MULTICENTER STUDY OF COQ10 & GPI 1485 IN EARLY UNTREATED PARKINSON'S DISEASE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objective of the study is to assess the impact of CoQ10 and GPI 1485 on the progression of PD in order to assess whether it is non-futile to proceed with further study of these agents. The progression of PD will be measured by the change in total UPDRS score between the baseline visit and month 12 or the time of sufficient disability to require symptomatic therapy (last visit before subject goes on symptomatic therapy), whichever occurs first. This is a multicenter, double-blind, pilot study of outpatients with early, untreated PD. De novo subjects will be equally randomized to one of the three study arms: (1) the group that receives active CoQ10 and placebo for GPI 1485, (2) the group that receives active GPI 1485 and placebo for CoQ10 and (3) the group that receives placebo for CoQ10 and GPI 1485. Subjects will remain on blinded study drug for 12 months. The primary comparison of each drug is to historical control data, but a placebo group is included in order to ascertain concurrent control rates.