氟[¹⁸F]贝他苯(Florbetaben F-18) - 药物靶点：APP_在研适应症：阿尔茨海默症，认知功能障碍，诊断试剂_专利_临床

概要

基本信息

药物类型

小分子化药、诊断用放射药物

别名

Florbetaben [¹⁸F]、florbetaben (18F)、氟比他班 F18

+ [6]

靶点

APP

作用机制

APP抑制剂(β-淀粉状蛋白A4抑制剂)、PET imaging(正电子发射断层成像术增强剂)

治疗领域

神经系统疾病其他疾病肿瘤+ [4]

在研适应症

阿尔茨海默症认知功能障碍诊断试剂+ [3]

非在研适应症

脑淀粉样血管病唐氏综合征额颞痴呆+ [2]

原研机构

Piramal Pharma Limited

在研机构

北京先通国际医药科技股份有限公司Life Molecular Imaging Ltd.

Isologic Innovative Radiopharmaceuticals Ltd.初创企业

非在研机构-

最高研发阶段批准上市

首次获批日期

欧盟 (2014-02-20),

认知功能障碍诊断试剂

最高研发阶段(中国)批准上市

特殊审评孤儿药 (欧盟)

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结构/序列

分子式C21H26FNO3

InChIKeyNCWZOASIUQVOFA-FWZJPQCDSA-N

CAS号902143-01-5

关联

34

项与氟[¹⁸F]贝他苯相关的临床试验

NCT06141356

/ RecruitingN/AIIT

[18F]Florbetazine ([18F]92) for Beta Amyloid PET Imaging in Alzheimer's Disease

[18F]Florbetazine ([18F]92) is a molecularly targeted imaging agent for Aβ protein with a novel diaryl-azine scaffold. It has shown specific binding affinity to Aβ aggregates in postmortem human AD brains and excellent brain pharmacokinetic properties with little non-specific retention in white matter in animal studies and a limited number of patients with Alzheimer's Disease (AD).
The purpose of the current study is to examine the binding properties of [18F]Florbetazine in human subjects and to compare the cortical and white matter binding with [11C]PiB or [18F]Florbetapir in the same subjects.
Imaging of the brain will be completed in healthy adult normal control participants and participants with cognitive impairment (including probable AD and dementia due to other conditions) to characterize [18F]Florbetazine uptake in the brain and its binding properties. [11C]PIB or [18F]Florbetapir PET imaging along with MRI will be completed in the same participants and the data will be compared with 18F-[18F]Florbetazine.

开始日期2023-01-30

申办/合作机构

北京协和医院

NCT05184088

/ Recruiting临床3期

An Open-label, Multi-center, Non-randomized Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of [18F]Florbetaben Positron Emission Tomography (PET) Imaging to Diagnose Cardiac AL Amyloidosis

This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with suspected cardiac amyloidosis.

开始日期2023-01-13

申办/合作机构

Life Molecular Imaging Ltd.

[+1]

NCT05361382

/ Recruiting临床1期IIT

Longitudinal Multicenter Head-to-Head Harmonization of Tau PET Tracers

The purpose of this study is to compare/harmonize cross-sectional and longitudinal tau tangle measurements obtained with the tau PET radiopharmaceuticals Flortaucipir and MK-6240 to elucidate the advantages and caveats of their use in clinical trials/practice and provide parameters to integrate their estimates.

开始日期2021-11-23

申办/合作机构

University of Pittsburgh

[+1]

100 项与氟[¹⁸F]贝他苯相关的临床结果

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100 项与氟[¹⁸F]贝他苯相关的转化医学

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100 项与氟[¹⁸F]贝他苯相关的专利（医药）

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89

项与氟[¹⁸F]贝他苯相关的文献（医药）

2024-12-01·Alzheimer's & Dementia

The Association between measures of Sleepiness and Subjective Cognitive Decline symptoms in a diverse population of cognitively normal older Adults

Article

作者: Betensky, Rebecca A ; Briggs, Anthony Q ; Masurkar, Arjun V. ; Bernard, Mark A

