Researchers at Lund University have received a $19.4 million (SEK 190 million) grant from the US National Institutes of Health (NIH) to develop a new blood test for Alzheimer’s disease based on the biomarker MTBR-tau243.
The five-year project, funded through the NIH’s National Institute on Aging, aims to clinically validate the biomarker and develop an FDA-approved blood test within the next five years.
The research will be led by Sebastian Palmqvist of Lund University and carried out from 2026 to 2031 in collaboration with Washington University in St. Louis, the University of Pennsylvania and the University of Alabama. Researchers will use patient cohorts in both Sweden and the United States.
Lund University said the grant is the largest research award it has so far received through a competitive process from a US funding organization.
“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,” said Sebastian Palmqvist, highlighting the contribution of colleagues in the BioFINDER research group and US collaborators.
Blood-based biomarkers have become increasingly important in Alzheimer’s diagnostics. One of the most widely used biomarkers is p-tau217, which can detect Alzheimer’s-related changes in the brain years before symptoms appear.
However, very early detection can also create a clinical challenge: a positive result may indicate Alzheimer’s-related brain changes without establishing that the disease is responsible for a patient’s current symptoms.
MTBR-tau243 could provide complementary information because it reflects the accumulation of tau tangles associated with the development of clinical symptoms, according to the researchers.
“What the field has been lacking is a blood test that reflects the stage of the disease associated with the symptoms themselves,” Palmqvist said.
The research team previously developed MTBR-tau243 in collaboration with Washington University. The new NIH-funded project will focus on validating the biomarker in clinical settings.
The researchers will also investigate whether combining MTBR-tau243 with p-tau217 can provide a more detailed picture of disease progression.
The study will examine whether the two biomarkers can help distinguish patients whose condition remains relatively stable from those who are more likely to experience faster deterioration. Repeated blood tests will also be used to determine whether changes in biomarker levels over time can improve predictions about disease progression.
According to Palmqvist, some patients may initially receive borderline results rather than a clearly positive or negative test. In such cases, repeat testing after one or two years could provide additional information about how the disease is progressing.
The researchers ultimately hope to establish a staging system for Alzheimer’s disease similar to the approach used in cancer care, where diagnosis is followed by an assessment of how advanced the disease is.
“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,” the researchers said.
Although the project will not directly evaluate treatment outcomes, the researchers say accurately determining the stage of Alzheimer’s disease could become important for both predicting how the condition will progress and selecting appropriate therapies.
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