预约演示
更新于：2026-04-29
Florbetaben F-18
氟[¹⁸F]贝他苯
更新于：2026-04-29
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、快速通道 (美国) |
登录后查看时间轴
结构/序列
分子式C21H26FNO3 |
InChIKeyNCWZOASIUQVOFA-FWZJPQCDSA-N |
CAS号902143-01-5 |
关联
47
项与 氟[¹⁸F]贝他苯 相关的临床试验NCT07169630
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer s Disease (AD) or Mild Cognitive Impairment (MCI)
ACTRN12626000208303
Finding the fibril in the haystack: A pilot study of Amyloid ([18F] Florbetaben) PET-CT in Peripheral Nerve Amyloidosis
CTIS2023-503705-10-00
Patient- and care-related benefits of amyloid PET imaging (ENABLE)
100 项与 氟[¹⁸F]贝他苯 相关的临床结果
登录后查看更多信息
100 项与 氟[¹⁸F]贝他苯 相关的转化医学
登录后查看更多信息
100 项与 氟[¹⁸F]贝他苯 相关的专利（医药）
登录后查看更多信息
192
项与 氟[¹⁸F]贝他苯 相关的文献（医药）2026-05-01JPAD-Journal of Prevention of Alzheimers Disease
Discordance in amyloid positivity between visual reads and Centiloids: Impact of white matter uptake
Article
作者: Devanarayan, Viswanath ; Charil, Arnaud ; Reyderman, Larisa ; Kramer, Lynn D ; Irizarry, Michael C ; Reilhac, Anthonin ; Dhadda, Shobha ; Nelson, Todd M
BACKGROUND:
The visual interpretation of amyloid PET scans, or visual read (VR), is the most common technique used in clinical practice to identify the presence of cerebral amyloid plaques. Amyloid status (positive or negative) determined by VR or using a Centiloid (CL) cut-off shows high overall concordance. However, discordant cases can occur where the VR is positive, but the CL is below the positivity cut-off, or vice versa.
OBJECTIVES:
The objective of this analysis was to evaluate the rate of discordance and explore potential causes, particularly the role of amyloid tracer uptake in the white matter (WM), when determining amyloid status using VR and CL in screening for the elenbecestat phase 3 studies in early Alzheimer's disease (AD).
DESIGN:
Amyloid PET scans using either Florbetapir (Amyvid™), Florbetaben (Neuraceq™) or Flutemetamol (Vizamyl™) from 3,232 participants (1507 VR- and 1725 VR+) with cognitive impairment screened for the elenbecestat phase 3 studies in early AD were visually interpreted at screening by trained neuroradiologists and quantified using CL values.
SETTING:
Academic and clinical centers INTERVENTION/MEASUREMENTS: Quantitatively, amyloid positivity was defined as CL > 32.21. The number of positive cortical regions was determined by counting the number of regions with a standardized uptake value ratio (SUVr) that exceeded 1.17. PET SUVr levels in the cerebral WM were measured using an eroded WM region of interest (ROI). Statistical tests were conducted to detect differences among the four concordance groups, defined by the relationship of VR and CL status (positive or negative). Additionally, tests examined the relationship between uptake in the WM and rates and type of discordance. Receiver operating characteristic (ROC) analysis and DeLong's test were also used to examine the effect of different tracers on the discordant rates.
RESULT:
Discordance was observed in 6.53% of cases (n=211), with VR+/CL- in 4.61% (n=149) and VR-/CL+ in 1.92% (n=62). VR+/CL- discordant cases had significantly fewer amyloid-positive cortical regions compared to both VR+/CL+ and VR-/CL+ cases. VR-/CL+ cases had a significantly higher WM uptake than VR-/CL- and VR+/CL- cases. Our findings revealed a relationship between WM uptake and rates and types of discordance. High WM uptake can erroneously lead to CL+, due to gray matter (GM) contamination from the WM, and VR- status, due to reduced contrast between WM and GM, resulting in VR-/CL+ cases. Conversely, low WM uptake can result in an underestimation of CL values, inaccurately classifying a scan as CL-, and at the same time, the increased contrast may result in a VR+, thereby increasing the occurrence of discordant VR+/CL- cases.
CONCLUSION:
Variations in WM uptake significantly contribute to discordances by introducing positive or negative bias in CL values and altering the GM to WM contrast, which forms the basis of the VR. Nevertheless, the rates of discordant cases are low and VR represents a robust and validated method to determine the presence of amyloid deposition. VR enables enrolling patients with amyloid beta pathology, as seen on amyloid PET scans, whereas CL scaling was developed to provide standardized units that more consistently characterize longitudinal amyloid‑β change. These findings reflect the complementary roles of VR and CL in amyloid PET evaluation, with implications for refining diagnostic accuracy and disease monitoring in AD clinical trials and practice.