AbstractBackgroundSubjective cognitive decline (SCD) is a preclinical stage of Alzheimer’s disease (AD), with correlations to cerebral amyloid and tau and accelerated cognitive decline. Studies have also revealed an association between sleep fragmentation and such AD biomarkers and cognitive decline, suggesting that cognitive function should be monitored in individuals experiencing excessive sleepiness. It is unclear if and how sleep dysfunction relates to SCD apart from AD biomarkers, as well as symptoms related to SCD and sleep dysfunction, such as depression. Furthermore, studies of SCD and sleep dysfunction have primarily focused on non‐Hispanic Whites. Hence, a better understanding of how sleep impacts preclinical AD risk in SCD is needed in more diverse cohorts. We investigated the cross‐sectional relationship between excessive sleepiness in cognitively normal older adults and SCD symptoms linked to cognitive domains in a cohort consisting of NHWs and Black/African Americans (B/AA).MethodThis retrospective cross‐sectional study included cognitively normal older participants (n = 147, age> 60 years, 61 B/AA, 86 NHW) evaluated at the NYU Alzheimer’s Disease Research Center. Participants underwent Uniform Data Set 3.0 psychometric testing to confirm normal cognition, Epworth Sleepiness Scale (ESS), Geriatric Depression Scale (GDS), and the Cognitive Change Index (CCI) as a measure of SCD. The CCI was further divided into subscores of non‐amnestic (i.e. executive) and amnestic domains (i.e. memory). Participants underwent amyloid (florbetaben) and tau (PI‐2620 or MK‐6240) PET MRI, with composite SUVR calculated by averaging key cortical regions. Multivariable linear regression models tested the association of ESS and covariates (GDS, amyloid SUVR, tau SUVR, race) to the three CCI outcome measures (total, non‐amnestic, amnestic).ResultESS (excessive sleepiness) was significantly positively associated with total CCI (p = 0.01042) as well as non‐amnestic (0.00771) and amnestic CCI subgroups (0.02583), after full covariate adjustment, as was GDS. Race did not show an independent statistically significant association.ConclusionThese results suggest that excessive sleepiness, independent of depression and amyloid and tau burdens, may be a significant contributor to SCD severity. Furthermore, these contributions impact both amnestic and non‐amnestic domains. Future studies are needed to investigate the longitudinal impact of excessive sleepiness on SCD outcomes.

2024-12-01·Alzheimer's & Dementia

Unusually young onset of spastic paraparesis in a carrier of both the A431E PSEN1 and A713T APP variants

Article

作者: Ringman, John M ; Islas, Miguel Angel Macias ; Villareal, Enrique Israel Velazquez ; Sheikh‐Bahaei, Nasim ; Craig, David

AbstractBackgroundThe ways in which diverse genetic variants interact to affect the phenotype of AD is poorly understood. The relatively consistent phenotype associated with specific mutations causing autosomal dominant AD (ADAD) provides the opportunity to study how other genetic variants contribute to disease manifestations.MethodWe performed an in‐depth case study of a patient with the A431E PSEN1 mutation who had onset of progressive spastic paraplegia at age 20.ResultThe proband was a Mexican woman known to be at 50% risk for inheriting the A431E PSEN1 mutation that commonly presents with cognitive changes and/or spastic paraplegia at age 40. At age 20 she began developing stiffness in her legs and difficulty walking. When seen at age 26 she had diffuse spasticity worse in the legs, slurred speech, and was cognitively intact. A flortaucipir PET scan at the time was negative as was a florbetaben scan 21 months later despite marked differences from controls in DTI measures in the corticospinal tract. Genetic screening demonstrated the presence of the A431E PSEN1 mutation and an A713T APP variant which was confirmed by WGS. The A713T APP variant was not present in her mother who had more typical disease nor in 62 other persons of Mexican origin.ConclusionThe A713T variant in APP has been shown to affect APP processing and Abeta nucleation and is considered to be a risk factor for AD. We hypothesize that the presence of this variant led to the early onset of spastic paraparesis in our proband despite Abeta deposition in brain being undetectable on PET. This finding suggests spastic paraplegia may be related to aberrant APP processing in a manner distinct from plaque formation.This study was funded by R01AG062007 and R01AG069013

