Continuation of NET-PD Trials at Indiana University

Wojcieszek, Joanne

Abstract

This application is for the continuation of a NET-PD clinical site at Indiana University. 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 reportdata 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 showing the clinical decline in PD patients with early treated PD. The primary objective of the study is to determine if there is a slowing of clinical decline in PD subjects defined by a combination of cognitive, physical, and quality of life measures. Enrollment began in 2007 and will continue through 2015, or end of study.

Public Health Relevance

The objective of this multiple center clinical trial will be to determine safety, tolerability and efficacy of one or more agents as neuroprotective therapies for Parkinson's disease (PD). 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.