Human plasma protein for Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- Patient inclusion criteria\n- Signed informed consent\n- Age up to 75 years\n- Diagnosis AD in early phase according to the IWG-2 criteria43\n- Decreased Aβ42 together with increased t-tau or p-tau in CSF\n- Increased tracer retention on amyloid Positron Emission Tomography (PET)\n- MMSE Score ≥20\n- Availability of a next of kin who knows the patient well and is willing to accompany the subject to all trial visits and to provide information about the patient’s functional level\n- The patient is judged fit for participation, and capable of taking part in the treatment and follow-up procedures\n- Ability to communicate in Norwegian or another Scandinavian language"}

Exclusion criteria

• {"criterion_text":"- Patient exclusion criteria Patients will be excluded from the study if they meet any of the following criteria:\n- Pregnancy or unwilling to use adequate birth control for the duration of and 6 months beyond study participation\n- Defined according to Clinical Trial Facilitation Group document ‘Recommendations related to contraception and pregnancy testing in clinical trials’\n- Positive for Hepatitis B, Hepatitis C or HIV at screening\n- Lack of competency to provide informed consent at inclusion\n- Any other condition judged to interfere with the safety of the patient or the intent and conduct of the study\n- Stroke\n- Anaphylaxis\n- Prior adverse reaction to any human blood product\n- Any history of a blood coagulation disorder or hypercoagulability\n- Congestive heart failure, defined as any previous heart failure hospitalisation, or current symptomatic heart failure in New York heart Association class ≥II with reduced, mid-range or preserved ejection fraction.\n- Coagulation defect or hypercoagulopathy\n- Uncontrolled hypertension\n- Renal failure\n- Prior intolerance to intravenous fluids\n- Recent history of uncontrolled atrial fibrillation\n- Bone marrow transplant\n- IgA deficiency\n- Severe protein S deficiency\n- Thrombocytopenia (platelets <40 x 109 /L)\n- Contraindication for Octaplasma\n- Any concurrent use of anticoagulant therapy, clopidogrel or acetylsalicylic acid/dipyridamole in combination\n- Initiation or change in the dosage of a acetylcholine esterase inhibitor (AChEI) or memantine during the trial (weeks 0–52). Participants will be urged to start on AChEI when diagnosis is communicated, and must be on a stable dose for at least 1 month prior to screening\n- 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\n- Prior or concurrent participation in amyloid antibody trials, except if the patient received placebo medication\n- Treatment with any human blood product, including intravenous immunoglobulin, during the 6 months prior to screening or during the trial\n- Concurrent daily treatment with benzodiazepines, typical or atypical antipsychotics, long-acting opioids or other medications that are judged to interfere with cognition.\n- 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\n- Claustrophobia\n- Any metallic surgical implant, like a pacemaker or chip incompatible with MRI\n- Certain metallic implants like joint prostheses 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"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients with adverse events after 1 year as a measure of safety and tolerability, and number of subjects who comply with the research protocol as a measure of feasibility.","definition_or_measurement_approach":"Proportion of patients with adverse events measured at 1 year; compliance measured as number of subjects who comply with the research protocol (counts of subjects adhering to protocol)."}

Secondary endpoints

• {"endpoint_text":"- Change in performance in the CERAD 10 word Test\n- Change in the Mini-Mental State Examination (MMSE) score\n- Change in performance in Trail-Making test A and B\n- Change in scores in other cognitive tests: the Clock Drawing Test, Controlled Oral Word Association Test (COWAT)-FAS, Visual Object and Space Perception (VOSP) Silhouettes\n- Change in Clinical Dementia Rating Scale Global score","definition_or_measurement_approach":"Change in score from baseline on the listed cognitive tests (CERAD 10-word, MMSE, Trail-Making A/B, Clock Drawing, COWAT-FAS, VOSP Silhouettes, CDR Global) measured at planned follow-up visits."}

Norway

Earliest CTIS Part Ii Submission Date

15-01-2025

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

462

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Norwegian University Of Science And Technolology

Organisation Type

Educational Institution

Country Of Registered Address

Norway