In a significant shift for Alzheimer’s care, the Alzheimer’s Association has released its first clinical practice guideline (CPG) focused on the use of blood-based biomarker (BBM) tests for diagnosing Alzheimer’s disease in specialized memory care settings.

Announced at the Alzheimer’s Association International Conference 2025 (AAIC) and published in Alzheimer’s & Dementia, the guideline recommends brand-agnostic use of BBM tests with defined thresholds of sensitivity and specificity to support faster, more accessible diagnosis for individuals with cognitive impairment.

The move is being described as a ‘pivotal moment’ in Alzheimer’s care. According to the Association, the guideline aims to reduce reliance on more invasive or expensive methods such as cerebrospinal fluid (CSF) testing and amyloid PET scans, while improving early detection through widely accessible blood-based testing.

Evidence-based recommendations

The new CPG is based on a systematic review of 49 observational studies covering 31 BBM tests. The Association used GRADE methodology to ensure transparency and rigour — a first in Alzheimer’s guideline development.

Key recommendations include:

• Triaging tool: BBM tests with ≥90% sensitivity and ≥75% specificity may be used to rule out Alzheimer’s pathology. A positive result should be confirmed with a second method.

• Confirmatory tool: BBM tests with ≥90% sensitivity and ≥90% specificity may serve as a substitute for PET or CSF testing in diagnosing Alzheimer’s disease.

• Good Practice Statement: BBM tests should only be used after a comprehensive clinical evaluation and interpreted in context by a healthcare professional.

Maria Carrillo, chief science officer at the Alzheimer’s Association, said the guideline empowers clinicians to adopt these emerging tools with greater confidence. “Adoption of these recommendations will lead to quicker, more accessible, more accurate diagnoses — and better outcomes for individuals and families affected by Alzheimer’s,” she said.

Not all tests are equal

The guideline cautions that diagnostic accuracy among commercially available BBM tests varies widely, and many do not meet the recommended thresholds. Importantly, the panel chose not to endorse specific tests, instead focusing on performance standards. To reduce bias, evaluators were blinded to test identities during review.

“This guideline helps clinicians apply these tools responsibly, avoid overuse or inappropriate use, and ensure that patients have access to the latest scientific advancements,” said Rebecca Edelmayer, vice president of scientific engagement at the Alzheimer’s Association.

Intended audience and future guidelines

The guideline is aimed at specialists — including neurologists, geriatricians, and psychiatrists — in memory care settings, as well as nurse practitioners and physician assistants working with patients experiencing cognitive decline. While primary care is not the intended setting, the Association notes the growing relevance of BBMs across disciplines.

This first release focuses on BBM analytes such as p-tau217, p-tau181, p-tau231, and the Aβ42:Aβ40 ratio, all associated with Alzheimer’s pathology.

The guideline is part of ALZPro™, the Alzheimer’s Association’s newly launched hub for dementia professionals, which centralizes clinical tools, training, and implementation resources. Additional CPGs are planned, including those addressing cognitive assessment tools (late 2025), treatment implementation (2026), and prevention (2027).