Safety and Efficacy of Plasma Transfusion From Exercise-trained Donors in Patients With Early Alzheimer's Disease

Exclusion Criteria

• •Pregnancy or unwilling to use adequate birth control for the duration of and 6 months beyond study participation. Defined according to Clinical Trial Facilitation Group document "Recommendations related to contraception and pregnancy testing in clinical trials".
• •Positive for Hepatitis B, Hepatitis C or HIV at screening.
• •Not qualified to give consent at inclusion.
• •Any other condition judged to interfere with the safety of the patient or the intent and conduct of the study.
• •Related to medical history:
• •Stroke
• •Anaphylaxis
• •Prior adverse reaction to any human blood product
• •Any history of a blood coagulation disorder or hypercoagulability
• •Congestive heart failure, defined as any previous heart failure hospitalization, or current symptomatic heart failure in New York heart Association class ≥II with reduced, mid-range or preserved ejection fraction.
• •Coagulation defect or hypercoagulopathy
• •Uncontrolled hypertension
• •Renal failure
• •Prior intolerance to intravenous fluids
• •Recent history of uncontrolled atrial fibrillation
• •Bone marrow transplant
• •IgA deficiency
• •Severe protein S deficiency
• •Thrombocytopenia (platelets \< 40 x 10 to the power of 9/L)
• •Contraindication for Octaplasma
• •Related to medications or other treatments:
• •Any concurrent use of anticoagulant therapy, clopidogrel or acetylsalicylic acid/Dipyridamol in combination.
• •Initiation or change in the dosage of a acetylcholine esterase inhibitor (AChEI) or memantine during the trial (week 0-52). Participants will be urged to start on AChEI when diagnosis is communicated, and must be on a stable dose for at least one month prior to screening.
• •Concurrent participation in another treatment trial for AD. If there was prior participation, the last dose of the investigational agent must have been given at least 6 months prior to screening, except if the patient received placebo medication.
• •Treatment with any human blood product, including intravenous immunoglobulin, during the 6 months prior to screening or during the trial.
• •Concurrent daily treatment with benzodiazepines, typical or atypical antipsychotics, long-acting opioids, or other medications that is judged to interfere with cognition. Intermittent treatment with short-acting benzodiazepines or atypical antipsychotics may be permitted, provided that no dose is administered within 72 hours prior to cognitive assessment.
• •Related to magnetic resonance imaging:
• •Claustrophobia
• •Any metallic surgical implant, like a pacemaker or clip that is incompatible with MRI.