Use of white matter reference regions for detection of change in florbetapir positron emission tomography from completed phase 3 solanezumab trials
Use of white matter reference regions for detection of change in florbetapir positron emission tomography from completed phase 3 solanezumab trials
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DOI：
10.1016/j.jalz.2017.02.009
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发表时间：
2017-10-01
影响因子：
14
通讯作者：
Mintun, Mark A.
中科院分区：
文献类型：
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作者：
Fleisher, Adam S.;Joshi, Abhinay D.;Mintun, Mark A.
导言：我们比较了受试者特定的白质(SSWM)和全小脑(CBL)参考区在检测淀粉样正电子发射断层扫描信号纵向变化方面的能力。方法：分析研究和实验研究中阿尔茨海默病引起的轻度痴呆患者(66名安慰剂组和63名Solanezumab组)阳性的florbetapir正电子发射断层扫描结果。为了与CBL进行比较，使用SSWM校正因子(SSWM归一化比[SSWMnr])对纵向数据进行第二次归一化。协方差分析评估了用solane zumab和安慰剂治疗之间基线到18个月的变化。样本和效应大小估计提供了观察到的治疗变化的幅度。结果：使用CBL的安慰剂和Solanezumab之间的纵向百分比变化不显著(P=.536)，但对SSWMnr显著(P=.042)。与CBL相比，SSWMnr技术提高了检测处理差异的能力，使效应大小增加了两倍多，样本量要求减少了85%至90%。讨论：在这些抗淀粉样蛋白治疗试验中，用SSWM参考区调整纵向标准化摄取值比率增加了均值变化检测，减少了方差，从而显著提高了检测变化的统计能力。(C)2017年阿尔茨海默氏症协会。爱思唯尔公司出版，版权所有。
Introduction: We compared subject-specific white matter (SSWM) and whole cerebellum (CBL) reference regions for power to detect longitudinal change in amyloid positron emission tomography signal.Methods: Positive florbetapir positron emission tomography scans were analyzed from participants (66 placebo treated and 63 solanezumab treated) with mild dementia caused by Alzheimer's disease from the EXPEDITION and EXPEDITION2 studies. For comparison to CBL, a second normalization was performed on longitudinal data using an SSWM correction factor (SSWM normalization ratio [SSWMnr]). Analysis of covariance assessed baseline to 18-month change between treatment with solanezumab and placebo. Sample and effect size estimations provided magnitude of observed treatment changes.Results: Longitudinal percent change between placebo and solanezumab using CBL was not significant (P = .536) but was significant for SSWMnr (P = .042). Compared with CBL, SSWMnr technique increased the power to detect a treatment difference, more than tripling the effect size and reducing the sample size requirements by 85% to 90%.Discussion: Adjusting longitudinal standardized uptake value ratios with an SSWM reference region in these antiamyloid treatment trials increased mean change detection and decreased variance resulting in the substantial improvement in statistical power to detect change. (C) 2017 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.