Summary:
This study will evaluate the safety, tolerability, and potential effects on cognition of GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with Parkinson's disease and cognitive impairment.
Inclusion Criteria:
- Diagnosis of Parkinson's Disease (PD), with at least 1 year of PD symptoms.
- Diagnosis of PD with mild cognitive impairment (PD-MCI) or probable or possible Parkinson's disease dementia according to Movement Disorder Society's Clinical Diagnostic criteria.
- Score on the Montreal Cognitive Assessment (MoCA) of 13-25.
- Modified Hoehn and Yahr Stages 1-4.
- Modified Hachinski Ischemic Scale (MHIS) score of 4 or less.
Exclusion Criteria:
- History of blood coagulation disorders or hypercoagulability.
- Current use of anticoagulant therapy. Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.
- Prior hypersensitivity reaction to any human blood product or any IV infusion.
- Treatment with any human blood product, including transfusions and IV immunoglobulin, during the 6 months prior to screening.
- History of immunoglobulin A or haptoglobin deficiency; stroke, anaphylaxis, or thromboembolic complications of IV immunoglobulins.
- Heart disease, as evidenced by myocardial infarction, unstable, new onset or severe angina, or congestive heart failure in the 6 months prior to dosing
- Hemoglobin < 10 g/dL in women and < 11 g/dL in men.
Qualified Participants May Receive:
Compensation for time and travel for all completed study visits if qualified.