This application is for the continuation of the NET-PD clinical trial at the University of Alberta site. NET-PD was designed to enroll patients in a serie of pilot studies and clinical trials of new agents for the treatment of Parkinson's disease (PD). The role of the clinical sites is to identify, screen, enroll, treat, and follow patients in these rials;to report data in a timely manner to the clinical coordinating center;and to report adverse effect amongst enrolled patients. Currently, the NET-PD consortium is conducting LSI, a multi-center, double-blind, phase 3 clinical trial designed to determine whether creatine is more effective than placebo in slowing clinical progression in patients with early, treated PD. All participants will receive treatment for a minimum of five years after the last participant was enrolled in the study. Enrollment in LSI began in 2007 and was completed in mid-2010 with the enrollment of a total of 1741 study participants from 50 clinical centers. At the University of Alberta site, we have enrolled 34 subjects in LSI (~2% of total study enrollment) and have a demonstrated retention rate of 85%. Our data has been reported in a timely fashion with query resolutions from our site rated as 68.2% timely vs 47.2% for the overall study. Our patients have experienced no significant adverse effects. At our site, the final patient visit is expected in May, 2015. Ours is one of only two non-US sites involved in NET-PD and as such is critical to ensure that the results from this clinical trial can be generalized to a non-US population.
Parkinson's disease is one of the most common neurodegenerative disorders, affecting at least 1% of the population over age 60. The disorder is inexorably progressive and a source of significant morbidity. The objective of this study is to evaluate one potential disease-modifying treatment that, if effective, will have a significant impact on slowing disease progression, thereby decreasing disability associated with the disease.
|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|