The Parkinson?s Institute will participate in a large-scale national clinical trial to learn if the nutritional supplement creatine can slow the progression of Parkinson’s disease (PD). While creatine is not an approved therapy for PD or any other condition, it is widely thought to improve exercise performance.
The potential benefit of creatine for PD was identified by Parkinson?s researchers through a new rapid method for screening potential compounds. The trial, which begins today, is sponsored by the National Institutes of Health (NIH).
The double-blind, placebo-controlled, phase III study is one of the largest PD clinical trials to date. The Parkinson?s Institute is one of 51 medical centers in the United States and Canada that will be recruiting patients as part of an effort to enroll 1720 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 Parkinson?s Institute has been affiliated with the program since 2002. 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.”
The enrolling investigator at The Parkinson?s Institute is Dr. Melanie Brandabur. “This study is significant because it examines whether we can delay disability in Parkinson?s disease,” said Dr. Brandabur. “The length of the study is unprecedented. No study of a potential disease-altering therapy has followed patients for five years. This data will enable us to make more accurate conclusions about the longitudinal effect of this treatment compared with placebo. In addition, previous studies looking at potential disease modifying therapies were limited to a select group of very early patients.”
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.
Avicena Group, Inc. will provide the creatine and the placebo for the study.