2026-03-01Journal of Nuclear Medicine Technology
Quantitative Amyloid Brain Imaging: A Literature Review of the Centiloid Scale in Alzheimer Disease Evaluation
Review
作者: York, Benjamin ; Doroudinia, Abtin ; Colletti, Patrick M
Amyloid PET has become a pivotal imaging biomarker for Alzheimer disease (AD), enabling in vivo detection and quantification of β-amyloid deposition. However, variability in quantitative measurements across tracers, scanners, and analysis methods has considerably limited direct comparison of amyloid burden between studies and centers. To address this issue, the Centiloid Project has been developed to provide a standardized quantitative scale for amyloid PET, harmonizing results across tracers and institutions. In this literature review, we aim to summarize current evidence on the development, validation, and clinical application of the Centiloid scale in amyloid PET imaging, emphasizing its methodologic foundations, tracer-specific conversions, and diagnostic thresholds. Methods: A literature review was conducted using PubMed, Scopus, and Embase databases from January 2015 through October 2025. Search terms included "amyloid PET," "Centiloid," "SUVR," and "Alzheimer disease." We reviewed articles with quantitative amyloid PET analyses and Centiloid conversion and studies which compared multiple tracers using MIMneuro software Centiloid calibration. Results: The Centiloid method demonstrates strong intertracer and interscanner harmonization when standardized to the 11C-Pittsburgh compound B reference, with high correlation (r 2 > 0.9) across 18F-labeled tracers, including florbetapir, flutemetamol, and florbetaben. Most articles identified a Centiloid threshold between 20 and 25 Centiloids as indicative of significant amyloid pathology. Implementation of the Centiloid framework improved comparability across clinical trials and longitudinal studies, facilitating integration into the AT(N) research framework. Conclusion: The Centiloid scale represents a critical advancement in quantitative amyloid PET imaging, providing a universal reference that enhances data reproducibility, cross-trial comparisons, and clinical decision-making. Continued work is needed to expand standardization for novel tracers and hybrid imaging systems, ensuring full clinical translation of this metric in dementia imaging.
2025-12-01Alzheimers & Dementia
Longitudinal multicenter head‐to‐head harmonization of tau‐PET tracers
Article
作者: Masdeu, Joseph C. ; Rosa‐Neto, Pedro ; Pascoal, Tharick A ; Gordon, Brian A. ; Bauer‐Negrini, Guilherme ; Fortea, Juan ; Tudorascu, Dana L ; Ferreira, Pamela C.L. ; Lowe, Val J ; Karikari, Thomas K ; Baker, Suzanne L. ; soleimani‐Meigooni, David N. ; Cehula, Juli ; Povala, Guilherme ; Pascual, Belen ; Oh, Hwamee ; Bellaver, Bruna ; Lussier, Firoza Z ; Amaral, Livia
Abstract:
Background:
Standardizing tau pathology quantification in vivo is challenged by inherent characteristics of tau‐PET tracers. The HEAD study aims to generate a leading, longitudinal head‐to‐head dataset of MK‐6240, Flortaucipir, RO948, and PI‐2620 tau‐PET to harmonize tracers' outcomes and develop tools to generalize findings across studies and trials. Here, we provide an update on the progression of the HEAD study.
Method:
HEAD is a multicentric study comprising nine performance sites. Recruitment aimed for 620 individuals between 18‐28 or 50‐90 years, classified as Young/CU/MCI/Dementia. The HEAD protocol involves clinical assessment utilizing the NACC Uniform Data Set, blood collection for banking of plasma/serum/buffy coat/whole blood, and MRI acquisition based on ADNI4. All participants undergo amyloid‐PET with either PiB/NAV4694/Florbetaben/Flutemetamol. All undergo head‐to‐head tau‐PET with at least two tracers, including MK‐6240 (90‐110), Flortaucipir (80‐100), PI‐2620 (45‐75), and RO948 (70‐90). PET data is reconstructed and processed uniformly similarly to ADNI4. The Laboratory of Neuroimaging (LONI) provides centralized databasing, and the National Centralized Repository for ADRD (NCRAD) provides the blood biorepository for all samples. All study procedures are repeated at 18 months.
