Parkinson disease (PD) is a progressive neurodegenerative disorder affecting 3/100 people over the age of 65. There is no cure and etiology is unknown. Medications such as levodopa provide good benefit for a number of years. However, disease progression results in significant disability, poor quality of life, and shortened life expectancy. NET-PD is a consortium of 49 Centre's in the US and Canada comprised of neurologists and research coordinators with expertise in carrying out clinical trials in PD. It has been active since 2003 with the aim of developing a disease modifying treatment for PD. The consortium has already completed 2 futility trials, resulting in the identification of creatine as promising compound. This has led to the initiation of a large simple trial (LS-1). The primary objective was to determine if there is a slowing of clinical decline in PD patients defined by a combination of cognitive, physical, and quality of life measures. Active treatment with creatine is being compared to a placebo control against a background of dopaminergic therapy and usual medical care. Over 1700 patients were enrolled between 2007-2010. The trial will continue for another 3 years until all patients have a minimum of 5 years follow up. Thus, retention is a major thrust of the last 3 years of the trial. At the University of Calgary, we have enrolled 44 patients with 98% retention. As a clinical trial site with over 25 years'experience, we feel confident in being able to ensure trial success, with excellent retention. The investigators and coordinators at the University of Calgary are active members in a number of committees, including data analysis, manuscript writing, and retention strategies. This trial is the largest of its kind in P. If creatine is shown to be neuroprotective, this will be the first compound shown to slow clinical progression in a neurodegenerative disorder. It will change the way we manage PD and bring hope to patients with this incurable disease. Secondly, this is the largest data set of information collected on PD, and is available to all investigators in the consortium. It will provide extensive information on PD.
The development of a neuroprotective treatment that slows progression will lead to a significant benefit in management and improvement in the quality of life for PD patients. In addition, the large amount of data gathered from this and related trials wll lead to an improved understanding of the clinical features and progression of PD, as well as information on how to conduct large scale multicenter trials.
|Wills, Anne-Marie A; Elm, Jordan J; Ye, Rong et al. (2016) Cognitive function in 1736 participants in NINDS Exploratory Trials in PD Long-term Study-1. Parkinsonism Relat Disord 33:127-133|
|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|
|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|