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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项与氟[¹⁸F]贝他苯相关的文献（医药）

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.

2024-11-07·PHYSICS IN MEDICINE AND BIOLOGY

PICASSO: a universal brain phantom for positron emission tomography based on the activity painting technique

Article

作者: Cherry, Simon R ; Spencer, Benjamin A ; Huang, Bangyan ; Qi, Jinyi ; Li, Tiantian ; Shanina, Ekaterina

Abstract:

Objective. This study presents a universal phantom for positron emission tomography (PET) that allows arbitrary static and dynamic activity distributions of various complexities to be generated using a single PET acquisition. Approach. We collected a high-statistics dataset (with a total of 22.4 × 109 prompt coincidences and an event density of 2.75 × 106 events mm−3) by raster-scanning a single plane with a 22Na point source mounted on a robotic arm in the field-of-view of the uEXPLORER PET/CT scanner. The source position was determined from the reconstructed dynamic frames. Uniquely, true coincidences were separated from scattered and random events based on the distance between their line-of-response and the known source location. Finally, we randomly sampled the dataset to generate the desired activity distributions modeling several different phantoms. Main results. Overall, the target and the reconstructed phantom images had good agreement. The analysis of a simple geometric distribution showed high quantitative accuracy of the phantom, with mean error of <–3.0% relative to the ground truth for activity concentrations ranging from 5.3 to 47.7 kBq ml−1. The model of a high-resolution 18F-fluorodeoxyglucose distribution in the brain illustrates the usefulness of the technique in simulating realistic static neuroimaging studies. A dynamic 18F-florbetaben study was modeled based on the time-activity curves of a human study and a segmented brain phantom with no coincidences repeating between frames. For all time points, the mean voxel-wise errors ranged from –4.4% to –0.7% in grey matter and from −3.9% to +2.8% in white matter. Significance. The proposed phantom technique is highly flexible and allows modeling of static and dynamic brain PET studies with high quantitative accuracy. It overcomes several key limitations of the existing phantoms and has many promising applications for the purposes of image reconstruction, data correction methods, and system performance evaluation, particularly for new high-performance dedicated brain PET scanners.

项与氟[¹⁸F]贝他苯相关的新闻（医药）

2025-02-11

·drugs

NIH-Funded Clinical Trial Will Evaluate New Dengue Therapeutic

February 11, 2025 -- A clinical trial supported by the National Institutes of Health (NIH) is testing an experimental treatment designed to help people suffering the effects of dengue, a mosquito-borne viral disease. The study is supported by NIH’s National Institute of Allergy and Infectious Diseases (NIAID), and will involve exposing adult volunteers to a weakened strain of dengue virus that causes a mild form of the disease and administering an investigational therapeutic at various doses to assess its safety and ability to lessen symptoms. Dengue is transmitted via infected Aedes mosquitoes and sickens as many as 400 million people each year, primarily in tropical and subtropical parts of the world, according to the U.S. Centers for Disease Control and Prevention. In 2024, dengue cases surged to record levels in the Americas with local U.S. transmission reported in Arizona, California, Florida, Hawaii, and Texas. Dengue is endemic in Puerto Rico, which reported nearly 1,500 cases last year. Most people with dengue do not develop symptoms, but those who do commonly experience severe headache and body aches, nausea and vomiting, fever and rash. One in 20 people who get sick with dengue progress to severe illness, which may lead to shock, internal bleeding, and death. There is currently no Food and Drug Administration-approved treatment for dengue. “When caring for a patient who is critically ill with dengue, healthcare providers have few options other than providing supportive care,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “We must find safe and effective therapeutics to provide much-needed relief to people suffering from dengue.” The new clinical trial will test the ability of AV-1, an investigational human monoclonal antibody therapeutic developed by AbViro (Bethesda, Maryland), to mitigate clinical symptoms when administered before and after dengue virus infection. The results of a previously completed NIAID-supported Phase 1 trial indicated that AV-1 is safe in humans, providing the basis for the new clinical trial to test its safety and efficacy. The Phase 2 clinical trial will enroll at least 84 healthy adult volunteers at two sites: the Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, and the University of Vermont Vaccine Testing Center in Burlington. Following an initial screening and physical examination, volunteers will be randomly assigned to one of two groups. One group will receive AV-1 one day prior to being challenged with a mild strain of dengue virus, and the other will receive AV-1 four days after being challenged with the dengue virus. Each group will be further subdivided to receive 100 mg, 300 mg, or 900 mg of AV-1, delivered in a 60-minute intravenous infusion. For each of the three dosage levels, 12 participants will receive the investigational monoclonal antibody, and two will receive a placebo. Before or after AV-1 dosing, each volunteer will receive an injection of attenuated (weakened) dengue virus. In earlier studies using this challenge virus, most volunteers developed a rash, and some had other mild dengue symptoms, such as joint and muscle pain or headache. None of the volunteers developed dengue fever or severe dengue. Volunteers will participate in regular follow-up visits with study staff for at least 155 days to carefully monitor the effects of the investigational monoclonal antibody. Through physical exams, diary cards and blood samples, researchers will document how the volunteers’ immune systems respond to the dengue virus challenge, how quickly the virus vanishes from their bloodstream and any symptoms they may experience. The researchers will use this information to determine how AV-1 affects the volunteers’ ability to recover from dengue compared to placebo and to determine the dosages at which AV-1 may be effective. If AV-1 shows promising results in this clinical trial, researchers may pursue further clinical evaluations of its safety and efficacy against dengue virus. For more information about the study, visit ClinicalTrials.gov and search the identifier NCT05048875. NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website. About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov. Source: NIH Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床2期疫苗