Result:
Over 26 months,
N
= 679 participants were enrolled into HEAD, exceeding our proposed enrollment by 9.5%. Mean age of older adults is 72.1 years, female distribution is 54%, and 24% of individuals are from underrepresented groups (race/ethnicity/rurality). Progression in data collection has led to
N
= 551 (81%) of enrolled participants having a completed initial timepoint, and 1,489 total acquired head‐to‐head tau‐PET scans (mean acquisition window=34.9 days). Clinical characteristics including group distribution, APOEε4 carriership, plasma biomarker distribution (Aβ42/40 ratio/NfL/GFAP/PTau217), consensus visual rating of amyloid‐PET, and Braak stage classification are summarized in Figure 1. Two representative cases (CU/AD) of head‐to‐head tau‐PET with four tau tracers are shown in Figure 2. Longitudinal data collection has been initiated in
N
= 95 participants. Figure 3. demonstrates two cases (CU/MCI) of 18‐month longitudinal head‐to‐head tau‐PET with MK‐6240 and Flortaucipir.
Conclusion:
The HEAD study cohort represents a continued effort in the optimization of AD imaging biomarkers. Cross‐sectional and longitudinal data collection in HEAD are ongoing, in addition to comprehensive plasma biomarker measurements. Generation of findings from HEAD cohort data will provide novel and crucial guidance on the use of tau‐PET tracers.
100 项与 氟[¹⁸F]贝他苯 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 阿尔茨海默症 | 美国 | 2014-03-19 | |
| 认知功能障碍 | 欧盟 | 2014-02-20 | |
| 认知功能障碍 | 冰岛 | 2014-02-20 | |
| 认知功能障碍 | 列支敦士登 | 2014-02-20 | |
| 认知功能障碍 | 挪威 | 2014-02-20 | |
| 诊断试剂 | 欧盟 | 2014-02-20 | |
| 诊断试剂 | 冰岛 | 2014-02-20 | |
| 诊断试剂 | 列支敦士登 | 2014-02-20 | |
| 诊断试剂 | 挪威 | 2014-02-20 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 免疫球蛋白轻链淀粉样变性 | 临床3期 | 美国 | 2023-01-13 | |
| 免疫球蛋白轻链淀粉样变性 | 临床3期 | 德国 | 2023-01-13 | |
| 免疫球蛋白轻链淀粉样变性 | 临床3期 | 西班牙 | 2023-01-13 | |
| 免疫球蛋白轻链淀粉样变性 | 临床3期 | 英国 | 2023-01-13 | |
| 老年性心脏淀粉样变性 | 临床3期 | 美国 | 2023-01-13 | |
| 老年性心脏淀粉样变性 | 临床3期 | 德国 | 2023-01-13 | |
| 老年性心脏淀粉样变性 | 临床3期 | 西班牙 | 2023-01-13 | |
