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 objectiv with this project will be to retain the currently enrolled research subjects in the neuroprotection pilot study LS-1, as well as continue participation in subsequent phase III trials addressing disease modifying therapy in PD. The University of Florida will act as one site with two branches at two UF-affiliated Movement Disorder Clinical Trial Centers: Shands at Gainesville and Shands at Jacksonville. Both sites will be acting as consortia sites under the tianner of the University of Florida, modeled after some of the current consortia Centers that successfully recruited as a group in the previous NET-PD trials. With two high-quality Movement Disorders Centers located in ethnically-diverse metropolitan areas serving almost the entire veteran and non-veteran population of North-Central and North-Eastern Florida, we anticipate easy retention of the currently enrolled subjects as well as recruitment in future studies. Each Center and its investigators carry an impressive history of successful participation, enrollment and collaboration in PD multi-center trials. The recruiting and enrolling investigators at the UF Centers are fellowship-trained in Movement Disorders. Furthermore, we are committed to the protection of all human trials subjects and will actively work to retain currently enrolled subject. These are our highest priorities. At each institution, every possible effort will be performed to ensure retention of the currently enrolled subjects, which we are extremely commited to.
PD is a progressive neurological disorder, which results in severe disability. A number of new compounds have been identified that have the potential to slow down or even halt the progression of PD. In this proposal, we will combine the expertise of two movement disorders centers among the large geographical area of Florida to retain subjects for the neuroprotection trial following good clinical practices.
|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|