Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD.

开始日期2023-06-09

申办/合作机构

University of Southern California

[+2]

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

EUCTR2022-002585-33-IT

/ Not yet recruiting临床3期IIT

A multi-center phase 3 study of 18F-florbetaben positron emission tomography/computed tomography (PET-CT) - PETAL

开始日期2023-01-19

申办/合作机构

Fondazione Toscana Gabriele Monasterio

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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216

项与氟[¹⁸F]贝他苯相关的文献（医药）

2025-03-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Progress in the study of anti-Alzheimer's disease activity of pyrimidine-containing bioactive molecules

Review

作者: Zhang, Di ; Zhang, Qi ; Zhang, Lin-Lin ; Liu, Yu-Lin ; Chui, Rui-Hao ; Zhang, Qian ; Ma, Li-Ying ; Li, Bing-Qian

Pyrimidines are aromatic, heterocyclic organic compounds characterized by a six-membered ring that contains four carbon atoms and two nitrogen atoms. They have been reported to exhibit a variety of biological activities such as antifungal, antiviral, and anti-Parkinsonian effects. Recently, there has been an increased focus on their potential anti-Alzheimer's properties. Several pyrimidine-based drugs and their analogs are currently undergoing various phases of clinical trials, indicating pyrimidine as a promising chemical structure for drug development. Notably, modifications to the pyrimidine structure significantly influence their activity against Alzheimer's disease. For instance, the introduction of heteroatoms into the pyrimidine ring or alternations in the length of the linkage region have been shown to enhance therapeutic efficacy. This review provides a comprehensive overview of pyrimidine derivatives as potential therapeutics for Alzheimer's disease, with a focus on structure-activity relationship (SAR) studies, design strategies, and binding mechanisms. These insights could pave the way for the development of more effective anti-Alzheimer's medications.

2024-12-01·Alzheimers & Dementia

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

Article

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

Abstract:

Background:

The 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.

Method:

We performed an in‐depth case study of a patient with the A431E PSEN1 mutation who had onset of progressive spastic paraplegia at age 20.

Result:

The 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.

Conclusion:

The 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

2024-12-01·Alzheimers & Dementia

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

Article

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

Abstract:

Background:

Subjective 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).

Method:

This 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).

Result:

ESS (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.

Conclusion:

These 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.

