MINOCYCLINE AMP; CREATINE 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 minocycline and creatine on the progression of Parkinson's Disease (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 dopaminergic therapy), whichever occurs first. This is a multicenter, double-blind, futility study of outpatients with early, untreated PD. De novo subjects will be equally randomized to one of the three study arms: (1) active minocycline and placebo for creatine, (2) active creatine and placebo for minocycline, and (3) placebo for minocycline and creatine. Subjects will remain on blinded study drug for 18 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.