Our goal was to assess the enrichment utility of hippocampal volume (HV) as an enrichment biomarker in amnestic mild cognitive impairment (aMCI) clinical trials, and, hence, develop a HV neuroimaging-informed clinical trial enrichment tool. Modeling of integrated longitudinal patient-level data came from open-access natural history studies in patients diagnosed with aMCI - the Alzheimer's disease Neuroimaging Initiative (ADNI)-1 and ADNI-2 - and indicated that a decrease of 1cm3 with respect to the analysis dataset median baseline intracranial volume-adjusted HV (ICV-HV; ~5cm3 ) is associated with more than 50% increase in disease progression rate as measured by the Clinical Dementia Rating Scale - Sum-of-Boxes (CDR-SB). Clinical trial simulations showed that the inclusion of aMCI subjects with baseline ICV-HV below the 84th or 50th percentile allowed an approximate reduction in trial size of at least 26% and 55%, respectively. This clinical trial enrichment tool can help design more efficient and informative clinical trials.

中文翻译：

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海马神经影像学知识的临床试验富集工具，用于使用开放数据的健忘性轻度认知障碍。

我们的目标是评估在轻度轻度认知障碍（aMCI）临床试验中海马体积（HV）作为富集生物标志物的富集效用，因此，开发了以HV神经影像学为指导的临床富集工具。纵向综合患者水平数据的建模来自对aMCI（阿尔茨海默氏病神经影像学倡议（ADNI）-1和ADNI-2）诊断为aMCI的患者的开放获取自然史研究，并表明与分析数据集相比减少了1cm3如临床痴呆症评定量表-盒总和（CDR-SB）所测量，中位基线颅内体积调节HV（ICV-HV;〜5cm3）与疾病进展率增加超过50％相关。临床试验模拟表明，纳入基线ICV-HV低于84％或50％的aMCI受试者，可使试验规模分别至少减少约26％和55％。此临床试验丰富工具可以帮助设计更有效，信息更丰富的临床试验。