Medical/Dental Professionals

Research and Clinical Trials

New PDD/LBD Treatment Tested in UB Clinical Trial

The Jacobs School of Medicine and Biomedical Sciences is among 72 sites nationwide that are recruiting patients for a 12-week, randomized, placebo-controlled drug trial for the first treatment designed to benefit patients with mild-to-moderate Lewy body dementia (LBD).

After Alzheimer’s disease, LBD and related Parkinson’s disease dementia (PDD) are some of the most common types of dementia affecting older adults; but they are severely understudied.

While LBD patients are often prescribed medications that treat psychosis and Alzheimer’s disease, there are no medications designed specifically to treat LBD.

Eli Lilly and Company has launched a clinical trial in hopes of changing that.

“Participating in this trial could help push this drug more quickly through the pipeline,” says Kinga Szigeti, MD, PhD, associate professor of neurology, who is principal investigator at UB.

LBD and PDD affect an estimated 1.4 million Americans. The condition often occurs after a patient has been diagnosed with Parkinson’s disease, the symptoms of which often begin with the inability to control movements but then progress to affect cognition.

In LBD, cognitive decline is the first symptom, frequently followed by Parkinsonian features. Both diseases are characterized by abnormal protein deposits called alpha-synuclein, which form Lewy bodies in the neurons.

A key distinction between PDD and most other kinds of dementia are the neuropsychiatric symptoms that can occur — such as hallucinations and Capgras delusion or “impostor syndrome” — where patients believe that a loved one has been replaced by an identical impostor.

“The neuropsychiatric symptoms can make this kind of dementia much more challenging for families to deal with than Alzheimer’s disease,” Szigeti says.

PDD symptoms also include a tendency to sleep for long periods at a time, sometimes 14-16 hours per day.

“Sleeping so much can cause patients to lose muscle mass, becoming more frail and more prone to infection,” Szigeti explains. “Changes in the nervous system can lead to an unhealthy drop in blood pressure and patients become more prone to falls.”

For these reasons, she notes, patients with this kind of dementia have a lifespan that is much shorter than for Alzheimer’s patients.

“Lewy body dementia has been very understudied in clinical trials,” Szigeti says.

While some medications used to treat psychosis can mitigate certain aspects of LBD, many of them also increase the risk of stroke or even death.

“For that reason, many patients and their families feel they have no options,” Szigeti says. “They find themselves between a rock and a hard place.”

But now, Western New York patients have an opportunity to participate in the first clinical trial to test a medication for LBD at the Jacobs School.

The advantage of the new drug — known as LY3154207 — is that it has a novel mechanism of action on dopamine, the brain chemical that Parkinson’s disease rapidly depletes.

The drug was designed to maximize the brain’s response to the remaining dopamine, therefore improving cognition, motor function and boosting wakefulness. It is taken in pill form.

“We are for the first time offering hope to these patients and their families, and an opportunity to participate in this trial,” Szigeti says.

Interested patients will be seen at UBMD Neurology, where Szigeti is director of its Alzheimer’s Disease and Memory Disorders Center.

Landmark Concussion Study May Change Standard of Care

Jacobs School of Medicine and Biomedical Sciences researchers have published results of the first randomized clinical trial of a treatment in the acute phase after a sport-related concussion.

The study, published Feb. 4 in JAMA Pediatrics, found that adolescent athletes who sustained concussions while playing a sport recovered more quickly when they underwent a supervised, aerobic exercise regimen.

The goal was to evaluate prescribed, progressive sub-symptom threshold exercise as a treatment within the first week of a concussion in adolescents after a few days of rest. Sub-symptom threshold exercise is physical activity that doesn’t exacerbate symptoms.  ​

The researchers followed 103 participants ages 13 to 18, with nearly the same number of males and females. All were seen at one of the UBMD Orthopaedics & Sports Medicine clinics in Western New York or at the Pan Am Clinic in Winnipeg, Manitoba, Canada, within 10 days after sustaining a sport-related concussion.

Patients who followed the aerobic exercise program took on average 13 days to recover while those in the control group, who performed stretching exercises, took 17 days. In addition, fewer patients in the exercise program took longer than four weeks to recover than did patients in the control group.

“This research provides the strongest evidence yet that a prescribed, individualized aerobic exercise program that keeps the heart rate below the point where symptoms worsen is the best way to treat concussion in adolescents,” says John J. Leddy, MD, clinical professor of orthopaedics and first author on the study.

Leddy, who is also director of the University at Buffalo Concussion Management Clinic, says the research team plans to investigate if the treatment is also effective in adults with concussion.

The researchers note that there is no proven treatment for concussion, especially among adolescents, who typically take the longest to recover.

“Until now, nothing else has been proven in any way effective for treating concussion,” says Barry S. Willer, PhD, senior author on the study, professor of psychiatry and director of research in the University at Buffalo Concussion Management Clinic. “This is the best evidence so far for a treatment that works.”

The findings directly contradict the conventional approach to concussion, which often consists of nearly total rest and eliminating most physical and mental activities, including schoolwork.

“Telling a teenager to go home and basically do nothing is depressing,” Willer says. “It can actually increase their physical and psychological symptoms and we see that particularly among girls. But with our approach, you’re saying, sure, you can return to school and you should start doing these exercises. Their chins are up, Mom and Dad are happy and so is the student.”

The fact that all states have now passed laws requiring schools to make accommodations for students who have sustained concussions is also helpful, Willer says, so that the student can opt out of some activities during the school day, if necessary.


Preventing Type 2 Diabetes with an Innovative Behavioral Weight Loss Program

The vast majority of people with prediabetes transition to Type 2 Diabetes. While Type 2 Diabetes can be prevented with weight loss and a change in lifestyle, many people with prediabetes discount the future and don’t focus on preventive health behaviors.  A clinical study conducted by Leonard H. Epstein, PhD, SUNY Distinguished Professor of Pediatrics, is evaluating an innovative behavioral weight control and habit change program to determine whether the program prevents persons with prediabetes from progressing to Type 2 Diabetes.  The study is funded by the National Institute of Diabetes and Digestive and Kidney Diseases.

The study will include people with prediabetes who are overweight or obese who have also been diagnosed with high cholesterol or high blood pressure. The majority of people with prediabetes also have high cholesterol or high blood pressure. The program consists of group sessions over six months where participants learn new healthy behaviors. Participants also engage in one-on-one sessions with a case manager to review progress and develop dietary intake and physical activity plans and make better decisions about habits that can prevent developing Type 2 Diabetes. The outcomes being evaluated include improvements in weight loss, decision-making, blood sugar levels, and prescription medication adherence. 

“The prevention of Type 2 Diabetes in an obese person with prediabetes requires developing a healthier lifestyle. The rational approach for someone with prediabetes would be to eat healthier, be more active, lose weight, and manage their comorbidities. However, research suggests that as many as 80% of individuals with prediabetes and hypertension and/or dyslipidemia will progress to Type 2 Diabetes,” said Epstein.

Researchers hope the study, titled MINDD 4 (Multisite Intervention Neuroimaging and Delay Discounting), will help prevent development of Type 2 Diabetes to improve health across the lifespan.

To find out more about this clinical study and other research being conducted by the University at Buffalo, contact UB Clinical and Translational Science Institute Recruitment Coordinator Briana Getman at 716-645-1376 or