A year-long clinical trial with five-year followup, led by the Norwegian University of Science and Technology, is examining whether a monthly transfusion of blood from runners can slow early stage Alzheimer’s disease.
Previous research has found those who exercise regularly are less likely to develop the condition. The monthly transfusions will go to around 60 people with early signs of Alzheimer’s.
A number of studies have shown that regular exercise and cardiac and respiratory fitness can lower the risk and the progression of the disease. A study in 2019 by St Olav’s Hospital in Norway — which is also part of the new trial — based on data from 30,000 people, revealed those who increased their lung capacity through exercise, had a 40 to 50% reduced risk of having Alzheimer’s more than 10 years later.
“Maintaining or improving cardiorespiratory fitness over time may be a target to reduce risk of dementia incidence and mortality, delay onset and increase longevity after diagnosis,” the researchers wrote in The Lancet Public Health.
One theory is that exercise causes complex chemical changes in the blood that affect the brain and counteract age-related and disease- related changes associated with Alzheimer’s.
These chemical changes were identified in a study by Stanford University in the US last year. Researchers measured the blood levels of 17,662 molecules before and after 10 minutes of exercise, and found specific changes occurred in more than half of the cases.
Some compounds increased, while others dropped. The molecules were involved in many different areas, from the immune system and appetite, to tissue repair and inflammation. Doctors described the molecular changes after exercise as a “symphony” that could be beneficial in dementia, reported the journal Cell. The idea behind the new treatment is that the same changes can be created in the brains of people with early-stage dementia through blood transfused from fit, young people who have exercised.
In the trial, expected to be concluded in September 2025, patients aged from 50 to 75 with mild cognitive impairment or early Alzheimer’s will be given monthly 200ml transfusions of blood for 12 months. The blood will be taken from 30 volunteers aged 18 to 40, who will run on a treadmill to the point of exhaustion, before giving a blood sample over the next four weeks. The blood will be processed to avoid contamination.
Patients will be monitored for five years and their brain volume, blood flow and disease markers will be measured. The results will be compared with a placebo group given saline transfusions.
Commenting on the trial, reports the Daily Mail, James Rowe, a professor of cognitive neurology at the University of Cambridge, said: “It is a very interesting idea. It may raise eyebrows, but there is serious science here, and we know that taking exercise lowers risk. We await the results with interest, and in the meantime, those of us who can, should be taking more exercise because we know it is one way we can all reduce the risk.”
Study details
Safety and Efficacy of Plasma Transfusion From Exercise-trained Donors in Patients With Early Alzheimer’s Disease (ExPlas)
Prof Ulrik Wisløff (Norwegian University of Science & Technology), Dr Sigrid Botne Sando (St Olav’s Hospital, Norway).
Published on ClinicalTrials.gov on 6 October 2021
Brief 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 hypothesise 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, randomised controlled clinical single centre 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 S. Olav’s 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).
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