A major goal of the neuroscience community is to develop treatment strategies that will slow or forestall the progression of chronic neurodegenerative diseases. Parkinson's disease (PD) is one of the most common adult neurodegenerative disorders, affecting over 1 million people in North America and the European Union. As a first step in identifying such therapies, the NINDS Exploratory Trials in Parkinson's disease (NET-PD) network successfully completed futility studies, which identified creatine as a potential agent to slow clinical decline in PD. The NET-PD network is now conducting a large, long-term, Phase 3 trial (known as LS1) comparing creatine to placebo. Our site #172 is one of the 50 NET-PD centers conducting the LS1 trial. In this renewal, we plan on continuing the execution of the trial at our center, enhance retention of enrolled subjects and complete the evaluations of all subjects enrolled at our site. All subjects are enrolled and the major effort isto enhance retention in order to test the primary hypothesis that daily administration of creatine (10 gm/day) is more effective than placebo in slowing clinical decline in PD between baseline and the 5 year follow-up visit against the background of dopaminergic therapy and best PD care. In addition, secondary measures of efficacy of creatine on individual PD measures will be assessed. We have implemented measures to enhance retention following uniform guidelines from the Clinical Coordinating Center. In addition, we have developed strategies that target the population at our site. These measures have been so far successful in retaining subjects past the 5 years of the trial.
Parkinson's disease (PD) is the most common neurodegenerative movement disorder. Current therapies treat the symptoms, however, do not modify the course of the disease. Disease modifying treatment are an unmet need for PD patients. The NET-PD program addresses this need. LS1 will help to determine if creatine can slow clinical decline and provide better information on the course of early PD than is currently available.
| 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 |
