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

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-ß 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.