2024-08-01·Alzheimer's & Dementia

Florbetaben amyloid PET acquisition time: Influence on Centiloids and interpretation

Article

作者: Younes, Kyan ; Mormino, Elizabeth C. ; Poston, Kathleen L. ; Zaharchuk, Greg ; Vossler, Hillary A. ; Carlson, Mackenzie L. ; Rathmann‐Bloch, Julia ; Henderson, Victor ; Harrison, Theresa M. ; Zeineh, Michael ; Wagner, Anthony ; Winer, Joseph R. ; Landau, Susan ; Sha, Sharon J. ; Young, Christina B. ; Davidzon, Guido A. ; Smith, Viktorija ; Johns, Emily ; Park, Jennifer

AbstractINTRODUCTIONAmyloid positron emission tomography (PET) acquisition timing impacts quantification.METHODSIn florbetaben (FBB) PET scans of 245 adults with and without cognitive impairment, we investigated the impact of post‐injection acquisition time on Centiloids (CLs) across five reference regions. CL equations for FBB were derived using standard methods, using FBB data collected between 90 and 110 min with paired Pittsburgh compound B data. Linear mixed models and t‐tests evaluated the impact of acquisition time on CL increases.RESULTSCL values increased significantly over the scan using the whole cerebellum, cerebellar gray matter, and brainstem as reference regions, particularly in amyloid‐positive individuals. In contrast, CLs based on white matter–containing reference regions decreased across the scan.DISCUSSIONThe quantification of CLs in FBB PET imaging is influenced by both the overall scan acquisition time and the choice of reference region. Standardized acquisition protocols or the application of acquisition time–specific CL equations should be implemented in clinical protocols.Highlights

Acquisition timing affects florbetaben positron emission tomography (PET) scan quantification, especially in amyloid‐positive participants.

The impact of acquisition timing on quantification varies across common reference regions.

Consistent acquisitions and/or appropriate post‐injection adjustments are needed to ensure comparability of PET data.

28

项与氟[¹⁸F]贝他苯相关的新闻（医药）

2025-01-13

·EndPoints

Lantheus to buy Life Molecular Imaging for $350M, netting Alzheimer's diagnostic

Radiopharmaceutical maker Lantheus Holdings plans to acquire Life Molecular Imaging for $350 million in a bid to build up its commercial Alzheimer’s diagnostics business. In addition to the $350 million upfront payment, the deal includes up to $400 million in potential earnout and milestone payments. Six months ago, Lantheus made a deal with Life Molecular Imaging to license a diagnostic and therapeutics pair of radiopharmaceuticals, both of which target a protein called gastrin-releasing peptide receptor that’s highly expressed in breast and prostate cancer. Lantheus’ top-selling drug is a radioactive agent used to diagnose prostate cancer called Pylarify. Lantheus is gaining five assets from the buyout, namely a commercial Alzheimer’s diagnostic agent called Neuraceq. It’s an area that Lantheus has been investing in, though previous acquisitions were for experimental agents. In July, Lantheus bought Meilleur Technologies and its experimental beta amyloid PET imaging agent called NAV-4694. In 2023, Lantheus bought Cerveau Technologies for its experimental tau-targeted PET imaging agent known as MK-6240. “This puts us squarely in the Alzheimer’s space a whole lot earlier — at least a year earlier — than we were planning with the launch of [MK-6240], and we’ve got a ready-[to]-go franchise,” CEO Brian Markison said.

