Byrd Alzheimer’s Institute ready to take clinical trials on the road
The USF Health Byrd Alzheimer’s Institute unveiled its mobile Memory Research Suite on June 28 – a groundbreaking traveling “clinic” designed to bring the latest clinical drug trials to senior communities across Florida.
That makes the institute the first academic research facility in the state with a mobile clinical trials unit dedicated to finding new treatments for Alzheimer’s disease, a memory-robbing illness that affects more than 5 million Americans and this week claimed the life of legendary women’s college basketball coach Pat Summit.
Although current drugs help mask the symptoms of Alzheimer’s disease, there are not yet effective medications to treat the underlying disease or to significantly delay its progression.
David Morgan, PhD, CEO of the Byrd Alzheimer’s Institute, says that 15 investigational drugs for Alzheimer’s disease and other forms of dementia are in the last stage (Phase 3) of clinical study with more in the pipeline, but getting promising drugs to the Food and Drug Administration for review can take four to five years, including more than two years for full enrollment of patients in a trial.
“We need to get drugs to patients sooner,” Dr. Morgan said. “We’re trying to accelerate the entire process, and we think that ideas like this will help do that and increase opportunities for drug study participation for a much broader range of Floridians than exists today.”
Scheduled to begin operation in August, the Memory Research Suite features a reception area, patient exam room, two testing rooms, an Americans with Disability Act compliant restroom, a phlebotomy area for blood draws as well as central air conditioning and wireless Internet access. The Byrd Institute’s clinical experts staffing the mobile unit will evaluate study participants and administer investigational medications at pre-selected study sites, expected to include memory disorder clinics, outpatient medical clinics, hospitals, churches, retirement communities.
“Up to this point, we were limited to only being able to enroll people willing to travel to our site,” said Amanda Smith, MD, medical director of the Byrd Alzheimer’s Institute. “By bringing a fully-functioning mobile unit to them, we hope to increase enrollment in trials, increase diversity in research, decrease the time it takes to complete the studies and, ultimately shorten the time it takes to get new treatments to the market.”
Ed Funai, MD, chief operating officer for USF Health and vice president of strategic development for USF, thanked the Byrd Institute faculty and staff for all they do to help position USF Health as a national leader in the fight against Alzheimer’s disease.
“We all know someone who has been affected by this horrible disease,” Dr. Funai said. “Clinical trials are essential for the development of more effective and efficient prevention, diagnoses and treatments for Alzheimer’s and memory-related disorders… What will take place inside our new mobile Memory Research Suite will make life better for generations to come.”
Following a ribbon-cutting, guests and media toured the 400-square-foot clinical research space on wheels, which was designed in collaboration with industry leaders from research organizations.
Among the guests was Sheila Nagley and her husband Bill, 74, who was diagnosed with Alzheimer’s disease in 2009. They make the more than one hour drive from their home in south St. Petersburg to the Byrd Institute monthly so that Bill can participate in an Eli Lilly-sponsored Phase 3 clinical trial testing whether solanezumab, a monoclonal antibody designed to help reduce build-up of amyloid plaques in the brains of people with early stages of Alzheimer’s, can slow the disease’s progression.
Bill does not know if the IV infusion he receives is the investigational drug or not; half of the participants in the double-blind randomized controlled study receive solanezumab and the other half get a placebo. But, at the end of the 18-month trial all participants are eligible for the medication.
“We don’t mind the drive (to Tampa), but if this portable facility was available closer to us in our community, we’d choose to use it,” Sheila said. “We started coming to the Byrd Institute in 2012, and they’ve really improved our quality of life with all their resources, including a support group and clinical trials. Having access to people actually doing the research is great.”
Video by Sandra C. Roa, and photos by Eric Younghans, USF Health Communications and Marketing