Department of Public Health Sciences, University of California, Davis, CA, USA.
Alzheimers Dement. 2010 May;6(3):257-64. doi: 10.1016/j.jalz.2010.03.002.
The Alzheimer's Disease Neuroimaging Initiative Phase 1 (ADNI-1) is a multisite prospective study designed to examine potential cerebrospinal fluid and imaging markers of Alzheimer's disease (AD) and their relationship to cognitive change. The objective of this study was to provide a global summary of the overall results and patterns of change observed in candidate markers and clinical measures over the first 2 years of follow-up.
Change was summarized for 210 normal controls, 357 mild cognitive impairment, and 162 AD subjects, with baseline and at least one cognitive follow-up assessment. Repeated measures and survival models were used to assess baseline biomarker levels as predictors. Potential for improving clinical trials was assessed by comparison of precision of markers for capturing change in hypothetical trial designs.
The first 12 months of complete data on ADNI participants demonstrated the potential for substantial advances in characterizing trajectories of change in a range of biomarkers and clinical outcomes, examining their relationship and timing, and assessing the potential for improvements in clinical trial design. Reduced metabolism and greater brain atrophy in the mild cognitive impairment at baseline are associated with more rapid cognitive decline and a higher rate of conversion to AD. Use of biomarkers as study entry criteria or as outcomes could reduce the number of participants required for clinical trials.
Analyses and comparisons of ADNI data strongly support the hypothesis that measurable change occurs in cerebrospinal fluid, positron emission tomography, and magnetic resonance imaging well in advance of the actual diagnosis of AD.
阿尔茨海默病神经影像学倡议第一阶段（ADNI-1）是一项多中心前瞻性研究，旨在研究潜在的阿尔茨海默病（AD）脑脊液和影像学标志物及其与认知变化的关系。本研究的目的是提供一个总体概述，总结候选标志物和临床指标在随访的头 2 年中观察到的总体结果和变化模式。
对 210 名正常对照者、357 名轻度认知障碍者和 162 名 AD 患者进行了分析，他们均有基线和至少一次认知随访评估。采用重复测量和生存模型来评估基线生物标志物水平作为预测指标。通过比较标记物在假设临床试验设计中捕捉变化的精度，评估改善临床试验的潜力。
ADNI 参与者完整数据的前 12 个月表明，在一系列生物标志物和临床结局的变化轨迹、检查其相关性和时间以及评估临床试验设计改进的潜力方面，具有取得重大进展的潜力。基线时轻度认知障碍患者的代谢减少和大脑萎缩增加与认知下降更快和向 AD 转化的比例更高有关。将生物标志物作为研究纳入标准或作为结果，可以减少临床试验所需的参与者人数。
对 ADNI 数据的分析和比较强烈支持这样一种假设，即在 AD 的实际诊断之前，脑脊液、正电子发射断层扫描和磁共振成像中就会发生可测量的变化。
