A Randomized Study to Assess the Safety of GRF6019 Infusions in Subjects With Mild to Moderate Alzheimer's Disease

This is a randomized, double-blind, dose-comparison concurrent control study to assess the
safety, tolerability, and feasibility of GRF6019, a plasma-derived product, administered by
intravenous (IV) infusion to subjects with mild to moderate Alzheimer's disease.

Subjects will be randomized 1:1 to a low dose or a high dose of active treatment in a
double-blind manner. All subjects will receive one infusion per day at the randomized dose
for 5 consecutive days during Week 1 and, again, during Week 13 (for a total of 10 doses per
subject). All IV infusions will take place at an inpatient research unit while the follow-up
visits after each treatment period will be on an outpatient basis. Subjects will participate
for a total of 6 months in this study.

Inclusion Criteria:

- Diagnosis of probable AD based upon the National Institute on Aging-Alzheimer's
Association (NIA-AA) Criteria

- MMSE Score 12-24 inclusive

- Modified Hachinski Ischemia Scale (MHIS) score of ≤ 4

- Provided a signed and dated informed consent form (either the subject and/or subject's
legal representative as well as the trial partner)

Exclusion Criteria:

- Evidence of clinically relevant neurological disorder(s) other than probable AD

- History of blood coagulation disorders or hypercoagulability; any concurrent use of an
anticoagulant therapy. (e.g., heparin, warfarin, thrombin inhibitors, Factor Xa
inhibitors). Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.

- Initiation or change in the dosage of cholinesterase inhibitors (AChEI), memantine,
Axona, vitamin E supplementation or selegiline within 3 months prior to screening.

- Heart disease (or history thereof), as evidenced by myocardial infarction, unstable,
new onset or severe angina, or congestive heart failure (New York Association Class
II, III or IV) in the 6 months prior to dosing; uncontrolled high blood pressure
(systolic blood pressure of 160 mmHg or higher and/or diastolic blood

- Prior hypersensitivity reaction to any human blood product or intravenous infusion;
any known clinically significant drug allergy.

- Treatment with any human blood product, including transfusions and intravenous
immunoglobulin, during the 6 months prior to screening.

- History of immunoglobulin A (IgA), haptoglobulin or C1 inhibitor deficiency; stroke,
anaphylaxis, or thromboembolic complications of intravenous immunoglobulins.

- Hemoglobin <10 g/dL in women; and <11 g/dL in men.