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: 7952112
• 负责人: ROBERT W HAMILL
• 金额: $ 4.48万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952112
• 关键词: Activities of Daily Living; Adverse effects; Beck depression inventory; Blood; Blood Pressure; Blood specimen; Clinic; Clinical; Clinical Research; Clinical Trials; Collection; Computer Retrieval of Information on Scientific Projects Database; Consent; Creatine; DNA; Data; Disease; Disease Progression; Electrocardiogram; Enrollment; Family history of; Funding; Future; Grant; Health; Impaired cognition; Individual; Institution; Investigational Drugs; Measures; Memory; 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; depression; 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 provide 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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 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，通过由一般测量的PD功能（步行能力、认知障碍和整体功能）组成的整体统计检验评价，肌酸治疗组在5年内的疾病进展将低于安慰剂组。 次要具体目的是使用基线和5年随访之间的数据比较肌酸组和安慰剂组的疗效、安全性和耐受性的其他指标。 在NET-PD LS-1中，正在进行一项血液样本采集子研究，以获得和储存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知情同意的受试者的筛选/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5年研究期间将至少进行9次。第二年后，将至少进行三次电话联系，以审查副作用、药物、健康提供访视和研究药物问卷。 最广泛的临床将包括以下内容：个人和家族病史、生命体征（脉搏、血压、体重）、日常生活活动、总体功能问卷、思维能力测试、记忆测试、抑郁量表（贝克抑郁量表）、血液和尿液检测（1 Tbs.将在三次访视时对一部分入组受试者进行合格个体的妊娠试验、帕金森病检查和ECG。 除临床程序外，在门诊访视期间将再次进行电话访视期间进行的问卷调查。