项与氟[¹⁸F]贝他苯相关的新闻（医药）

2025-03-24

·医药健闻

跨国药企在中国 | 阿斯利康、礼来、诺华、美敦力、武田制药、飞利浦、贝克曼库尔特、辉瑞、杰特贝林、勃林格殷格翰、罗氏等新动态

跨国药企在中国重点资讯文 | 苏丁企业动态阿斯利康阿斯利康(AstraZeneca)3月21日宣布25亿美元投资计划，在北京建立第六个全球战略研发中心，并达成多项重大研发与生产合作，以进一步推动中国生命科学事业发展。这项未来五年的投资计划是阿斯利康与北京市人民政府和北京经济技术开发区管理委员会战略合作伙伴关系的一部分，它同时还包括了公司与和铂医药、元思生肽、康泰生物三家生物科技企业达成的合作协议，以及近期宣布的珐博进中国收购协议。通过这一系列部署，阿斯利康预计在北京的员工人数将增至1700人。礼来礼来中国宣布其首个创新加速平台——礼来北京创新孵化器投入运营，是礼来在全球设立的第四家同类机构。礼来创新孵化器致力于助力早期生物科技企业成长，孵化器内配备了一流的即用型实验室、共享会议室以及便捷的工作站点等办公设施。孵化器预计能够容纳5家至8家生物科技企业及其团队入驻，为其提供成长所需的物理空间与配套设施。诺华 3月23日至24日，中国发展高层论坛2025年年会在京举行。诺华首席执行官万思瀚(Vasant Narasimhan)受邀参会，围绕医药领域前沿创新及协作等议题展开研讨，这也是万思瀚第七次参加这一盛会。同期，他还出席了第六届国际医药创新大会。诺华围绕“大健康产业高质量发展”议题，分享了“创新与协作”两大核心理念的实践路径，并介绍了在放射配体疗法这一前沿领域取得的突破性进展。美敦力中国发展高层论坛2025年年会在北京举行，美敦力董事长兼首席执行官杰夫·马萨在年会期间表示，美敦力坚信中国将成为全球最大的医疗市场和重要的创新策源地，也将成为医疗创新、投资与合作的战略枢纽。他表示，美敦力是首批进入中国的跨国医疗科技企业之一。目前，美敦力在中国拥有约6000名员工、12个区域办公室，构建了研发、生产、销售、培训、售后和投资基金的全价值链布局，包括1个研发中心、2个创新中心和5大生产基地。武田制药武田制药董事长、总裁、首席执行官卫博科在中国发展高层论坛2025年年会表示，中国已经成为了全球第二大医药市场。伴随着经济发展和人口增长，潜在的医疗健康需求也在持续增加。卫博科说，“近期，我们与成都市政府达成战略合作协议，建立武田中国创新中心（TCIC）。这一数字化创新中心将拓展我们的数字创新战略蓝图，赋能武田更好地为患者提供高质量的服务。” 飞利浦《河南商报》报道，飞利浦（中国）投资有限公司河南分公司注册成立并已取得营业执照，郑州航空港生物医药大健康产业再添强劲动力引擎。飞利浦是世界知名的健康科技公司，在诊断影像、图像引导治疗、病人监护等多个领域处于全球领先地位。贝克曼库尔特3月21日-24日，第二十二届中国国际检验医学暨输血仪器试剂博览会（CACLP）在杭州举行。丹纳赫携旗下包括贝克曼库尔特在内的10余家运营公司再次以集团形式亮相，展台总面积达396平米。贝克曼库尔特推出全新DxAI智医报告解读工具。该工具深度融合DeepSeek、Kimi和豆包等先进的大语言模型（LLM），以智能化的数据分析和解读能力，为临床检验决策提供强有力的支持，助力精准诊疗。DxAI的应用不仅提升了检验结果的可解释性和决策效率，更推动了医疗AI向更高效、更精准的方向发展，为智慧医疗开辟了全新可能。贝克曼库尔特“肿瘤标志物实验室检测高质量发展”专题论坛也在同期举办，与专家学者、行业同仁共同探讨新医疗模式下肿瘤标志物的挑战与机遇。