Parkinson's Disease Neuroprotection Trial: Clinical Center

帕金森病神经保护试验：临床中心

• 批准号: 7567917
• 负责人: W.R. WAYNE MARTIN
• 金额: $ 5.08万
• 依托单位: UNIVERSITY OF ALBERTA
• 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/7567917
• 关键词: Brain; Clinical; Clinical Trials; Controlled Clinical Trials; Development; Disease Progression; Dopamine Agonists; Double-Blind Method; Economics; Enrollment; Iron; Levodopa; Longitudinal Studies; Magnetic Resonance Imaging; Medical; Multi-Institutional Clinical Trial; Parkinson Disease; Patients; Pharmaceutical Preparations; Placebo Control; Placebos; Rate; Recruitment Activity; Site; Surrogate Endpoint; Surrogate Markers; base; brain volume; design; disability; indexing; neuron loss; neuroprotection; research clinical testing

DESCRIPTION (provided by applicant): The long-term objectives are to develop a neuroprotective strategy that can be applied to patients with Parkinson's disease (PD) in order to alter disease progression, and to evaluate in the setting of a multi-center clinical trial the efficacy of any such strategies. In PD, there is a prolonged course of progressive neuronal loss which is not altered by existing treatments. The development of neuroprotective strategies is therefore important to lessen the medical, societal, and economic impact of PD-related disability Patients will be recruited with early Parkinson's disease who have been symptomatic for fewer than five years, and who have received levodopa or dopamine agonists for no more than six months. Patients will be followed clinically over a period of three years to assess the potential neuroprotective benefit associated with a drug or drugs chosen by the Steering Committee. Although the multi-center trial will be based on clinical rather than surrogate endpoints, at this site, magnetic resonance imaging will be used to obtain a quantitative index of regional brain iron concentration which we hypothesize to correlate with disease progression.

描述（由申请人提供）：长期目标是制定一种神经保护策略，可以应用于帕金森氏病（PD）以改变疾病进展，并在多中心临床试验的情况下进行评估。在PD中，存在长时间的进行性神经元损失，并未因现有治疗而改变。因此，神经保护策略的发展对于减轻与PD相关残疾患者的医学，社会和经济影响至关重要，将与早期的帕金森氏病招募，这些帕金森氏病的症状少于五年，并且已经接受了左旋多巴或多巴胺激动剂的症状不超过六个月。将在三年的时间内临床遵循患者，以评估指导委员会选择的药物或药物相关的潜在神经保护益处。尽管多中心试验将基于临床而非替代端点，但在此地点，磁共振成像将用于获得区域脑铁浓度的定量指数，我们假设该指数与疾病进展相关。