PRESS RELEASE
TORONTO, July 29, 2025 — In a landmark step toward transforming Alzheimer’s disease diagnosis in specialty care, the Alzheimer’s Association today released its first clinical practice guideline (CPG) on the use of blood-based biomarker (BBM) tests. The guideline is being reported at the Alzheimer’s Association International Conference® 2025 (AAIC®) in Toronto and online, and published in Alzheimer’s & Dementia®: The Journal of the Alzheimer’s Association.
The CPG provides clear evidence-based, brand-agnostic recommendations to support more accurate and accessible diagnosis of Alzheimer’s using blood-based biomarker tests. The recommendations are linked to a systematic review using a robust and transparent methodology, and will be updated regularly as evidence evolves.
“This is a pivotal moment in Alzheimer’s care,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer and medical affairs lead, and a co-author of the guideline. “For the first time, we have a rigorously evidence-based guideline that empowers clinicians to use blood biomarker tests confidently and consistently. Adoption of these recommendations will lead to quicker, more accessible, more accurate diagnoses — and better outcomes for individuals and families affected by Alzheimer’s.”
The recommendations in the new CPG — both of which apply only to patients with cognitive impairment being seen in specialized care for memory disorders — are:The guideline cautions that there is significant variability in diagnostic test accuracy and many commercially available BBM tests do not meet these thresholds.
“Not all BBM tests have been validated to the same standard or tested broadly across patient populations and clinical settings, yet patients and clinicians may assume these tests are interchangeable,” said Rebecca M. Edelmayer, Ph.D., Alzheimer’s Association vice president of scientific engagement and a co-author of the guideline. “This guideline helps clinicians apply these tools responsibly, avoid overuse or inappropriate use, and ensure that patients have access to the latest scientific advancements.”
Compared to standard-of-care PET imaging and CSF tests, blood-based biomarkers are typically less costly, more accessible and more acceptable to patients. The guideline emphasizes that BBM tests do not substitute for a comprehensive clinical evaluation by a health care professional, and should be ordered and interpreted by a health care professional in the context of clinical care.
This is the first evidence-based guideline using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology in the Alzheimer’s space. The use of GRADE ensures a transparent, structured and evidence-based process for evaluating the certainty of evidence and formulating recommendations. This strengthens the credibility and reproducibility of the guideline and allows for explicit linkage between evidence and recommendations.
This guideline’s primary audience includes specialists involved in the diagnostic evaluation of cognitive impairment in specialized care settings. A specialist is defined as a health care provider, typically in neurology, psychiatry or geriatrics, who cares for adults with cognitive impairment or dementia. It also applies to primary care providers, nurse practitioners and physician assistants in specialized care settings.
A panel of 11 clinicians convened by the Alzheimer’s Association — including clinical neurologists, geriatricians, nurse practitioners, physician assistants and subject-matter experts — conducted a systematic review and formulated evidence-based recommendations for using blood-based biomarkers in individuals with objective cognitive impairment, including those with mild cognitive impairment (MCI) or dementia. Final recommendations were informed by public comments and input from the Association’s National Early-Stage Advisory Group, which includes people living with early-stage Alzheimer’s.
For this initial iteration of the guideline, the BBMs included plasma phosphorylated-tau (p-tau) and amyloid-beta (Aβ) tests measuring the following analytes: p-tau217, ratio of p-tau217 to non-p-tau217 ×100 (%p-tau217), p-tau181, p-tau231, and ratio of Aβ42 to Aβ40. The various BBM tests measure abnormal forms of either amyloid beta or tau protein, the two biomarkers associated with Alzheimer's disease. Forty-nine (49) observational studies were reviewed and 31 BBM tests were evaluated.
The panel determined that endorsing specific tests was premature, opting for a brand-agnostic, performance-based approach that blinded panel members to the tests they were evaluating to minimize bias. This ensures the guideline’s credibility, durability and actionability. According to the panel: “Ranking or endorsing specific tests is premature at this time. Instead, test accuracy data and accuracy judgments reported in this guideline are meant to serve as a resource for clinicians … to aid them in choosing which test(s) to order.”
The panel formulated two recommendations and one Good Practice Statement for the use of BBM tests in the diagnostic workup of patients with objective cognitive impairment being seen in specialized care.This CPG is part of ALZPro™, the Alzheimer’s Association’s comprehensive hub of resources to promote best practices, empowering health professionals across disciplines to reduce risk, advance early detection, improve care and expand equitable access for all communities. ALZPro unites care resources, relevant scientific findings, clinical guidelines and insights, continuing education and implementation tools on one platform.
Upcoming clinical practice guidelines will address cognitive assessment tools (Fall 2025), clinical implementation of staging criteria and treatment (2026) and prevention of Alzheimer’s and other dementias (2027). This clinical practice guideline was convened and funded by the Alzheimer's Association, but the Association was not involved in formulating the clinical questions or recommendations.
About the Alzheimer's Association International Conference® (AAIC®)
The Alzheimer’s Association International Conference (AAIC) is the world’s largest gathering of researchers from around the world focused on Alzheimer’s and other dementias. As a part of the Alzheimer’s Association’s research program, AAIC serves as a catalyst for generating new knowledge about dementia and fostering a vital, collegial research community.
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About the Alzheimer's Association®
The Alzheimer’s Association is a worldwide voluntary health organization dedicated to Alzheimer’s care, support and research. Our mission is to lead the way to end Alzheimer’s and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer’s and all other dementia®. Visit alz.org or call +1 800.272.3900.
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