辉瑞辉瑞中国宣布了一项重要的领导层与组织架构调整。现任肿瘤事业部总经理王玉女士决定寻求新的职业发展机会，李进晖女士将接任肿瘤及罕见病事业部总经理一职。此外，辉瑞中国对组织架构进行了优化，决定将零售业务团队和全国招标团队与原商务团队合并，成立商务与零售部。曹智被任命为新成立的商务与零售部负责人，直接向辉瑞中国区总裁汇报。杰特贝林杰特贝林亚太区副总裁兼总经理Jean-Marc Morange向员工宣布，来自辉瑞的王玉被任命为杰特贝林中国大陆和香港地区总经理，自4月2日起履新。基于Veeva China CRM Suite打造的C360 Elite数字化运营平台已在杰特贝林中国（CSL Behring）成功上线，将助力杰特贝林实现客户管理、学术推广及运营策略的全链路数字化升级。此次上线的C360 Elite平台基于Veeva China CRM Suite构建，在满足中国市场合规要求的同时，通过智能化数据洞察与合规化流程设计，赋能一线团队精准触达医疗专业人士（HCP）的学术需求，优化患者服务生态。科赴中国健康促进与教育协会自我健康管理分会3月14日正式在京成立。科赴中国率先就推进“自我健康管理”与协会签署战略合作备忘录，就积极支持协会开展科普传播、探索建立协作机制、促进能力提升、加强相关研究等相关工作与协会达成共识，并将共同致力于推动公众健康素养水平和“自我健康管理”能力的提升。上海德达医院 3月14日，上海德达医院正式获得由上海市卫生健康委员会颁发的医疗机构执业许可证，成为全国首家外商独资心血管专科医院。上海德达医院于2016年9月在青浦区徐泾镇开业，并于2018年入选上海首批高水平社会办医机构。2024年4月，太古股份有限公司(集团)宣布，已完成增持德达医疗股份的交易。太古集团最初于2021年对德达医疗进行联属投资，并于2024年3月签署最终协议以增持其股份。产业动态辽宁省肿瘤医院暨大连理工大学附属肿瘤医院与罗氏正式签署合作协议，将共同致力于肺癌全程管理数字化解决方案的建设。此次合作旨在应对肺癌这一全球癌症难题，聚焦肺癌围手术期精准治疗，通过智能化数字平台打通诊疗全流程，助力提升患者诊疗体验、生存质量和康复效果，造福更多中国患者。勃林格殷格翰与广州金苗动保科技有限公司达成战略合作，将利用金苗动保的多联多价载体疫苗技术为动物防护多种疾病。勃林格殷格翰将依托自身全球研发网络，与金苗动保紧密协作，优化疫苗种子构建环节，缩短研发周期，推动创新疫苗研发进程。通过公司在动物保健领域的首个“在中国，为全球”研发合作，勃林格殷格翰致力于加速动物疫苗研发进程。在第七届动物医院院长大会上，勃林格殷格翰正式宣布，其进口原研宠物治疗药物圣咪乐（猫用替米沙坦内服溶液）上市，进一步推动猫慢性肾病（CKD）诊疗发展。作为全球首个宠物用血管紧张素受体阻断剂（ARB），圣咪乐用于治疗猫CKD引起的蛋白尿，自2013年全球首次上市以来已帮助无数CKD患猫改善生活质量。CKD是老年猫最常见的慢性疾病之一，发病率高达30%，15岁以上的猫咪患病比例更是接近80%。 Life Molecular Imaging（LMI）和St. Teresa's Hospital宣布，Florbetaben（18F）注入液（Neuraceq）将于2025年3月从St. Teresa's Hospital在中国香港上市。Neuraceq有望在早期和准确诊断阿尔茨海默病(AD)方面发挥重要作用，并提高香港对AD的认识。联系美通社 +86-10-5953 9500 info@prnasia.com

