MODERATO Study for Parkinson's Disease Patients With Mild Cognitive Impairment
This is a clinical research study. The purpose of this study is to find out whether the study drug is effective in improving memory function, or cognition, in people with mild cognitive impairment in Parkinson disease (PD-MCI).
Up to 170 subjects will be enrolled in this study across 30 study centers. Approximately six subjects are expected to be enrolled at Rush University Medical Center. Eligible subjects will be randomized (assigned by chance) to receive either an active study drug or placebo (inactive tablet). Subjects will be asked to participate for up to 24 weeks and will include four study visits at the study center.
In order to participate you must meet the following criteria:
- Are 45 through 75 years of age.
- Have a diagnosis of idiopathic Parkinson disease.
- Have mild cognitive impairment but cannot have dementia.
- Are on a stable dopaminergic medication schedule.
- Are able to provide written consent to participate.
You will be excluded from the study if any of the following criteria apply to you:
- Have a history of vascular disease (e.g., stroke).
- Have a history of melanoma (e.g., skin cancer).
- Have undergone deep brain stimulation (DBS).
- Have impaired liver function.
- Have pyschosis or are receiving antipsychotic treatment.
- Have taken any investigational products within 60 days prior to the screening/baseline visit.
This is a partial list of eligibility requirements.