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

• Published in: Alzheimer's & dementia Vol. 18; no. 12; pp. 2669 - 2686
• Main Authors: Hansson, Oskar, Edelmayer, Rebecca M., Boxer, Adam L., Carrillo, Maria C., Mielke, Michelle M., Rabinovici, Gil D., Salloway, Stephen, Sperling, Reisa, Zetterberg, Henrik, Teunissen, Charlotte E.
• Format: Journal Article
• Language: English
• Published: United States John Wiley and Sons Inc 01.12.2022
• Subjects: accuracy; Alzheimer Disease - diagnostic imaging; Alzheimer Disease - pathology; Alzheimer's disease; Amyloid beta-Peptides - cerebrospinal fluid; amyloid-beta; appropriate use recommendations; biomarkers; Biomarkers - cerebrospinal fluid; blood-based; blood-based biomarkers; Clinical Medicine; clinical-diagnosis; Cognitive Dysfunction - cerebrospinal fluid; dementia; diagnosis; fibrillary acidic protein; Humans; Klinisk medicin; Longitudinal Studies; Medical and Health Sciences; Medicin och hälsovetenskap; Neurologi; Neurology; Neurosciences; Neurosciences & Neurology; Neurovetenskaper; Peptide Fragments - cerebrospinal fluid; phosphorylated; plasma neurofilament light; Positron-Emission Tomography; prevalence; Prognosis; Review; tau 181; tau Proteins - cerebrospinal fluid; validation; diagnosis; blood-based biomarkers; appropriate use recommendations; Alzheimer's disease; prognosis
• ISSN: 1552-5260; 1552-5279; 1552-5279
• DOI: 10.1002/alz.12756

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.