并购诊断试剂

2025-01-08

·先通医药

氟[18F]贝他苯注射液正式落地国内医院！可提前15-20年诊断阿尔茨海默病！

点蓝色字关注“先通医药” 1月8日，先通医药明星产品氟[18F]贝他苯注射液（商标名：欧韦宁®），正式开始向京津冀鲁等地区医院供药，首都医科大学宣武医院成功完成国内第一例患者检查使用。随后，中日友好医院也顺利完成了临床使用。这是欧韦宁®获得NMPA批准后的首批商业化实践，标志着淀粉样蛋白（Aβ）PET显像剂实现了国内GMP标准化生产，迈向商业化新阶段。 ▲欧韦宁®产品图借助欧韦宁®，阿尔茨海默病（AD）患者在痴呆症状出现前的15-20年即可检测出Aβ阳性，实现早期、无创的精准诊断，从而抓住疾病干预的“黄金期”，实现早诊早治。 AD是一种起病隐匿、缓慢进展的神经退行性疾病，临床进展不可逆，表现为学习、记忆力等认知功能下降，伴有精神行为异常，并导致日常生活能力下降，包括临床前阶段、轻度认知障碍（MCI）和痴呆阶段[1]。据全国性研究显示，2019年中国 60 岁以上人群MCI约3 877万，痴呆患者约1 507万，其中AD患者约983万，占全球AD患者的四分之一，高发病率、死亡率，带来的社会经济负担日益明显[2]。然而，与此相对的是，目前我国公众对AD认知低，近50%AD患者被误认为自然衰老。由于既往医院可提供的检查方法、治疗手段有限，很多的AD患者未能得到及时确诊和治疗。[3] 随着Aβ-PET显像剂进入临床应用，以及AD治疗已经迈入靶向Aβ单抗精准治疗的新阶段，大量患者迫切需要通过Aβ-PET显像进行疾病确诊及后期疗效评估。精准治疗的前提是精准诊断。Aβ即脑内β-淀粉样蛋白，其在大脑中的异常沉积被认为是AD疾病病理发生的始发和核心事件。Aβ-PET全称为淀粉样蛋白正电子发射断层显像，是一种热门的脑显像技术，因其可以可视化显示Aβ在脑中的分布和量化沉积斑块的严重程度，在AD精准诊断中具有重要价值。 Aβ-PET检测用于AD诊断，获得《2024美国阿尔茨海默病学会（AA）诊断和分期标准修订版》、《2024 国际工作组（IWG）推荐：阿尔茨海默病临床-生物学架构》、《2018中国痴呆与认知障碍诊治指南》等权威指南一致推荐。 Aβ-PET显像剂氟[18F]贝他苯注射液已在欧美及亚洲多个国家和地区上市，10年间未有严重不良事件报告，其安全性和有效性获得了广泛的临床认可。2023年9月，氟[18F]贝他苯注射液（商标名：欧韦宁®）在中国获批，成为国内首个获批的Aβ-PET显像剂，也是中国近二十年来首个获批的PET显像剂，为实现国内AD的早期、精准、无创诊断，提供了有利“武器”。欧韦宁®现已实现商业供货，将大力推动我国Aβ-PET检测的普及。先通医药联席总裁唐艳旻表示：“欧韦宁®的临床应用标志着我国在AD早期诊断方面迈出重要一步，同时，对AD治疗新药研发精准入组，对Aβ单抗治疗的启动和疗效评估，带来更多的可及性。未来，先通医药将继续以患者为中心，依托脑神经、肿瘤、心脏等领域的放射性药物布局，不断推出高品质创新药物，造福更多患者。” ▌参考文献 [1] 中华医学会神经病学分会痴呆与认知障碍学组,中华医学会核医学分会. 淀粉样蛋白PET显像在阿尔茨海默病诊断中的应用专家共识[J]. 中华医学杂志, 2023,103(45):3615-3626. . [2]王刚,齐金蕾,刘馨雅,等. 中国阿尔茨海默病报告2024[J]. 诊断学理论与实践,2024,23(3):219-256. [3] Jia L, Du Y, Chu L, et al. Prevalence, risk factors, and management of dementia and mild cognitive impairment in adults aged 60 years or older in China: a cross-sectional study. Lancet Public Health. 2020 Dec;5(12):e661-e671. *滑动查看 END 关于先通医药先通医药是中国创新放射性药物领域的领先企业，专注于放射性药物的研发创新及落地应用以改善患者的健康水平。先通医药于2014年正式开展新一代放射性药物的研发，总部位于北京，在上海设有研发中心，在江苏、广东、四川建设有现代化放射性药物智能生产基地；同时，在美国设有分支机构，并与十几家跨国药企达成战略合作。全球放射性药物主要应用于神经、心血管、肿瘤三大疾病领域，先通医药已实现全面布局，并拥有20+精准诊断和靶向治疗放射性药物研发管线。凭借自身的研发优势，先通医药获得了投资机构的青睐，2020年4月至今，已成功募资超20亿元人民币，未来不久将登陆主要资本市场，成为中国放射性药物领域的创新力量。

