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

This is a randomized, double-blind, placebo-controlled study to assess the safety,
tolerability and potential cognitive benefit of GRF6019, a human plasma protein fraction.
GRF6019 or placebo will be administered intravenously to subjects with severe Alzheimer's
disease every day for 5 consecutive days. The total study duration for each subject is
approximately 9 weeks.

Inclusion Criteria:

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

- MMSE Score 0-10 inclusive

- Modified Hachinski Ischemia Scale (MHIS) score of 4 or less

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

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.

- Unstable coronary heart disease, e.g. myocardial infarction or severe or unstable
angina in the 6 months prior to dosing.

- Moderate to severe congestive heart failure (New York Association Class III or IV).

- Poorly controlled high blood pressure (systolic blood pressure of 160 mmHg or higher
and/or diastolic blood pressure of 100 mmHg or higher) despite treatment during the 3
months prior to dosing, or treatment refractory high blood pressure, defined as
treatment requiring 3 or more antihypertensives from different classes.

- 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.