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）：这是密歇根大学帕金森氏病临床中心（PDCC）的申请。该PDCC的目标是确定早期，轻度帕金森氏病（PD）的受试者，他们招募了对神经保护治疗的飞行员和大型多臂试验，对招募受试者的跟进直到审判完成以及对受试者进行后跟进，以确定治疗效果的存在。受试者将从密歇根大学现有诊所的转诊基地，安阿伯退伍军人事务医疗中心，通过全州范围的审判向密歇根州的神经病学家宣传，并通过密歇根州的主要外行PD组织，密歇根州帕克森的基金会（MPF）。我们已经与MPF合作从事PD的全州教育和临床护理活动。既定的合作和全州范围的活动将增强密歇根州内适当的主题的招聘。受试者将被招募，然后是经验丰富的运动障碍临床医生，在临床试验中具有丰富的经验。我们的中心开发了一个有希望的疾病进展目标。 [14C]二氢苯乙烷正电子发射断层扫描（DTBZ-PET）。在我们的站点和周围地点招募的一部分受试者可以与DTBZ-PET串行。在试验试验中，该子集可用于评估DTBZ-PET作为疾病状态的生物标志物，并可能是评估推定神经保护剂的筛查方法。在大型的多臂试验中，将遵循DTBZ-PET作为疾病进展的客观标志。通过共享密歇根州其他PDCC的受试者以确保有效利用PET成像，可以增强DTBZ-PET的使用。