Despite a COVID-19 surge hospitalizing more younger people, the 18-29 age group targeted by the Prevent COVID U trial has the lowest adult vaccination rates

Tampa, FL (July 29, 2021) — The USF Health Morsani College of Medicine has begun enrolling university students and other young adults, including those not planning to be vaccinated, for an expanded nationwide study evaluating coronavirus infection and transmission in people ages 18 through 29. Individuals must not be vaccinated or have a positive SARS-CoV-2 test result before they start the study.

USF Health is one of more than 50 sites across the U.S. participating in the “Prevent COVID U” randomized controlled clinical trial. For this two-arm study using the Moderna COVID-19 mRNA vaccine, 6,000 individuals will be randomly selected to receive the vaccine right away at enrollment. Another 6,000 will be randomized to follow local guidance and their preference for vaccination timing or be vaccinated through the study after four months.

Additionally, the expanded study will enroll up to 6,000 young adults who choose not to be vaccinated. This control group will help ensure a large enough group of non-vaccinated people to compare infection and transmission rates with study participants vaccinated right away at enrollment.

Prevent COVID U was designed to test whether, and to what degree, the Moderna vaccine can prevent infection with SARS-CoV-2 (including asymptomatic infection), limit virus in the nose, and reduce transmission of the virus from young adults to their close contacts. The study, headquartered at Fred Hutchinson Cancer Research Center and conducted through the COVID-19 Prevention Network (CoVPN), is funded by the federal COVID-19 Response program and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Kami Kim, MD, director of the USF Health Morsani College of Medicine Division of Infectious Disease, is principal investigator for the Prevent COVID U study at the University of South Florida.

“This study has implications for public health guidance as new COVID-19 variants continue to emerge,” said principal investigator Kami Kim, MD, division director of Infectious Disease and International Medicine at the USF Health Morsani College of Medicine. “It will help us answer critical questions about whether a person can become infected after vaccination, and if the vaccine will stop the virus from spreading to others.”

Dr. Kim emphasized that the 18-to-29 age group has the lowest COVID-19 vaccination rate among all adults. This group, including many students on college campuses like USF, are more likely to show no symptoms when infected, so may pass on the virus to less healthy individuals, she added.

“The Delta variant outbreaks in Florida and other states are sending much younger people to the hospital and reports indicate that nearly all are not vaccinated,” Dr. Kim said. “The few vaccinated people who are hospitalized usually have other medical problems, and if tested for COVID-19 antibodies they’ve shown a poor antibody response to the vaccine.”

In Florida, where about 48% of the population is fully vaccinated, officials say the Delta variant is a driving factor in the statewide increase in COVID-19 cases.

All Prevent COVID U participants will complete questionnaires using an eDiary app twice weekly, swab their nose daily for SARS-CoV-2 infection, and provide periodic blood samples. They will also be asked to identify their “close contacts,” such as family members, friends or roommates, who will then be invited to take part in the trial.

Credit: B.Stefanov- stock.adobe.com

At the end of the study, the Moderna vaccine will be offered to all those in the control group in case they change their minds about vaccination. All individuals who choose to be vaccinated will get their second mRNA vaccine dose one month after the first.

All study volunteers will be compensated for their time and participation, even if they never choose to get vaccinated.

For more information, please call (813) 974-4842 or email CRC@usf.edu, or visit PreventCovidU.org to sign up.

Early treatment with the FDA-approved antiparasitic drug nitazoxanide prevents mild or moderate COVID-19 symptoms from progressing to severe illness and hospitalization, a clinical study co-led by USF Health’s Christian Bréchot, MD, PhD, indicates.

The Phase 3 randomized, double-blind, controlled clinical trial, conducted at 36 centers in the U.S. and Puerto Rico, was led by Jean-Francois Rossignol, MD, PhD, executive chairman of Tampa-based Romark LLC, and Christian Brechot, MD, PhD, president of the Global Virus Network; associate vice president for International Partnerships and Innovation at USF; and professor, Division of Infectious Disease, Department of Internal Medicine at the USF Health Morsani College of Medicine.

The findings posted April 20 to medRxiv, a preprint server for health sciences.

USF Health’s Christian Brechot, MD, PhD, co-led the multicenter clinical study.

