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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 主要研究将评估研究性药物肌酸是否能够减缓帕金森氏病（PD）的进展。 研究假设是，用肌酸治疗的群体比安慰剂上的疾病进展要比安慰剂上的疾病进展较少，这是通过一项由普遍测量的PD功能组成的全球统计检验评估的：门诊能力，认知障碍和全球功能。 次要的特定目的是使用基线和5年随访之间的数据进行其他疗效，安全性和耐受性的措施比较肌酸和安慰剂组。 在Net-PD LS-1中，正在进行一个子研究，以收集血液样本，以获取并存储DNA，以进行未来的PD/和神经系统疾病研究。 在同意参与者的筛查/基线访问中，用于DNA采样的血液采集是一次抽血。 在临床访问期间将进行涉及人类受试者的程序，在5年研究中将至少有9个。第二年之后，将至少有三个电话联系人来审查副作用，药物，健康提供者访问和研究用药问卷。 最广泛的临床临床将包括以下内容：个人病史，生命体征（脉搏，血压，体重），日常生活活动，整体运作的问卷调查，思维能力测试，记忆测试，抑郁量表（贝克抑郁量表），血液和尿液测试（1 tbs。参加参与者。 除了临床程序外，在访问诊所期间还会再次管理在电话期间进行的问卷调查。