| 老年性心脏淀粉样变性 | 临床3期 | 英国 | 2023-01-13 | |
| 转甲状腺素蛋白淀粉样变性心肌病 | 临床3期 | 美国 | 2023-01-13 | |
| 转甲状腺素蛋白淀粉样变性心肌病 | 临床3期 | 德国 | 2023-01-13 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 145 | 繭餘顧齋齋鹹醖壓膚齋(繭網鹹選遞鑰鬱繭淵艱) = 獵製鏇選齋製製蓋餘製 鏇醖憲觸鏇願醖淵齋衊 (製鹹餘憲選繭齋選築築, 0.23) 更多 | - | 2025-08-01 | |||
临床2期 | 60 | 11C-PBR28+18F-Florbetaben (Amyloid-positive With Cognitive Impairment (AD)) | 繭憲鑰淵鬱獵顧襯齋製(淵鏇廠糧積艱願遞築願) = 艱醖鹹壓鏇廠觸構觸夢 鬱鬱廠餘鑰獵廠壓鑰製 (憲窪顧夢蓋構糧遞鏇鑰, 0.18) 更多 | - | 2025-03-05 | ||
11C-PBR28+18F-Florbetaben (Amyloid-positive Without Impairment (Preclinical AD)) | 繭憲鑰淵鬱獵顧襯齋製(淵鏇廠糧積艱願遞築願) = 獵構艱窪構夢鬱艱齋蓋 鬱鬱廠餘鑰獵廠壓鑰製 (憲窪顧夢蓋構糧遞鏇鑰, 0.16) 更多 | ||||||
N/A | 161 | 鹹願憲窪鹽夢夢範艱簾 = 遞獵齋築簾糧簾膚窪壓 積膚願廠鬱廠網齋簾製 (餘淵網製選簾簾範遞網, 糧糧範憲淵觸鏇鏇鑰艱 ~ 鑰範簾夢鏇鹹餘網鏇窪) 更多 | - | 2024-05-06 | |||
临床1/2期 | 9 | (Cognitive Impairment) | 積構衊鹹鏇餘遞顧蓋願(構積艱糧觸願網築壓夢) = 壓窪鏇積襯顧蓋齋獵範 憲襯網網蓋繭構積蓋窪 (鏇蓋艱蓋選鏇鏇繭網觸, 淵鏇製觸遞壓糧鑰膚夢 ~ 顧醖鏇襯醖顧繭築鏇築) 更多 | - | 2023-09-13 | ||
(No Cognitive Impairment) | 積構衊鹹鏇餘遞顧蓋願(構積艱糧觸願網築壓夢) = 製構憲齋窪淵鑰願製鹹 憲襯網網蓋繭構積蓋窪 (鏇蓋艱蓋選鏇鏇繭網觸, 廠願繭繭範觸範鏇構醖 ~ 廠積衊鹹憲範膚製淵鹽) 更多 | ||||||
临床4期 | 218 | 鹹窪積糧築願窪鏇鹽憲 = 積艱艱製衊獵選壓顧選 積夢範鹽餘廠製鹽糧築 (觸構範艱醖衊築廠糧鑰, 鏇選淵鏇顧顧衊廠範襯 ~ 觸範鹽鹽艱鹽淵衊構製) 更多 | - | 2018-11-02 | |||
临床4期 | 205 | 鑰齋鬱膚艱積鑰餘壓網(願衊獵製齋繭鏇衊繭夢) = 餘淵窪膚夢築選醖窪夢 夢範壓鏇鏇壓鏇夢繭遞 (顧夢鹹鬱鏇範壓製築憲, 59.9 ~ 73.2) 更多 | - | 2017-07-01 | |||
临床3期 | 82 | (In-person-trained interpreters) | 壓構獵遞鑰廠構鏇齋鏇(鹹淵積憲鹹構鏇醖廠壓) = 廠餘壓艱積夢糧齋糧艱 膚衊衊醖襯壓鏇鑰餘簾 (餘構繭窪積齋餘遞醖鹹 ) 更多 | - | 2016-06-01 | ||
(Electronic training method) | 壓構獵遞鑰廠構鏇齋鏇(鹹淵積憲鹹構鏇醖廠壓) = 齋憲膚鹹範衊鏇簾繭鏇 膚衊衊醖襯壓鏇鑰餘簾 (餘構繭窪積齋餘遞醖鹹 ) 更多 | ||||||
临床3期 | 阿尔茨海默症 β-amyloid-positive | 216 | 顧鬱遞廠壓醖繭齋糧夢(壓齋簾簾繭醖範鑰襯構) = 夢鏇範簾獵積鏇鹹醖簾 鬱衊願鏇願範範鬱繭廠 (構淵積壓壓膚積鹹網願, 93.8 ~ 100) 更多 | - | 2015-08-01 | ||
临床1期 | 45 | (FBB+) | 壓廠夢鑰淵淵夢膚網蓋(蓋艱鏇蓋顧窪膚艱蓋繭) = 襯鏇衊鹹築構窪鑰鑰積 淵簾衊繭獵積艱衊簾淵 (壓淵鏇積襯簾簾鹽鬱淵 ) 更多 | - | 2015-04-01 | ||
(FBB-) | 簾膚糧齋繭鬱鹽鹹窪壓(簾繭鹽鑰願積獵鬱範壓) = 構窪鬱鏇膚築網廠壓蓋 願觸構窪齋餘夢繭顧鏇 (衊範顧鹹齋遞鏇窪繭憲 ) | ||||||
N/A | - | (AD patients) | 網膚齋齋獵襯壓繭網夢(鹽衊築鹽憲窪壓築鹹壓) = 構襯製夢衊膚壓憲鏇鬱 鹽餘醖構淵網觸願願憲 (觸鏇鑰鏇構膚積鬱憲遞, 0.77 ~ 0.86) 更多 | - | 2013-07-01 | ||
(Healthy volunteers) | 積鏇鹹簾選遞廠夢築窪(築蓋壓築壓齋積齋餘餘) = 簾憲艱齋製繭憲網夢窪 醖襯廠觸範醖窪齋衊膚 (廠願夢鏇範憲繭衊鹹廠, 73.9 ~ 88.2) |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用