2025-02-08

·贝壳社

贝壳圈1月Newsletter｜近亿元融资；受聘为生物与医药制造专委会委员；人才政策宣讲活动圆满举办……

▲点击图片，了解详情 January 2025年1月刊贝壳社 1月17日，浙江省工程师学会生物与医药制造专业委员会成立大会在杭州康恩贝中心隆重举行。贝壳社创始人兼董事长姜慧霞女士应邀出席本次大会并受聘为委员，与来自全省生物与医药制造领域的专家学者、企业代表等齐聚一堂，共同见证了这一重要时刻。贝壳学社校友融资 2025年开门红 | 妙顺生物完成新一轮近亿元融资 ■ 妙顺生物CEO张金保、核心高管艾康、左智敏、邹志方分别为贝壳学社五期、六期、七期校友。近日，妙顺（上海）生物科技有限公司（以下简称：妙顺生物）宣布完成近亿元A+轮融资，本轮融资由兴证资本领投，济高财金公司、南京市创新投资集团跟投，凯乘资本连续担任独家财务顾问。本轮融资获得了知名投资机构以及地方国资的认可和支持，募集资金将主要用于加速一系列原代细胞模型、配套试剂耗材以及科研业务的开发，以及进一步扩大海外业务范围与规模，加速企业成长为生物医药细胞应用全产业链一站式供应商。2023年，妙顺生物获得了中科海创领投、高瓴创投(GL Ventures)、毅达资本、泰坦科技（688133.SH）、凯乘资本跟投的超亿元A轮融资。校友动态 2024胡润全球瞪羚企业榜发布，先通医药凭卓越创新实力荣耀上榜 ■ 先通医药董事长徐新盛五期 1月8日，全球最大的创业企业榜单编制机构胡润研究院于北京亦庄发布《2024胡润全球瞪羚企业榜》（Hurun Future Unicorns – Global Gazelles Index 2024），榜单列出了全球成立于2000年之后，三年内最有可能达到独角兽级十亿美金估值的高成长性企业。先通医药凭借在放射性药物领域的卓越表现荣耀上榜，成为2024全球803家瞪羚企业之一，彰显了强劲的市场竞争力和持续的创新实力。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！ 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、中日友好医院均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。重磅新品│艾馨甘®黄金早诊期发现肝癌，获批上市！ ■ 艾米森总经理张良禄三期 1月13日，中国国家药监局（NMPA）官网公示，武汉艾米森自主研发的艾馨甘®——GNB4和Riplet基因甲基化联合检测试剂盒（荧光PCR法）获批上市（注册证号：国械注准 20253400101）。重磅新品获批上市│针对中国食管癌的OK靶标组合：1管血，查食管癌！ 1月21日，中国国家药监局（NMPA）官网公示，武汉艾米森自主研发的艾思宁®——KCNA3和OTOP2基因甲基化联合检测试剂盒（荧光PCR法）获批上市（注册证号：国械注准20253400207）。喜报 | 锐翌生物获上海市企业技术中心认定 ■ 锐翌生物CEO秦楠二期 ■ 锐翌生物副总经理刘晶五期近日，上海市经济和信息化委员会发布2024年度下半年（第33批）市级企业技术中心公示名单，上海锐翌生物科技有限公司（贝壳基金投资企业）荣获“2024年度上海市企业技术中心”称号。全球首例超显微外科手术机器人辅助颈深淋巴-静脉吻合术（LVA）治疗阿尔茨海默症 ■ 迪视医疗CEO 崔迪六期 1月15日，迪视医疗自主研发的超显微外科手术机器人取得重要进展，由浙江省人民医院淋巴外科及显微重建外科主任郑有卯教授团队主刀，成功完成全球首例超显微外科手术机器人辅助颈深淋巴-静脉吻合术（LVA）治疗阿尔茨海默症。