Mayo Clinic researchers confirm the tests accuracy after a second analysis

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Mayo Clinic researchers validated an FDA-approved blood test that diagnoses Alzheimers disease with 95% sensitivity and 82% specificity in outpatient settings.
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The test offers a less invasive and more cost-effective alternative to PET scans and spinal taps by analyzing key plasma biomarkers associated with amyloid plaque buildup.
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The findings, featured at the American Academy of Neurology Annual Meeting, could revolutionize clinical trial screening and early diagnosis of Alzheimer's disease.
A blood test approved by the U.S. Food and Drug Administration to detect Alzheimer's disease has just received a significant vote of confidence. Mayo Clinic researchers have confirmed the accuracy of the test after a second round of analysis in outpatient memory clinics.
The test, which measures key plasma biomarkers, may offer a faster, less invasive, and more accessible alternative to conventional diagnostic methods such as PET scans and spinal taps, the researchers agreed.
The results, published in Alzheimer's and Dementia: The Journal of the Alzheimers Association, highlight the potential for widespread clinical use of the test as new treatments for early-stage Alzheimers emerge.
Our study found that blood testing affirmed the diagnosis of Alzheimers disease with 95% sensitivity and 82% specificity, said Dr. Gregg Day, a Mayo Clinic neurologist and dementia specialist. This is similar in accuracy to cerebrospinal fluid biomarkers and much more convenient and cost-effective.
From invasive to accessible
Traditional Alzheimers diagnostics often require expensive and invasive tools to detect amyloid plaque accumulation in the brain. This blood test, developed by Mayo Clinic Laboratories, measures two plasma proteins associated with amyloid buildup A42/40 and p-tau217.
Researchers found that p-tau217 levels were significantly elevated in patients with Alzheimers disease and said that kidney function, which can affect plasma levels, should be considered when interpreting results.
The study involved 509 patients treated for a spectrum of cognitive conditions at the Mayo Clinic Memory Disorder Clinic in Florida. Participants ranged from 32 to 89 years old and included individuals with Alzheimers disease, Lewy body dementia, vascular cognitive impairment, and other neurodegenerative conditions. Alzheimer's was determined to be the cause of symptoms in 56% of the patients.
Implications for early detection
Blood test results showed that 95% of patients whose cognitive issues were attributed to Alzheimers tested positive for elevated p-tau217. Researchers said this technology could streamline the selection of clinical trial participants, monitor treatment efficacy, and help detect Alzheimers in people not yet showing cognitive symptoms.
This is a pivotal step, Day said. But, we must now expand testing to more diverse populations and evaluate how disease-specific factors may affect biomarker accuracy.
Posted: 2025-06-12 13:25:45