Could young Athletes' plasma slow Alzheimer's? new study tests the idea
NCT ID NCT05068830
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether blood plasma from young, healthy, and very fit donors is safe and can help people with early Alzheimer's disease. Sixty patients aged 50-75 will receive monthly transfusions of either this 'exercise plasma' or a saltwater placebo over a year. Researchers will monitor side effects and check for changes in memory, brain function, and blood markers.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2021
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Neurology and Clinical Neurophysiology, St Olavs Hospital
Trondheim, Norway
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Other studies related to the condition(s) this trial covers.
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