氟代苯丙氨酸 PET 成像检测阿尔茨海默病中的淀粉样β斑块：III 期研究。

Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: phase 3 study.

机构信息

Department of Nuclear Medicine, University of Leipzig, Leipzig, Germany.

Banner Sun Health Research Institute, Sun City, AZ, USA.

出版信息

Alzheimers Dement. 2015 Aug;11(8):964-74. doi: 10.1016/j.jalz.2015.02.004. Epub 2015 Mar 28.

DOI:10.1016/j.jalz.2015.02.004

PMID:25824567

Abstract

BACKGROUND

Evaluation of brain β-amyloid by positron emission tomography (PET) imaging can assist in the diagnosis of Alzheimer disease (AD) and other dementias.

METHODS

Open-label, nonrandomized, multicenter, phase 3 study to validate the (18)F-labeled β-amyloid tracer florbetaben by comparing in vivo PET imaging with post-mortem histopathology.

RESULTS

Brain images and tissue from 74 deceased subjects (of 216 trial participants) were analyzed. Forty-six of 47 neuritic β-amyloid-positive cases were read as PET positive, and 24 of 27 neuritic β-amyloid plaque-negative cases were read as PET negative (sensitivity 97.9% [95% confidence interval or CI 93.8-100%], specificity 88.9% [95% CI 77.0-100%]). In a subgroup, a regional tissue-scan matched analysis was performed. In areas known to strongly accumulate β-amyloid plaques, sensitivity and specificity were 82% to 90%, and 86% to 95%, respectively.

CONCLUSIONS

Florbetaben PET shows high sensitivity and specificity for the detection of histopathology-confirmed neuritic β-amyloid plaques and may thus be a valuable adjunct to clinical diagnosis, particularly for the exclusion of AD.

TRIAL REGISTRATION

ClinicalTrials.govNCT01020838.

摘要

背景

正电子发射断层扫描（PET）成像评估脑β-淀粉样蛋白可辅助阿尔茨海默病（AD）和其他痴呆的诊断。

方法

开放性、非随机、多中心、3 期研究，通过比较体内正电子发射断层扫描与死后组织病理学，对（18）F 标记的β-淀粉样蛋白示踪剂氟比他滨进行验证。

结果

分析了 74 名已故受试者（216 名试验参与者中的 47 名）的脑部图像和组织。47 例神经纤维状β-淀粉样蛋白阳性病例中，46 例被读取为 PET 阳性，27 例神经纤维状β-淀粉样蛋白斑块阴性病例中，24 例被读取为 PET 阴性（敏感性 97.9%[95%置信区间或 93.8-100%]，特异性 88.9%[95%置信区间 77.0-100%]）。在一个亚组中，进行了区域性组织扫描匹配分析。在已知强烈聚集β-淀粉样蛋白斑块的区域，敏感性和特异性分别为 82%至 90%，86%至 95%。