Mayo Clinic Laboratories > Alzheimer’s disease: Shifting the diagnostic paradigm

At the forefront of a new era in Alzheimer’s disease testing

Earlier answers to guide care

For patients experiencing mild cognitive impairment (MCI) due to Alzheimer’s disease, accurate diagnosis before dementia sets in can help them prepare for what lies ahead. Diagnosis at the onset of MCI supports integration of lifestyle medicine, facilitates access to disease-modifying therapies, and enables entry into clinical trials.

Our innovative plasma biomarker testing can provide clarity to patients in the initial stages of cognitive decline related to Alzheimer’s disease. Noninvasive and intended for patients aged 50 and above, our assays evaluate for biomarkers in the blood associated with amyloid beta (Aβ) pathology in the brain using clinically supported protein phosphorylated Tau 217 (p-Tau217) and biomarker ratios.

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The integration of Mayo Clinic Laboratories into the Mayo Clinic Alzheimer’s Disease Research Center enables development of the most relevant patient-focused evaluations. Our dementia testing experts are available to consult on complex cases.
Our plasma-based assays detect for biomarkers that have been identified through scientific research as being the most clinically relevant. Using an automated immunoassay with innovative instrumentation, these tests are clinically validated in our lab and designed for ease of use. 
Our offerings use cut-off ranges carefully chosen to optimize testing sensitivity and specificity to provide the highest level of diagnostic accuracy available. Providing definitive answers and a fast time to results, our Alzheimer’s assays deliver accurate answers that can improve access to treatments.

A proactive testing approach

Research on Alzheimer’s disease laboratory testing continues to reveal insights on the role of fluid biomarkers in detecting amyloid pathology. Recognition of these biomarkers has resulted in the development of numerous biomarker evaluations. However, not all tests provide adequate sensitivity and/or specificity to enable diagnostic confidence. Nor do all tests evaluate for the most clinically relevant biomarkers.

The discovery that phosphorylated Tau proteins in the blood can identify brain amyloid pathology propelled development of plasma-based biomarker testing. Among fluid-based biomarkers known to predict Aβ pathology, p-Tau217 exhibits the highest levels of diagnostic accuracy. Our digital resource examines the evolution of plasma-based biomarker testing and explains how results from these evaluations can offer patients and their families hope for the future. 

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Fill out the form to download our digital guide on Alzheimer’s disease testing at Mayo Clinic Laboratories.

Dementia testing: Shifting the diagnostic paradigm*

*Available in English, Spanish, French, and Arabic

One-stop laboratory solution

In cases where blood-based biomarker testing does not yield definitive answers, Mayo Clinic Laboratories offers a comprehensive menu of dementia testing.

Alzheimer's diseasePrion diseaseAutoimmune dementiaGenetic testingNonspecific
p-Tau217 plasma biomarker testingRapidly progressive dementiaAutoimmune and paraneoplastic antibody testingApolipoprotein E genotypingNeurofilament light chain
C2N plasma biomarker testingCreutzfeldt-Jakob diseaseNotch3 full gene analysis
Cerebrospinal fluid biomarker testingFrontotemporal dementia and amyotrophic lateral sclerosis
C9orf72 hexanucleotide
APP, PSEN1, PSEN2

Highlights

Resources

References
  1. 2023 Alzheimer’s disease facts and figures. Alzheimer’s Dement. 19:1598-1695. https://doi.org/10.1002/alz.13016
  2. Dhana K, Franco OH, Ritz EM, et al. Healthy lifestyle and life expectancy with and without Alzheimer’s dementia: population based cohort study. BMJ. 2022; 377:e068390. doi:10.1136/bmj-2021-068390
  3. Sims JR, Zimmer JA, Evans CD, et al. Donanemab in early symptomatic Alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA. 2023;330(6):512–527. doi:10.1001/jama.2023.13239
  4. Ashton NJ, Brum WS, Di Molfetta G, et al. Diagnostic accuracy of a plasma phosphorylated tau 217 immunoassay for Alzheimer disease pathology. JAMA Neurol. 2024 Mar 1;81(3):255-263. doi:10.1001/jamaneurol.2023.5319. PMID: 38252443; PMCID: PMC10804282.
  5. Figdore DJ, Griswold M, Bornhorst JA, et al. Optimizing cutpoints for clinical interpretation of brain amyloid status using plasma p-tau217 immunoassays. Alzheimer’s Dement. 2024 Jul 19;20(9)6506-6516. doi:10.1002/alz.14140. PMID: 39030981.
  6. Andrade-Guerrero J, Santiago-Balmaseda A, Jeronimo-Aguilar P, et al. Alzheimer’s disease: an updated overview of its genetics. Int J Mol Sci. 2023 Feb 13;24(4):3754. doi:10.3390/ijms24043754. PMID: 36835161; PMCID: PMC9966419.
  7. Alzheimer’s Disease Genetics Fact Sheet. National Institute on Aging. https:// www.nia.nih.gov/health/genetics-and-family-history/alzheimers-disease-geneticsfact-sheet. Reviewed March 2023. Accessed June 2024.
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