药物开发 药物开发
Lieza G Exalto1,2, Siti S Syaziyah3, Xiaotian T Fang1
1Julius Clinical, Zeist, Netherlands.
Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 25, 2025
概括
女性不太可能符合阿尔茨海默氏症的条件.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 医学研究 医学研究
背景情况:
- 阿尔茨海默病 (AD) 药物试验往往缺乏相对于全球痴呆症人口的女性参与.
- 行业利益相关者致力于包容性试验,重点关注参与和招聘.
- 本研究调查了试验设计,特别是资格标准如何影响基于性别的参与率.
研究的目的:
- 分析常见的阿尔茨海默病临床试验资格标准对参与资格的男女比例的影响.
- 确定特定的标准,不成比例地影响妇女在AD试验中的资格.
主要方法:
- 从 563 个注册在 clinicaltrials.gov.gov 上的二期和三期AD 药物试验中提取了资格标准.
- 根据前5个最常见的纳入标准,手动注释了113项试验.
- 在阿姆斯特丹阿尔茨海默氏症中心对一组被诊断患有阿尔茨海默氏症或轻度认知障碍 (MCI) 的男性和女性连续应用了这些标准.
主要成果:
- 排名前五的标准包括:没有其他中枢神经系统 (CNS) 疾病,护理人员参与,迷你精神状态检查 (MMSE) 评分范围 (24-30),没有研究程序的禁忌,年龄范围 (55-85).
- 将这些标准连续应用于3835名患者 (48%为女性),女性的资格明显下降.
- 最终的资格是男性31%,女性16%,主要是由于MMSE得分较低,女性缺乏护理人员的可用性.
结论:
- 在阿尔茨海默氏症临床试验中常用的资格标准导致女性的资格率低于男性.
- 呈现时MMSE得分较低和护理人员可用性减少似乎是导致这种差异的关键因素.
- 试验设计应考虑这些因素,以促进更公平地将女性纳入AD药物试验.
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