“Combining safe, potent therapies with vaccination programs will be critical to controlling this pandemic,” study principal investigator Dr. Brechot said. “Despite the remarkable advances in developing effective COVID-19 vaccines, we still urgently need new treatments to help prevent severe disease and hospitalizations.”

This is particularly the case earlier in the disease – before the COVID-19 virus replicates extensively and infection spreads from the lungs, potentially triggering an immune system-induced “cytokine storm” that damages other organs. Monoclonal antibodies, while achieving promising results when infused early enough, are costly, prone to resistance by viral mutations, and must be administered in a hospital or clinic, Dr. Brechot added.

Nitazoxanide, an existing drug widely prescribed to treat intestinal parasites, has a proven safety record in children and adults. In cell culture studies, it has been shown to inhibit replication of several different respiratory viruses, including the human coronavirus MERS, influenza viruses, and rhinoviruses. Researchers attribute the drug’s broad-spectrum antiviral activity to its interference with cell pathways that the virus exploits to multiply. Recently, nitazoxanide was identified as a promising candidate for early treatment of SARS-CoV-2.

With this in mind, the team led by Dr. Rossignol and Dr Brechot investigated whether nitazoxanide, could be repurposed to stop mild or moderate COVID-19 from worsening.

In the latest clinical trial, the researchers tested the effectiveness of nitazoxanide in 379 outpatients, ages 12 to 83, with laboratory-confirmed mild or moderate COVID-19. Study participants (whose COVID respiratory symptoms began no more than 72 hours before entering the trial) were randomized into one of two groups, both treated for five days. One group received 300 mg. extended release nitazoxanide tablets twice daily (a 600 mg dose); the second group received placebo tablets matching the real drug’s appearance twice daily.

Monoclonal antibodies, which have shown promise for early COVID-19 treatment, are costly, administered at a hospital or clinic, and prone to resistance by viral mutations.

Among the findings of the efficacy analysis:

• Time to sustained response (a measure of how long COVID mild or moderate symptoms lasted) was not reduced by nitazoxanide.

• Nitazoxanide treatment was associated with an 85% decrease in progression to severe illness, compared to placebo. Only one of all 184 outpatients in the nitazoxanide group progressed to severe disease (a rate of 0.5%), while seven out of 195 (3.6%) in the placebo group did.

• A subgroup of 238 study participants (63% of the total 379) were at high risk of developing severe COVID illness based on Centers for Disease Control and Prevention (CDC) criteria (age, underlying medical conditions, etc.). Of these higher-risk individuals the rate of progression to severe disease was significantly lower for the nitazoxanide-treated group (0.9%), than for the placebo group (5.6%).

• Treatment reduced the rate of hospitalization by 79% in the nitazoxanide group (0.5%), compared to the placebo group (2.6%).

The researchers emphasize that larger studies are needed to confirm their results.

New, easily accessible antiviral treatments are still urgently needed to prevent the progression of mild or moderate COVID-19 to severe illness and hospitalizations.

“The availability of a safe, oral, scalable, host-directed antiviral for the early treatment of COVID-19 in persons at high risk of severe illness could play an important role in reducing the number of severe illnesses and hospitalizations during this ongoing major public health crisis,” they concluded.

The study was funded by the Romark Institute for Medical Research.

USF Health’s Jerri Edwards, PhD, recently ranked #8 among National Institute of Health-funded principal investigators in Psychiatry by the 2018 Blue Ridge Institute for Medical Research Rankings, with funding of $4,602,776.

Dr. Edwards, a professor of psychiatry and behavioral neurosciences at the USF Health Morsani College of Medicine, was ranked among 1,170 principal investigators in Departments of Psychiatry nationwide.  She is nationally recognized for her research examining the effectiveness of computerized cognitive training in preventing or delaying Alzheimer’s disease and related dementias, as well as normal age-related cognitive decline. She also studies how music training may improve cognitive abilities — such as thinking, remembering and reasoning — in older adults who are non-musicians.

