Jefferson also participating in minority patient recruitment effort

		Neurology Pathology News Archive Featured in the Media JeffNEWS

Thomas Jefferson University Hospital in Philadelphia has been named one of 51 medical centers in the United States and Canada to participate in a large-scale, National Institutes of Health (NIH)-supported clinical trial to learn if the nutritional supplement creatine can slow the progression of Parkinson’s disease (PD).

The double-blind, placebo-controlled, phase III study is one of the largest PD clinical trials to date. The trial – which is expected to enroll 1,720 people with early-stage PD – is the first large study in a series of NIH-sponsored clinical trials called NET-PD (NIH Exploratory Trials in Parkinson’s Disease).

“The study is important because it is the first time that the NIH has undertaken such a large scale, long-term study of a possible Parkinson’s therapy aimed at slowing the course of the disease,” notes Jefferson principal investigator Jay Schneider, Ph.D., professor of pathology, anatomy and cell biology and neurology at Jefferson Medical College and director of the Parkinson’s Disease Research Unit at Thomas Jefferson University.

At the same time, Jefferson has garnered another distinction, being named one of only 15 centers nationwide that are participating in a consortium to develop strategies aimed at reversing a woeful lack of participation of ethnically diverse groups in PD trials. Few minority groups, such as African Americans, Hispanics and Asian Americans, for example, participate in Parkinson’s trials. The NET-PD group hopes to develop strategies to increase minority participation, recruiting and retaining diverse populations into the current trial.

PD is a progressive, degenerative disorder of the brain in which patients develop symptoms such as tremor, slowness of movements, and stiffness of muscles. It affects at least one million people in the United States. Although certain drugs, such as levodopa, can reduce the symptoms of PD, there are no proven treatments that can slow the progressive deterioration in function.

Studies have suggested that creatine can improve the function of mitochondria, which produce energy inside cells. It also may act as an antioxidant that prevents damage from compounds that are harmful to cells in the brain.

The study will enroll people who have been diagnosed with PD within the past five years and who have been treated for two years or less with levodopa or other drugs that increase the levels of dopamine in the brain. Many of the symptoms of PD result from the loss of dopamine, a neurotransmitter that helps to control movement. Half of the participants will receive creatine and half will receive a placebo. Neither the participants nor their doctors will know which treatment they receive. The investigators will measure disease progression using standard rating scales that measure quality of life, ability to walk, cognitive function, and the ability to carry out other activities of daily living.

As enrollment only now begins for this large creatine trial, Dr. Schneider hopes that the experimental educational program will increase recruitment of racially and ethnically diverse participants into the study.

“The problem of recruiting diverse populations into clinical trials is not unique to Parkinson’s disease trials,” says Dr. Schneider. “However, it is important to have different populations represented in evaluations of new treatments. This new intervention study is aimed at increasing community awareness about the NET-PD trial and fostering cooperation between neurologists and other physicians in the community who have minority Parkinson’s disease patients and the NET-PD researchers.

“We need to do a better job educating the lay public as well as community physicians about the value of having diverse populations participate in these types of clinical trials,” he says. “We know from other studies, particularly with some heart medications, that not all treatments work equally well for all groups. The hope is that if the strategy we use to increase minority enrollment is effective, it could become a model for use in future studies.”

For more information, contact the Parkinson’s Disease Research Unit at 215-955-8700.