Parkinson's disease is an inexorably progressive disorder of unknown cause in which neurons of the substantia nigra progressively degenerate resulting in ever greater degrees of brain dopamine deficiency. While a number of treatments have been developed that improve the neurochemical deficit, no treatment has been demonstrated in humans that delays the progression of the disease (as distinguished from masking symptoms). Such an effect is highly desirable because if this could be achieved, a significant delay in clinical deterioration of patients could be realized. This competitive continuation proposal aims to continue UT Southwestern Medical Center as a Clinical Site for ongoing conduct of the NET-PD clinical trials. These include the ongoing LS-1 study and FS-ZONE study. LSI is a 5 year double-blind, placebo controlled investigation of creatine as a possible disease-modifying agent for PD. FS-ZONE is a 44 week futility trial assessing pioglitazone as a possible disease-modifying agent for PD. UT Southwestern Medical Center in Dallas, TX is well suited to continuing its work as a Clinical Site of the NET-PD network. It functions as the primary academic referral center for North Texas, and its four staff neurologists are experienced in the design, conduct, and reporting of clinical trials in Parkinson's disease. If funded, the site will continue its active follow-up of te 49 subjects currently enrolled in the NET-PD LS1 trial and will continue to recruit and follow subjects for the ongoing FS-ZONE study. While it is unclear if either agent under study will slow the progression of PD, this unique network of clinical research centers is ideally suited to perform large scale, long duration, scientifically sound clinical trials that have great promise fo ultimately discovering a drug or drugs that can slow the degenerative process of PD.

Public Health Relevance

The search for a disease modifying treatment for PD is of paramount importance because by slowing disease progression, disability can be reduced and patient quality of life can be improved. These studies have the best chance of discovering such an agent due to the large size of the study population and the rigorous clinical trial methodology being employed.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
2U10NS044545-11
Application #
8458269
Study Section
Special Emphasis Panel (ZNS1-SRB-B (34))
Program Officer
Moy, Claudia S
Project Start
2002-09-15
Project End
2015-11-30
Budget Start
2013-01-01
Budget End
2013-11-30
Support Year
11
Fiscal Year
2013
Total Cost
$114,184
Indirect Cost
$42,557
Name
University of Texas Sw Medical Center Dallas
Department
Neurology
Type
Schools of Medicine
DUNS #
800771545
City
Dallas
State
TX
Country
United States
Zip Code
75390