Safety and efficacy of plasma transfusion from exercise-trained donors in patients with early Alzheimer’s disease: the ExPlas Study

Phase 1

• Conditions: Early Alzheimer's disease; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-000148-24-NO
• Lead Sponsor: orwegian University of Science and Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-10
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

?Signed informed consent
?Age 50-75 years
?Diagnosis AD in early phase according to the IWG-2 criteria (42)
?In-vivo evidence of Alzheimer´s pathology (one of the following):
oDecreased Aß42 together with increased t-tau or p-tau in CSF
?Increased tracer retention on amyloid PET
?Mini-Mental State Examination (MMSE) Score =20
?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 patient’s functional level
?The patient is judged fit for the study and capable to cooperate in treatment and follow-up.
?Ability to communicate in Norwegian or another Scandinavian language

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following 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 109/L)
?Contraindication for Octaplasma

Related to medications or other treatments:
?Any concurrent use of anticoagulant therapy, clopidogrel or acetylsalicylic acid/dipyridamole
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 are 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 incompatible with MRI
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified