Parkinson's disease (PD) is one of the most common adult neurodegenerative disorders, affecting over one million people in North America. Although effective symptomatic treatments are available for PD, there are no medications available to forestall the inexorable clinical decline. As a first step in identifying such therapies, the NINDS Exploratory Trials in Parkinson's disease (NET-PD) network successfully completed futility studies, identifying creatine as a potential agent to slow clinical decline in PD. The NET-PD network is now conducting a large, long-term. Phase 3 trial (known as LS1) comparing creatine to placebo using a novel design and statistical approach.
The aims of this competitive renewal are to complete follow-up and retention of enrolled subjects in the LS-1 study and to assess the efficacy of creatine using a novel primary composite clinical decline outcome. Secondary analyses include individual components of the primary outcome measure, use of health services, levodopa-dose equivalents, safety, and tolerability. The Washington University School of Medicine site has demonstrated outstanding retention in the NET-PD studies (97-100%) and 99% query resolution. The Washington University School of Medicine site has extensive experience with clinical trials and management of PD, making this an ideal site for this exploratory PD trials network.

Public Health Relevance

The NET-PD studies are designed to find medications that slow Parkinson disease clinical progression. This application supports the study visits for the 33 research subjects in the LS-1 study at Washington University School of Medicine clinical trials site. If the LS-1 study demonstrates that creatine slows the progression of Parkinson disease, this study will have a substantial impact on the treatment of all PD patients worldwide.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
2U10NS044455-11
Application #
8458273
Study Section
Special Emphasis Panel (ZNS1-SRB-B (34))
Program Officer
Moy, Claudia S
Project Start
2002-09-30
Project End
2015-11-30
Budget Start
2013-01-01
Budget End
2013-11-30
Support Year
11
Fiscal Year
2013
Total Cost
$76,509
Indirect Cost
$26,174
Name
Washington University
Department
Neurology
Type
Schools of Medicine
DUNS #
068552207
City
Saint Louis
State
MO
Country
United States
Zip Code
63130
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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