Conference Coverage

Alzheimer’s Association Issues First Guideline for Blood-Based Biomarker Testing

Anthony Calabro, MA

Key Highlights

  • The Alzheimer’s Association has released its first clinical guideline on the use of blood-based biomarker (BBM) tests for Alzheimer disease.
  • BBM tests with 90% sensitivity or greater and 75% specificity or greater may be used to rule out Alzheimer pathology; those with 90% or greater for both may replace CSF or PET testing.
  • Recommendations apply only to patients with objective cognitive impairment seen in specialty care.
  • The guideline is based on a systematic review of 49 studies evaluating 31 BBM tests.

The Alzheimer’s Association has published its first clinical practice guideline for the use of blood-based biomarker (BBM) tests in diagnosing Alzheimer disease among patients with cognitive impairment seen in specialty care. The guideline, released at the Alzheimer’s Association International Conference 2025 in Toronto, Canada, and published in Alzheimer’s & Dementia, offers structured, evidence-based recommendations to inform clinical decisions regarding the use of BBM tests as part of the diagnostic process.

Clinicians currently face a range of unvalidated or variably accurate BBM testing options. This guideline seeks to establish a consistent standard for how and when these tests should be used in clinical practice. Compared to established diagnostic tools like PET imaging and CSF biomarker analysis, blood-based tests are more accessible and less invasive, but clinical guidance for their use has been lacking until now.

The guideline was developed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology and informed by a systematic review of 49 observational studies covering 31 BBM tests. A panel of 11 clinicians, including neurologists, geriatricians, and advanced practice providers, contributed to the review and formulation of recommendations. To reduce bias, the panel remained blinded to test brands and evaluated BBM assays based solely on diagnostic performance.

The panel issued two formal recommendations:

  • BBM tests with sensitivity of 90% or greater and specificity of 75% or greater may be used as a triaging tool in the diagnostic workup of Alzheimer disease among patients with objective cognitive impairment seen in specialty memory care.
    • A negative result can help rule out Alzheimer pathology with high probability.
    • A positive result should be followed by confirmatory testing with CSF or PET.
  • BBM tests with both sensitivity and specificity of 90% or greater may be used as a confirmatory test in place of PET amyloid imaging or CSF testing for patients with objective cognitive impairment.
    • This recommendation applies only in specialized care settings and should be interpreted in the clinical context.

The guideline, which is available on ALZPro™, the Alzheimer’s Association’s platform for clinical guidelines, also includes a Good Practice Statement advising that BBM testing should follow a comprehensive clinical evaluation and not be used in isolation. The clinician’s assessment of the patient’s pre-test probability for Alzheimer disease pathology should guide testing decisions.

Upcoming clinical practice guidelines will address cognitive assessment tools (Fall 2025), clinical implementation of staging criteria and treatment (2026), and prevention of Alzheimer disease and other dementias (2027).

“For the first time, we have a rigorously evidence-based guideline that empowers clinicians to use blood biomarker tests confidently and consistently,” Maria C. Carrillo, PhD, Alzheimer’s Association chief science officer and medical affairs lead, and a co-author of the guideline said in a press release. “Adoption of these recommendations will lead to quicker, more accessible, more accurate diagnoses — and better outcomes for individuals and families affected by Alzheimer’s.”

Reference
Alzheimer’s Association. Alzheimer’s Association releases its first clinical practice guideline for blood‑based biomarker tests. Alzheimer’s Association Int Conf (AAIC) News Release. Toronto; July 29, 2025. Available at: https://aaic.alz.org/releases-2025/clinical-practice-guideline-blood-based-biomarkers.asp.