A Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Participants with Treated Parkinson’s Disease (PD).  Large Study 1 (LS-1 Acronym:  NET-PD Large Study-1 (LS-1)

This is a multi-center, double-blind, study to determine if creatine is more effective than placebo in slowing the clinical decline of Parkinson’s disease (PD) patients with early, treated PD.  Treated will be defined as receiving dopaminergic therapy (dopamine agonists or levodopa) for a period of greater than 90 days but not longer than 2 years.  At least 1720 subjects from approximately 52 sites in the US and Canada will be enrolled.  Approximately 45 are anticipated to be enrolled at RUMC.  Subjects will be randomized in a 1:1 ratio to receive creatine or placebo.  Subjects will remain on blinded study drug for a minimum of 5 years or until the last subject enrolled completes 5 years.  The duration of the study is to be a minimum of 5 years in order to allow sufficient time to determine if the two groups differ in disease progression while continued follow up beyond 5 years will be provided longer term information on progression for a subset of subjects.

You may be eligible to participate in this study if you:

• Are be willing and able to give informed consent and willing to commit to long-term follow-up
• Have Parkinson’s disease (asymmetric features including bradykinesia plus resting tremor and/or rigidity) within 5 years of diagnosis
• Are treated/responsive to dopaminergic therapy (dopamine agonists or levodopa) for at least 90 days, but not longer that 2 years

You will be excluded from this study if you:

• Have used creatine 14 days prior to baseline or during the study
• Have participated in other drug studies or have received other investigational drugs within 30 days prior to baseline
• Have a history of known hypersensitivity or intolerability to creatine

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.