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

Criteria the registry did not label

• Patient inclusion criteria:
• Diagnosis AD in early phase according to the IWG-2 criteria.
• Mini-Mental State Examination (MMSE) Score ≥20.
• In-vivo evidence of Alzheimer´s pathology (one of the following):
  • Decreased Aβ42 together with increased t-tau or p-tau in CSF.
  • Increased tracer retention on amyloid PET.
• Availability of a next of kin who knows the patient well and is willing to accompany the subject to all trial visits and give information about the patients functional level.
• Signed informed consent.
• The patient is judged fitted for the study and capable to cooperate in treatment and follow-up.
• Ability to communicate in Norwegian or another Scandinavian language.
  • Patient 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.
  • Certain metallic implants like joint replacements may be permitted, provided that specific manufacturer specifications are available, and that the device is known to be safe for 7T MRI. In case a patient is not eligible for the 7T scanner, the 3T scanner will be used.