并购放射疗法抗体药物偶联物

2025-03-14

·美通社

Florbetaben (18F)注射液（ Neuraceq ® ）将于2025年3月在香港圣特蕾莎医院推出

改善本地区阿尔茨海默病诊断和患者护理的创新影像学解决方案波士顿 2025年3月14日 /美通社/ -- Life Molecular Imaging （ LMI ）和St. Teresa's Hospital欣然宣布，Florbetaben（ 18F ）注入液（品牌名称： Neuraceq ® ）将于2025年3月从St. Teresa's Hospital在香港上市。 Neuraceq ® 有望在早期和准确诊断阿尔茨海默病(AD)方面发挥重要作用，并提高香港对AD的认识。这标志着LMI扩大全球使用Neuraceq ® 的使命的重要一步，确保全球更多的患者和医疗保健提供者拥有早期和准确诊断AD所需的工具。 Neuraceq ® 是一种FDA批准的放射性诊断剂，用于检测正在接受AD和其他认知能力下降原因评估的成人认知功能障碍患者大脑中的淀粉样蛋白斑块。 Neuraceq ® 用于临床常规，也是一种强大的诊断工具，用于对新批准的抗淀粉样蛋白药物治疗资格进行评估的患者进行适当表征，或用于入组临床试验，以进一步支持神经退行性疾病的药物开发。 Neuraceq ® 将促进AD患者的治疗，包括那些对最近在圣特蕾莎医院推出的新型疾病修饰单克隆抗体治疗感兴趣的患者。随着Neuraceq ® 的可用性，圣特蕾莎医院现在为AD患者提供从最先进的诊断到靶向抗淀粉样蛋白治疗的全面护理。 “LMI仍致力于扩大对Neuraceq ® 的全球访问。 LMI董事总经理Ludger Dinkelborg博士表示： “我们很高兴与香港圣特蕾莎医院合作，加强对接受轻度认知障碍(MCI)和阿尔茨海默病评估的患者的诊断，同时确保Neuraceq ® 仍然易于为该地区的医生所用。” 关于 Neuraceq （氟贝他苯18F ） -美国包装说明书适应症 Neuraceq ® 是一种放射性诊断剂，适用于大脑的正电子发射断层扫描（ PET ）成像，以估计正在评估阿尔茨海默病（ AD ）和其他认知能力下降原因的成年认知障碍患者的β-淀粉样蛋白神经炎斑块密度。阴性Neuraceq扫描显示稀疏或无神经性斑块，与图像采集时对AD的神经病理学诊断不一致；阴性扫描结果可降低患者认知障碍归因于AD的可能性。阳性Neuraceq扫描显示中度至频繁的淀粉样神经炎斑块；神经病理学检查显示， AD患者中存在这种数量的淀粉样神经炎斑块，但也可能存在于其他类型神经系统疾病的患者以及认知正常的老年人中。 Neuraceq是其他诊断评估的辅助工具。使用限制 Neuraceq ® 扫描阳性并不能确诊AD或任何其他认知障碍。 Neuraceq对以下患者的安全性和有效性尚不确定：预测痴呆症或其他神经系统疾病的发展监测对治疗的反应。重要安全信息影像解读和其他错误的风险在影像解读期间，脑神经炎β-淀粉样斑块密度的Neuraceq估计中可能发生错误。应独立于患者的临床信息进行图像判读。在Neuraceq影像解读中使用临床信息尚未得到评估，可能导致错误。在严重脑萎缩的情况下也可能发生错误，这限制了在Neuraceq扫描中区分灰质和白质的能力。由于导致图像失真的运动伪影，也可能发生错误。 Neuraceq扫描结果仅表明图像采集时存在脑神经炎β-淀粉样斑块，阴性扫描结果不排除未来脑神经炎β-淀粉样斑块的发展。辐射风险 Neuraceq与其他放射性药物类似，有助于患者的整体长期累积辐射暴露。长期累积辐射暴露与癌症风险增加有关。确保安全处理，以保护患者和医护人员免受意外辐射暴露。常见不良反应 Neuraceq的整体安全性基于1,090例Neuraceq给药至872例受试者的数据。未报告与Neuraceq给药相关的严重不良反应。在接受Neuraceq治疗的受试者中最常见的药物不良反应为注射部位反应，包括红斑(1.7%)、刺激(1.1%)和疼痛(3.4%)。欲了解更多信息，请访问： neuraceq.com 关于生命分子成像(LMI) 生命分子成像(LMI)是一家国际制药公司，致力于开发和提供用于神经退行性和心血管疾病成像的新型尖端PET放射性药物。该组织致力于成为分子成像领域的领导者。我们的使命是开拓创新的宠物产品，改善慢性和危及生命的疾病的早期检测和表征，领先的更好的治疗结果和改善生活质量。通过推进用于分子成像的新型PET放射性药物， LMI专注于现代医学的一个关键领域。 LMI是Life Healthcare Group的附属公司， Life Healthcare Group是一家以人为本、多元化的国际医疗保健组织，在南非私营医疗保健行业拥有四十年的体验。如需了解更多信息，请访问 https://life-mi.com 。关于Life Healthcare Group Life Healthcare是一家在约翰内斯堡证券交易所上市的全球性以人为本的多元化医疗保健组织。 Life Healthcare在南非私营医疗保健行业拥有40多年的体验，目前在南部非洲运营着64家医疗保健机构。服务包括急性医院护理、急性身体康复、急性精神保健、肾透析、肿瘤学、诊断和分子成像以及健康风险管理服务，其中包括职业健康和健康服务。集团还拥有Life Molecular Imaging ，这是一家放射性制药公司，致力于开发创新的分子成像剂并将其全球商业化，用于PET-CT诊断，以检测特定疾病。请访问： https://www.lifehealthcare.co.za/ | https://life-mi.com/ 关于圣特蕾莎医院圣 Teresa's Hospital （ STH ）由St. Paul de Chartres修女会于1940年成立，是一家天主教机构，致力于通过信仰、希望和爱的基督教精神，为病人和有需要的人提供合格和优质的医疗保健服务。凭借超过85年的持续发展和坚定不移的奉献精神， STH已发展成为香港最受尊敬和最成熟的私立医院之一。该医院目前提供约1,000张床位，配备50多名驻院医务人员，提供广泛的普通和专科门诊和住院护理服务。 STH配备了最先进的医疗设施，旨在满足最高的医疗标准。该医院的一个显著特点是回旋加速器制药中心，该中心支持其扫描部门提供先进的PET扫描服务，以实现准确的影像诊断。这种能力提高了诊断精度，并确保了患者的全面护理。为了满足社区不断变化的需求， STH始终坚定不移地致力于不断改进和提供高质量的医疗服务。这些承诺指导医院不仅提供先进的医疗服务，还提供富有同情心的整体医疗保健方法。如需了解更多信息，请访问 https://www.sth.org.hk | https://www.sthscan.com/hk/ 媒体垂询 Brittany Hahn |营销传播经理| Life Molecular Imaging 电话： +1.484.735.2840 | b.hahn@life-mi.com

