Clinical, Memory Research Unit, Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.
Memory Clinic, Skåne University Hospital, Malmö, Sweden.
Alzheimers Dement. 2022 Dec;18(12):2669-2686. doi: 10.1002/alz.12756. Epub 2022 Jul 31.
Blood-based markers (BBMs) have recently shown promise to revolutionize the diagnostic and prognostic work-up of Alzheimer's disease (AD), as well as to improve the design of interventional trials. Here we discuss in detail further research needed to be performed before widespread use of BBMs. We already now recommend use of BBMs as (pre-)screeners to identify individuals likely to have AD pathological changes for inclusion in trials evaluating disease-modifying therapies, provided the AD status is confirmed with positron emission tomography (PET) or cerebrospinal fluid (CSF) testing. We also encourage studying longitudinal BBM changes in ongoing as well as future interventional trials. However, BBMs should not yet be used as primary endpoints in pivotal trials. Further, we recommend to cautiously start using BBMs in specialized memory clinics as part of the diagnostic work-up of patients with cognitive symptoms and the results should be confirmed whenever possible with CSF or PET. Additional data are needed before use of BBMs as stand-alone diagnostic AD markers, or before considering use in primary care.
基于血液的标志物（BBM）最近显示出有望彻底改变阿尔茨海默病（AD）的诊断和预后工作，以及改善干预试验的设计。在这里，我们详细讨论了在广泛使用 BBM 之前需要进行的进一步研究。我们已经建议将 BBM 用作（预）筛选器，以识别可能具有 AD 病理变化的个体，以便纳入评估疾病修饰疗法的试验，前提是 AD 状态通过正电子发射断层扫描（PET）或脑脊液（CSF）测试得到确认。我们还鼓励在正在进行的和未来的干预性试验中研究纵向 BBM 变化。然而，在关键试验中，BBM 不应作为主要终点。此外，我们建议在专门的记忆诊所中谨慎地开始使用 BBM，作为具有认知症状的患者诊断工作的一部分，并且应尽可能使用 CSF 或 PET 来确认结果。在将 BBM 用作独立的 AD 诊断标志物之前，或者在考虑将其用于初级保健之前，需要额外的数据。