这不仅标志着超显微外科手术机器人技术在治疗阿尔茨海默症领域具有重要应用价值，也展示了机器人超显微操作技术助力治疗全球超过5000万阿尔茨海默症病患的重大潜力。迪福润丝生物获杭州市高新区（滨江）2024年度专利导航项目 ■ 迪福润丝CEO宋家升六期高新区（滨江）于2024年12月中旬举行2024年度专利导航项目立项评审会。区经信局副局长丁巍、区市场监管局副局长吕德军出席会议，省保护中心、省知识产权研究与服务中心等单位专家，区经信局、区市场监管局相关负责人，产业联盟、企业、科研机构等单位代表91人参加会议。经过会议讨论、评比，最终确定10个项目为高新区（滨江）2024年度专利导航立项项目。迪福润丝的“鼻喷式减毒流感疫苗关键技术专利导航”项目成功入围。禾元生物“稻米造血”荣膺央视2024新质生产力年度案例 ■ 禾元生物首席医学官秦志杰四期 1月20日晚，中央广播电视台财经频道播出“2024新质生产力年度盛典”，发布“2024新质生产力年度案例”“2024新质生产力年度报告”，介绍“新质生产力指数指标体系”。活动现场，十个极具代表性的“新质生产力年度案例”正式亮相。其中，禾元生物的“稻米造血”项目成功入选。青蓝港湾园区企业 1月13日上午，杭州瑞科材启生物科技有限公司入驻天目医药港医药产业孵化园的签约仪式成功举办。新锦集团、杭州瑞科材启生物科技有限公司、贝壳社相关负责人参加项目签约仪式。 1月下旬，杭州莱佰盛智能科技有限公司入驻天目医药港医药产业孵化园的签约仪式成功举办。新锦集团、杭州莱佰盛智能科技有限公司、贝壳社相关人员参加项目签约仪式。园区动态 1月13日上午，“挥毫迎新春墨韵暖人才”暨人才政策宣讲活动在天目医药港医药产业孵化园成功举办。此次活动由浙江杭州青山湖科技城管委会、杭州市临安区新锦产业发展集团有限公司主办，杭州临贝医疗科技有限公司（贝壳社）、杭州继创网络科技有限公司、交通银行杭州临安支行协办。活动定向邀约了十余家企业的高层次人才参加。 1月16日下午，天目医药港医药产业孵化园相关工作人员会同临安区科技创新服务中心副主任章威、久安公司工作人员对园区开展了春节前安全生产大检查。此次节前安全大检查，紧盯安全生产中的关键区域与核心环节，彻查风险隐患，确保不留死角。天目医药港医药产业孵化园将以更高标准、更严要求落实各项安全防范措施，为园区提供优质温馨安全的环境。关于贝壳社贝壳社是国内领先的医健创新创业服务平台，为医健创业者提供全路径创业服务。通过产业空间运营、创业教育、投资孵化、数字化赋能、企业价值增长等服务体系，给医健创业企业提供产业空间、人才战略培养、投融资、产业生态资源、数字化转型等服务。同时，贝壳社布局澳洲，帮助国内生物医药企业加速走向海外；成立“泰格-泰珑-贝壳社企业经营服务中心”为企业成长提供全生命周期的增值服务，提高企业运营效率，加快企业成长发展。我们深度链接政府、科研院所、临床机构、投资机构、第三方服务商、CXO等行业资源，致力于赋能医疗健康创业公司成长，推动创新技术造福人类生命健康。往期推荐 1 惠民保，已走到2.0的边缘 2 国产爆红新药，有人开始掉队 _ 3 Cell重磅发现：安眠药物会扰乱睡眠期间大脑的废物清除，可能导致阿尔茨海默病 _ *声明：本文仅用于分享，不构成任何投资建议，且非治疗方案推荐。投稿请添加小助手：bioclub666

