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

描述(由申请人提供)：本提案的目标是继续作为临床站点参与全国帕金森氏病神经保护研究(NET-PD)。西北大学帕金森氏病和运动障碍中心(PDMDC-NU)自2005年以来一直是净PD临床中心。该中心在LS1研究的受试者招募和保留方面取得了成功。该中心正在积极努力履行 为FS-Zone研究招募人员。我们致力于招募、保留和跟踪研究参与者，作为Net-PD联盟的临床中心。该项目的目标将是：a.保留Net-PD LS1(肌酸治疗预防帕金森病进展的第三阶段随机、双盲、安慰剂对照试验)的参与者。B.在Net-PD FS区招募和保留适当的研究参与者(一项评估吡格列酮预防帕金森病进展的随机、双盲、安慰剂对照无效性研究)。我们致力于与Net PD临床试验协调中心(CTCC)、统计中心(SCC)和其他临床中心合作，以确保研究的成功完成，并参与研究结果的数据分析。作为临床中心，我们致力于通过确保质量和及时收集数据，继续与Net PD CTCC、统计中心(SCC)合作。我们也准备参与这两项研究的数据分析。西穆尼博士是Net PD LS1写作小组的主席之一。Simuni博士已于2010年10月担任FS区域研究的国家首席调查员，并因此致力于带头成功招聘、保留、数据获取和分析该研究。

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.