact with the clinical trial candidate and is able to attend study visits.
Troriluzole is a prodrug of riluzole, a drug first approved by the Federal Drug Administration in 1995 to slightly slow disease progression in patients with Amyotrophic Lateral Sclerosis (ALS).
A prodrug is an inactive medication that changes into a drug after ingestion. When a person takes troriluzole, the body converts it into the active drug riluzole. This means the prodrug troriluzolecan be taken once a day, while riluzole is administered twice a day. Unlike riluzole, patients do not need to fast before and after taking troriluzole, and troriluzole has potential for better safety and tolerability than riluzole.
The Miller Schoolis one of more than 30 sites in the U.S. participating in the T2 Protect AD study. The study is sponsored by New Haven-based Biohaven Pharmaceutical Holding Company Ltd., and is coordinated by the Alzheimer’s Disease Cooperative Study (ADCS), a large clinical research consortium, based at the University of California, San Diego.
The T2 Protect AD trial comes at a time when Alzheimer’s research is focused on earlier stages of the disease and there are not as many clinical trials for people already diagnosed with Alzheimer’s. “Simply put, we need to identify more and better treatments for the millions of people already diagnosed with Alzheimer’s disease and the T2 Protect Study is designed for that population” said Dr. Baumel.
For more information about participating in the T2 Protect AD study at the University of Miami, call (305) 243-0184 or visit T2 Protect AD.
About Alzheimer’s disease
An estimated 5.7 million people in the U.S. suffer from mild-to-moderate AD, with those numbers expected to triple by 2050 without prevention or cure. Alzheimer's disease is a progressive, fatal neurodegenerative dementia that accounts for 60 - 80 percent of dementia cases. Although there are FDA-approved medications for symptomatic treatment of AD, their clinical benefits are generally limited. Novel therapeutic approaches aimed at normalizing synaptic and extra-synaptic glutamate levels, such as troriluzole, may offer the potential for symptomatic benefit in AD by improving cognitive function, as well as the potential for disease modification by preventing the loss of synapses.
About University of Miami -- Department of Neurology
The Department of Neurology is one of the premier Departments in the country with more than 70 renowned research and clinical faculty in most of the neurological sub-specialties. Together with Neurosurgery, US News and World Report ranked the department in the top 50 among departments in the country and it’s ranked among the top 16 in National Institutes of Health funding.
The mission of the Department is fourfold—to expand the knowledge of the causes, treatments, and cures for neurological disease; to conduct cutting-edge research; to provide unparalleled care to patients and to train the next generation of practitioners and neuroscientists. For more information, please visit: http://neurology.med.miami.edu/about-us