临床3期引进/卖出上市批准放射疗法

2025-01-21

·PRNewswire

Life Molecular Imaging Secures FDA Fast Track Designation for [18F]Florbetaben in Diagnosing Cardiac AL and ATTR Amyloidosis

[18F]florbetaben has been granted a Fast Track designation for cardiac amyloidosis, which will expedite the development of [18F]florbetaben for this indication [18F]florbetaben previously received orphan drug status as a diagnostic for the management of AL amyloidosis in EU and US The efficacy of [18F]florbetaben in diagnosing cardiac amyloidosis is being evaluated in an ongoing multi-center Phase 3 study BOSTON, Jan. 21, 2025 /PRNewswire/ -- Life Molecular Imaging (LMI), an international pharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to [18F]florbetaben for the diagnosis of cardiac amyloid light-chain (AL) and amyloid transthyretin-related (ATTR) amyloidosis. Fast Track is an FDA process designed to facilitate the development and expeditious evaluation of drugs which are used to treat serious conditions and fill an unmet medical need. The purpose of Fast Track is to get important new drugs to patients earlier. [18F]florbetaben PET is validated and approved to detect neuritic beta amyloid plaques in the brain and is available via a global supply network marketed as Neuraceq®. [18F]florbetaben has demonstrated its capability to identify amyloid deposits in the heart, including AL and ATTR. These findings led to its Orphan Drug Designation by both the European Commission and the FDA in 2020 for diagnosis of AL amyloidosis. The current Phase 3 trial (NCT05184088) aims to further validate [18F]florbetaben's efficacy in the diagnosis of cardiac amyloidosis. "The FDA's Fast Track Designation is a pivotal achievement that highlights the potential of [18F]Florbetaben to address a critical gap in diagnosing cardiac AL and ATTR amyloidosis", said Dr. Ludger Dinkelborg, CEO of Life Molecular Imaging. "Diagnosing cardiac AL amyloidosis is complex and challenging", added Dr. Andrew Stephens, MD, PhD, CMO of Life Molecular Imaging. "[18F]florbetaben PET imaging of patients with suspected cardiac amyloidosis has the potential to streamline the diagnostic process, providing earlier and appropriate access to therapy and improved monitoring of such interventions." About [18F]florbetaben Neuraceq® ([18F]florbetaben) 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. Neuraceq has been approved for routine clinical use in this indication by FDA, EMA and MHRA, and has local regulatory approval in other countries such as Canada, UK, Japan, China, Taiwan, and Korea. [18F]florbetaben is currently under investigation as a targeted radiopharmaceutical for the detection of amyloid deposits in the heart and other organs of patients with cardiac and systemic amyloidosis of AL and ATTR type. Most Common Adverse Reactions In clinical trials including demented and non-demented subjects, the most frequently observed adverse drug reactions in 872 subjects with 1090 Florbetaben (18F) administrations were injection/application site erythema (1.7%), injection site irritation (1.1%), and injection site pain (3.4%). 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

