Continuation of NET-PD Trials at the University of Michigan

密歇根大学继续进行 NET-PD 试验

• 批准号: 8459176
• 负责人: KELVIN L CHOU
• 金额: $ 7.36万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 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/8459176
• 关键词: Academic Medical Centers; Americas; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Commit; Communities; Conduct Clinical Trials; Creatine; Disorder by Site; Enrollment; Ensure; Foundations; Funding; Futility; Future; Goals; Grant; Health system; Measures; Michigan; Minority; Monitor; National Institute of Neurological Disorders and Stroke; Neurodegenerative Disorders; North America; Outcome Measure; Parkinson Disease; Participant; Patient advocacy; Pharmaceutical Preparations; Pharmacotherapy; Phase II Clinical Trials; Phase III Clinical Trials; Pioglitazone; Placebos; Process; Quality of life; Records; Recruitment Activity; Research Infrastructure; Research Subjects; Safety; Site; Testing; Universities; Visit; advocacy organizations; base; disability; experience; follow-up; palliative; public health relevance; rasagiline; research study; statistical center; treatment strategy; trial comparing

DESCRIPTION (provided by applicant): Current pharmacotherapy for Parkinson's disease (PD) is palliative. There is no treatment proven unequivocally to arrest or slow progression of PD. The NINDS Exploratory Trials in Parkinson's Disease (NET-PD) consortium was initiated to conduct clinical research trials of promising agents that could slow the clinical progression of PD. The clinical investigators and staff at the University of Michigan Health System have been involved as a NET-PD site since the inception of NET-PD and have been active participants in all clinical trials conducted by the NET-PD group. Our site has an excellent subject recruitment and retention record. Our site is committed to the safe conduct of clinical trials and has several measures in place to ensure participant safety. We actively participated in the original FS-1 and FS-TOO futility studies. We then enrolled 37 subjects in the LS-1 creatine study and are currently conducting follow-up visits on 33 subjects (retention rate 89%). We are committed to retaining and following these 33 subjects through completion of the LS-1 trial. We are also in the process of enrolling subjects for the FS-ZONE study, which is investigating whether pioglitazone can slow down the clinical progression of PD and have enrolled 2 subjects to date. Additionally, we have strong ties with the Michigan Parkinson Foundation (MPF), the major lay organization for PD in Michigan and plan on implementing a new initiative to increase and retain minority enrollment. Based on our previous experience in NET-PD, our clinical research infrastructure, and connection with the local PD community, we at the University of Michigan believe that we are well-equipped to continue serving as a clinical center for the remaining NET-PD trials. We plan on continuing to cooperate with other NET-PD centers, including the Coordination and Statistical Centers towards the goal of completing the current trials (LS-1 and FS-ZONE).

描述（由申请人提供）：目前帕金森病（PD）的药物治疗是姑息性的。没有明确证明可以阻止或减缓PD进展的治疗。NINDS帕金森病探索性试验（NET-PD）联盟的发起是为了对可能减缓PD临床进展的有前途的药物进行临床研究试验。自NET-PD成立以来，密歇根大学卫生系统的临床研究者和工作人员一直作为NET-PD研究中心参与其中，并积极参与NET-PD组进行的所有临床试验。我们的研究中心具有出色的受试者招募和保留记录。我们的研究中心致力于安全进行临床试验，并采取了多项措施来确保参与者的安全。我们积极参与了最初的FS-1和FS-TOO无效性研究。然后，我们在LS-1肌酸研究中招募了37名受试者，目前正在对33名受试者进行随访访视（留存率89%）。我们致力于保留并随访这33例受试者，直至LS-1试验完成。我们还正在招募FS-ZONE研究的受试者，该研究正在研究吡格列酮是否可以减缓PD的临床进展，迄今为止已招募了2例受试者。此外，我们与密歇根州帕金森基金会（MPF）有着密切的联系，该基金会是密歇根州PD的主要非专业组织，并计划实施一项新的举措，以增加和保留少数民族入学率。基于我们之前在NET-PD方面的经验，我们的临床研究基础设施以及与当地PD社区的联系，我们密歇根大学相信我们有能力继续作为剩余NET-PD试验的临床中心。我们计划继续与其他NET-PD中心合作，包括协调和统计中心，以实现完成当前试验（LS-1和FS-ZONE）的目标。

项目成果

The MDS-UPDRS tracks motor and non-motor improvement due to subthalamic nucleus deep brain stimulation in Parkinson disease.

• DOI: 10.1016/j.parkreldis.2013.06.010
• 发表时间: 2013-11
• 期刊: Parkinsonism & related disorders
• 影响因子: 4.1
• 作者: Chou KL;Taylor JL;Patil PG
• 通讯作者: Patil PG

Validity and Efficacy of Screening Algorithms for Assessing Deep Brain Stimulation Candidacy in Parkinson Disease.

• DOI: 10.1002/mdc3.12103
• 发表时间: 2014-12-01
• 期刊: MOVEMENT DISORDERS CLINICAL PRACTICE
• 影响因子: 4
• 作者: Coleman, Robert R;Kotagal, Vikas;Patil, Parag G;Chou, Kelvin L
• 通讯作者: Chou, Kelvin L

Fatigue in Parkinson's disease: report from a mutidisciplinary symposium.

• DOI: 10.1038/npjparkd.2015.25
• 发表时间: 2016
• 期刊: NPJ Parkinson's disease
• 作者: Friedman JH;Beck JC;Chou KL;Clark G;Fagundes CP;Goetz CG;Herlofson K;Kluger B;Krupp LB;Lang AE;Lou JS;Marsh L;Newbould A;Weintraub D
• 通讯作者: Weintraub D