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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
2U10NS053381-06
Application #
8460258
Study Section
Special Emphasis Panel (ZNS1-SRB-B (34))
Program Officer
Moy, Claudia S
Project Start
2006-05-17
Project End
2015-11-30
Budget Start
2013-01-01
Budget End
2013-11-30
Support Year
6
Fiscal Year
2013
Total Cost
$95,141
Indirect Cost
$33,426
Name
University of Florida
Department
Neurology
Type
Schools of Medicine
DUNS #
969663814
City
Gainesville
State
FL
Country
United States
Zip Code
32611
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