Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: Phase 3 study
نویسندگان
چکیده
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.
منابع مشابه
Beta-amyloid imaging with florbetaben
Florbetaben is a fluorine-18 (18F)-labeled stilbene derivative that was developed as a positron emission tomography (PET) tracer for routine clinical application to visualize β-amyloid plaques in the Alzheimer's disease (AD) brain. The tracer successfully completed a global multicenter phase 0-III development program and was, as a consequence, recently approved by the US Food and Drug Administr...
متن کاملImpact of beta-amyloid-specific florbetaben PET imaging on confidence in early diagnosis of Alzheimer's disease.
BACKGROUND Early diagnosis of Alzheimer's disease (AD) may be corroborated by imaging of beta-amyloid plaques using positron emission tomography (PET). Here, we performed an add-on questionnaire study to evaluate the relevance of florbetaben imaging (BAY 949172) in diagnosis and consecutive management of probable AD patients. METHODS AD patients with a clinical diagnosis in accordance with th...
متن کاملEvaluation of early-phase [18F]-florbetaben PET acquisition in clinical routine cases
OBJECTIVES In recent years several [18F]-labelled amyloid PET tracers have been developed and have obtained clinical approval. There is accumulating evidence that early (post injection) acquisitions with these tracers are equally informative as conventional blood flow and metabolism studies for diagnosis of Alzheimer's disease, but there have been few side-by-side studies. Therefore, we investi...
متن کاملWhole Brain Voxel-Wise Analysis of Cerebral Retention of Beta-Amyloid in Cognitively Normal Older Adults Using 18F-Florbetaben
Objective Recently developed 18F-labelled amyloid beta (Aβ) positron emission tomography (PET) tracers have demonstrated potentials to enable more prevalent application of amyloid imaging in the clinical setting. The aim of this study is to demonstrate cerebral retention of Aβ in cognitively normal older adults, by implementing voxel-based analysis on images acquired from 18F-Florbetaben amyloi...
متن کاملDetection of Alzheimer\\\\\\\'s Disease using Multitracer Positron Emission Tomography Imaging
Alzheimer's disease is characterized by impaired glucose metabolism and demonstration of amyloid plaques. Individual positron emission tomography tracers may reveal specific signs of pathology that is not readily apparent on inspection of another one. Combination of multitracer positron emission tomography imaging yields promising results. In this paper, 57 Alzheimer's disease neuroimaging ini...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Alzheimer's & Dementia
دوره 11 شماره
صفحات -
تاریخ انتشار 2015