Michigan Parkinson's Disease Clinical Center

描述(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)的申请书。PDCC的目标是识别早期轻度帕金森病(PD)受试者，将他们招募到神经保护治疗的试点和大型多臂试验中，对招募的受试者进行跟踪，直到试验完成，以及试验后对受试者进行跟踪，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诊所转介基地招募，通过在密歇根州向神经科医生公布试验的全州范围，以及通过密歇根州的主要非PD组织密歇根州帕金森基金会(MPF)。我们已经与强积金合作，在全州范围内开展帕金森氏症的教育和临床护理活动。已建立的合作和全州范围内的活动将促进密歇根州内适当学科的招聘。受试者将被招募，并由在临床试验中具有重要经验的有经验的运动障碍临床医生跟踪。我们中心已经开发出一种有前景的疾病进展的客观标记物；[14C]二氢四苯并嗪正电子发射断层扫描(DTBZ-PET)。在我们网站和周围网站招募的受试者子集可以通过DTBZ-PET进行连续跟踪。在试点试验中，这一亚组可以用来评估DTBZ-PET作为疾病状态的生物标记物，并可能作为评估假定的神经保护剂的筛选方法。在大型多臂试验中，一部分患者将接受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，DTBZ-PET的使用将得到加强，以确保PET成像的有效使用。

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.