Early Parkinson's Disease Clinical Trial

This study is designed to assess the ability of investigational product (IP) to slow the progression of Parkinson's disease (PD). Preclinical animal model data have already demonstrated that IP has neuroprotective activity, but further development will require human clinical experience. This study will also allow determination of safety and tolerability of IP over many months in subjects with PD.
 

In order to participate you must meet the following criteria:

• Are a male or female ≥ 50 years of age.
• Have a body mass index (BMI) greater than 18.5 kg/m2 and less than 45 kg/m2.
• Have been diagnosed with "Clinically Probable PD" according to the MDS clinical diagnostic criteria, with documented diagnosis of PD per treating physician's records within three years of the Screening visit. Disease severity according to modified Hoehn & Yahr stage ≤ 2.
• Projected to not required to start dopaminergic therapy within 9 months from Baseline.

You will be excluded from the study if any of the following criteria apply to you:

• Are currently, or within 60 days of Screening, using any prescription, investigational, or over the counter medication for the symptomatic treatment of PD or to slow the progression of PD. Treatment with Monoamine Oxidase B (MAOB) inhibitors will be allowed if the dose is stable for at least 30 days prior to Screening and subjects agree to remain on it for the duration of the study.
• Have prior use of dopaminergic therapy (e.g., levodopa, dopamine agonist, amantadine) for 30 or more days any time in the past.
• Have a history of any surgery on the brain itself including deep brain stimulation for PD (note this does not include surgeries on the skull that do not affect the brain, e.g., small meningioma removal).

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 email, please include the title of the study in your message.