Research Project
8317471
Parkinson's disease (PD) is characterized by the gradual death of dopamine-producing brain cells, which in patients results in increasing tremors, motor slowness and stiffness, and impaired balance and walking. Treatments to ameliorate the symptoms of PD exist, but these gradually lose effectiveness as the disease progresses. NET-PD was initially funded in 2001 for the purpose of identifying pharmaceutical agents that could delay or prevent disease progression in PD. In its initial funding period, the NET-PD coordinating center, statistical center, and 50 enrollment sites rapidly screened a number of potentially neuroprotective agents for efficacy and identified one, a highly purified form of creatine (PD-02), as a promising candidate for assessment in a longitudinal clinical trial. NET-PD subsequently undertook a large double-blind placebo-controlled trial to determine if PD-02 use does indeed delay or prevent progression of PD over a 5-year follow-up period. PD-02 has been supplied to NET-PD at no cost by Avicena Group, Inc., which holds the patent on the creatine blending and purification process. Unfortunately, this situation has changed for unavoidable reasons, and in order to avoiding halting the current trial, NINDS proposed purchasing PD-02 directly from Avicena Group's supplier, Deseret Laboratories International, until such time as Avicena Group is able to resume supplying it at no cost. The purpose of this contract is therefore to purchase from Deseret Laboratories, in quantities sufficient for a six month supply, the nutraceutical compound, PD-02, and placebo, for use in the NIH Exploratory Trials in Parkinson's Disease (NET-PD) multi-site clinical trial that is currently in progress.
