The aim of the Neuroprotection Exploratory Trials in Parkinson's Disease (NET-PD) is to evaluate whether selected agents slow the clinical progression of Parkinson's Disease. NET-PD was designed to enroll patients in a series of pilot studies and clinical trials of new agents for the treatment of Parkinson's Disease. The role of the clinical sites is to identify, screen, enroll, treat and follow patients in these trials;to reportthe data in a timely manner to the data coordinating center, and to report adverse effects among enrolled patients. Currently, NET-PD is conducting the LS-1 study, a multi-center, double-blind, phase III clinical trial designed to determine whether or not creatine is more effective than placebo in slowing the clinical decline in Parkinson's Disease patients with early, treated Parkinson's Disease.
Parkinson's disease (PD) is one of the most common adult neurodegenerative disorders, affecting over 1 million people in North America and the European Union. As a first step in identifying such therapies, the NET-PD network successfully completed futility studies, which identified creatine as a potential agent to slow clinical decline in PD. Th NET-PD network is now conducting a long-term. Phase 3 trial (known as LS1) comparing creatine to Placebo. Disclaimer: Please note that the following critiques were prepared by the reviewers prior to the Study Section meeting and are provided in an essentially unedited form. While there is opportunity for the reviewers to update or revise their written evaluation, based upon the group's discussion, there is no guarantee that individual critiques have been updated subsequent to the discussion at the meeting. Therefore, the critiques may not fully reflect the final opinions of th individual reviewers at the close of group discussion or the final majority opinion of the group. Thus the Resume and Summary of Discussion is the final word on what the reviewers actually considered critical at the meeting.
|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|