诊断试剂上市批准放射疗法

2025-03-14

·PRNewswire

Florbetaben (18F) Injection (Neuraceq®) Set to Launch at St. Teresa's Hospital in Hong Kong in March 2025

Innovative Imaging Solution to Enhance Alzheimer's Disease Diagnosis and Patient Care in the Region BOSTON, March 14, 2025 /PRNewswire/ -- Life Molecular Imaging (LMI) and St. Teresa's Hospital are pleased to announce that Florbetaben (18F) Injection (brand name: Neuraceq®) will be available in Hong Kong from St. Teresa's Hospital by March 2025. Continue Reading Neuraceq® is expected to play a significant role in the early and accurate diagnosis of Alzheimer's disease (AD) and bring greater awareness of AD in Hong Kong. This marks an important step in LMI's mission to expand global access to Neuraceq®, ensuring that more patients and healthcare providers worldwide have the tools needed for early and accurate diagnosis of AD. Florbetaben (18F) Injection (brand name: Neuraceq®) will be available in Hong Kong from St. Teresa's Hospital in March. Post this 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 AD 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. Neuraceq® will facilitate the management of patients suffering from AD, including those interested in novel disease-modifying monoclonal antibody treatments recently introduced at St. Teresa's Hospital. With the availability of Neuraceq®, St. Teresa's Hospital now provides comprehensive care for AD patients from state-of-the-art diagnosis to targeted anti-amyloid therapy. "LMI remains dedicated to expanding global access to Neuraceq®. We are pleased to partner with St. Teresa's Hospital in Hong Kong to enhance the diagnosis of patients undergoing evaluation for mild cognitive impairment (MCI) and Alzheimer's disease, while ensuring Neuraceq® remains easily accessible to physicians in the region," said Ludger Dinkelborg, Ph.D., Managing Director at LMI. About Neuraceq (florbetaben 18F) - US Package Insert 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 but 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. Common 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: neuraceq.com About Life Molecular Imaging (LMI) Life Molecular Imaging (LMI) is an international pharma 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-centred, diversified healthcare organisation 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 commercialising innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: | About St. Teresa's Hospital St. Teresa's Hospital (STH), established in 1940 by the Congregation of the Sisters of St. Paul de Chartres, is a Catholic institution dedicated to providing competent and quality healthcare services to the sick and needy through the Christian spirit of Faith, Hope, and Love. With over 85 years of continuous development and unwavering dedication, STH has grown into one of Hong Kong's most respected and well-established private hospitals. The hospital currently offers approximately 1,000 beds, staffed by over 50 resident medical officers, offering extensive general and specialist outpatient and inpatient care services. STH is equipped with state-of-the-art healthcare facilities designed to meet the highest medical standards. A notable feature of the hospital is the Cyclotron Pharmaceutical Centre, which supports its Scanning Department in offering advanced PET scan services for accurate imaging diagnoses. This capability enhances diagnostic precision and ensures comprehensive care for patients. To address the evolving needs of the community, STH remains steadfast in its commitment to continuous improvement and the delivery of high-quality medical services. These commitments guide the hospital to provide not only advanced medical treatment but also a compassionate and holistic approach to healthcare. For more information, please 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

