The goal of this proposal is to participate as a clinical site in exploratory trials of neuroprotective agents for patients with early Parkinson's disease (PD). PD is a slowly progressive neurological disorder, which results in severe disability. Current therapies do not alter the course of the disease. However, a number of new compounds have been identified that have the potential to slow down or even halt the progression of PD. If any of these compounds can truly protect viable neurons from degenerating, they would delay or even prevent significant disability in the millions of patients who suffer from PD. Our primary objective with this project will be to recruit and retain research subjects in the neuroprotection pilot studies and subsequent phase III trials. The University of Florida will act as one site with 3 equal branches on 3 UF-affiliated Movement Disorder Clinical Trial Centers: Shands @ Gainesville, Malcom Randall VA Medical Center, and Shands @ Jacksonville. All three sites will be acting as consortia sites under the banner of the University of Florida, modelled after some of the current consortia Centers that successfully recruited as a group in the first 2 pilot NET-PD trials. With 3 high-quality Movement Disorders Centers located in 2 ethnically-diverse metropolitan areas serving almost the entire veteran and non-veteran population of North-Central and North- Eastern Florida, we anticipate easy recruitment of at least 2 PD patients per month (24 total/year) for both the pilot studies and the large simple phase III trial. Each Center and its investigators carry an impressive history of successful participation, enrollment and collaboration in PD multi-center trials. All 3 recruiting and enrolling investigators at the 3 UF Centers are fellowship-trained in Movement Disorders. Furthermore, we are committed to the protection of all human trials subjects and will actively try to recruit women and racial/ethnic minorities. These are our highest priorities. At Shands @ Gainesville, we will facilitate recruitment of minorities with the assistance of the Office of Minority Affairs at the University of Florida College of Medicine, At Shands @ Jacksonville, minority recruitment will also be the priority as 1/3 of the Dooulation of the citv of Jacksonville is considered ethnic.
|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|
|Troche, M S; Okun, M S; Rosenbek, J C et al. (2010) Aspiration and swallowing in Parkinson disease and rehabilitation with EMST: a randomized trial. Neurology 75:1912-9|