Parkinson's Disease Neuroprotection Trial

帕金森病神经保护试验

• 批准号: 7559494
• 负责人: RICHARD STANLEY BURNS
• 金额: $ 9.5万
• 依托单位: ST. JOSEPH'S HOSPITAL AND MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2012-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7559494
• 关键词: Clinical; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Data; Development; Diagnosis; Ensure; Female; Institutes; Measures; Minority; National Institute of Neurological Disorders and Stroke; Nerve Degeneration; Neurologic; Neuroprotective Agents; Parkinson Disease; Participant; Patients; Pilot Projects; Population; Protocols documentation; Recruitment Activity; Research; Research Design; Safety; Site; Southwestern United States; clinical research site; experience; neuroprotection; research study; statistical center

DESCRIPTION (provided by applicant): The objective of this application is to be selected by the Neurodegeneration and Clinical Trial Groups of the NINDS to participate in the Parkinson Disease Neuroprotection Clinical Trial. It is our understanding that the study design will include 42 clinical sites, the use of two or more neuroprotective agents, and an initial pilot study followed by a larger trial of approximately 3000 subjects with early Parkinson's Disease . It is also our understanding that the protocol for this study is currently under development by representatives from the coordinating center, statistical center, the NINDS Oversight Committee and others. As a clinical site for the study, Dr. Mark Stacy and the research staff at the Muhammad Ali Parkinson Research Center (MAPRC) at Barrow Neurological Institute agree to recruit and follow the required number of participants for the duration of the study, collect accurate and timely data and strictly adhere to the protocol.As a major referral center for Parkinson's Disease patients in the southwestern United States, approximately 4800 PD patients are examined and treated annually at our site. The MAPRC has extensive experience in the execution of clinical trials in the Parkinson's population, averaging approximately 15 to 20 clinical research studies annually. If given the opportunity to act as a clinical center for the Parkinson Disease Neuroprotection trial we will recruit the appropriate number of eligible subjects, taking special effort to ensure adequate representation of females and minorities. We will take all appropriate measures to protect these subjects and follow the participants for the entire duration of the trial.

描述（由申请人提供）：该申请的目的应由NIND的神经退行性变性和临床试验组选择，以参加帕金森氏病神经保护临床试验。我们的理解是，研究设计将包括42个临床部位，使用两种或多种神经保护剂，以及最初的试点研究，然后对大约3000名患有早期帕金森氏病的受试者进行了更大的试验。我们还了解，这项研究的协议目前正在开发由协调中心，统计中心，NINDS监督委员会等的代表进行开发。作为该研究的临床站点，马克·史黛西（Mark Stacy）博士和巴罗神经学研究所（Barrow Neurological Institute）的穆罕默德·阿里·帕金森研究中心（MAPRC）的研究人员同意招募并遵循所需的参与者来进行研究持续时间，并及时遵守该协议，并严格遵守该协议的主要参考中心。在我们的网站。 MAPRC在帕金森氏症人群中执行临床试验方面具有丰富的经验，每年平均约15至20个临床研究。如果有机会担任帕金森氏病神经保护试验的临床中心，我们将招募适当的合格受试者，以确保对女性和少数民族的充分代表。我们将采取所有适当的措施来保护这些主题，并在整个试验期间跟随参与者。