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

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          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.

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          Neurofilaments as biomarkers in neurological disorders

          Michael Khalil, Charlotte E. Teunissen, Markus Otto … (2018)
          Neuroaxonal damage is the pathological substrate of permanent disability in various neurological disorders. Reliable quantification and longitudinal follow-up of such damage are important for assessing disease activity, monitoring treatment responses, facilitating treatment development and determining prognosis. The neurofilament proteins have promise in this context because their levels rise upon neuroaxonal damage not only in the cerebrospinal fluid (CSF) but also in blood, and they indicate neuroaxonal injury independent of causal pathways. First-generation (immunoblot) and second-generation (enzyme-linked immunosorbent assay) neurofilament assays had limited sensitivity. Third-generation (electrochemiluminescence) and particularly fourth-generation (single-molecule array) assays enable the reliable measurement of neurofilaments throughout the range of concentrations found in blood samples. This technological advancement has paved the way to investigate neurofilaments in a range of neurological disorders. Here, we review what is known about the structure and function of neurofilaments, discuss analytical aspects and knowledge of age-dependent normal ranges of neurofilaments and provide a comprehensive overview of studies on neurofilament light chain as a marker of axonal injury in different neurological disorders, including multiple sclerosis, neurodegenerative dementia, stroke, traumatic brain injury, amyotrophic lateral sclerosis and Parkinson disease. We also consider work needed to explore the value of this axonal damage marker in managing neurological diseases in daily practice.
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            High performance plasma amyloid-β biomarkers for Alzheimer’s disease

            Akinori Nakamura, NAOKI KANEKO, Victor Villemagne … (2018)
            To facilitate clinical trials of disease-modifying therapies for Alzheimer's disease, which are expected to be most efficacious at the earliest and mildest stages of the disease, supportive biomarker information is necessary. The only validated methods for identifying amyloid-β deposition in the brain-the earliest pathological signature of Alzheimer's disease-are amyloid-β positron-emission tomography (PET) imaging or measurement of amyloid-β in cerebrospinal fluid. Therefore, a minimally invasive, cost-effective blood-based biomarker is desirable. Despite much effort, to our knowledge, no study has validated the clinical utility of blood-based amyloid-β markers. Here we demonstrate the measurement of high-performance plasma amyloid-β biomarkers by immunoprecipitation coupled with mass spectrometry. The ability of amyloid-β precursor protein (APP)669-711/amyloid-β (Aβ)1-42 and Aβ1-40/Aβ1-42 ratios, and their composites, to predict individual brain amyloid-β-positive or -negative status was determined by amyloid-β-PET imaging and tested using two independent data sets: a discovery data set (Japan, n = 121) and a validation data set (Australia, n = 252 including 111 individuals diagnosed using 11C-labelled Pittsburgh compound-B (PIB)-PET and 141 using other ligands). Both data sets included cognitively normal individuals, individuals with mild cognitive impairment and individuals with Alzheimer's disease. All test biomarkers showed high performance when predicting brain amyloid-β burden. In particular, the composite biomarker showed very high areas under the receiver operating characteristic curves (AUCs) in both data sets (discovery, 96.7%, n = 121 and validation, 94.1%, n = 111) with an accuracy approximately equal to 90% when using PIB-PET as a standard of truth. Furthermore, test biomarkers were correlated with amyloid-β-PET burden and levels of Aβ1-42 in cerebrospinal fluid. These results demonstrate the potential clinical utility of plasma biomarkers in predicting brain amyloid-β burden at an individual level. These plasma biomarkers also have cost-benefit and scalability advantages over current techniques, potentially enabling broader clinical access and efficient population screening.
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              Blood phosphorylated tau 181 as a biomarker for Alzheimer's disease: a diagnostic performance and prediction modelling study using data from four prospective cohorts