Jerri Edwards, PhD

Dr. Edwards is the co-principal investigator for a new $2.7 million randomized controlled clinical trial known as Preventing Alzheimer’s with Cognitive Training, or the PACT study, which is funded by the NIH’s National Institute on Aging.  USF is conducting this first-of-its kind, large primary prevention trial with Michigan State University (David Morgan, PhD, co-principal investigator).  The researchers are examining whether a specific regimen of computer brain exercises can significantly reduce the risk of cognitive decline, or dementias like Alzheimer’s disease, in a healthy, diverse population of adults age 65 or older.

The PACT study builds upon previously published research by Dr. Edwards and others indicating that computerized brain training targeting specific cognitive functions and challenging older adults to adapt their performance over time can help maintain mental and physical function. In the case of the 2017 Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study, such training even reduced the risk of dementia. Conclusive evidence about whether and how brain training can protect against Alzheimer’s-related cognitive impairment is still needed.

Prevention research takes on increased urgency in the wake of recent failures of investigational Alzheimer’s drugs from major pharmaceutical companies to halt brain degeneration.

For more information on the PACT study go to www.pactstudy.org or call the USF Cognitive Aging Lab at (813) 974-6703.

Jan. 29, 2019 – What if solving brain games and puzzles on a computer could reduce the chances of developing dementia such as Alzheimer’s or delay the debilitating loss of function associated with the disease?

That’s the question researchers from the University of South Florida (USF) are seeking to answer through a pioneering new study that will test a training regimen designed to improve brain function. Using a $2.7-million grant from the National Institutes of Health (NIH), the researchers are developing a clinical trial for up to 1,600 older adults, who will learn a mental exercise routine focused on processing information to target cognitive improvements over time.

“This is a large primary prevention trial to examine if computerized cognitive exercises will reduce the risk of dementia,” said Elizabeth Hudak, PhD, research assistant professor at the USF Health Morsani College of Medicine (MCOM). “It is the first-of-its-kind study that will train adults on these exercises.”

As one ages, cognitive functions associated with thinking and memory can decline. Dementia is a general term for a decline that interferes with daily life, and Alzheimer’s is the most common form of dementia.

An estimated 5.7 million Americans live with Alzheimer’s today. By 2050, the number is projected to rise to nearly 14 million, according to the Alzheimer’s Association.

The primary investigators of the new study “Preventing Alzheimer’s Disease with Cognitive Training” are Jerri Edwards, PhD, of the MCOM Department of Psychiatry and Behavioral Neurosciences and David Morgan, PhD, of Michigan State University. They will oversee four training facilities, three in Tampa Bay and one in Michigan, which will each host up to 400 older adults.

One of the training sites will be located on the campus of USF St. Petersburg (USFSP).

“What we have learned is that the types of activities people do as they age really matter,” said Jennifer O’Brien, PhD, assistant professor of psychology who will supervise data collection and analysis at USFSP. “Those that target these cognitive functions that continue to challenge a person and adapt with performance across time are beneficial to improving quality of life.”

The clinical trial at USF will consist of a variety of brain games on a computer in which participants are asked to indicate what they saw or heard and solve puzzles. Each participant will visit a training facility three times to learn how to follow the mental regimen. Over three years, they will complete a total of 45 hours of computerized training exercises on their own. Researchers will then monitor for cognitive improvements or signs of decline.

Prior studies have shown such training is an effective way to reduce chances of developing dementia. In 2017, findings from the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study showed that among nearly 3,000 healthy older adults, those who completed 11 or more computerized sessions were up to 48 percent less likely to develop dementia across a 10-year period than adults who did no exercises at all.

“Cognitive training enhances mental quickness and visual attention, improves gait speed and balance, promotes safer and prolonged driving mobility and maintains health and well-being, including protection against depression,” said Alisa Houseknecht, coordinator of the clinical trial at USF.

The researchers will recruit adults age 65 and older who are willing to commit to the exercise training and are not experiencing dementia or other forms of neurological disease. A family history of Alzheimer’s does not disqualify a person.

Ultimately, researchers hope this short-term study will show enough feasibility for a longer, more rigorous clinical trial in the future. If the researchers can enroll 1,600 older adults in the trial, the research team will apply for a larger grant to train and monitor a cohort of participants for five to seven years. For the follow-up study, neuroimaging of the brain and genetic testing will be incorporated to get a better understanding of which individuals are more likely to develop dementia and would benefit from this training.

