Safety and Efficacy of Plasma Transfusion From Exercise-trained Donors in Patients With Early Alzheimer's Disease
Status:
Recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
Introduction Given that exercise training reduces the risk of developing Alzheimer's disease
(AD), induces changes in the blood composition and has widespread systemic benefits, it is
reasonable to hypothesize that exercised plasma may have rejuvenative properties. The main
objective is to test safety and tolerability of transfusing exercised plasma (ExPlas) from
young, healthy, fit adults to patients with early AD. The study is a pilot for a future
efficacy study. The key secondary objectives are examining the effect of plasma transfusions
on cognitive function, fitness level, vascular risk profile, assessment of cerebral blood
flow and hippocampal volume, quality of life, functional connectivity assessed by resting
state functional MRI and biomarkers in blood and cerebrospinal fluid.
Methods and analysis ExPlas is a double-blinded, randomized controlled clinical single center
trial. Patients aged 50-75 years with diagnosis mild cognitive impairment or early AD will be
recruited from two Norwegian hospitals. ExPlas is plasma drawn by plasmapheresis once a month
for 4 months, from a total of 30 donors (aged 18-40, BMI ≤27 kg/m2 and VO2max >50 mL/kg/min).
All units will be virus inactivated by the Intercept method in accordance with procedures at
St. Olavs Hospital. Comparison with isotonic saline allows differentiation from a non-blood
product. The main study consists of 6 rounds of examinations in addition to 12 plasma
transfusions divided over three 4-weeks periods during study year-1. Follow-up examinations
after 2 and 5 years after baseline is also planned.
Ethics and dissemination Written informed consent will be obtained from all participants and
participation is voluntary. All participants have a next of kin who will follow them
throughout the study and represent the patient's interest. The study is approved by the
Regional Committee for Medical and Health Research Ethics (REK 2018/702) and the Norwegian
Medicines Agency (EudraCT No. 2018-000148-24).