A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease

Exclusion Criteria

• •1. Any contraindication for plasma exchange due to behavioral disorders or abnormal coagulation parameters, such as for example:
• •* Hypocalcemia (Ca++ \< 8.7 mg/dL)
• •* Thrombocytopenia (\<100,000/µL)
• •* Fibrinogen \<1.5 g/L
• •* Prothrombin time (Quick) p\<60% versus control (international normalized ratio (INR) \>1.5)
• •* Beta-blocker treatment and bradycardia \<55/min
• •* Treatment with angiotension-converting enzyme inhibitors (ACEIs) (increased risk of allergic reactions)
• •2. Hemoglobin \< 10 g/dL
• •3. Difficult venous access precluding plasma exchange.
• •4. A history of frequent adverse reactions (serious or otherwise) to blood products.
• •5. Hypersensitivity to albumin or allergies to any of the components of Albutein.
• •6. History of immunoglobulin A (IgA) deficiency.
• •7. Known allergies to Flebogamma DIF components such as sorbitol.
• •8. History of thromboembolic complications of intravenous immunoglobulins.
• •9. Plasma creatinine \> 2 mg/dl.
• •10. Uncontrolled 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 last 3 months).
• •11. Liver cirrhosis or any liver problem with glutamic pyruvic transaminase (GPT) \> 2.5 x upper limit of normal (ULN), or bilirubin \> 2 mg/dL.
• •12. Heart diseases, as evidenced by myocardial infarction, severe or unstable angina, or heart failure (New York Association Class II, III or IV) in the past 12 months.
• •13. Participation in other clinical trials, or the receipt of any other investigational drug in the three months prior to the start of the study.
• •14. Any condition complicating adherence to the study protocol (illness with less than one year of expected survival, known drug or alcohol abuse, etc.).
• •15. Pregnant or nursing women or women not using effective contraceptive methods for at least one month after plasma exchange.
• •17. Less than three months with stable treatment for behavioral disorders or insomnia.
• •18. Patients being treated with anticoagulants or antiplatelet therapy (antiaggregants) should not be recruited in the study.