“We will be looking across time to see who ends up with dementia and who does not,” O’Brien said. “We estimate that even if this intervention delays onset of dementia by only one year, that would be 9.2 million fewer cases across the next 30 years.”

For more information about the clinical trial, visit: www.pactstudy.org or call the Cognitive Aging Lab at 813-974-6703.

Those helped by the new injectable enzyme therapy, recently approved by the FDA, can safely eat foods that have been forbidden for years

Patient Jennifer Mazorra, left, is examined by USF Health’s Dr. Amarilis Sanchez-Valle, a lead researcher for the clinical trial leading to recent FDA approval of the first injectable enzyme therapy for adults with the rare genetic disease PKU.

Jennifer Mazorra has spent most of her life on a diet that severely restricted what she could eat – no meat, fish, eggs, and dairy or other high-protein foods, no artificial sweeteners, and carefully measured amounts of fruits, vegetables and starches.

Mazorra, 35, was diagnosed as a newborn with the rare genetic disease phenylketonuria, or PKU, which prohibits the body from breaking down the amino acid phenylalanine found in all natural proteins. The condition is primarily controlled by a strict diet that can be difficult to maintain. If unmanaged, PKU can damage the nervous system and lead to chronic intellectual, developmental and behavioral problems.

“I was born with PKU – it’s detected by one of the screening tests that all newborns get with a heel stick. As an infant, my mother had to stop breastfeeding and give me a special formula that replaced all the essential amino acids except phenylalanine,” said Mazorra, a nurse practitioner who lives in Naples, Fla. “As a child, she was always aware that every morsel of food that went into my mouth could be tied to my IQ as an adult.”

So Mazorra enthusiastically agreed when USF Health physician Amarilis Sanchez-Valle, MD, of the USF Health Metabolic Clinic, which Mazorra visits routinely to monitor her PKU, suggested a potential option to the lifelong dietary regimen.  In 2014, Mazorra became one of the first participants in a study testing a new injectable drug for adults with PKU.

Dr. Sanchez-Valle directs the USF Health Metabolic Clinic, serving a 14-county service area in Florida, which treats children and adults with all types of hereditary errors in metabolism.

Dr. Sanchez-Valle was a lead investigator of a clinical trial for that injectable enzyme therapy, which had shown promise in breaking down and lowering blood phenylalanine concentrations in those difficult to treat with existing therapy.

The drug, Palynziq, developed by BioMarin Pharmaceutical Inc., was approved in May 2018 by the U.S. Food and Drug Administration.

It took more than a year for Mazorra to start feeling the effects of the drug, and she coped with a milder form of one of its most serious side effects, allergic reaction, by taking an antihistamine before injecting Palynziq.  (All patients treated with Palynziq must be prescribed and instructed how to use auto-injectable epinephrine in case of severe allergic reaction while taking Palynziq.) Pain, sensitivity or itching at the injection site and joint pain are the most common side effects, which typically subside quickly, Dr. Sanchez-Valle said.

The reactions were worth the effort, Mazorra said, when the therapy dropped her phenylalanine levels to normal for the first time in her life and helped her feel healthier.

“My quality of life has been so much better,” she said. “I can think more clearly now.  I’m more energetic and my mood is improved.”

Mazorra, diagnosed with PKU as an infant, has been able to attain phenylalanine levels within normal ranges by taking Palynziq.   She is part of a continuation study investigating differing doses of the new drug.

Dr. Sanchez-Valle, an associate professor of pediatrics who treats children and adults with inherited metabolic disorders from across the university’s 14-county service area, said patients traveled from as far away as Miami over the last few years seeking out a study offering a potential alternative to the PKU diet.

“It’s an exciting time for patients with PKU,” she said. “With this newly approved medication, we’re seeing what we never have before – patients eating normal diets and maintaining levels of phenylalanine within normal ranges.”

Mazorra credits Dr. Sanchez-Valle and her USF Health team for giving her the confidence to become pregnant when others had warned her of the risk of complications from maternal PKU. Babies do not inherit the disorder unless both parents carry the PKU gene, but high levels of phenylalanine in the mother can pass through the placenta as toxins, putting a child at risk for heart problems, cognitive delays and other birth defects.

