Pacific Health Research and Education Institute (PHREI) is currently conducting 2 Net-PD studies coordinated by the University of Rochester Clinical Coordination Center and the Statistical Coordinating Center at the University of Texas School of Public Health. A Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Study of Creatine in Subjects with Treated Parkinson's Disease (PD) Long-term Study-1 (LS-1): PHREI is one of 50 centers conducting the Phase III LS-1 clinical trial. This application requests funding for the three final required years of the trial. Our goal is to complete the trial with no further drop outs or individuals who are lost to follow-up. Additionally, we aim to complete all case report forms in a timely fashion without errors. It is hoped that the results of this trial wil show that the creatine treated group has less progression compared to the placebo group as measured by the global statistical test. A Multicenter, Double-Blind, Placebo-Controlled Phase II Study of Pioglitazone in Early PD (FS-ZONE): For this trial, PHREI is one of 43 sites. No additional funding is being requested for this study. Our overall aims are: 1)to complete all visit with maximum retention of subjects for the ongoing LS-1 clinical trial, in order to determine if creatine is more effective than placebo in slowing clinical decline in treated subjects with PD;2) to successfully recruit six subjects and complete all visits for ongoing FS-ZONE clinical trial to determine whether it is futile to proceed with studying pioglitazone as a potential agent to slow progression of PD;and 3) to participate in analyses and manuscript preparation of the main outcomes for both LS-1 (global statistical test) and FS-Zone (change in total UPDRS) and secondary analyses evaluating the effects of creatine and pioglitazone on individual PD clinical measures and on safety and tolerability.
Parkinson's disease (PD) is the second most common neurodegenerative disease affecting 1-3% of individuals aged >65. While there are medications that manage the symptoms effectively for a time, there is no cure for PD and no proven strategy for slowing progression. Therefore, a major priority for this field is to identify interventions tht slow progression and this is the aim of the NET-PD studies.
|Wills, Anne-Marie A; Elm, Jordan J; Ye, Rong et al. (2016) Cognitive function in 1736 participants in NINDS Exploratory Trials in PD Long-term Study-1. Parkinsonism Relat Disord 33:127-133|
|Wills, Anne-Marie A; Pérez, Adriana; Wang, Jue et al. (2016) Association Between Change in Body Mass Index, Unified Parkinson's Disease Rating Scale Scores, and Survival Among Persons With Parkinson Disease: Secondary Analysis of Longitudinal Data From NINDS Exploratory Trials in Parkinson Disease Long-term Study 1 JAMA Neurol 73:321-8|
|Elm, Jordan J; NINDS NET-PD Investigators (2012) Design innovations and baseline findings in a long-term Parkinson's trial: the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease Long-Term Study-1. Mov Disord 27:1513-21|
|Mauldin, Patrick D; Guimaraes, Paulo; Albin, Roger L et al. (2008) Optimal frequency for measuring health care resource utilization in Parkinson's disease using participant recall: the FS-TOO resource utilization substudy. Clin Ther 30:1553-7|