University to conduct clinical trial for Parkinson's disease

The U-M Health System (UMHS) will participate in a large-scale national clinical trial to learn if the nutritional supplement creatine can slow the progression of Parkinson's disease. While creatine is not an approved therapy for the disease or any other condition, it widely is thought to improve exercise performance.

The potential benefit of creatine Parkinson's was identified by researchers through a new rapid method for screening potential compounds. The trial, which began March 22, is sponsored by the National Institutes of Health (NIH).

The double-blind, placebo-controlled, phase III study is one of the largest Parkinson's disease clinical trials to date. UMHS is one of 51 medical centers in the United States and Canada—and one of only two centers in Michigan—that will be recruiting patients as part of an effort to enroll 1,720 people with early-stage Parkinson's. Michigan State University also is participating.

"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 Dr. Elias Zerhouni, 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 the disease.

This is the first large study in a series of NIH-sponsored clinical trials called NET-PD (NIH Exploratory Trials in Parkinson's Disease). U-M researchers have been affiliated with the program since 2002. NIH has organized the large network of sites to allow researchers to work with Parkinson's patients over a long period of time, with a goal of finding effective and lasting treatments.

The primary investigator at U-M is Dr. Roger Albin, professor in the Medical School Department of Neurology and co-director of the UMHS Movement Disorders Clinic. "We're excited to participate in this large scale effort to slow the progression of PD," he says. U-M is a National Parkinson Foundation Center of Excellence.

Parkinson's disease 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 1 million people in the United States. Although certain drugs, such as levodopa, can reduce its symptoms, 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.

The study will enroll people who have been diagnosed with Parkinson's disease 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 Parkinson's result from the loss of dopamine, a neurotransmitter that helps to control movement.

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.

People interested in learning more about this study can obtain more information by calling (800) 352-9424, sending e-mail to info@parkinsontrial.org, or going to www.parkinsontrial.org to see a list of study sites.

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