Mazorra had to stop taking Palynziq weeks before and all during pregnancy, and stick to the strict diet again while battling food cravings.  It wasn’t easy, but with careful monitoring and the help of a metabolic dietitian, she and her husband are now the proud parents of a healthy 8-month-old boy, Sebastian.

Mazorra at home with 8-month-old son Sebastian and husband Gabe. | Photo courtesy of Jennifer Mazorra

Six weeks after giving birth Mazorra resumed Palynziq.  And, she is participating in a continuation study investigating differing doses of the new drug in an expanded population of adult patients to track long-term safety and effectiveness.  Dr. Sanchez-Valle is hopeful that eventually the drug will be studied in teens.

Meanwhile, Mazorra focuses more on her improved quality of life than on long-term effects. Things as simple as enjoying peanut butter toast, a snack off limits to her since childhood.

“I eat peanut butter toast every day now,” she said.

-Photos by Freddie Coleman, USF Health Communications and Marketing

USF Health professor Dr. Richard Lockey helping develop rare blood disorder drug

Asphyxiation is a frightening experience, not just for the sufferer, but also for those who’ve witnessed someone’s inability to breathe.

University of South Florida professor Dr. Richard Lockey is working to prevent some people from ever facing that life-threatening attack.

He’s involved in a study recently published in the New England Journal of Medicine testing a first-of-its kind medication for those with hereditary angioedema and a C1 inhibitor deficiency. The rare blood disorder causes spontaneous swelling in various parts of the body, which could be deadly if it occurs in areas such as the tongue or larynx.

Richard Lockey, MD

Lanadelumab is a monoclonal antibody administered by injection every two weeks, helping patients avoid asphyxiation and costly trips to the emergency room, allowing them to live a full life. Previously, up to 20 percent died before the age of 20. Existing long-term preventive treatments can cause serious side effects for a significant percentage of patients.

Thirty-seven patients from across the country participated in the multisite, double-blind, placebo-controlled clinical trial (Phase 1).  Dr. Lockey says in this early study lanadelumab was almost 100 percent effective, with minimal side effects. The drug works by inhibiting the enzyme kallikrein, blocking a cascade of molecular processes leading to angioedema.

“If this disease is in your family and you inherit the gene, we can give you this monoclonal antibody every two weeks to prevent attacks (of spontaneous swelling) from occurring,” said Dr. Lockey, director of the Division of Allergy and Immunology in the USF Health Morsani College of Medicine Department of Internal Medicine.  “It can enable people to live a normal life.”

Once the study is complete, researchers hope to win FDA approval, stocking pharmacy shelves in the next couple years.

About 10,000 people are diagnosed with hereditary angioedema.

– Story by Tina Meketa, USF Communications

Tampa, FL (Dec. 2, 2014) — The University of South Florida (USF) Morsani College of Medicine is conducting a clinical research study on erectile dysfunction (ED) in patients suffering from Parkinson’s disease.  The principal investigator for the study is Dr. Theresa Zesiewicz, a medical doctor, professor of neurology and the director of clinical research for the USF Frances Zesiewicz Parkinson’s Research Foundation.

The new pilot study will test the safety and effectiveness of an investigational combination medication for ED in patients with Parkinson’s disease who fail to respond to current standard ED medications.  Enrollment begins this month.

While Parkinson’s disease is a movement disorder, the non-movement symptoms, including ED can present challenges to the normal activities of life.  ED is more common in men with Parkinson’s disease, with a reported prevalence rate of approximately 60 percent.  The current standard of care is oral treatment with phosphodiesterase-5 inhibitor (PDE-5i) medications, such as Cialis^®, Viagra^®, or Levitra^®; however, a large percentage of these patients fail to respond adequately to this treatment.

Dr. Theresa Zesiewicz

“Clearly, this is a patient population in need of improved treatments,” said Dr. Zesiewicz. “The non-motor symptoms of Parkinson’s disease are often more bothersome and hinder quality of life to a greater degree than the motor symptoms of the disease, including tremor and rigidity. It’s important that we continue to identify non-motor symptoms in our patients and develop new strategies to treat them.”

