生物标志物 生物标志物
Rianne N Esquivel1, Shriya Mathur1, Christine Parker2
1GSK, Collegeville, PA, USA.
Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 26, 2025
概括
像PrecivityAD和pTau181这样的血液生物标志物可以通过预先查粉样蛋白阳性来加速阿尔茨海默病的临床试验. 这减少了与传统确认性检测相关的患者负担和运营成本.
科学领域:
- 神经学 神经学
- 生物标志物 生物标志物
- 临床试验 临床试验
背景情况:
- 早期阿尔茨海默氏症 (AD) 的临床试验由于粉样蛋白阳性率低,招生速度较慢.
- 验证性检测 (心血管功能生物标志物,粉样蛋白PET) 增加了患者的负担和运营挑战.
- 基于血液的生物标志物为预先查和丰富试验群体提供了潜在的解决方案.
研究的目的:
- 评估血液基生物标志物 (PrecivityAD和Elecsys pTau181) 在早期AD临床试验中对粉样蛋白阳性进行预查的疗效.
- 评估这些生物标志物对减少侵入性确认性测试需求的影响.
主要方法:
- 纳入了PrecivityAD和Elecsys pTau181测试,用于PROGRESS-AD第二阶段试验的选过程.
- 血液生物标志物结果与粉样蛋白PET和脑脊液 (Aβ42/40比) 的比较用于ROC分析.
- 对证实性测试进行了积极百分比协议 (PPA),负百分比协议 (NPA) 和积极预测值 (PPV) 的分析.
主要成果:
- pTau181显示了85.0%的PPA和59.5%的NPA.
- 预测AD显示PPA为64.6%和NPA为42.9%.
- PrecivityAD的PPV为96.4%,pTau181的PPV为90.0%,显著降低了屏幕故障率至9.9%.
结论:
- 基于血液的生物标志物在早期AD试验中显著减少了对CSF或PET测试的需求.
- 这些生物标志物可以降低参与者负担,改善试验可访问性,并提高临床试验设计.
- 需要进一步的研究来解决局限性问题,例如对粉样蛋白阴性个体的不完整确认结果和潜在的偏见.
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