Bridging the Gap: The Global CEOi Collaborative Workgroup for Adoption of Alzheimer’s disease Blood‐Based Biomarkers in Clinical Practice

Abstract

AbstractBackgroundThe United States healthcare system is not prepared for disease modifying therapies (DMTs) of Alzheimer’s disease (AD). Eligibility for DMTs will be contingent on confirmation of AD pathology using biomarkers. Major difficulties are expected in providing PET and CSF testing in the population. Blood‐based biomarkers (BBMs) could greatly reduce the burden of biomarker testing by triaging patients for subsequent confirmation of AD brain pathology in specialty and primary care. The Global CEO Initiative on Alzheimer’s Disease (CEOi) has convened a Workgroup (WG) to develop guidelines and recommendations for the widespread adoption of BBMs in clinical practice to support feasible, timely, and accurate AD dementia diagnosis among symptomatic patients.MethodOver 80 stakeholders spanning academia, healthcare, advocacy, industry, non‐profit, and venture capital have joined the Workgroup, ensuring a wide range of expertise. The Workgroup consists of three active workstreams. Workstream A has defined use cases for symptomatic patients and minimum viable test specifications; Workstream B will provide recommendations on implementing BBMs in clinical practice; and Workstream C serves to educate practicing clinicians on outputs garnered from Workstreams A and B. Jointly led by 2 CEOi‐nominated experts, each Workstream has a core team, consisting of 6‐8 experts, and meet on a weekly basis to drive the WG objectives. General Workstream meetings are held periodically for the core team to present plans and outputs for full group input and feedback.ResultWorkgroup members have conceptualized the clinical care pathway for operationalizing BBM across specialty and primary care settings; and will present a feasible framework for real‐world implementation of BBMs. We have defined appropriate‐use criteria for BBMs in clinical settings, including test specifications, and will provide actionable recommendations to accelerate adoption in clinical care, while critically considering implementation challenges such as test result interpretation, and value to existing diagnostic pathway. Strategies to facilitate optimal implementation including novel educational tools will be disseminated.ConclusionThe Workgroup seeks rapid, efficient and effective utility of BBMs in clinical practice that is scientifically valid, and patient focused. Successful adoption will facilitate effectual triaging of patients for comprehensive diagnostic evaluations, streamlining patient access to appropriate and integrated care.