上市批准临床结果优先审批临床研究申请上市

2025-01-06

·PRNewswire

Life Molecular Imaging and SOFIE announce Neuraceq® availability in Somerset, NJ

Improved supply capabilities of Neuraceq® to provide better patient access to amyloid PET BOSTON, Jan. 6, 2025 /PRNewswire/ -- Life Molecular Imaging (LMI), an international pharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging, and SOFIE Biosciences (SOFIE), a national US manufacturer and developer of PET radiopharmaceuticals, announce that the companies have expanded their strategic partnership and licensing agreement to provide and distribute Neuraceq® out of SOFIE's radiopharmaceutical manufacturing site located in Somerset, NJ. This agreement results in increased availability of Neuraceq® for imaging centers, physicians, and patients with cognitive impairment in eastern Pennsylvania, New Jersey, and New York. The first doses have been made available on January 3rd, 2025. Neuraceq® is an FDA-approved radioactive diagnostic agent for the detection of amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. Neuraceq® is used in clinical routine and is also a powerful diagnostic tool for the appropriate characterization of patients assessed for treatment eligibility with newly approved anti-amyloid drugs, or for enrollment in clinical trials to further support drug development in neurodegenerative diseases. "LMI is devoted to expanding access to Neuraceq® for patients and physicians seeking confirmation of amyloid plaque in the brain, particularly for patients who are being evaluated for AD and may qualify for newly approved therapeutics. By increasing Neuraceq® manufacturing capabilities in Somerset, NJ, in partnership with SOFIE, we are strengthening our efforts to meet the growing demand for amyloid PET imaging. This initiative underscores our devotion to enhancing patient access and supporting the medical and patient communities in this important area of healthcare," said Colleen Ruby, US Country Head, and Chief Operating Officer, Americas and APAC. "SOFIE is proud to support the AD community through the manufacture and dispensing of Neuraceq®. With the continued growth in amyloid targeting therapies, the diagnosis and staging using PET is more important than ever. We are excited to partner with LMI to continue rapidly increasing access to this important diagnostic tool," said Brian Schumer, PharmD, SOFIE Chief Operating Officer. About Neuraceq® (florbetaben 18F) Indication Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. A negative Neuraceq® scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Neuraceq® scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD and may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq® is an adjunct to other diagnostic evaluations. Limitations of Use A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder. Safety and effectiveness of Neuraceq® have not been established for: Predicting development of dementia or other neurologic conditions Monitoring responses to therapies. Important Safety Information Risk for Image Interpretation and Other Errors Errors may occur in the Neuraceq® estimation of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of Neuraceq® images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq® scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq® scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future. Radiation Risk Neuraceq®, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure. Adverse Reactions The overall safety profile of Neuraceq® is based on data from 1,090 administrations of Neuraceq® to 872 subjects. No serious adverse reactions related to Neuraceq® administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq® were injection site reactions consisting of erythema (1.7%), irritation (1.1%) and pain (3.4%). For more information please visit: About Life Molecular Imaging (LMI) Life Molecular Imaging (LMI) is an international radiopharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit . About Life Healthcare Group Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years' experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: | For media queries Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging Tel: +1.484.735.2840 | [email protected] SOURCE Life Molecular Imaging WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引进/卖出

100 项与氟[¹⁸F]贝他苯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	氟[¹⁸F]贝他苯	V09AX06	DB09148

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
认知功能障碍	挪威	Life Molecular Imaging Ltd.	2014-02-20
认知功能障碍	欧盟	Life Molecular Imaging Ltd.	2014-02-20
认知功能障碍	列支敦士登	Life Molecular Imaging Ltd.	2014-02-20
认知功能障碍	冰岛	Life Molecular Imaging Ltd.	2014-02-20
诊断试剂	冰岛	Life Molecular Imaging Ltd.	2014-02-20
诊断试剂	列支敦士登	Life Molecular Imaging Ltd.	2014-02-20
诊断试剂	欧盟	Life Molecular Imaging Ltd.	2014-02-20
诊断试剂	挪威	Life Molecular Imaging Ltd.	2014-02-20
阿尔茨海默症	加拿大	Isologic Innovative Radiopharmaceuticals Ltd.初创企业	-

