A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment

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.

This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of GRF6021, a plasma derived product, administered by intravenous (IV) infusion to subjects with Parkinson's disease (PD) and cognitive impairment. The study duration for the subjects will be approximately 7 months.

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.