A Study to Assess the Safety of GRF6021 Infusions in 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, haptoglobin, or C1 inhibitor 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.