In the current clinical study, Dr. Zesiewicz will treat volunteer, Parkinson’s disease patients who have ED with a combination medication designed to help those who respond poorly to PDE-5i medications, such as Cialis^®, Viagra^®, or Levitra^®_.  All qualifying study participants will receive the active medications. Participant progress and the effectiveness of the medication will be monitored and assessed in comparison to baseline values. Sagene Pharmaceuticals Inc., of Oldsmar, FL, which holds the intellectual property for the combination medication, is helping to fund this study. The pilot study is designed to help determine the value of this product as a potentially new treatment for ED in the Parkinson’s population.

The USF Parkinson’s Disease Foundation and Clinical Research Center treats approximately 2,500 patients per year from the Tampa Bay region and surrounding areas. Located in the Carol & Frank Morsani Center for Advanced Healthcare on the USF Tampa campus, the center focuses on clinical care and new therapies for motor and non-motor symptoms of Parkinson’s disease. Dr. Zesiewicz and nurse practitioners Tracy Jones, ARNP, and Terry McClain, ARNP, provide state-of-the-art care to patients with Parkinson’s disease.

For more information, please call 813-974-5909 and ask to speak to Tanya Aranca or Kevin Allison.

About Sagene Pharmaceuticals

Sagene Pharmaceuticals is a biopharmaceutical company developing novel applications for combinations of FDA-approved drugs to treat ED. Sagene has shown that its patented combinations can enhance efficacy of current ED treatments by targeting multiple disease pathways not typically addressed by approved drugs. The combination approach for treating diseases with FDA-approved drugs to improve their therapeutic effect, reduces development risk, time and costs by utilizing the 505(b)(2) NDA approval process. Sagene has assembled a team of experts experienced in drug development, clinical trials and regulatory affairs. Sagene has conducted preclinical studies showing proof of concept and the benefits of combination therapy in laboratory animals and human platelets. Sagene is seeking funding partners to develop its ED combination in areas of unmet need such as Parkinson’s disease and diabetes. The company is headquartered in Oldsmar, FL.

For more information about Sagene Pharmaceuticals, please visit the Company’s website at www.sagenepharma.com.

About USF Health USF Health’s mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the College of Pharmacy, the School of Biomedical Sciences and the School of Physical Therapy and Rehabilitation Sciences; and the USF Physician’s Group. The University of South Florida is a Top 50 research university in total research expenditures among both public and private institutions nationwide, according to the National Science Foundation. For more information, visit www.health.usf.edu

Media contact:
Anne DeLotto Baier, USF Health Communications
abaier@health.usf.edu or (813) 974-3303

Tampa is only site on Florida’s west coast for the large-scale, NIH-funded clinical trial

Tampa, FL (June 9, 2014) — A new clinical trial at USF Health is evaluating the ability of a common antibiotic, doxycycline, to slow the growth of small abdominal aortic aneurysms, possibly preventing or delaying the need for surgery.

USF Health is one of only two sites in Florida, and 16 nationwide, participating in the $12.2-million study sponsored by the National Institutes of Health.  The other Florida site is Baptist Health Medical Center in Miami.

“The intent is to test if doxycycline — which is widely available, relatively inexpensive, and has minimal side effects — can reduce inflammation in the abdominal aorta and prevent small aneurysms from becoming larger,” said local principal investigator Murray Shames, MD, a vascular surgeon at USF Health Morsani College of Medicine and Tampa General Hospital.

“If drug treatment can do that, we could potentially improve care and reduce the costs of surveillance and operations needed to fix large aneurysms.”

USF Health/TGH vascular surgeon Dr. Murray Shames leads the local NIH-sponsored trial testing the effects of the common antibiotic doxycycline on the growth of abdominal aortic aneurysms.

An abdominal aortic aneurysm is a ballooning or bulge in the lower part of the aorta, a major blood vessel running from the heart through the center of the chest and abdomen. Since the aorta is the body’s main supplier of blood, a ruptured abdominal aortic aneurysm can cause life-threatening bleeding.  If an aortic aneurysm bursts, it is fatal more than half the time.

When aortic aneurysms are small and low risk, less than 5 cm. or about the size of a plum, doctors closely monitor with ultrasound any changes in the aneurysm’s size and rate of growth.  Surgery is performed to fix the aneurysm only when it reaches a size at which the risk of rupture outweighs the risk of surgery.

