Wang Ming-Yu, Chen Ke-Liang, Huang Yu-Yuan, Chen Shu-Fen, Wang Rong-Ze, Zhang Yi, Hu He-Ying, Ma Ling-Zhi, Liu Wei-Shi, Wang Jun, Xin Jia-Wei, Zhang Xue, Li Meng-Meng, Guo Yu, Dong Qiang, Cheng Wei, Tan Lan, Cui Mei, Zhang Ya-Ru, Yu Jin-Tai
Department of Neurology, Qingdao Municipal Hospital, Qingdao University, Qingdao, China.
Department of Neurology, Weifang People's Hospital, Weifang, China.
Transl Psychiatry. 2025 Apr 7;15(1):130. doi: 10.1038/s41398-025-03345-z.
Cerebrospinal fluid (CSF) biomarkers have been widely adopted in Alzheimer's disease (AD) diagnosis. However, no studies focused on the application of CSF biomarkers in the clinical practice of complex and atypical patients with cognitive impairment in China. This study aimed to evaluate the added value of CSF AD biomarkers in cognitively impaired patients with complex conditions in a memory clinical setting. A total of 633 participants were included from the National Center for Neurological Disorders in Shanghai, China. The CSF AD biomarkers were measured with ELISA. Cutoff values were firstly identified using Youden's index. The neurologists proposed etiology diagnosis with a percentage estimate of their confidence and prescribed medication before and after CSF disclosure. Changes in etiological diagnosis, diagnostic confidence, and management plan were compared across the groups. Of the 633 patients (mean [SD] age, 61.1 [11.3] years; 295 males [46.6%]), 372 (58.8%) were diagnosed with dementia, 103 (16.3%) with mild cognitive impairment, and 158 (24.9%) with subjective cognitive decline. Using those pre-defined cutoffs, we categorized patients into 3 groups: Alzheimer's continuum (68.1%), non-AD pathologic change (11.1%), and normal AD biomarkers (20.8%). After CSF disclosure, the proposed etiology changed in 158 (25.0%) participants and the prescribed medication changed in 200 (31.6%) patients. Mean diagnostic confidence increased from 69.5-83.0% (+13.5%; P < 0.001). In conclusion, CSF AD biomarkers significantly impacted the diagnosis, diagnostic confidence, and treatment plans for Chinese patients with complex cognitive impairment. CSF AD biomarkers are a useful tool for clinicians beyond routine clinical assessment.
脑脊液（CSF）生物标志物已广泛应用于阿尔茨海默病（AD）的诊断。然而，在中国，尚无研究关注脑脊液生物标志物在复杂和非典型认知障碍患者临床实践中的应用。本研究旨在评估脑脊液AD生物标志物在记忆门诊环境中复杂病情的认知障碍患者中的附加价值。共有633名参与者来自中国上海的国家神经疾病中心。采用酶联免疫吸附测定法（ELISA）检测脑脊液AD生物标志物。首先使用约登指数确定临界值。神经科医生在脑脊液检测结果披露前后提出病因诊断，并给出诊断置信度的百分比估计值，同时开具药物处方。比较各组病因诊断、诊断置信度和治疗方案的变化。在这633例患者中（平均[标准差]年龄为61.1[11.3]岁；男性295例[46.6%]），372例（58.8%）被诊断为痴呆，103例（16.3%）为轻度认知障碍，158例（24.9%）为主观认知下降。使用预先定义的临界值，我们将患者分为3组：阿尔茨海默病连续体组（68.1%）、非AD病理改变组（11.1%）和AD生物标志物正常组（20.8%）。脑脊液检测结果披露后，158例（25.0%）参与者的拟诊病因发生了变化，200例（（31.6%）患者的处方药物发生了变化。平均诊断置信度从69.5%提高到83.0%（提高了13.5%；P < 0.001）。总之，脑脊液AD生物标志物对中国复杂认知障碍患者的诊断、诊断置信度和治疗方案有显著影响。脑脊液AD生物标志物是临床医生在常规临床评估之外的有用工具。
