Michigan Parkinson's Disease Clinical Center

密歇根帕金森病临床中心

• 批准号: 7559500
• 负责人: KELVIN L CHOU
• 金额: $ 7.21万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 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/7559500
• 关键词: Biological Markers; Clinic; Clinical; Clinical Trials; Collaborations; Disease; Disease Marker; Disease Progression; Employment; Enrollment; Ensure; Evaluation; Foundations; Goals; Medical center; Methods; Michigan; Morbidity - disease rate; Movement Disorders; Natural History; Neurologist; Neuroprotective Agents; Parkinson Disease; Patients; Positron-Emission Tomography; Recruitment Activity; Screening procedure; Site; Symptoms; Universities; Upper arm; Veterans; Work; base; clinical care; dihydrotetrabenazine; experience; follow-up; mortality; novel; pilot trial; therapy development; treatment effect

DESCRIPTION (provided by applicant): This is an application for a Parkinson's Disease Clinical Center (PDCC) at the University of Michigan. The goals of this PDCC are identification of subjects with early, mild Parkinson's disease (PD), their recruitment into pilot and large, multi-arm trials of neuroprotective treatments, follow up of recruited subjects until trial completion, and post-trial follow up of subjects to ascertain the presence of treatment effects. Subjects will be recruited from the existing referral base of clinics at the University of Michigan, the Ann Arbor Veterans Affairs Medical Center, via state-wide publicity of the trial to neurologists in Michigan, and through the major lay PD organization in Michigan, the Michigan Parkinson's Foundation (MPF). We are already working with the MPF on statewide educational and clinical care activities for PD. The established collaborations and state-wide range of activities will enhance recruitment of appropriate subjects within Michigan. Subjects will be enrolled and followed by experienced Movement Disorder clinicians with prior significant experience in clinical trials. Our center has developed a promising objective marker of disease progression; [14C]dihydrotetrabenazine positron emission tomography (DTBZ-PET). A subset of subjects recruited at our site and surrounding sites could be followed serially with DTBZ-PET. In pilot trials, this subset could be used to evaluate DTBZ-PET as a biomarker of disease status and possibly as a screening method for evaluation of putative neuroprotective agents. In large, multi-arm trials, a subset of patients would be followed with DTBZ-PET as an objective marker of disease progression. The use of DTBZ-PET will be enhanced by sharing of subjects from other PDCCs within Michigan to ensure efficient use of PET imaging.

描述（由申请人提供）：这是一份申请密歇根大学帕金森病临床中心（PDCC）的申请。本PDCC的目标是确定患有早期轻度帕金森病（PD）的受试者，招募他们参加神经保护治疗的中试和大型多组试验，对招募的受试者进行随访直到试验完成，并对受试者进行试验后随访以确定治疗效果的存在。受试者将从密歇根大学安娜堡退伍军人事务医疗中心现有的转诊基础诊所中招募，通过全州范围内对密歇根州神经科医生的试验宣传，以及通过密歇根州主要的PD组织密歇根帕金森基金会（MPF）招募。我们已经与MPF合作，在全州范围内开展PD教育和临床护理活动。已建立的合作关系和全州范围的活动将加强在密歇根州招募适当的学科。受试者将被招募，并由有丰富临床试验经验的运动障碍临床医生进行随访。我们的中心开发了一种很有前景的疾病进展的客观标记；[14C]二氢四苯那嗪正电子发射断层扫描（DTBZ-PET）。在我们的站点和周围站点招募的受试者子集可以连续使用DTBZ-PET进行随访。在试点试验中，该亚群可用于评估DTBZ-PET作为疾病状态的生物标志物，并可能作为评估假定的神经保护剂的筛选方法。在大型多组试验中，一部分患者将接受DTBZ-PET作为疾病进展的客观标志。DTBZ-PET的使用将通过共享密歇根州内其他pdcc的受试者来加强，以确保PET成像的有效使用。