Lund University researcher Sebastian Palmqvist has received a $19.4 million grant from the U.S. National Institutes of Health to develop a clinical blood test for Alzheimer’s disease. The project, running from 2026 to 2031, aims to create an FDA-approved test based on the biomarker MTBR-tau243 to better stage the disease.
The funding, provided through the National Institute on Aging, represents the largest grant from a U.S. funder that Lund University has secured in competition to date, according to the university. The project involves collaborations with Washington University in St. Louis, the University of Alabama, and the University of Pennsylvania, utilizing cohorts in both the U.S. and Sweden.
Distinguishing Symptoms from Early Pathology
Current clinical blood tests rely on the p-tau217 biomarker, which can detect Alzheimer’s-related brain changes years before symptoms appear. While this early detection is a strength, Sebastian Palmqvist noted that a positive p-tau217 result does not confirm that Alzheimer’s is the actual cause of a patient’s current symptoms.
The new project focuses on MTBR-tau243, a marker developed in collaboration with Washington University. Unlike p-tau217, MTBR-tau243 reflects the tau tangles that accumulate as symptoms develop. According to Palmqvist, if this specific test is positive, clinicians will know the disease has progressed enough to explain the patient’s symptoms.
A Staging System for Neurodegeneration
The ultimate goal of the five-year project is to implement a framework for Alzheimer’s similar to the staging used in cancer treatment. In oncology, clinicians classify disease by stage, ranging from cellular changes to large tumors or metastases. A similar system for Alzheimer’s would help determine a patient’s prognosis and inform treatment choices.
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.
Sebastian Palmqvist, principal investigator at Lund University
To achieve this, researchers plan to combine p-tau217 and MTBR-tau243 measurements. By monitoring changes over time via repeated blood tests, the team aims to distinguish between stable patients and those at risk of deteriorating rapidly.
Replacing Invasive Diagnostic Standards
This push toward blood-based diagnostics follows years of reliance on more invasive methods. According to Washu, Alzheimer’s was historically diagnosed symptomatically, but up to a third of people diagnosed based on cognitive symptoms alone are misdiagnosed.
To confirm a diagnosis and qualify patients for therapies that slow disease progression, doctors must find positive evidence of amyloid plaques. This is typically done through Amyloid positron emission tomography (PET) brain scans or cerebrospinal fluid analyses via spinal taps. However, research published Feb. 21, 2024, in Nature Medicine showed that blood tests can identify Alzheimer’s pathology as accurately as these FDA-approved spinal fluid tests and brain scans, even in patients with mild symptoms.
The Role of Washington University and C2N Diagnostics
Washington University researchers previously created the first approved blood test for brain amyloid using mass spectrometry, which received an FDA Breakthrough Device
designation in 2019. They later developed a second test measuring the ratio of phosphorylated tau-217 (ptau-217) and unphosphorylated tau.
These advancements have already moved into the commercial sector. A test combining amyloid and tau blood measures is currently marketed by the Washington University startup C2N Diagnostics under the name PrecivityAD2.
Moving Toward Primary Care
While these tests are currently used in specialist memory clinics, the next hurdle is accessibility. Oskar Hansson, a professor of neurology at Lund University, stated that these blood tests will eventually replace the need for costly PET imaging and cerebrospinal fluid tests in those clinics.
The current research effort is now expanding to determine if these Alzheimer’s blood tests can function effectively within primary care settings, a process Hansson noted is currently being investigated in Sweden.