在临床前阿尔茨海默病随机对照试验中研究中止的随机化前预测因素
R Raman1, K Hussen, M C Donohue
1Rema Raman, PhD, Alzheimer's Therapeutic Research Institute, Keck School of Medicine, University of Southern California, San Diego, USA,
The journal of prevention of Alzheimer's disease
|July 24, 2024
概括
年龄较大的参与者和焦虑程度较高的参与者更有可能从A4试验中断. 患有痴呆症的家族史和APOE ε4携带者不太可能退学,为未来的AD预防研究设计提供了信息.
科学领域:
- 临床试验 临床试验
- 神经退行性疾病 神经退行性疾病
- 预防阿尔茨海默氏病 预防阿尔茨海默氏病
背景情况:
- 参与者停止治疗会影响临床试验的功率,偏见和可解释性.
- 参与者保留对于试验成功至关重要,类似于招聘.
研究的目的:
- 在A4研究中确定与过早停药相关的随机化前特征.
- 在临床前阿尔茨海默氏病试验中为参与者选择和留住参与者的策略提供信息.
主要方法:
- 分析了A4试验中的1169名参与者,将他们分为完成者或放弃者.
- 使用单变量和多变量通用线性混合模型 (GLMM) 来评估断药的预测因素.
- 包括人口,临床,粉样蛋白PET和遗传因素作为潜在的预测因素.
主要成果:
- 29%的参与者在盲目阶段中断了治疗.
- 较高的查国家特征焦虑清单 (STAI) 评分和年龄较大预测停药.
- 患有痴呆症的家族史和APOE ε4载体状态与较低的停药率有限相关.
结论:
- 高龄和更高的基线焦虑增加了在临床前阿尔茨海默病试验中脱学风险.
- 患有痴呆症的家族史和APOE ε4携带可能是预防退学的保护因素.
- 结果有助于设计未来的试验,以改善参与者保留和研究结果.
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