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Neuroprotection Exploratory Trials in Parkinson's Disease: NET-PD

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On September 11, 2013, the NINDS stopped the NET-PD LS-1 study of creatine for treatment of early stage Parkinson's disease, acting on the recommendation of the study's Data Safety Monitoring Board (DSMB). During the most recent DSMB review, the results of an interim analysis showed that it was futile to complete the study because longer patient follow-up was not likely to demonstrate a statistically significant difference between creatine and placebo. The investigators did not find any safety concerns related to creatine at dosages of 5 grams twice daily for up to 5 years of treatment.

The LS-1 study enrolled 1,741 patients with early Parkinson's disease at more than 50 sites throughout North America. Participants were randomized to receive either a highly purified form of creatine or matching placebo twice daily. Creatine is hypothesized to support and stabilize mitochondrial function and act as an antioxidant. Mitochondrial dysfunction and oxidative stress have both been implicated as contributors to Parkinson's disease.

Results:

Writing Group for the NINDS Exploratory Trials in Parkinson Disease (NET-PD) Investigators, Kieburtz K, Tilley BC, Elm JJ, Babcock D, et al. Effect of creatine monohydrate on clinical progression in patients with Parkinson disease: a randomized clinical trial. JAMA. 2015 Feb 10;313(6):584-93. doi: 10.1001/jama.2015.120.


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