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Could young Athletes' plasma slow Alzheimer's? new study tests the idea

NCT ID NCT05068830

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

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

50 to 75 years

Sex

Anyone

Healthy volunteers

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

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

  • Department of Neurology and Clinical Neurophysiology, St Olavs Hospital

    Trondheim, Norway

More trials for these conditions

Other studies related to the condition(s) this trial covers.