生物标志物 生物标志物
Kazuya Kurachi1, Nozomu Watanabe1, Osamu Shibata1
1LabCorp Japan, G.K., Chuo-ku, Tokyo, Japan.
Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 24, 2025
概括
APOE基因型定型SNP阵列准确评估了阿尔茨海默病 (AD) 的抗粉胺β (Aβ) 抗体药物治疗患者的粉胺相关成像异常 (ARIA) 风险. 这项测试对于在开始AD治疗之前识别有风险的患者至关重要.
科学领域:
- 神经学 神经学
- 遗传学 是一个遗传学.
- 药物基因组学 药物基因组学
背景情况:
- 针对阿尔茨海默氏症 (AD) 的抗胺β (Aβ) 抗体药物的最近批准需要对副作用的风险评估.
- 与粉样蛋白相关的成像异常 (ARIA) 是常见的副作用,其发病率因apolipoprotein E (APOE) 基因型而异.
- 建议在抗Aβ治疗之前进行APOE基因型鉴定,以确定ARIA风险.
研究的目的:
- 确认APOE基因型单核酸多态 (SNP) 阵列对评估ARIA风险的有用性.
- 为了验证由美国实验室公司控股公司提供的APOE阿尔茨海默病风险LDT.
主要方法:
- 来自全血的DNA样本使用定制基因类型阵列进行分析.
- 评估了两种常见的APOE基因变异 (rs429358和rs7412).
- 个人被分为六种不同的APOE基因型 (ε2/ε2, ε2/ε3, ε2/ε4, ε3/ε3, ε3/ε4, ε4/ε4).
主要成果:
- APOE基因型化SNP阵列与聚合酶链反应 (PCR) 方法显示出100%的一致性.
- 使用的PCR方法与Donanemab第三期临床试验 (TRAILBLAZER-ALZ 2) 的程序一致.
- 在所有六种测试的APOE基因型中都观察到高一致性,每种基因型至少有六个样本.
结论:
- APOE基因造型SNP阵列是对接受抗Aβ抗体治疗的患者预测ARIA风险的验证和有价值的工具.
- 预计这种测试的广泛采用将改善患者的安全性和阿尔茨海默病的治疗选择.
- 这种基因测试通过识别ARIA风险较高的患者来支持AD治疗的个性化医疗方法.
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