阿尔茨海默病（Alzheimer’s disease，AD）是一种慢性进展的神经退行性疾病，被认为是一种临床-生物学实体。近年来，以影像学和体液标志物为代表的早期诊断技术不断涌现，推动 AD 诊断标准更新迭代，为疾病修饰治疗研发奠定基础。然而，过度倚重生物学标志物检测，也存在显著的缺陷。2021 年，DUBOIS 在 Lancet 发表的国际工作组（International Working Group，IWG）诊断建议中，指出了纯生物学标志物标准的不足，并对临床实践中是否检测生物学标志物给出了建议。本文回顾 AD 诊断标准的变迁，对其临床及科研诊疗提出建议。

Alzheimer’s disease (AD) is a chronic progressive neurodegenerative disorder. In recent years, early diagnosis technologies represented by imaging and humoral biomarkers resulted in continued evolution of the AD diagnostic criteria and laid the foundation for the research and development of disease modification therapy. The advancement of fluid and imaging biomarkers resulted in continued evolution of the criteria and facilitated the development of disease modifying therapy. This, however, pertained clearly shortcomings, particularly when applied in a clinical setting. In 2021, DUBOIS and the International Working Group presented the current limitations of pure biomarkers in the diagnosis of AD and proposed recommendations for whether to detect biomarkers in clinical practice. This paper reviews the evolution of AD diagnostic criteria and provides insights for the clinical and research applications accordingly.