fMRI Evaluation of Parkinson's Disease

描述（由申请人提供）：帕金森病（PD）是一种进行性和不可治愈的神经系统疾病，影响全球约400万人。据估计，仅美国的医疗保健费用就超过60亿美元。虽然许多FDA批准的治疗干预措施（药物，手术和生理）已可用于管理与PD相关的运动和认知并发症，但随着疾病的进展，大多数干预措施随着时间的推移变得不那么有效。目前的挑战是开发出更有效、更持久的治疗方法，除了控制症状外，还能改变疾病的进程。 识别相对于现有治疗的增量治疗功效可能会受到现有临床结果测量的阻碍，这些测量的可靠性和灵敏度相对较低。因此，下一波临床试验可能需要与临床结果相关的可靠和敏感的生物标志物。在该项目的第一阶段，我们建议测试功能性磁共振成像（fMRI）的疗效，作为一种生物标志物，用于量化PD的治疗反应。第二阶段将需要开发一个基于专利技术的标准化神经成像平台，该平台将在广泛的MRI扫描仪平台上实施。该商业平台将针对学术医疗中心、医院和诊所以及制药行业，以促进PD治疗反应的评估。

DESCRIPTION (provided by applicant): Parkinson's disease (PD) is a progressive and incurable neurological disease affecting an estimated 4 million people worldwide. Health care costs in the U.S. alone have been estimated in excess of $6B. While many FDA-approved therapeutic interventions (pharmaceutical, surgical and physiological) have become available for the management of the motor and cognitive complications associated with PD, the majority of interventions become less effective over time as the disease progresses. The challenge is to develop more effective and longer lasting treatments that alter the disease course in addition to managing symptoms. Identifying incremental therapeutic efficacy over existing treatments may be hindered by existing clinical outcome measures that suffer from relatively low reliability and sensitivity. The next wave of clinical trials, therefore, will likely require reliable and sensitive biological markers that correlate with clinical outcomes. In Phase I of this project, we propose to test the efficacy of functional magnetic resonance imaging (fMRI), as a biomarker for quantifying a therapeutic response in PD. Phase II will entail the development of a standardized neuroimaging platform based on proprietary technology to be implemented across wide range of MRI scanner platforms. This commercial platform will target academic medical centers, hospitals, and clinics, as well as the pharmaceutical industry, in order to facilitate the evaluation of therapeutic response in PD.