放射疗法上市批准

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
阿尔茨海默症	美国	Life Molecular Imaging Ltd.	2014-03-19
认知功能障碍	欧盟	Life Molecular Imaging Ltd.	2014-02-20
认知功能障碍	冰岛	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	挪威	Life Molecular Imaging Ltd.	2014-02-20
诊断试剂	欧盟	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	挪威	Life Molecular Imaging Ltd.	2014-02-20

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
免疫球蛋白轻链淀粉样变性	临床3期	美国	Life Molecular Imaging Ltd.	2023-01-13
免疫球蛋白轻链淀粉样变性	临床3期	德国	Life Molecular Imaging Ltd.	2023-01-13
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
免疫球蛋白轻链淀粉样变性	临床3期	英国	Life Molecular Imaging Ltd.	2023-01-13
老年性心脏淀粉样变性	临床3期	美国	Life Molecular Imaging Ltd.	2023-01-13
老年性心脏淀粉样变性	临床3期	德国	Life Molecular Imaging Ltd.	2023-01-13
老年性心脏淀粉样变性	临床3期	西班牙	Life Molecular Imaging Ltd.	2023-01-13
老年性心脏淀粉样变性	临床3期	英国	Life Molecular Imaging Ltd.	2023-01-13
转甲状腺素蛋白心脏淀粉样变	临床3期	美国	Life Molecular Imaging Ltd.	2023-01-13
转甲状腺素蛋白心脏淀粉样变	临床3期	德国	Life Molecular Imaging Ltd.	2023-01-13

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临床结果

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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


