University of Colorado Parkinson's Disease Clinical Research

描述(申请人提供)：帕金森氏症(PD)影响至少50万美国人，随着我们人口的老龄化，影响还会更多。对症药物最初可以极大地改善患者的生活。然而，随着时间的推移，残疾和不可预测的运动波动发生，疾病在大多数情况下无情地发展到终末期的痴呆和行动不便。对于成千上万受影响的美国人来说，迫切需要延缓疾病进展的治疗(神经保护)。为了开发神经保护疗法，NINDS资助了NIH PD探索性试验(Net-PD)计划，该计划由一个临床试验协调中心、一个统计中心和50个临床站点组成。到目前为止，Net-PD计划已经成功地完成了四项无效性试验，目前正在进行第五项无效性试验(吡格列酮)，并正在完成一项大型简单(LSI)第三阶段随机、双盲、安慰剂对照临床试验(肌酸)。这些活动为PD社区贡献了宝贵的科学进步。我们的网站，科罗拉多大学丹佛大学(UCD)，是50个精选的临床网站之一。目前的净PD试验预计还需要三年时间才能完成；这项申请是为完成试验而申请资金。在临床现场招募和留住受试者将是成功的关键。UCD网站的具体目标是(1)完成LSI研究，保留85%的受试者，75%的受试者活跃在研究和研究药物上，(2)高度遵守研究方案和法规要求。UCD网站对Net-PD方案目前的成功作出了很大贡献。例如，在伦敦政治经济学院，UCD是注册人数第四多的网站，在研究药物的受试者保留率方面是第九高。利希博士 在Net-PD计划的招聘和留住委员会任职，因此帮助制定了各种战略，大多数网站都采用这些战略来最大限度地招聘和留住员工。我们的网站以比所有50个网站的平均水平更可靠和更及时的方式输入数据和处理查询。UCD在本申请中详细介绍了许多优势，包括对受试者的个性化专家护理，这是我们成功的基础，也是我们的网站成为Net-PD计划强大而必要的资产的原因。

DESCRIPTION (provided by applicant): Parkinson's disease (PD) affects at least a half million Americans, and more as our population ages. Symptomatic medications can dramatically improve the lives of patients initially. However, with time disabling and unpredictable motor fluctuations occur, and the disease relentlessly progresses in most to dementia and immobility in the end stages. Therapy that slows progression of disease (neuroprotection) is desperately needed for the many thousands of affected Americans. In an effort to develop neuroprotective therapy the NINDS funded the NIH Exploratory Trials in PD (NET- PD) program, which consists of a Clinical Trials Coordination Center, a Statistical Center and 50 Clinical Sites. To date the NET-PD program has successfully completed four futility trials, is currently conducting a fifth futility trial (pioglitazone), and is in the process of completing a large simple (LSI) Phase III randomized, double-blinded, placebo-controlled clinical trial (creatine). These activities have contributed valuable scientific advances to the PD community. Our site, the University of Colorado Denver (UCD), is one of 50 selected Clinical Sites. The current NET-PD trials are expected to take three more years to complete; this application is a request for funding to complete the trials. Recruitment and retention of subjects at the Clinical Sites will be crucial fo success. The Specific Aims for the UCD site are (1) to complete the LSI study with retention of >85% of subjects and with >75% active in Study and on study drug, and (2) to do so with high adherence to study protocol and regulatory requirements. The UCD site has contributed greatly to the current success of the NET-PD program. For example, in LSI UCD is the fourth highest enrolling site and is the ninth highest in terms of retention of subjects on study drug. Dr. Leehey serves on the NET-PD program's Recruitment & Retention Committee and thus helped develop severally strategies that most sites employ to maximize recruitment and retention. Our site enters data and handles queries in a more reliable and timely fashion than average for all 50 sites. UCD has a number of strengths detailed in this application, including individualized expert care to subjects, which underlie our success and the reason our site is a strong and necessary asset to the NET-PD program.