The Alzheimer's Association appropriate use recommendations for blood biomarkers in Alzheimer's disease

Alzheimers Dement. 2022 Dec;18(12):2669-2686. doi: 10.1002/alz.12756. Epub 2022 Jul 31.

Abstract

Blood-based markers (BBMs) have recently shown promise to revolutionize the diagnostic and prognostic work-up of Alzheimer's disease (AD), as well as to improve the design of interventional trials. Here we discuss in detail further research needed to be performed before widespread use of BBMs. We already now recommend use of BBMs as (pre-)screeners to identify individuals likely to have AD pathological changes for inclusion in trials evaluating disease-modifying therapies, provided the AD status is confirmed with positron emission tomography (PET) or cerebrospinal fluid (CSF) testing. We also encourage studying longitudinal BBM changes in ongoing as well as future interventional trials. However, BBMs should not yet be used as primary endpoints in pivotal trials. Further, we recommend to cautiously start using BBMs in specialized memory clinics as part of the diagnostic work-up of patients with cognitive symptoms and the results should be confirmed whenever possible with CSF or PET. Additional data are needed before use of BBMs as stand-alone diagnostic AD markers, or before considering use in primary care.

Keywords: Alzheimer's disease; appropriate use recommendations; blood-based biomarkers; diagnosis; prognosis.

Publication types

  • Review
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Alzheimer Disease* / diagnostic imaging
  • Alzheimer Disease* / pathology
  • Amyloid beta-Peptides / cerebrospinal fluid
  • Biomarkers / cerebrospinal fluid
  • Cognitive Dysfunction* / cerebrospinal fluid
  • Humans
  • Longitudinal Studies
  • Peptide Fragments / cerebrospinal fluid
  • Positron-Emission Tomography
  • Prognosis
  • tau Proteins / cerebrospinal fluid

Substances

  • Biomarkers
  • Amyloid beta-Peptides
  • tau Proteins
  • Peptide Fragments