fMRI Evaluation of Parkinson's Disease

描述(申请人提供)：帕金森氏病(PD)是一种进行性和不可治愈的神经系统疾病，全世界估计有400万人受到影响。据估计，仅在美国，医疗保健成本就超过60亿美元。虽然FDA批准的许多治疗干预措施(药物、手术和生理干预)已经可以用于管理与帕金森病相关的运动和认知并发症，但随着疾病的进展，大多数干预措施的有效性会降低。挑战是开发更有效和更持久的治疗方法，除了控制症状外，还能改变疾病的进程。 现有的临床结果指标可靠性和敏感度相对较低，可能会阻碍确定相对于现有治疗方法的增量治疗效果。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记物。在这个项目的第一阶段，我们建议测试功能磁共振成像(FMRI)作为量化帕金森病治疗反应的生物标志物的有效性。第二阶段将需要开发一个基于专有技术的标准化神经成像平台，该平台将在各种核磁共振扫描仪平台上实施。这一商业平台将面向学术医疗中心、医院和诊所，以及制药行业，以促进对帕金森病治疗反应的评估。

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.