Neuroprotection Exploratory Trials in Parkinson's Disease (NET-PD)

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DESCRIPTION (provided by applicant): The goal of this proposal is to continue to participate as a clinical site in the nation-wide study of neuroprotection in Parkinson's disease (NET-PD). Parkinson's Disease and Movement Disorders Center at Northwestern University (PDMDC-NU) has been a NET PD Clinical Center since 2005. The Center has demonstrated success in subject's recruitment and retention for the LS1 study. The Center is actively working on fulfilling recruitment for the FS-Zone study. We are committed to recruit, retain and follow research participants as a Clinical Center in the NET-PD consortium. The objective of the project will be to: A. Retain participants in the NET-PD LS1 (a phase 3 randomized, double-blind, placebo-controlled trial of creatine treatment for the prevention of Parkinson's Disease progression). B. Recruit and retain appropriate research participants in the NET-PD FS-ZONE (a randomized, double-blind, placebo-controlled futility study evaluating pioglitazone for the prevention of Parkinson's Disease progression). We are committed to collaborate with the NET PD Clinical Trial Coordination Center (CTCC), Statistical Center (SCC), and other Clinical Centers to assure successful study completion, and to participate in the data analysis of the study results. As a Clinical Center, we are committed to continue working cooperatively with the NET PD CTCC, Statistical Center (SCC) by assuring quality and timely data collection. We also are prepared to participate in the data analysis for both studies. Dr. Simuni chairs one of the NET PD LS1 writing groups. Dr. Simuni has assumed the leadership role as the national Principal investigator for the FS Zone study in October 2010 and as such is committed to spearhead the successful recruitment, retention, data acquisition and analysis of the study.