This application is for the continuation of the NET-PD Trials at the University of Virginia. NET-PD was conceived and designed as a standing consortium organized to efficiently evaluate novel and potentially disease-modifying therapies for the treatment of Parkinson's disease through exploratory and clinical efficacy trials. As a NET-PD clinical site, our role is to identify, recruit, screen, enroll, treat, and retain participats in the NET-PD clinical trials;to enter data accurately and in a timely fashion;to ensure the safety and privacy of our participants;to report quickly and completely all adverse events, following the established protocols and procedures. Currently, our role for this proposal is to treat, follow, an retain currently enrolled participants In the LS-1 creatine trial protocol. The LS-1 study is a double-blind, clinical efficacy trial designed to determine whether or not creatine Is more effective than placebo in slowing the clinical decline in PD patients with early, treated PD. Enrollment began in 2007 and was completed In 2010. All patients will be followed for a minimum of 5 years or until the end of the study, now expected to be completed in 201.5. This site is also an enrolling site for the FS-ZONE protocol, which is a double-blind, placebo-controlled, phase II study of pioglitazone in early PD.
Parkinson's disease is a common neurodegenerative disorder affecting 1% of the population aged 65 and older. While symptomatic therapies have resulted in significant improvements in quality of Iife, no current therapy is proven to slow or arrest the disease course. The development of an effective disease-modifying therapy would have profound Impact on the current clinical management of this ultimately fatal disease.
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|Wills, Anne-Marie A; Pérez, Adriana; Wang, Jue et al. (2016) Association Between Change in Body Mass Index, Unified Parkinson's Disease Rating Scale Scores, and Survival Among Persons With Parkinson Disease: Secondary Analysis of Longitudinal Data From NINDS Exploratory Trials in Parkinson Disease Long-term Study 1 JAMA Neurol 73:321-8|
|Voss, T S; Elm, J J; Wielinski, C L et al. (2012) Fall frequency and risk assessment in early Parkinson's disease. Parkinsonism Relat Disord 18:837-41|
|Elm, Jordan J; NINDS NET-PD Investigators (2012) Design innovations and baseline findings in a long-term Parkinson's trial: the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease Long-Term Study-1. Mov Disord 27:1513-21|
|Mauldin, Patrick D; Guimaraes, Paulo; Albin, Roger L et al. (2008) Optimal frequency for measuring health care resource utilization in Parkinson's disease using participant recall: the FS-TOO resource utilization substudy. Clin Ther 30:1553-7|