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
阿尔茨海默症	申请上市	澳大利亚	Life Molecular Imaging Ltd.	2009-11-01
阿尔茨海默症	申请上市	法国	Life Molecular Imaging Ltd.	2009-11-01
阿尔茨海默症	申请上市	德国	Life Molecular Imaging Ltd.	2009-11-01
免疫球蛋白轻链淀粉样变性	临床3期	西班牙	Life Molecular Imaging Ltd.	2023-01-13
阿尔茨海默症	临床1期	日本	Life Molecular Imaging Ltd.	2009-11-01
脑淀粉样血管病	临床1期	美国	Life Molecular Imaging Ltd.	2009-11-01
脑淀粉样血管病	临床1期	德国	Life Molecular Imaging Ltd.	2009-11-01
脑淀粉样血管病	临床1期	法国	Life Molecular Imaging Ltd.	2009-11-01
脑淀粉样血管病	临床1期	日本	Life Molecular Imaging Ltd.	2009-11-01
脑淀粉样血管病	临床1期	澳大利亚	Life Molecular Imaging Ltd.	2009-11-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01222351 (CTgov)	N/A	阿尔茨海默症 \| 认知功能障碍	161	BAY 94-9172 (Florbetaben)	鑰壓齋遞簾築夢積憲夢(蓋築齋鏇製鹽簾構獵構) = 鏇餘願範膚淵繭鏇膚選遞膚衊鑰壓糧蓋憲繭選 (淵顧醖襯醖獵淵壓糧鏇, 選艱積簾襯艱製鹹憲膚 ~ 選觸憲憲鏇構築鹹顧餘) 更多	-	2024-05-06
NCT03744312 (CTgov)	临床1/2期	阿尔茨海默症 \| 炎症	9	Florbetaben+11C-ER176 (Cognitive Impairment)	醖蓋選範範糧餘積獵壓(製鹹膚壓構獵鬱獵糧鹹) = 鏇廠蓋糧選範網廠願餘齋淵顧簾獵範襯蓋蓋窪 (鹽鬱顧構醖繭衊築鑰獵, 鹹艱鑰顧網製顧繭築範 ~ 顧築廠鏇艱襯糧鑰網選) 更多	-	2023-09-13
				Florbetaben+11C-ER176 (No Cognitive Impairment)	醖蓋選範範糧餘積獵壓(製鹹膚壓構獵鬱獵糧鹹) = 積膚齋鏇醖鑰構選製醖齋淵顧簾獵範襯蓋蓋窪 (鹽鬱顧構醖繭衊築鑰獵, 鬱繭夢築窪廠鏇積鏇鏇 ~ 糧襯鹹鏇顧簾廠構廠襯) 更多
AMYPAD Diagnostic and Patient Management Study (EANM2022)	N/A	记忆障碍 amyloid burden	729	18f-florbetaben (FBB)	憲獵壓艱窪窪窪窪製齋(憲襯廠壓範觸鹹願獵鑰) = 鑰鑰衊壓選憲艱簾鹹構齋鏇淵襯鬱醖餘鹽糧窪 (構積築窪範膚鹹繭遞艱, 17.87) 更多	-	2022-09-22
				18f-flutemetamol (FTM)	憲獵壓艱窪窪窪窪製齋(憲襯廠壓範觸鹹願獵鑰) = 鹽築鹹襯齋遞鹹淵顧齋齋鏇淵襯鬱醖餘鹽糧窪 (構積築窪範膚鹹繭遞艱, 17.87) 更多
EANM2021	N/A	淀粉样蛋白斑 \| 牙周炎	-	18 F-Florbetaben (Absence of periodontal disease or mild periodontitis)	觸網網鏇簾願膚糧鬱選(築憲顧襯壓襯範積製餘) = 鏇衊艱廠遞憲遞襯觸艱鹽顧製觸簾鏇艱壓積鬱 (鬱餘構壓製獵觸鹹願夢 )	-	2021-09-24