              Thomas Karikari, Tharick A. Pascoal, Nicholas J. Ashton … (2020)
              CSF and PET biomarkers of amyloid β and tau accurately detect Alzheimer's disease pathology, but the invasiveness, high cost, and poor availability of these detection methods restrict their widespread use as clinical diagnostic tools. CSF tau phosphorylated at threonine 181 (p-tau181) is a highly specific biomarker for Alzheimer's disease pathology. We aimed to assess whether blood p-tau181 could be used as a biomarker for Alzheimer's disease and for prediction of cognitive decline and hippocampal atrophy.
              Article 0 comments Cited 440 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Oskar Hansson: Oskar.Hansson@med.lu.se
                Journal
                Journal ID (nlm-ta): Alzheimers Dement
                Journal ID (iso-abbrev): Alzheimers Dement
                Journal ID (doi): 10.1002/(ISSN)1552-5279
                Journal ID (publisher-id): ALZ
                Title: Alzheimer's & Dementia
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Print): 1552-5260
                ISSN (Electronic): 1552-5279
                Publication date (Electronic): 31 July 2022
                Publication date (Print): December 2022
                Volume: 18
                Issue: 12 ( doiID: 10.1002/alz.v18.12 )
                Pages: 2669-2686
                Affiliations
                [ 1 ] Clinical Memory Research Unit Department of Clinical Sciences Malmö Lund University Malmö Sweden
                [ 2 ] Memory Clinic Skåne University Hospital Malmö Sweden
                [ 3 ] Alzheimer's Association Chicago Illinois USA
                [ 4 ] Department of Neurology University of California San Francisco Memory and Aging Center San Francisco California USA
                [ 5 ] Department of Epidemiology and Prevention Wake Forest University School of Medicine Winston‐Salem North Carolina USA
                [ 6 ] Departments of Neurology and Psychiatry Alpert Medical School of Brown University Providence Rhode Island USA
                [ 7 ] Center for Alzheimer Research and Treatment Brigham and Women's Hospital, Massachusetts General Hospital, Harvard Medical School Boston Massachusetts USA
                [ 8 ] Department of Psychiatry and Neurochemistry Institute of Neuroscience and Physiology The Sahlgrenska Academy at the University of Gothenburg Mölndal Sweden
                [ 9 ] Clinical Neurochemistry Laboratory Sahlgrenska University Hospital Mölndal Sweden
                [ 10 ] Department of Neurodegenerative Disease UCL Institute of Neurology Queen Square London UK
                [ 11 ] UK Dementia Research Institute at UCL London UK
                [ 12 ] Hong Kong Center for Neurodegenerative Diseases Clear Water Bay Hong Kong People's Republic of China
                [ 13 ] Neurochemistry Laboratory Department of Clinical Chemistry Amsterdam University Medical Centers Vrije Universiteit Amsterdam Neuroscience Amsterdam the Netherlands
                Author notes
                [*] [* ] Correspondence

                Oskar Hansson, Memory Clinic, Skåne University Hospital, SE‐20502 Malmö, Sweden.

                E‐mail: Oskar.Hansson@ 123456med.lu.se

                Article
                Publisher ID: ALZ12756
                DOI: 10.1002/alz.12756
                PMC ID: 10087669
                PubMed ID: 35908251
                SO-VID: d90f2f38-b7ae-4b83-a0ea-bbc4e5321ef7
                Copyright © © 2022 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.
                License:

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                Date revision received : 28 June 2022
                Date received : 11 May 2022
                Date accepted : 08 July 2022
                Page count
                Figures: 2, Tables: 2, Pages: 18, Words: 13887
                Categories
                Subject: Review Article
                Subject: Review Articles
                Custom metadata
                source-schema-version-number 2.0
                cover-date December 2022
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:6.2.7 mode:remove_FC converted:11.04.2023

                Keywords: alzheimer's disease,appropriate use recommendations,blood‐based biomarkers,diagnosis,prognosis
                Data availability:
                Keywords: alzheimer's disease, appropriate use recommendations, blood‐based biomarkers, diagnosis, prognosis

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