In 2005 we were selected to participate as a Clinical Site by the NINDS in the Neuroprotection Exploratory Trials in Parkinson's Disease initiative (RFA-NS-05-004). We enrolled 46 subjects in the phase 3 trial evaluating creatine 10 gm/day compared with placebo over the period April 2007 through April 2010. One of these subjects, and Hispanic gentleman, moved to Colorado where he was scheduled to continue in the trial at another site. A second subject was withdrawn per study protocol because of renal function at the screening/baseline visit. Six subjects have terminated early from the study, in each case due to worsening medical illness or distance of current residence to the study site. All of the remaining 38 subjects continue in the study and there have been no missed follow-up visits. Performance data provided by the Coordination Center indicate that of the 45 subjects enrolled (not including the subject who moved to Colorado), 100% of forms were received (loaded) with timeliness in 85.8% (ranked 10/50 sites);100% of queries were resolved (closed), timely in 67.9% (third best of 50 sites).
The Specific Aim of this study is to continue to collaborate, as a clinical center, In the Neuroprotection Exploratory Trials in Parkinson's Disease (NET-PD) initiative. We expect to continue all patient follow-up activities necessary for the successful completion of the creatine trial, and have all of the needed resources and personnel in place to complete this trial successfully. Of the 45 subjects enrolled (not including the Hispanic subject who moved to Colorado), 23 are males, 22 are females. We have enrolled one African-American male and one male who identify himself as both American Indian and White (captured in the Inclusion Enrollment Report as "More Than One Race"). We have also enrolled 5 subjects in the FS-Zone (pioglitazone) futility study, all of whom continue in the study with no missed follow-up visits.
The NET-PD initiative continues to be timely and exciting as, despite the availability of increasingly sophisticated medical and surgical treatments to alleviate many of its symptoms, no treatment has, to date, been definitely proven to slow or arrest the progression of Parkinson's disease.