This session will provide an overview of the rapidly evolving landscape of: (i) the use, reporting and interpretation of cerebrospinal fluid (CSF) Alzheimer’s disease biomarkers in clinical care, (ii) the development of peripheral (i.e.,blood-based) biomarkers and assays for Alzheimer’s disease,  and (iii) the state of disease-modifying therapeutics for Alzheimer’s disease, including currentand future uses of biomarkers related to therapeutics.

Routine imaging technologies (e.g., magnetic resonance imaging) and observation of clinical syndromes have demonstrated only modest accuracy for diagnosing Alzheimer’s disease in cognitively impaired individuals. As such, biomarkers are needed to help differentiate neurodegenerative disorders with overlapping phenotypes, particularly in the early stages of disease when diagnosis can be challenging and there is the greatest treatment potential. On the basis of extensive evidence, a core set of CSF biomarkers for Alzheimer’s disease are now recommended by the international community for use in patient care, and the ever-expanding data on blood-based biomarkers suggests new roles in research and patient care. For CSF biomarkers, we will review the clinical use scenarios and implementation considerations for clinical laboratories. For blood-based biomarkers, we will review key biomarkers and associated analytical approaches, as laboratorians need to be aware the strengths and weaknesses of these emerging assays and proposed use scenarios. We will also review advancements indisease-modifying therapies for Alzheimer’s disease and discuss current applications of CSF and blood-based biomarker testing in clinical trials, and anticipated future uses in guiding therapy decisions.