The objective of this application is to be selected by the Neurodegeneration and Clinical Trial Groups of the NINDS to participate in the Parkinson Disease Neuroprotection Clinical Trial. It is our understanding that the study design will include 42 clinical sites, the use of two or more neuroprotective agents, and an initial pilot study followed by a larger trial of approximately 3000 subjects with early Parkinson's Disease . It is also our understanding that the protocol for this study is currently under development by representatives from the coordinating center, statistical center, the NINDS Oversight Committee and others. As a clinical site for the study, Dr. Mark Stacy and the research staff at the Muhammad Ali Parkinson Research Center (MAPRC) at Barrow Neurological Institute agree to recruit and follow the required number of participants for the duration of the study, collect accurate and timely data and strictly adhere to the protocol.As a major referral center for Parkinson's Disease patients in the southwestern United States, approximately 4800 PD patients are examined and treated annually at our site. The MAPRC has extensive experience in the execution of clinical trials in the Parkinson's population, averaging approximately 15 to 20 clinical research studies annually. If given the opportunity to act as a clinical center for the Parkinson Disease Neuroprotection trial we will recruit the appropriate number of eligible subjects, taking special effort to ensure adequate representation of females and minorities. We will take all appropriate measures to protect these subjects and follow the participants for the entire duration of the trial.
|Wills, Anne-Marie A; PÃ©rez, 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|