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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 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，接受肌酸治疗的那组人比服用安慰剂的那组人的疾病进展要慢5年，这是通过一项全球统计测试进行评估的，该测试包括一般测量的PD功能：步行能力、认知障碍和全球功能。次要的具体目标是利用基线和5年随访期间的数据，比较肌酸组和安慰剂组在有效性、安全性和耐受性方面的额外测量。在Net-PD LS-1内，正在进行一项血液样本采集的子研究，以获取和存储DNA，用于未来的PD/和神经疾病研究。DNA采样的血液采集是在同意参与者的筛查/基线访问时一次性抽血。 涉及人类受试者的程序将在临床访问期间进行，在5年研究期间将至少进行9次。在第二年之后，将有至少三次电话联系，以审查副作用、药物、医疗服务提供者的访问，以及研究用药问卷。最广泛的临床包括：个人和家族病史、生命体征(脉搏、血压、体重)、日常生活能力、总体功能问卷、思维能力测试、记忆力测试、抑郁量表(Beck抑郁量表)、血和尿检(1TBS)。将采集血液进行常规测试)、符合条件的个人怀孕测试、帕金森氏症检查和心电图将在三次访问中对一部分登记的参与者进行。除了临床程序外，在电话中进行的问卷调查将在访问诊所时再次进行。

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.