The Alzheimer's Association Appropriate Use Recommendations for Blood Biomarkers in Alzheimer’s Disease
Oskar Hansson, Rebecca M. Edelmayer, Adam L. Boxer, Marı́a C. Carrillo, Michelle M. Mielke, Gil D. Rabinovici, Stephen Salloway, Reisa A. Sperling, Henrik Zetterberg, Charlotte E. Teunissen
Abstract
Abstract Background Blood‐based markers (BBMs) have recently showed promise to revolutionize the diagnostic and prognostic work‐up of Alzheimer's disease (AD), as well as to improve the design of interventional trials. Method Here we discuss in detail further research needed to be performed before widespread use of BBMs. Result 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. Conclusion We recommend use of AD‐associated BBMs as (pre‐)screeners in trials and cautious introduction of BBMs in clinical practice, provided AD status in confirmed whenever possible using CSF or PET. We summarize prioritized research needed to be performed before widespread use of AD‐associated BBMs in clinical trials and practice, including different types of preanalytical, analytical and real‐world clinical studies.