CLINICAL TRIAL: CREATINE IN SUBJECTS WITH TREATED PARKINSON'S DISEASE (PD)

临床试验：肌酸治疗帕金森病 (PD) 患者

• 批准号: 8166974
• 负责人: ROBERT W HAMILL
• 金额: $ 3.25万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-03-01 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166974
• 关键词: Activities of Daily Living; Adverse effects; Beck depression inventory; Blood; Blood Pressure; Blood specimen; Clinic; Clinical; Clinical Trials; Collection; Computer Retrieval of Information on Scientific Projects Database; Consent; Creatine; DNA; Data; Disease Progression; Electrocardiogram; Enrollment; Family history of; Funding; Future; Grant; Health Personnel; Impaired cognition; Individual; Institution; Investigational Drugs; Measures; Memory; Mental Depression; Parkinson Disease; Participant; Pharmaceutical Preparations; Physiologic pulse; Placebos; Pregnancy Tests; Procedures; Qualifying; Questionnaires; Research; Research Personnel; Resources; Safety; Sampling; Source; Telephone; Testing; Thinking; Time; United States National Institutes of Health; Urine; Visit; Weight; follow-up; human subject; nervous system disorder; sample collection

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The main study will evaluate whether the investigational drug Creatine is able to slow the progression of Parkinson's Disease (PD). The research hypothesis is that the group being treated with Creatine will show less disease progression by 5 years than the group on placebo as evaluated by a Global Statistical Test comprised of generally measured PD functioning: ambulatory capacity, cognitive impairment, and global functioning. Secondary specific aims are to compare the Creatine and placebo groups on additional measures of efficacy, safety, and tolerability using data between baseline and 5 years follow up. Within the NET-PD LS-1 a sub-study is being conducted for blood sample collection to obtain and store DNA for future PD/and neurological disease research. The blood collection for DNA sampling is a one time blood draw taking at the screening/baseline visit of consenting participants. Procedures involving human subjects will be conducted during clinical visit of which there will be at least 9 during the 5 year study. After the second year there will be at least three telephone contacts to review side effects, medications, health provider visits, and a study medication questionnaire. The most extensive clinical will comprise of the following: Personal and Family Medical History, Vital Signs (pulse, blood pressure, weight), Activities of Daily Living, Overall Functioning Questionnaire, Thinking Ability Test, Memory Test, Depression Scale (Beck Depression Inventory), Blood and urine testing (1 Tbs. of blood will be collected for routine testing), Pregnancy test for qualifying individuals, Parkinson's exam, and ECG will be performed at three visits on a subset of enrolled participants. In addition to the clinical procedures, questionnaires performed during telephone calls will again be administered during visits to the clinic.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 主要研究将评估研究药物肌酸是否能够减缓帕金森病（PD）的进展。 研究假设是，根据总体统计测试的评估，肌酸治疗组的疾病进展速度比安慰剂组少 5 年，该统计测试包括一般测量的 PD 功能：行走能力、认知障碍和整体功能。 第二个具体目标是使用基线和 5 年随访之间的数据来比较肌酸组和安慰剂组的功效、安全性和耐受性的其他措施。 NET-PD LS-1 正在进行一项子研究，用于收集血液样本，以获得和存储 DNA，用于未来的 PD/和神经系统疾病研究。 用于 DNA 采样的血液采集是在同意参与者的筛选/基线访视时进行的一次性抽血。 涉及人类受试者的程序将在临床访视期间进行，在为期 5 年的研究期间将至少进行 9 次。第二年之后，将至少进行三次电话联系，以审查副作用、药物、医疗服务提供者访问和研究药物调查问卷。 最广泛的临床将包括以下内容：个人和家庭病史、生命体征（脉搏、血压、体重）、日常生活活动、整体功能问卷、思维能力测试、记忆力测试、抑郁量表（贝克抑郁量表） 、血液和尿液检测（将收集 1 汤匙血液用于常规检测）、合格个体的妊娠检测、帕金森病检查和心电图将在 3 次就诊时对一部分登记的参与者进行。 除了临床程序外，在电话访问期间进行的问卷调查将在访问诊所时再次进行。