USF expects to enroll 25 patients, ages 55 and older who have been diagnosed with small abdominal aortic aneurysms, in the local trial.  Nationwide, 248 men and women will be enrolled.

Abdominal aortic aneurysms typically grow slowly, no more than a half-centimeter each year, and predicting which ones will enlarge rapidly is difficult, Dr. Shames said. “Right now we watch and wait until the aneurysm gets bigger to intervene, because there’s nothing else to do. That waiting can create a lot of anxiety for patients.”

Bernard Remas, 82, of Fort Myers, was one of the first patients enrolled in the randomized, double-blind, placebo-controlled trial at USF Health.  Remas’s abdominal aortic aneurysm was diagnosed about two years ago.  Like many people, he experienced no symptoms and his aneurysm was diagnosed by doctors when he underwent an imaging test for another reason.

Patients are randomized to receive either two doses of doxycycline a day, or a placebo. They will be followed for two years, getting their blood drawn and CT scans every six months.

Remas doesn’t know if he’s taking the tested drug or a placebo, but he says “the study seemed like a good thing to do…it’s pretty easy and painless.” If taking a medication could safely help him avoid an operation to repair an aneurysm, that would be preferable, he said.

USF Health’s Dr. Shames was involved in some earlier rat studies showing that doxycycline and similar anti-inflammatory drugs helped block the enzymes that weaken aortic walls.  Now, he’s part of a comprehensive trial that will determine whether the promising data gained from years of animal studies for slowing aneurysm growth can be replicated in humans.

“If treatment with this medication proves effective, it could become the gold standard for treating small abdominal aortic aneurysms,” he said.

Adominal aortic aneurysm is more common in men and those age 65 or older. Risk factors include family history, smoking, high blood pressure, high cholesterol and atherosclerosis (hardening of arteries).  The U.S. Preventive Services Task Force recommends ultrasound screening for abdominal aortic aneurysms for men ages 65 to 75 who have ever smoked, even if they have no symptoms.

For more information about the Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial at USF Health, please contact Stephenie Yapchanyk, vascular surgery research coordinator at (813) 259-0683, or Syapchan@health.usf.edu

  -USF Health-
USF Health’s mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the College of Pharmacy, the School of Biomedical Sciences and the School of Physical Therapy and Rehabilitation Sciences; and the USF Physician’s Group. The University of South Florida is a Top 50 research university in total research expenditures among both public and private institutions nationwide, according to the National Science Foundation. For more information, visit www.health.usf.edu

-Tampa General Hospital-
Tampa General is a 1018-bed academic medical center on the west coast of Florida that serves as the region’s only center for Level l trauma, comprehensive burn care, and adult solid organ transplants. It is the primary teaching hospital for the USF Health Morsani College of Medicine. TGH is a comprehensive stroke center and a state-certified spinal cord and brain injury rehabilitation center.

Media contacts:
Anne DeLotto Baier, USF Health Communications, (813) 974-3303, or abaier@health.usf.edu
Ellen Fiss, Tampa General Hospital, (813) 844-6397, or efiss@tgh.org

Photo by Eric Younghans, USF Health Communications

The U.S. Food and Drug Administration yesterday designated fast-track status to EPI-743 for the treatment of Friedreich’s ataxia – a move that will help accelerate clinical development of the investigational drug, currently being tested in a multisite, double-blind, placebo-controlled trial led by the University of South Florida.

The phase 2b clinical trial of EPI-743 in adults with Friedreich’s ataxia, sponsored by Edison Pharmaceuticals, Inc., in collaboration with the Friedrich’s Ataxia Research Alliance, has been underway since early 2013 at the USF Health, the Children’s Hospital of Philadelphia and the University of California in Los Angeles.  Neurologist Theresa Zesiewicz, MD, director of the USF Ataxia Research Center, is the lead investigator for the national trial.

Researchers are primarily testing the effectiveness of EPI-743, a potent antioxidant, on vision, in patients with Friedreich’s ataxia, many of whom experience varying degrees of visual changes. Secondarily, the study is evaluating neurological function.

