The five-year project evaluates MTBR-tau243 alongside p-tau217 to stage disease progression, predict clinical decline, and clarify ambiguous test results.
Lund University has received a $19.4 million grant from the National Institutes of Health and the National Institute on Aging (NIH/NIA) to fund the clinical validation of a new blood-based biomarker test for Alzheimer’s disease. Running from 2026 to 2031, the five-year project aims to advance diagnostic accuracy and disease staging using the novel tau biomarker MTBR-tau243.
Led by principal investigator Sebastian Palmqvist, associate professor of neuroscience and senior lecturer in neurology at Lund University and senior consultant at Skåne University Hospital, the research initiative represents the largest competitive grant Lund University has received from a US funder. The project will be conducted across patient cohorts in Sweden and the US in collaboration with researchers from Washington University in St. Louis, the University of Pennsylvania, and the University of Alabama.
“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,” says Erik Renström, vice-chancellor of Lund University, in a release. “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.”
Addressing Clinical Gaps in Tau Biomarkers
Current blood-based clinical tests for Alzheimer’s disease frequently measure phosphorylated tau 217 (p-tau217). While p-tau217 identifies Alzheimer’s-related cerebral pathology years before memory loss and cognitive symptoms emerge, an elevated result does not verify that Alzheimer’s pathology is the direct cause of a patient’s active cognitive symptoms.
In contrast, MTBR-tau243 reflects the tau tangles that build up in the brain as symptoms develop. The biomarker was developed through a collaboration between Lund University and Washington University in St. Louis. The clinical test is being developed and validated utilizing analytical assay methods from C2N Diagnostics, a specialized diagnostics company based in St. Louis, Missouri.
“What the field has been lacking is a blood test that reflects the stage of the disease associated with the symptoms themselves,” says Palmqvist, in a release. “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.”
Prognosis, Staging, and Longitudinal Monitoring
In addition to initial diagnostic validation, the study will examine how effectively plasma MTBR-tau243 and p-tau217 predict disease trajectory when measured together and tracked longitudinally. Evaluating both biomarkers in tandem is intended to help clinicians distinguish between patients likely to remain clinically stable and those at risk of rapid cognitive deterioration.
Serial testing may also resolve diagnostic ambiguity in clinical laboratory practice. Investigators hypothesize that patients with borderline or intermediate initial test results can undergo follow-up testing after one or two years to assess biomarker shifts and establish clearer prognostic outcomes.
Ultimately, the investigators aim to establish a clinical staging framework for Alzheimer’s disease comparable to oncology models that categorize disease extent from isolated changes to advanced progression. Establishing defined disease stages in the clinical laboratory could provide actionable prognostic data and guide targeted therapeutic selection.
Photo credit: Sebastian Palmqvist, associate professor of neuroscience and senior lecturer in neurology specializing in cognition at Lund University, and senior consultant at Skåne University Hospital
Photo caption: Tove Smeds, Lund University
