The double-blind, placebo-controlled, phase III study is one of the largest PD clinical trials to date. The Feinstein, based in Manhasset, NY, is one of 51 institutions in the United States and Canada – and one of only two in New York -- that will be recruiting patients as part of an effort to enroll 1,720 people with early-stage PD.

“This study is an important step. We are pleased to have so many sites participating in this study, which may help us move more quickly toward developing a therapy that could change the course of this devastating disease,” says Elias A. Zerhouni, M.D., director of the NIH. “The goal is to improve the quality of life for people with Parkinson's for a longer period of time than is possible with existing therapies.” Currently there is no treatment that has been shown to slow the progression of PD.

The trial is the first large study in a series of NIH-sponsored clinical trials called NET-PD (NIH Exploratory Trials in Parkinson's Disease).

The Feinstein’s primary investigator in this study is Andrew Feigin, MD, director of neuroscience experimental therapeutics, and associate director of the Harvey Cushing Institutes of Neuroscience Movement Disorders Institute at North Shore University Hospital in Manhasset, NY. Dr. Feigin has been doing research on creatine and Parkinson’s since 2002.

“We are excited to be part of this innovative study aimed at modifying the progression of Parkinson’s disease,” said Dr. Feigin. “North Shore University Hospital is one of only two sites in New York State (SUNY Downstate Medical Center in Brooklyn is the other) participating in this important study. This represents a unique opportunity for patients with PD in our area to get involved in clinical research.”

The NIH has organized this large network of sites to allow researchers to work with PD patients over a long period of time, with a goal of finding effective and lasting treatments. NET-PD builds on a developmental research process -- from laboratory research to pilot studies in a select group of patients to the definitive phase III trial of effectiveness in people with PD.

“This study is an example of our commitment to Parkinson’s research,” said Story C. Landis, Ph.D., director of the National Institute of Neurological Disorders and Stroke (NINDS), the NIH institute leading the study. “We are trying to explore every possible option for reducing the burden of this disease.”

PD is a degenerative disorder of the brain in which patients develop symptoms such as progressive 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.

Creatine is marketed as a nutritional supplement. Studies have suggested that it 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. In a mouse model of PD, creatine is able to prevent loss of the cells that are typically affected.

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.

Avicena Group, Inc. will provide the creatine and the placebo for the study.

PD patients interested in participating in the study at North Shore University Hospital can call 516-562-2905. For a complete list of study sites, call 1-800-352-9424, email info@parkinsontrial.org, or visit http://www.parkinsontrial.org.

The NINDS is a component of the NIH within the Department of Health and Human Services and is the nation’s primary supporter of biomedical research on the brain and nervous system.

The National Institutes of Health — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

About The Feinstein Institute for Medical Research

Headquartered in Manhasset, NY, and part of the North Shore-LIJ Health System, The Feinstein Institute for Medical Research is among the top six percent of all institutions that receive funding from the National Institutes of Health. Building on its strengths in neurodegenerative and psychiatric disorders, genomics and human genetics, immunology and inflammation, and oncology and cell biology, its goal is to understand the biological processes that underlie various diseases and translate this knowledge into new tools for diagnosis and treatment. For more information, please visit www.FeinsteinInstitute.org.

Media Contacts: Marian Emr or Margo Warren, 301-496-5924
Terry Lynam/Feinstein Institute 516-465-2640