药物开发 药物开发
Cai Gillis1, Shardae Showell1, Kristen Lu1
1Biogen, Cambridge, MA, USA.
Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 26, 2025
概括
数以百万计的50岁以上的主观认知衰退 (SCD) 的人可能患有临床前阿尔茨海默病 (AD). 然而,只有很小一部分符合临床试验的条件,这凸显了对临床前阿尔茨海默病研究更好的诊断工具的需求.
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:
- 阿尔茨海默病 (AD) 具有临床前阶段,在认知障碍之前生物标志物积累.
- 招募临床前AD (preAD) 试验是困难的,因为缺乏选工具.
- 个人主观认知衰退 (SCD) 报告症状但没有客观损伤可能是一个关键的招聘池.
研究的目的:
- 估计9个欧洲国家50岁以上的粉样蛋白阳性 (Aβ+) SCD个体的数量.
- 评估寻求医疗保健专业人员 (HCP) 咨询的SCD预AD个体的潜在池.
- 为了确定预估的临床试验合格的preAD个体的数量.
主要方法:
- 将年龄分层的SCD患病率应用于联合国9个欧洲国家的人口数据.
- 利用了来自"粉样蛋白生物标志物研究"的年龄分层Aβ+概率估计.
- 整合了欧洲寻求SCD症状和preAD试验查失败标准的欧洲寻求帮助数据.
主要成果:
- 据估计,在9个欧洲国家,约有840万年龄在50岁以上的SCD患者可能患有preAD.
- 据估计,大约有150万患有SCD的预AD患者可能会咨询医疗保健工作者.
- 据估计,大约有46万个人有资格参加预AD临床试验.
结论:
- 据估计,在欧洲约800万患有SCD的预AD个体中,只有5.5%可能被识别并符合试验的条件.
- 未来的研究应该包括tau病理和APOE ε4状态在估计中.
- 开发更好的生物标志物和诊断工具对于增加预AD试验参与者识别至关重要.
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