Emory University is participating in one of the largest ever Parkinson's disease (PD) clinical trials to determine if the nutritional supplement creatine can slow the symptom progression of this disorder.
PD is a degenerative disorder of the brain in which patients develop tremor, slowness of movements and stiffness of muscles. It affects at least one million people in the U.S. Currently, there are a number of effective treatments to mask the symptoms but none to slow their progression.
Emory is among 51 medical centers in the U.S. and Canada recruiting the 1,720 participants with early-stage PD required to complete this study. The double-blind, placebo-controlled, phase III study is the first large national study following a series of smaller clinical trials sponsored by the National Institutes of Health (NIH).
"The premise for this important research study is supported by a large body of laboratory data and the promising results of an earlier smaller clinical study of creatine in Parkinson's disease," says Dr. Jorge Juncos, primary investigator at Emory University.
"If positive, the results will have a lasting impact in the treatment of all stages of this illness," says Dr. Juncos. "Our goal is to offer enhanced therapies to patients with Parkinson's that will improve their quality of life and slow the progression of symptoms."
Creatine is marketed as a nutritional supplement, but is not an approved therapy for PD or any other condition. Studies have suggested that it can improve energy production by the mitochondria, the "powerhouse" of cellular metabolism. In persons without PD and in patients with PD, it can improve exercise performance so long as the person is also exercising regularly. It is important to note that creatine is no substitute for exercise and its short-term use in PD does not directly affect motor symptoms, says Dr. Juncos.
Creatine also acts as an antioxidant to prevent damage from compounds that are harmful to cells in the brain. In mouse model studies of PD, creatine was able to prevent the loss of the dopamine cells in the brain, the same cells that are also affected in PD.
"This study is an example of our commitment to Parkinson's research," says Story C. Landis, PhD, 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 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 improve dopamine transmission in the brain. Many of the symptoms of PD result from the loss of dopamine, a brain chemical 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 to which the participants have been assigned.
The investigators will measure disease progression using standard rating scales that measure quality of life, cognitive function, walking and the ability to carry out other activities of daily living.
Source: Emory University