The Parkinsonís Institute to conduct Phase III Clinical Trial of creatine for Parkinsonís disease
Nutritional supplement may slow progression of disease
The Parkinsonís Institute will participate in a large-scale national clinical trial to learn if the nutritional supplement creatine can slow the progression of Parkinsonís 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 Parkinsonís 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 Parkinsonís 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.
ďThis 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,Ē says Elias A. Zerhouni, M.D., director of the NIH. ďThe goal is to improve the quality of life for people with Parkinsonís for a longer period of time than is possible with existing therapies.Ē 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 Parkinsonís Disease). The Parkinsonís 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 Į from laboratory research to pilot studies in a select group of patients to the definitive phase III trial of effectiveness in people with PD.
ďThis study is an example of our commitment to Parkinsonís research,Ē said Story C. Landis, Ph.D., director of the National Institute of Neurological Disorders and Stroke (NINDS), the NIH institute leading the study. ďWe are trying to explore every possible option for reducing the burden of this disease.Ē
The enrolling investigator at The Parkinsonís Institute is Dr. Melanie Brandabur. ďThis study is significant because it examines whether we can delay disability in Parkinsonís disease,Ē said Dr. Brandabur. ďThe 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.Ē
This study follows patients that are still early in the disease process but already taking medications for their symptoms. Not only does this allow more patients to participate, it also generates data that is applicable to a wider range of PD patients. Another measure designed to broaden the applicability of the findings is the minority recruitment aspect, in which participating Institutionís will enroll a more diverse population into the study.
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.
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