Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 5805-5816 |
| Number of pages | 12 |
| Journal | Alzheimer's and Dementia |
| Volume | 19 |
| Issue number | 12 |
| Early online date | 2023 |
| DOIs | |
| Publication status | Published - Dec 2023 |
Keywords
- Alzheimer's disease
- diagnosis
- diagnosis pathway
- diagnostic test
- plasma biomarkers
- triage tool
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In: Alzheimer's and Dementia, Vol. 19, No. 12, 12.2023, p. 5805-5816.
Research output: Contribution to journal › Review article › Academic › peer-review
TY - JOUR
T1 - The potential clinical value of plasma biomarkers in Alzheimer's disease
AU - Blennow, Kaj
AU - Galasko, Douglas
AU - Perneczky, Robert
AU - Quevenco, Frances-Catherine
AU - van der Flier, Wiesje M.
AU - Akinwonmi, Akin
AU - Carboni, Margherita
AU - Jethwa, Alexander
AU - Suridjan, Ivonne
AU - Zetterberg, Henrik
N1 - Funding Information: Prof. Blennow has served as a paid consultant and attended scientific advisory boards, educational programs, and/or data monitoring committees for Acumen, ALZpath, BioArtic, Biogen, Eisai, Julius Clinical, Lilly, Ono Pharma, Novartis, Roche Diagnostics and Siemens Healthineers; has received grants to his institution from the Alzheimer's Association (ZEN‐21‐848495 and SG‐23‐1038904 QC), Hjärnfonden (Sweden; #FO2017‐0243, and #ALZ2022‐0006), the Swedish Alzheimer Foundation (#AF‐930351, #AF‐939721, and #AF‐968270), the Swedish Research Council (#2017‐00915 and #2022‐00732) and the Swedish state (the ALF agreement; #ALFGBG‐715986, and #ALFGBG‐965240); and is a co‐founder of Brain Biomarker Solutions in Gothenburg AB (BBS), which is part of the GU Ventures Incubator Program. Dr. Galasko has served as a paid consultant for Fujirebio and Roche Diagnostics. Prof. Perneczky has received speaker's fees and honoraria from AstraZeneca, Biogen, Eisai, Eli Lilly, Grifols, Janssen‐Cilag, Novo Nordisk, Roche, Schwabe, and Tabuk. Prof. Perneczky is supported by the Davos Alzheimer's Collaborative, the Deutsche Forschungsgemeinschaft, the German Center for Neurodegenerative Diseases, the Robert‐Vogel‐Foundation, the Sheffield National Institute for Health Research Biomedical Research Centre, the University of Cambridge – Ludwig‐Maximilians‐University Munich Strategic Partnership, and the VERUM Foundation. Dr. Quevenco was previously employed by and owned stock or stock options during employment in Roche Diagnostics International Ltd, Rotkreuz, Switzerland, and Altoida Inc, Washington, DC, USA, and is currently employed by Eli Lilly & Co., Geneva, Switzerland. Dr. Quevenco is also an executive committee member of the Women's Brain Project. Prof. van der Flier runs or has previously run research programs funded by Alzheimer Nederland, AVID, Biogen MA Inc, Combinostics, Edwin Bouw fonds, Eisai, EU‐FP7, EU‐JPND, Fujifilm, Gieskes‐Strijbis fonds, Health∼Holland, Hersenstichting CardioVascular Onderzoek Nederland, Life‐MI, Novartis‐NL, NWO, Pasman stichting, Philips, Roche BV, stichting Alzheimer & Neuropsychiatrie Foundation, stichting Dioraphte, stichting Equilibrio, Topsector Life Sciences & Health, and ZonMW and has been an invited speaker at Biogen MA Inc, Danone, Eisai, European Brain Council (all funding paid to institution), Novo Nordisk, Springer Healthcare, and WebMD Neurology (Medscape). She holds the Pasman chair (Amsterdam University Medical Centre) and has served as a paid consultant for Biogen MA Inc. (all funding paid to institution), Eisai, Oxford Health Policy Forum CIC, and Roche. She has participated on scientific advisory boards for Biogen MA Inc, Roche, and Eli Lilly (all funding paid to institution). She is a member of the steering committee of PAVE and Think Brain Health and was previously an associate editor of (2020‐2021) and is currently an associate editor of . Dr. Akinwonmi and Dr. Carboni are currently employed by Roche Diagnostics International Ltd, Rotkreuz, Switzerland and own stock or stock options in F. Hoffmann‐La Roche. Dr. Jethwa is currently employed by Roche Diagnostics GmbH, Penzberg, Germany, and is named on a pending European patent application: “A novel antibody for detection of amyloid beta 42 (Aβ42)”. Dr. Suridjan was previously employed by Roche Diagnostics International Ltd, Rotkreuz, Switzerland, and owned stock or stock options in F. Hoffmann‐La Roche. Prof. Zetterberg has served as a paid consultant and/or attended scientific advisory boards for AbbVie, Acumen, Alector, Alzinova, ALZPath, Annexon, Apellis, Artery Therapeutics, AZTherapies, CogRx, Denali, Eisai, Nervgen, Novo Nordisk, Optoceutics, Passage Bio, Pinteon Therapeutics, Prothena, Red Abbey Labs, re MYND, Roche, Samumed, Siemens Healthineers, Triplet Therapeutics, and Wave. He has given lectures in symposia sponsored by Alzecure, Biogen, Cellectricon, Fujirebio, and Roche and is a co‐founder of Brain Biomarker Solutions in Gothenburg AB (BBS), which is part of the GU Ventures Incubator Program. Prof. Zetterberg is also chair of the Alzheimer's Association