Parkinson's disease (PD) affects at least a half million Americans, and more as our population ages. Symptomatic medications can dramatically improve the lives of patients initially. However, with time disabling and unpredictable motor fluctuations occur, and the disease relentlessly progresses in most to dementia and immobility in the end stages. Therapy that slows progression of disease (neuroprotection) is desperately needed for the many thousands of affected Americans. In an effort to develop neuroprotective therapy the NINDS funded the NIH Exploratory Trials in PD (NET- PD) program, which consists of a Clinical Trials Coordination Center, a Statistical Center and 50 Clinical Sites. To date the NET-PD program has successfully completed four futility trials, is currently conducting a fifth futility trial (pioglitazone), and is in the process of completing a large simple (LSI) Phase III randomized, double-blinded, placebo-controlled clinical trial (creatine). These activities have contributed valuable scientific advances to the PD community. Our site, the University of Colorado Denver (UCD), is one of 50 selected Clinical Sites. The current NET-PD trials are expected to take three more years to complete;this application is a request for funding to complete the trials. Recruitment and retention of subjects at the Clinical Sites will be crucial fo success.
The Specific Aims for the UCD site are (1) to complete the LSI study with retention of >85% of subjects and with >75% active in Study and on study drug, and (2) to do so with high adherence to study protocol and regulatory requirements. The UCD site has contributed greatly to the current success of the NET-PD program. For example, in LSI UCD is the fourth highest enrolling site and is the ninth highest in terms of retention of subjects on study drug. Dr. Leehey serves on the NET-PD program's Recruitment &Retention Committee and thus helped develop severally strategies that most sites employ to maximize recruitment and retention. Our site enters data and handles queries in a more reliable and timely fashion than average for all 50 sites. UCD has a number of strengths detailed in this application, including individualized expert care to subjects, which underlie our success and the reason our site is a strong and necessary asset to the NET-PD program.
The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time. 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.