Alzheimer's Association releases its first clinical practice guideline for blood-based biomarker tests

At the Alzheimer's Association International Conference 2025, the Association released release of its first clinical practice guideline (CPG) on the use of blood-based biomarker (BBM) tests.¹ The CPG provides clear, evidence-based, brand-agnostic recommendations to support more accurate and accessible diagnosis of Alzheimer's using BBM 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, PhD, 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 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; they are not,” said Rebecca M. Edelmayer, PhD, 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, BBM tests 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 in the Alzheimer's space that uses Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. 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 is 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 BBM tests 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.”

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 CPGs will address cognitive assessment tools, clinical implementation of staging criteria and treatment, and prevention of Alzheimer's and other dementias.

This CPG was convened and funded by the Alzheimer's Association, but the Association was not involved in formulating the clinical questions or recommendations.

The Alzheimer's Association Center for Dementia Respite Innovation (CDRI) is awarding more than $4 million in grants to 41 community-based service providers to drive innovative models of quality dementia-specific respite care. The CDRI is administered through a partnership of the Alzheimer's Association, the University of Minnesota School of Public Health and USAging.

The 41 grant recipients are the second-year recipients of a 5-year, $25 million grant program to enhance respite services for the nearly 12 million dementia caregivers nationwide. Respite care provides caregivers with a temporary rest from caregiving, while the person living with Alzheimer's continues to receive person-centered care in a supportive environment. Respite care can be provided at home — by a friend, other family member, volunteer or paid service — or in a professional or community-based care setting, such as adult day care or a faith-based organization.

“Caring for someone living with dementia is often a 24/7 responsibility,” said Sam Fazio, PhD, vice president, Care and Support Programs and Research at the Alzheimer's Association. “These grants are aimed at creating dementia-specific respite programs that give caregivers a break, while ensuring the person living with dementia gets high-quality care in a safe, caring environment. There is a tremendous need for these programs across the country, and we hope these grants can start bridging current gaps.”

The 41 grant recipients span 26 states from Alaska to Florida and include new pilot and start-up programs to bring or expand dementia-specific respite programs in these communities. Several of the service providers selected serve communities at higher risk for Alzheimer's or other dementia — an important objective of the 5-year program. See a complete list of this year's grant recipients.

In conjunction with the grant, the CDRI will also provide online training and ongoing technical assistance to the grant recipients focusing on improving person-centered care efforts to support program sustainability after the grant period and to ensure that respite services are dementia-capable, especially in communities at higher risk for Alzheimer's or other dementia. The CDRI will also collect data and evaluate the impact of these innovative projects over the 5 years to inform public policy.

“In our second year, we have incorporated insights and experiences from our first year of programming. We've strategically enhanced our education resources to provide more comprehensive support, doubled the number of grants awarded to extend our national reach, and introduced a 2-year start-up award option,” said Isabella Marini, associate director, Center for Dementia Respite Innovation. “This allows grant recipients more flexibility and stability as they develop critical respite programs that provide much-needed relief to families navigating the challenging journey of dementia care. Our goal is not just to fund programs, but to create meaningful, sustainable support systems that recognize the incredible dedication of caregivers across the country.”

According to the 2022 National Strategy to Support Family Caregivers, gaps in the availability of and access to respite can be significant, adding to the stress and burden of unpaid caregivers. Respite care is often costly, and with limited availability in many communities, caregivers are frequently left with responsibility for the bulk of the expenses. The CDRI grant and the sub-grants it will generate will result in developing and piloting cost-efficient, effective, strengths-based, person-centered, innovative models of dementia-specific respite care.

The Alzheimer's Association created the CDRI in 2024 after receiving a $25 million grant from the Administration for Community Living (ACL), a division of the U.S. Department of Health and Human Services. The ACL grant is the largest ever made to the Association.

ACKNOWLEDGMENTS

This project is supported by the Administration for Community Living (ACL), U.S. Department of Health and Human Services (HHS), as part of a financial assistance award totaling $13,261,685 with 75% funded by ACL/HHS and 25% funded by non-government sources. The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement by, ACL/HHS, or the U.S. Government.