Global Biomarker Standardization Consortium and is a Wallenberg Scholar supported by grants from the AD Strategic Fund and the Alzheimer's Association (#ADSF‐21‐831376‐C, #ADSF‐21‐831381‐C, and #ADSF‐21‐831377‐C), the Alzheimer Drug Discovery Foundation USA (#201809‐2016862), the Bluefield Project, the European Union Horizon Europe Research and Innovation programme (grant agreement #101053962), the European Union's Horizon 2020 research and innovation program under the Marie Skłodowska‐Curie grant (grant agreement #860197; MIRIADE), the European Union Joint Program – Neurodegenerative Disease Research (JPND2021‐00694), the Erling‐Persson Family Foundation, Hjärnfonden (Sweden; #FO2022‐0270), the Olav Thon Foundation, the Swedish Research Council (#2022‐01018), the Swedish state (the ALF agreement; #ALFGBG‐71320), and the UK Dementia Research Institute at UCL (UKDRI‐1003). Author disclosures are available in the supporting information . Alzheimer, Research & Therapy Brain Funding Information: Third‐party medical writing assistance, under the direction of the authors, was provided by Anna King, PhD, of Ashfield MedComms (Macclesfield, UK), an Inizio company, and was funded by Roche Diagnostics International Ltd (Rotkreuz, Switzerland). ELECSYS is a trademark of Roche. All other product names and trademarks are the property of their respective owners. This study was funded by Roche Diagnostics International Ltd (Rotkreuz, Switzerland). Publisher Copyright: © 2023 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.
PY - 2023/12
Y1 - 2023/12
N2 - INTRODUCTION: Many people with cognitive complaints or impairment never receive an accurate diagnosis of the underlying condition, potentially impacting their access to appropriate treatment. To address this unmet need, plasma biomarker tests are being developed for use in Alzheimer's disease (AD). Plasma biomarker tests span various stages of development, including in vitro diagnostic devices (or tests) (IVDs), laboratory-developed tests (LDTs) and research use only devices (or tests) (RUOs). Understanding the differences between each test type is important for appropriate implementation into the AD diagnostic pathway and care continuum. METHODS: Authors reviewed scientific literature (PubMed, meeting abstracts and presentations, company press releases and websites) on AD plasma biomarkers. RESULTS: This article defines IVDs, LDTs, and RUOs, discusses potential clinical applications and highlights the steps necessary for their clinical implementation. DISCUSSION: Plasma biomarkers could revolutionize many areas of the AD diagnostic pathway and care continuum, but further research is needed. HIGHLIGHTS: There is a need for a minimally invasive Alzheimer's disease (AD) diagnostic tool. AD plasma biomarker tests exist at various stages of commercial development. Understanding the development stage of a test is important for its appropriate use. Plasma biomarker tests could function as a triage tool to streamline AD diagnosis. Further steps remain before AD plasma biomarkers can be used routinely.
AB - INTRODUCTION: Many people with cognitive complaints or impairment never receive an accurate diagnosis of the underlying condition, potentially impacting their access to appropriate treatment. To address this unmet need, plasma biomarker tests are being developed for use in Alzheimer's disease (AD). Plasma biomarker tests span various stages of development, including in vitro diagnostic devices (or tests) (IVDs), laboratory-developed tests (LDTs) and research use only devices (or tests) (RUOs). Understanding the differences between each test type is important for appropriate implementation into the AD diagnostic pathway and care continuum. METHODS: Authors reviewed scientific literature (PubMed, meeting abstracts and presentations, company press releases and websites) on AD plasma biomarkers. RESULTS: This article defines IVDs, LDTs, and RUOs, discusses potential clinical applications and highlights the steps necessary for their clinical implementation. DISCUSSION: Plasma biomarkers could revolutionize many areas of the AD diagnostic pathway and care continuum, but further research is needed. HIGHLIGHTS: There is a need for a minimally invasive Alzheimer's disease (AD) diagnostic tool. AD plasma biomarker tests exist at various stages of commercial development. Understanding the development stage of a test is important for its appropriate use. Plasma biomarker tests could function as a triage tool to streamline AD diagnosis. Further steps remain before AD plasma biomarkers can be used routinely.
KW - Alzheimer's disease
KW - diagnosis
KW - diagnosis pathway
KW - diagnostic test
KW - plasma biomarkers
KW - triage tool
UR - http://www.scopus.com/inward/record.url?scp=85170529080&partnerID=8YFLogxK
U2 - https://doi.org/10.1002/alz.13455
DO - https://doi.org/10.1002/alz.13455
M3 - Review article
C2 - 37694991
SN - 1552-5260
VL - 19
SP - 5805
EP - 5816
JO - Alzheimer's and Dementia
JF - Alzheimer's and Dementia
IS - 12
ER -