Continuation of NET-PD Trials at the University of Kansas Medical Center

堪萨斯大学医学中心继续进行 NET-PD 试验

• 批准号: 8459102
• 负责人: RAJESH PAHWA
• 金额: $ 5.9万
• 依托单位: UNIVERSITY OF KANSAS 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: 2002-09-30 至 2015-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8459102
• 关键词: Activities of Daily Living; Address; Adult; Affect; Caregivers; Caring; Chronic; Clinical; Communities; Creatine; Data; Data Collection; Dependence; Deterioration; Digit structure; Disease; Disease Progression; Dose; Double-Blind Method; England; Enrollment; Enzymes; Evaluation; Futility; Goals; Grant; Health; Health Care Costs; Health Services; Hospitalization; Individual; Kansas; Levodopa; Measures; Medical center; Mental Depression; Minocycline; Modality; Movement Disorders; National Institute of Neurological Disorders and Stroke; Neurodegenerative Disorders; Neurosciences; North America; Nursing Homes; Outcome Measure; Parkinson Disease; Participant; Persons; Phase; Phase III Clinical Trials; Pioglitazone; Placebo Control; Placebos; Property; Quality of life; Randomized; Research; Safety; Telephone; Testing; Therapeutic Equivalency; Time; United States; Universities; Visit; Work; cognitive function; disability; follow-up; health care service utilization; improved; member; primary outcome; programs; statistical center; treatment strategy

DESCRIPTION (provided by applicant): Parkinson's disease (PD) affects an estimated one million persons in the United States and results in significant disability as the disease progresses, in many cases making daily activities difficult to complete. This disability leads to deterioration in the quality of life of both persons with PD and their caregivers. It also significantly increases healthcare costs and usage including hospitalizations and nursing home placement. One of the largest unmet needs in PD research is the identification of treatments that could be neuroprotective or slow the progression of the disease. The NET-PD program was established to address this issue by forming a network of clinical centers throughout North America with designated coordinating and statistical centers to identify and examine potential neuroprotective therapies. As part of this initiative 2 futility trials examining creatine, minocycline, co-enzyme Q10 and GPI-1485 were conducted as a unique approach for PD studies, to quickly identify potentially neuroprotective therapies. These studies suggested that creatine may have potential as a neuroprotective therapy for PD while the other therapies were found to be futile. This led to a large simple study of creatine (LS-1) which is a Phase III, randomized, double-blind, placebo-controlled, multi-center trial. The University of Kansas Medical Center enrolled subjects in both futility trials and is currently participating in the LS-1 study (31 subjects enrolled) as well as an additional trial, FS-ZONE, to examine the potential neuroprotective properties of pioglitazone. The specific aims of the current proposal are to complete ail follow-up evaluations such that the last subject enrolled in LS-1 has at least 5 years of follow-up. The study will allow for the examination of the long-term safety and efficacy of creatine as well as an examination of multiple data points to determine if there is a slowing of disease progression. The focus of the University of Kansas will be to complete all required study visits and assessments and to make sure that all remaining subjects (28) continue their participation in the study until its completion.

描述（由申请人提供）：帕金森病 (PD) 在美国影响了大约 100 万人，随着疾病的进展会导致严重残疾，在许多情况下导致日常活动难以完成。 这种残疾导致帕金森病患者及其护理人员的生活质量恶化。它还显着增加了医疗保健成本和使用量，包括住院和疗养院安置。 PD 研究中最大的未满足需求之一是确定可能具有神经保护作用或减缓疾病进展的治疗方法。 NET-PD 计划的建立是为了解决这个问题，通过在整个北美建立一个临床中心网络，并指定协调和统计中心来识别和检查潜在的神经保护疗法。作为该计划的一部分，进行了 2 项无效试验，检查肌酸、米诺环素、辅酶 Q10 和 GPI-1485，作为 PD 研究的独特方法，以快速识别潜在的神经保护疗法。这些研究表明，肌酸可能具有作为帕金森病神经保护疗法的潜力，而其他疗法被发现是徒劳的。这导致了一项针对肌酸 (LS-1) 的大型简单研究，这是一项 III 期、随机、双盲、安慰剂对照、多中心试验。堪萨斯大学医学中心在两项无效试验中招募了受试者，目前正在参加 LS-1 研究（招募了 31 名受试者）以及另一项试验 FS-ZONE，旨在检查吡格列酮的潜在神经保护特性。当前提案的具体目标是完成所有后续评估，使最后一个参加 LS-1 的受试者至少有 5 年的时间 的后续行动。该研究将检查肌酸的长期安全性和有效性，以及检查多个数据点以确定疾病进展是否会减慢。堪萨斯大学的重点将是完成所有必需的研究访问和评估，并确保所有剩余受试者 (28) 继续参与研究直至完成。