POSTCEPT

后CEPT

• 批准号: 7604700
• 负责人: JOSEPH Mark SAVITT
• 金额: $ 0.03万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604700
• 关键词: 2beta-carbomethoxy-3beta-(4-iodophenyl)tropane; Behavioral; Biological Markers; Clinical; Clinical Trials; Cognition; Cognitive; Computer Retrieval of Information on Scientific Projects Database; DNA; Data; Data Set; Enrollment; Funding; Grant; Image; Impaired cognition; Institution; Longitudinal Studies; Measures; Mental Depression; Modeling; Motor; Natural History; Observational Study; Parkinson Disease; Participant; Patients; Persons; Rate; Research; Research Personnel; Resources; Risk Factors; Sensitivity and Specificity; Smell Perception; Source; Testing; United States National Institutes of Health; Visit; cohort; follow-up; novel; repository; research clinical testing; single photon emission computed tomography; success

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The overall objective of this project is to demonstrate the feasibility of enrolling a cohort of former clinical trial participants into a follow-up observational study that will be used to develop biomarkers and assess the treated natural history of Parkinson's disease (PD). The required aspects of this study are the core data set items. Other activities such as FOUND, and imaging are integrated studies that are encouraged. Specific objectives are to: 1) Establish a mechanism for longitudinal follow-up of patients with PD who have participated in the Parkinson Study Group (PSG) PRECEPT study and determine rates of participation and retention for in-person and remote follow-up. Clear milestones will be used to assess the success of these efforts: a) proportion of subjects initially enrolled into the follow-up project from the PRECEPT clinical trial cohort b) annual retention for in-person visits c) annual retention for SPECT imaging d) proportion of subjects providing DNA to NINDS (Coriell) repository e) proportion of subjects participating in remote follow-up through the FOUND study 2) Demonstrate the feasibility of this mechanism to evaluate biomarkers and novel clinical signs in cross-sectional and longitudinal studies. This will be done through longitudinal use of beta-CIT SPECT in conjunction with olfactory (smell) testing (UPSIT) to determine the sensitivity and specificity of smell testing for identifying subjects with and without dopaminergic deficiency on SPECT. 3) Use this cohort to follow the treated natural history of PD (motor, cognitive and behavioral), to validate measures of cognition, and to develop models and prediction rules for motor and non-motor complications, including: a) administration of the Montreal Cognitive Assessment (MOCA) in conjunction with the NINDS Parkinson's Disease Data and Organizing Center (PD-DOC) core clinical evaluation (R Kurlan, PI) to determine the MOCA's sensitivity to change in PD. b) modeling of onset of motor complications, depression, and rate of cognitive decline in this treated natural history cohort in an attempt to identify specific risk factors.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本项目的总体目标是证明将一组前临床试验参与者纳入随访观察性研究的可行性，该研究将用于开发生物标志物并评估帕金森病（PD）的治疗自然史。本研究所需的方面是核心数据集项目。 其他活动，如FOUND和成像是鼓励的综合研究。 具体目标是： 第一章 建立参与帕金森研究组（PSG）PRECEPT研究的PD患者纵向随访机制，并确定面对面和远程随访的参与率和保留率。将使用明确的里程碑来评估这些努力的成功： a）、 PRECEPT临床试验队列中最初入组随访项目的受试者比例 B）每年保留亲自访问的费用 c）SPECT成像的年度保留 d）、 向NINDS（Coriell）储存库提供DNA的受试者比例 e）通过FOUND研究参与远程随访的受试者比例 （二） 证明该机制在横断面和纵向研究中评价生物标志物和新临床体征的可行性。 这将通过纵向使用β-CIT SPECT结合嗅觉（嗅觉）测试（UPSIT）来完成，以确定嗅觉测试的灵敏度和特异性，用于识别SPECT上有和没有多巴胺能缺陷的受试者。 3)使用该队列跟踪PD的治疗自然史（运动、认知和行为），验证认知测量，并开发运动和非运动并发症的模型和预测规则，包括： a）、 实施蒙特利尔认知评估（莫卡）结合NINDS帕金森病数据和组织中心（PD-DOC）核心临床评价（R Kurlan，PI），以确定莫卡对PD变化的敏感性。 B） 在这个治疗的自然史队列中，对运动并发症、抑郁症和认知能力下降的发生率进行建模，以试图确定特定的风险因素。