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• W2980884493 abstract "AD diagnosis is currently performed at specialist centers by clinical evaluation, neuropsychological testing, and confirmatory CSF and/or PET analysis of AD biomarkers; diagnostic pathways vary by country. CSF/PET is only performed in a limited number of patients due to invasiveness, cost and availability. With the anticipated approval of disease-modifying treatments (DMTs), blood-based biomarker (BBBM) assays are in development to support management of patients with cognitive symptoms and suspected AD in primary care settings. BBBM assays would provide a minimally invasive means to measure plasma amyloid-β peptides and identify patients with high likelihood of amyloid-β pathology. We aimed to identify desirable characteristics for BBBM assays, and approaches for implementation. An advisory board of experts in the neurodegenerative diseases field was convened. Target populations, clinical performance and practicalities of implementing a BBBM assay were discussed. Preliminary data on clinical performance of Elecsys® BBBM assays for amyloid-β(1–40)/amyloid-β(1–42) ratio in the Swedish BioFINDER cohort (N=843; cognitively unimpaired, MCI and AD patients) were shared (Hansson, AAIC 2019). AUC for prediction of amyloid-β positivity was 0.8; diagnostic accuracy increased with inclusion of APOE genotype and cognitive function. A population-based model was constructed to estimate trends in specialist center referrals (2017–2023) following BBBM assay introduction. Recommended target population was patients with mild cognitive impairment in primary care settings; future use was encouraged in routine triage for elderly. Assay sensitivity of 85% and specificity of 50% were considered suitable for identifying patients with high likelihood of amyloid-β pathology. For population screening, higher specificity was preferable to minimize false-positives. Pre-analytical sample handling appeared feasible in most primary care settings; ≤2 hour timeframe for centrifugation would permit transfer to central laboratories. Modelling predicted that BBBM assays with this performance would increase EU specialist center referrals; the proportion of patients correctly identified with amyloid-β pathology would increase (Figure). Concerns were raised regarding increased burden on specialist centers; would be justified by DMT availability." @default.
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• W2980884493 date "2019-07-01" @default.
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• W2980884493 title "P3-239: OPTIMIZED PATHWAYS FOR EARLY DETECTION OF ALZHEIMER'S DISEASE WITH BLOOD-BASED BIOMARKERS" @default.
• W2980884493 doi "https://doi.org/10.1016/j.jalz.2019.06.3269" @default.
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