dard therapies from 90 days to two years and follow them for five years. Half the enrollees will get creatine and half placebo. The hope is for at least a 20 percent reduction in disease progression, so that at the end of five years, patients on creatine will look like placebo patients at four years, says Buff Dill, MCG study coordinator.
A number of methods will be used to periodically measure disease progression, including the Unified Parkinson’s Disease Rating Scale.
Following disease progression over many years and measuring endpoints such as falling, nursing home placement, dementia and death is the only way to effectively assess treatment for a disease that typically progresses slowly, Dr. Sethi says. In fact, the study may be extended five more years, based on preliminary results and funding, he says.
Those who get creatine may have the added benefit of increased muscle, as is true of athletes, Dr. Sethi says, noting that many patients experience muscle atrophy and weight loss.
Although creatine is available over the counter, he believes Parkinson’s patients will still be interested in the study. “Patients realize that we don’t know if it works. They are willing to take the risk of being on placebo for the cause of science and to learn more about the disease,” he says, noting the altruistic nature of many of his patients. “They want to beat this disease and if they can’t, they want to help somebody else beat it.”
Avicena Group, Inc., will provide creatine and placebo for this first large study in a series of National Institutes of Health-sponsored exploratory trials in Parkinson’s.
MCG will participate in a similar study of coenzyme Q10, another natural supplement that boosts energy production, later this year. Dr. Sethi, project director of the Parkinson Research Alliance of India, which is working to bring more clinical trials to his homeland, plans to incorporate these supplements intoPage: 1 2 3 Related medicine news :1
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