Alzheimer's researcher Sebastian Palmqvist has been awarded USD 19.4 million (SEK 190 million) from the US National Institutes of Health (NIH), through its National Institute on Aging (NIA). The funds are to be used to develop a clinical test based on the biomarker MTBR-tau243. The goal is to develop an FDA-approved blood test within five years that will benefit patients.
"It's a great pleasure to receive this grant to carry out such a clinically significant project for a large and vulnerable group of patients. It has been a long journey, and this is very much a team effort together with our co-applicants in the US, the entire BioFINDER group and, not least, my research colleagues Niklas Mattsson-Carlgren and Erik Stomrud," says Sebastian Palmqvist, associate professor of neuroscience and senior lecturer in neurology.
The project is led by Sebastian Palmqvist, the principal investigator at Lund University. It will be carried out in collaboration with three American universities - Washington University in St. Louis, the University of Pennsylvania and the University of Alabama - over a five-year period from 2026 to 2031. The project will involve cohorts in Sweden and the US. The grant is the largest grant from a US funder that Lund University has secured in competition to date.
"The fact that an NIH grant of this calibre is being led from Lund University is strong international recognition of Sebastian Palmqvist and his colleagues in our Alzheimer's research. It is particularly encouraging since it demonstrates how cross-border collaboration also translates into tangible benefits for patients. The development of a new blood-based clinical test could make a real difference to both patients and the healthcare system," says Erik Renström, Vice-Chancellor of Lund University.
Previous research
Research into biomarkers for Alzheimer's disease has evolved from analyses of cerebrospinal fluid and PET scans to blood-based diagnostics, which have become increasingly important in recent years. The blood-based diagnostic test currently used in clinics around the world is based on the p-tau217 biomarker, which can detect Alzheimer's-related changes in the brain many years before symptoms become apparent. While early diagnosis has its strengths, it also presents a challenge: the patient's current symptoms may have a different cause.
"What the field has been lacking is a blood test that reflects the stage of the disease associated with the symptoms themselves. Levels of p-tau217 rise as the first changes occur in the brain, many years before memory is affected. This is a strength, but it also means that a positive test result does not confirm that Alzheimer's is actually the cause of the patient's symptoms. MTBR-tau243, on the other hand, reflects the tau tangles that build up in the brain as symptoms develop. If the test is positive, we know that the disease has progressed to the point where it can explain the symptoms. We have developed the marker in collaboration with Washington University in the US, and this is the one we are now going to validate clinically," says Sebastian Palmqvist.
New test expected to provide information about disease prognosis
The project will also investigate how accurately the blood tests can predict the progression of the disease. By combining p-tau217 and MTBR-tau243 and monitoring changes over time, the aim is to be better able to distinguish between people whose condition remains stable and those at risk of deteriorating more rapidly. Repeated blood tests can also provide more reliable prognoses when a single measurement does not give a clear answer.
"Our hypothesis is that, in many cases, the test results will not be entirely clear, but may instead indicate a borderline result. We will then need to follow up in one or two years to see how the result has changed. By that point, we will know more and be better able to say what is likely to happen in the future. We will therefore also be carrying out longitudinal measurements using these two blood tests together," says Sebastian Palmqvist.
The ultimate aim of the five-year project is to place Alzheimer's disease within a framework similar to that already used for many types of cancer. There, clinicians do more than identify the type of cancer a patient has, they also assess the stage of the disease.
"Cancer is always classified by stage, ranging from just a few cellular changes to a large tumour, or even metastases spread throughout the body."
A similar staging system for Alzheimer's disease could serve two important purposes: to provide the patient with a prognosis and to inform the choice of treatment.
"Even though the project will not study the effects of treatment, this staging is absolutely crucial, both to provide the patient with a prognosis - when will the condition deteriorate - and to determine the right type of treatment."
The authors are solely responsible for the content of this press release, which does not necessarily reflect the official position of the National Institutes of Health/National Institute on Aging (NIH/NIA).