For more on the fast track status of EPI-743, go to: http://www.firstwordpharma.com/node/1195801#axzz2wKgT2a1W

//www.youtube.com/watch?v=wcaOx28CjKg

NT-020, a proprietary supplement including blueberries and green tea, improved cognitive processing speed in clinical trial participants without impaired memory

Tampa, FL (Feb. 6, 2014) – Declines in the underlying brain skills needed to think, remember and learn are normal in aging. In fact, this cognitive decline is a fact of life for most older Americans.

Therapies to improve the cognitive health of older adults are critically important for lessening declines in mental performance as people age. While physical activity and cognitive training are among the efforts aimed at preventing or delaying cognitive decline, dietary modifications and supplements have recently generated considerable interest.

Now a University of South Florida (USF) study reports that a formula of nutrients high in antioxidants and other natural components helped boost the speed at which the brains of older adults processed information.

The USF-developed nutritional supplement, containing extracts from blueberries and green tea combined with vitamin D3 and amino acids, including carnosine, was tested by the USF researchers in a clinical trial enrolling 105 healthy adults, ages 65 to 85.

University of South Florida researchers Paula Bickford, PhD, and Brent Small, PhD, teamed up to investigate the effects of a USF-developed, antioxidant-rich nutritional supplement on the cognitive performance of older adults.

The two-month study evaluated the effects of the formula, called NT-020, on the cognitive performance of these older adults, who had no diagnosed memory disorders.

Those randomized to the group of 52 volunteers receiving NT-020 demonstrated improvements in cognitive processing speed, while the 53 volunteers randomized to receive a placebo did not. Reduced cognitive processing speed, which can slow thinking and learning, has been associated with advancing age, the researchers said.

The study, conducted at the USF Health Byrd Alzheimer’s Institute, appears in the current issue of Rejuvenation Research (Vol. 17 No. 1, 2014).  Participants from both groups took a battery of memory tests before and after the interventions.

“After two months, test results showed modest improvements in two measures of cognitive processing speed for those taking NT-020 compared to those taking placebo,” said Brent Small, PhD, a professor in USF’s School of Aging Studies. “Processing speed is most often affected early on in the course of cognitive aging. Successful performance in processing tasks often underlies more complex cognitive outcomes, such as memory and verbal ability.”

Blueberries, a major ingredient in the NT-020 formula, are rich in polyphenols, a type of antioxidant containing a polyphenolic, or natural phenol substructure.

“The basis for the use of polyphenol-rich nutritional supplements as a moderator of age-related cognitive decline is the age-related increase in oxidative stress and inflammation,” said study co-principal investigator Paula C. Bickford, PhD, a professor in the Department of Neurosurgery and Brain Repair, USF Health Morsani College of Medicine, and senior research career scientist at the James A. Haley Veterans’ Hospital in Tampa. “Non-vitamin polyphenols are the most abundant modulators of oxidative stress and inflammation in our diet. NT-020 is 95 percent polyphenols.”

One of the main ingredients of the supplement, called NT-20, is extracted from blueberries.

In several preclinical trials, researchers gave aging laboratory rats NT-020 to see if it boosted memory and other cognitive performance by promoting the health of neurons in the aging brain. Those studies demonstrated that NT-020 promoted the growth of stem cells in the brain, produced an overall rejuvenating effect, benefitted animals with simulated stroke, and led to better cognitive performance.

The researchers plan future clinical trials with longer intervention periods so that the optimal time for taking the formula may be better understood.  The researchers speculated that if the study had included participants cognitively less healthy, or those with memory impairments, they may have observed “more robust findings.”

“In the future, having markers of oxidative stress and inflammation, as well as brain-based measures of functioning, may allow us to identify the manner by which this compound, as well as others, may influence functioning,” they concluded.

The NT-020 formula was patented by the University of South Florida, in partnership with the James A. Haley Veterans’ Hospital, and licensed to Natura Therapeutics, Inc.  The supplement is commercially available as NutraStem®.

The study was supported by a grant from the University of South Florida Neuroscience Collaborative to Dr. Small and Dr. Bickford.

Dr. Bickford is a co-founder of Natura Therapeutics, Inc.

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Video Editor:  Klaus Herdocia, USF Health Communications

Media contact:
Anne DeLotto Baier, USF Health Communications
abaier@health.usf.edu or (813) 974-3303

Media release by Florida Science Communications, Inc.