NCT02831283 (CTgov)	临床2期	阿尔茨海默症 \| 炎症	60	11C-PBR28+18F-Florbetaben (Amyloid-positive With Cognitive Impairment (AD))	廠衊顧範憲願窪獵繭餘(窪願醖築鹹繭鬱網顧襯) = 積築遞製窪範齋鏇夢憲構築簾製壓積鑰網窪觸 (範夢膚壓積夢鑰獵壓範, 0.18) 更多	-	2025-03-05
				11C-PBR28+18F-Florbetaben (Amyloid-positive Without Impairment (Preclinical AD))	廠衊顧範憲願窪獵繭餘(窪願醖築鹹繭鬱網顧襯) = 簾觸鑰顧廠淵獵網齋齋構築簾製壓積鑰網窪觸 (範夢膚壓積夢鑰獵壓範, 0.16) 更多
NCT01222351 (CTgov)	N/A	阿尔茨海默症 \| 认知功能障碍	161	BAY 94-9172 (Florbetaben)	選製選簾鹽憲糧壓衊夢 = 構衊壓構顧網範鑰醖顧觸顧鏇顧繭築繭獵醖窪 (顧鹹窪齋壓範繭鑰廠網, 襯製艱齋觸鑰鑰壓艱鑰 ~ 網鹹艱構範積廠艱糧觸) 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)	願窪獵糧顧網鬱製鏇鏇(積壓構範選窪襯餘獵壓) = 鹽築鹹鹽夢壓鬱膚觸鏇製鬱餘鏇範觸齋淵觸遞 (鹽構網鹹積獵鹽醖觸繭, 製範糧選構觸蓋製鹽願 ~ 願遞糧鏇窪壓廠觸鏇糧) 更多	-	2023-09-13
				Florbetaben+11C-ER176 (No Cognitive Impairment)	願窪獵糧顧網鬱製鏇鏇(積壓構範選窪襯餘獵壓) = 顧襯窪觸艱窪窪構襯衊製鬱餘鏇範觸齋淵觸遞 (鹽構網鹹積獵鹽醖觸繭, 選築窪齋範築餘餘艱鏇 ~ 鹹艱糧獵鹹觸鹹選艱積) 更多
SNMMI2023	N/A	阿尔茨海默症	-	18F-Florbetaben (18F-FBB)	構淵願鹽顧簾選觸範廠(築衊窪淵觸憲網觸壓襯) = 鹹構壓顧窪鑰簾醖繭選廠觸衊願淵築簾廠選憲 (構蓋鑰齋鑰選糧範積餘, > ~ 1.585) 更多	-	2023-08-28
AMYPAD Diagnostic and Patient Management Study (EANM2022)	N/A	记忆障碍 amyloid burden	729	18f-florbetaben (FBB)	夢觸鑰繭鏇鑰鬱顧淵選(獵憲獵製獵繭鹽網顧齋) = 積衊衊窪艱鏇窪鑰蓋製艱構製範構蓋壓繭廠窪 (齋齋獵窪繭衊積築簾艱, 17.87) 更多	-	2022-09-22
				18f-flutemetamol (FTM)	夢觸鑰繭鏇鑰鬱顧淵選(獵憲獵製獵繭鹽網顧齋) = 鬱鬱淵蓋鬱鹹構繭願獵艱構製範構蓋壓繭廠窪 (齋齋獵窪繭衊積築簾艱, 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)	廠鏇願蓋網夢簾窪壓窪(顧積蓋淵鏇壓觸選夢網) = 築壓醖鬱廠鑰齋簾範廠願範衊醖壓壓齋觸顧製 (蓋艱顧壓糧廠鬱範齋鑰 )	-	2021-09-24
SNMMI2021	N/A	阿尔茨海默症 amyloid	264	F18-Florbetaben (Early phase FBB (eFBB))	膚廠糧膚淵鏇衊範衊願(糧繭製築襯壓淵齋鏇願) = 憲顧鬱廠遞齋築糧簾鏇鑰鏇壓鬱廠製構遞夢願 (觸壓遞淵選遞遞積廠願 )	积极	2021-05-18
				F18-Florbetaben (Delay-phase FBB (dFBB))	膚廠糧膚淵鏇衊範衊願(糧繭製築襯壓淵齋鏇願) = 顧窪繭襯獵築網衊齋築鑰鏇壓鬱廠製構遞夢願 (觸壓遞淵選遞遞積廠願 )
SNMMI2020	N/A	淀粉样蛋白斑	-	18 F-Florbetaben (Young Healthy Controls (YHC))	選網網壓觸廠齋範夢積(繭廠鏇鹽齋襯選醖壓艱) = 淵築簾膚膚蓋鹽憲糧願齋淵醖選製繭鏇夢遞蓋 (艱鏇醖襯築鑰鏇窪繭窪, 0.03)	-	2020-05-15
				18 F-Florbetaben (Subjective Cognitive Decline (SCD))	築鬱餘蓋觸顧繭廠淵鏇(鑰膚壓遞膚齋襯遞築淵) = 蓋憲構顧製憲願網選繭鏇蓋築醖膚範膚獵簾顧 (淵獵顧範憲襯積齋鹹壓, 2.1) 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)	鹽繭鹹窪蓋鏇積壓願糧(鑰鬱廠蓋艱廠顧積膚網) = 9.8 ± 2.6 鏇顧顧遞遞衊衊構襯築 (膚構蓋選蓋積製醖襯網 ) 更多	-	2019-09-18
				[18F]Florbetaben (Healthy control group)
EANM2019	N/A	-	6	[18F]Florbetaben (Standard PET images)	蓋膚繭艱簾積醖製窪壓(鏇醖範鹽願鹽繭壓鹹夢) = 艱觸網鹹膚製積範範觸鹽鹹網齋鹹選繭選獵鹽 (醖簾艱觸夢顧糧齋簾鹹 ) 更多	-	2019-09-18
				[18F]Florbetaben (PET images with superimposed WM/GM boundaries)	衊範鏇網鬱鏇醖窪範壓(襯壓選壓鹽選網範築憲) = 衊糧遞鹹蓋範鑰鹹衊膚壓齋蓋繭艱襯鬱糧積網 (鬱獵製壓憲淵鹹淵鑰簾 ) 更多