Blood-based biomarkers in Alzheimer's disease: Future directions for implementation

Ivonne Suridjan; Wiesje M van der Flier; Andreas U Monsch; Nerida Burnie; Robert Baldor; Marwan Sabbagh; Josep Vilaseca; Dongming Cai; Margherita Carboni; James J Lah

doi:10.1002/dad2.12508

Blood-based biomarkers in Alzheimer's disease: Future directions for implementation

Alzheimers Dement (Amst). 2023 Dec 4;15(4):e12508. doi: 10.1002/dad2.12508. eCollection 2023 Oct-Dec.

Authors

Ivonne Suridjan¹, Wiesje M van der Flier^{2

3}, Andreas U Monsch⁴, Nerida Burnie⁵, Robert Baldor⁶, Marwan Sabbagh⁷, Josep Vilaseca^{8

9}, Dongming Cai^{10

11

12}, Margherita Carboni¹, James J Lah¹³

Affiliations

¹ Roche Diagnostics International Ltd Rotkreuz Switzerland.
² Alzheimer Center Amsterdam Neurology, Epidemiology and Data Science, Vrije Universiteit Amsterdam Amsterdam UMC location VUmc Amsterdam The Netherlands.
³ Amsterdam Neuroscience Neurodegeneration Amsterdam The Netherlands.
⁴ Memory Clinic University Department of Geriatric Medicine FELIX PLATTER Basel Switzerland.
⁵ General Practice, South West London CCG London UK.
⁶ Department of Family Medicine and Community Health UMass Chan Medical School, North Worcester Massachusetts USA.
⁷ Barrow Neurological Institute Dignity Health/St Joseph's Hospital and Medical Center Phoenix Arizona USA.
⁸ Department of Medicine Universitat de Vic-Central Catalonia University Vic Spain.
⁹ Primary Health Care Service Althaia Foundation - Clinical and University Network in Manresa, Dr. Joan Soler Manresa Spain.
¹⁰ Alzheimer's Disease Research Center Icahn School of Medicine at Mount Sinai New York New York USA.
¹¹ N. Bud Grossman Center for Memory Research and Care University of Minnesota Minneapolis Minnesota USA.
¹² Geriatric Research Education and Clinical Center (GRECC) Minneapolis VA Health Care System, One Veterans Dr Minneapolis Minnesota USA.
¹³ Goizueta Alzheimer's Disease Research Center Emory University School of Medicine Atlanta Georgia USA.

Abstract

Introduction: Disease-modifying therapies (DMTs) for Alzheimer's disease (AD) will increase diagnostic demand. A non-invasive blood-based biomarker (BBBM) test for detection of amyloid-β pathology may reduce diagnostic barriers and facilitate DMT initiation.

Objective: To explore heterogeneity in AD care pathways and potential role of BBBM tests.

Methods: Survey of 213 healthcare professionals/payers in US/China/UK/Germany/Spain/France and two advisory boards (US/Europe).

Results: Current diagnostic pathways are heterogeneous, meaning many AD patients are missed while low-risk patients undergo unnecessary procedures. Confirmatory amyloid testing (cerebrospinal fluid biomarkers/positron emission tomography) is utilized in few patients, resulting in diagnostic/treatment delays. A high negative-predictive-value test could streamline the diagnostic pathway by reducing unnecessary procedures in low-risk patients; supporting confirmatory testing where needed. Imminent approval of DMTs will increase need for fast and reliable AD diagnostic tests.

Discussion: An easy-to-use, accurate, non-invasive BBBM test for amyloid pathology could guide diagnostic procedures or referral, streamlining early diagnosis and DMT initiation.

Highlights: This study explored AD care pathways and how BBBM may meet diagnostic demandsCurrent diagnostic pathways are heterogeneous, with country and setting variationsMany AD patients are missed, while low-risk patients undergo unnecessary proceduresAn easy-to-use, accurate, non-invasive BBBM test for amyloid pathology is neededThis test could streamline early diagnosis of amyloid pathology and DMT initiation.

Keywords: Alzheimer's disease; amyloid pathology; blood‐based biomarker; clinical practice; diagnosis; qualitative; screening.