The goal of this application is to collaborate with a coordination center, a biostatistics center, the NINDS program oversite group and 41 study sites throughout the United States for the implementation of a large, multi-center controlled clinical trial. In this trial we propose to recruit, enroll, and evaluate 84 subjects during the conduct of a neuroprotective trial in Parkinson's disease. The Movement Disorders Center (MDC) at Washington University School of Medicine has participated in over 20 clinical trials in Parkinson's disease;nine of these trials were with untreated subjects. As the only academic movement disorder program within a 200 mile radius, the MDC has an extensive primary care referral base necessary to recruit a largenumber of de novo patients. Initialstudyrecruitment will occur from within the MDC clinical practice. In addition, we will utilize the Greater St. Louis Chapter of the American Parkinson Disease Association (APDA) and the APDA informationand referral service to identify newly diagnosed subjects. Other recruitment strategies will include local TV, radio, and print media, web-based advertisements, and free Parkinson's Disease screenings. We propose that the study pilot phase include investigation of the validity and accuracy of electronic data entry using either a web-based or local system. The MDC has pioneered the development of an electronic medical record directly applicable to clinical practice and research studies in movement disorders. In addition,we propose that duringthe pilotphase of the study, a biomarker such as [18F]FDOPA PET undergo necessary validation to determine if the study medication interfereswith uptake of the biomarker. If a biomarker proves to be unaffected by the studymedicationand meets other criteriaproposed in this application, the biomarker could be used to assess disease progression in a sub-set of study subjects. The MDC at Washington University School of Medicine providesthe breadthof clinical and basic research experience requiredto be a productive site in this large, multi-centerneuroprotectivetrial in PD.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10NS044455-10
Application #
8204820
Study Section
Special Emphasis Panel (ZNS1-SRB-L (01))
Program Officer
Moy, Claudia S
Project Start
2002-09-30
Project End
2012-11-30
Budget Start
2011-12-01
Budget End
2012-11-30
Support Year
10
Fiscal Year
2012
Total Cost
$72,086
Indirect Cost
$24,661
Name
Washington University
Department
Neurology
Type
Schools of Medicine
DUNS #
068552207
City
Saint Louis
State
MO
Country
United States
Zip Code
63130
Xiao, J; Zhao, Y; Bastian, R W et al. (2010) Novel THAP1 sequence variants in primary dystonia. Neurology 74:229-38
Mauldin, Patrick D; Guimaraes, Paulo; Albin, Roger L et al. (2008) Optimal frequency for measuring health care resource utilization in Parkinson's disease using participant recall: the FS-TOO resource utilization substudy. Clin Ther 30:1553-7