SNMMI2020	N/A	淀粉样蛋白斑	-	18 F-Florbetaben (Young Healthy Controls (YHC))	網觸膚獵積簾鹹艱衊鹽(製壓襯糧衊衊艱廠觸憲) = 築鏇鬱顧願鏇糧構鑰衊遞鬱淵繭鑰夢製艱蓋簾 (願鬱醖觸襯窪繭鹽鹽鬱, 0.03)	-	2020-05-15
				18 F-Florbetaben (Subjective Cognitive Decline (SCD))	糧糧蓋壓膚範獵齋窪蓋(選簾餘糧糧淵築願鹹築) = 範醖鹽築餘襯齋顧衊願糧觸窪鏇願範築艱齋齋 (餘選憲齋衊積廠鹽夢簾, 2.1) 更多
EANM2019	N/A	-	6	[18F]Florbetaben (Standard PET images)	網壓壓顧觸淵鬱構簾獵(築壓遞網鹽壓鏇齋遞夢) = 願壓鹽蓋醖鹹願淵蓋繭襯獵夢獵鹽廠糧繭鏇襯 (襯網齋積壓鬱鬱淵遞窪 ) 更多	-	2019-09-18
				[18F]Florbetaben (PET images with superimposed WM/GM boundaries)	(憲顧簾繭糧艱餘鏇願構) = 構顧積齋願鬱顧夢艱齋獵膚積淵積繭簾膚蓋蓋 (築窪網蓋齋築築窪醖夢 ) 更多
EANM2019	N/A	过氧物酶体病 gene defect \| very long chain fatty acids (VLVFA)	4	[18F]Florbetaben (X-linked adulthood cerebral adrenoleukodystrophy (X-ACALD) patients)	獵願壓艱衊鬱齋遞壓觸(醖鑰廠艱齋鏇齋遞蓋鑰) = 9.8 ± 2.6 鬱顧醖艱醖繭蓋襯顧夢 (廠鹽壓顧夢鏇網鬱觸窪 ) 更多	-	2019-09-18
				[18F]Florbetaben (Healthy control group)
EANM2018	N/A	-	44	18F-Florbetaben (Amyloid-PET)	遞築鹹淵鬱鬱糧鹹遞觸(憲築顧廠簾襯衊範鹽壓) = 齋構餘艱觸窪齋獵遞鬱鏇膚齋遞構鏇襯糧鹽糧 (鑰衊範簾鹽夢簾窪淵構 )	积极	2018-09-18
AAIC2018	N/A	轻度痴呆 \| 轻度认知障碍 ApolipoproteinE (APOE) genotype	152	[F-18] FLORBETABEN (Cognitively Normal)	網壓艱遞積簾鬱廠網餘(糧夢顧獵醖鬱廠鹽顧構) = 壓壓廠膚壓壓窪鏇衊壓鹽網簾衊襯鏇醖顧夢鹹 (襯鹹壓憲繭顧壓鑰遞襯 )	-	2018-07-01
				[F-18] FLORBETABEN (Mild Cognitive Impairment)	網壓艱遞積簾鬱廠網餘(糧夢顧獵醖鬱廠鹽顧構) = 膚糧鬱廠襯淵壓衊遞網鹽網簾衊襯鏇醖顧夢鹹 (襯鹹壓憲繭顧壓鑰遞襯 )
EANM2017	N/A	amyloid-positive \| amyloid-negative	107	18F-FlorbetabenFDG-Florbetaben (FDG-PET)	顧鬱壓願鹹齋範鏇築鏇(壓襯鏇鹹淵鑰蓋膚衊築) = 鏇鹹窪鹹選夢鹽膚餘積鬱糧鹽顧鏇鏇壓憲觸製 (積獵蓋鬱窪鹽憲齋膚網 )	积极	2017-09-11
				18F-Florbetaben (FBB-PET)	顧鬱壓願鹹齋範鏇築鏇(壓襯鏇鹹淵鑰蓋膚衊築) = 積遞艱憲艱淵夢壓醖顧鬱糧鹽顧鏇鏇壓憲觸製 (積獵蓋鬱窪鹽憲齋膚網 )