Clinical Center for Neuroprotection in Parkinson Disease

帕金森病神经保护临床中心

• 批准号: 8458269
• 负责人: RICHARD B DEWEY
• 金额: $ 11.42万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-15 至 2015-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8458269
• 关键词: Activities of Daily Living; Brain; Caring; Clinical; Clinical Research; Clinical Trials; Creatine; Deterioration; Digit structure; Disease; Disease Progression; Dopamine; Dose; Double-Blind Method; England; Enrollment; Funding; Futility; Health; Health Services; Human; Individual; Investigation; Levodopa; Masks; Measures; Medical center; Mental Depression; Methodology; Modality; Neurologist; Neurons; Outcome Measure; Parkinson Disease; Participant; Patients; Pharmaceutical Preparations; Pioglitazone; Placebo Control; Placebos; Population Study; Process; Quality of life; Recruitment Activity; Reporting; Safety; Site; Substantia nigra structure; Symptoms; Testing; Texas; Therapeutic Equivalency; Visit; Work; clinical research site; cognitive function; design; disability; experience; follow-up; improved; neurochemistry; neuroprotection; primary outcome; sound

DESCRIPTION (provided by applicant): Parkinson's disease is an inexorably progressive disorder of unknown cause in which neurons of the substantia nigra progressively degenerate resulting in ever greater degrees of brain dopamine deficiency. While a number of treatments have been developed that improve the neurochemical deficit, no treatment has been demonstrated in humans that delays the progression of the disease (as distinguished from masking symptoms). Such an effect is highly desirable because if this could be achieved, a significant delay in clinical deterioration of patients could be realized. This competitive continuation proposal aims to continue UT Southwestern Medical Center as a Clinical Site for ongoing conduct of the NET-PD clinical trials. These include the ongoing LS-1 study and FS-ZONE study. LSI is a 5 year double-blind, placebo controlled investigation of creatine as a possible disease-modifying agent for PD. FS-ZONE is a 44 week futility trial assessing pioglitazone as a possible disease-modifying agent for PD. UT Southwestern Medical Center in Dallas, TX is well suited to continuing its work as a Clinical Site of the NET-PD network. It functions as the primary academic referral center for North Texas, and its four staff neurologists are experienced in the design, conduct, and reporting of clinical trials in Parkinson's disease. If funded, the site will continue its active follow-up of te 49 subjects currently enrolled in the NET-PD LS1 trial and will continue to recruit and follow subjects for the ongoing FS-ZONE study. While it is unclear if either agent under study will slow the progression of PD, this unique network of clinical research centers is ideally suited to perform large scale, long duration, scientifically sound clinical trials that have great promise fo ultimately discovering a drug or drugs that can slow the degenerative process of PD.

描述（由申请人提供）：帕金森病是一种原因不明的不可阻挡的进行性疾病，其中黑质神经元进行性退化，导致更大程度的脑多巴胺缺乏。虽然已经开发了许多改善神经化学缺陷的治疗方法，但在人类中没有证明可以延迟疾病进展的治疗方法（与掩蔽症状不同）。这样的效果是非常期望的，因为如果可以实现这一点，则可以实现患者临床恶化的显著延迟。本竞争性延续提案旨在继续UT西南医学中心作为临床研究中心，持续开展NET-PD临床试验。其中包括正在进行的LS-1研究和FS-ZONE研究。LSI是一项为期5年的双盲、安慰剂对照研究，旨在研究肌酸是否可能作为PD的疾病改善剂。FS-ZONE是一项为期44周的无效性试验，评估吡格列酮作为PD的可能疾病调节剂。 德克萨斯州达拉斯的UT西南医学中心非常适合继续作为NET-PD网络的临床研究中心开展工作。它是北德克萨斯州的主要学术转诊中心，其四名神经科医生在帕金森病临床试验的设计，实施和报告方面经验丰富。如果获得资助，该研究中心将继续对目前入组NET-PD LS 1试验的49名受试者进行积极随访，并将继续为正在进行的FS-ZONE研究招募和随访受试者。虽然目前尚不清楚研究中的任何一种药物是否会减缓PD的进展，但这种独特的临床研究中心网络非常适合进行大规模，长时间，科学合理的临床试验，这些试验最终有望发现一种或多种药物，可以减缓PD的退行性过程。