临床3期快速通道孤儿药上市批准

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

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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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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)	鹽艱窪鹹餘醖衊製壓餘(鬱鏇遞願窪積觸醖憲遞) = 網壓簾膚願積鑰網膚繭顧築壓蓋鹽鑰簾淵憲選 (糧繭鹹網鑰鏇窪夢壓繭, 鹹鏇鏇醖廠簾襯膚憲窪 ~ 襯範鹽獵築鏇鹽鏇壓憲) 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)	範蓋鏇窪醖憲製淵淵觸(選繭蓋齋壓齋簾艱衊壓) = 獵衊衊鹽顧網憲艱醖壓襯簾製衊觸鬱壓憲窪醖 (簾衊鏇糧積鑰夢齋積齋, 簾觸廠願築製簾夢衊範 ~ 壓襯膚醖獵憲餘鹽願襯) 更多	-	2023-09-13
				Florbetaben+11C-ER176 (No Cognitive Impairment)	範蓋鏇窪醖憲製淵淵觸(選繭蓋齋壓齋簾艱衊壓) = 構獵鹹餘鏇襯醖構窪選襯簾製衊觸鬱壓憲窪醖 (簾衊鏇糧積鑰夢齋積齋, 廠膚觸襯網艱顧淵範淵 ~ 淵膚顧顧鹽觸衊遞鬱襯) 更多
SNMMI2023	N/A	阿尔茨海默症	-	18F-Florbetaben (18F-FBB)	獵襯艱遞憲獵壓鬱構觸(鬱鹽顧積鑰築醖鏇艱積) = 夢範糧顧襯淵願廠鑰構範顧鑰餘構醖觸遞餘齋 (獵鏇夢齋淵艱繭獵遞範, > ~ 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)	鑰艱蓋廠範壓鹹憲襯醖(鑰廠衊觸範鹹繭襯網艱) = 構鬱願憲鬱選壓糧夢齋窪網顧顧壓醖襯淵蓋網 (鹽襯艱顧鬱窪夢廠鑰鹹, 17.87) 更多	-	2022-09-22
				18f-flutemetamol (FTM)	鑰艱蓋廠範壓鹹憲襯醖(鑰廠衊觸範鹹繭襯網艱) = 顧築鏇膚鏇襯鹽鏇蓋衊窪網顧顧壓醖襯淵蓋網 (鹽襯艱顧鬱窪夢廠鑰鹹, 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)	壓繭夢淵簾襯醖鑰憲淵(壓窪蓋蓋製艱艱願鹹壓) = 衊積憲製淵築醖遞獵鹽選淵壓餘獵積膚淵襯襯 (獵廠獵餘獵膚鬱製鏇網 )	-	2021-09-24
SNMMI2021	N/A	阿尔茨海默症 amyloid	264	F18-Florbetaben (Early phase FBB (eFBB))	蓋願鏇鏇鹽鬱繭窪簾膚(繭鹹構蓋壓淵淵廠構鏇) = 廠醖顧鏇簾遞觸獵鏇製繭顧餘蓋築選窪範襯憲 (廠網艱選遞觸衊構選觸 )	积极	2021-05-18
				F18-Florbetaben (Delay-phase FBB (dFBB))	蓋願鏇鏇鹽鬱繭窪簾膚(繭鹹構蓋壓淵淵廠構鏇) = 蓋淵鏇築憲醖鬱齋壓簾繭顧餘蓋築選窪範襯憲 (廠網艱選遞觸衊構選觸 )
SNMMI2020	N/A	淀粉样蛋白斑	-	18 F-Florbetaben (Young Healthy Controls (YHC))	壓窪鑰選簾窪網觸醖範(衊築鬱積願簾壓糧壓積) = 鹽鏇膚遞醖醖製鹽構築積淵鹽範遞鬱願遞壓艱 (廠糧積選製積壓構鏇觸, 0.03)	-	2020-05-15
				18 F-Florbetaben (Subjective Cognitive Decline (SCD))	獵積製獵襯齋選膚簾憲(遞廠鏇齋範糧鑰淵醖淵) = 顧夢觸繭網鬱鑰憲衊鑰蓋憲積蓋範襯膚廠艱觸 (壓範衊範鹹膚範憲醖艱, 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)	齋醖繭繭膚簾膚築衊鬱(醖淵簾憲鑰壓膚鑰壓範) = 9.8 ± 2.6 構糧淵鬱遞鹽觸簾憲襯 (選鹹顧觸積觸鹹簾憲襯 ) 更多	-	2019-09-18
				[18F]Florbetaben (Healthy control group)
EANM2019	N/A	-	6	[18F]Florbetaben (Standard PET images)	襯淵衊繭願願構築鬱膚(齋網醖壓選顧壓積鏇築) = 窪遞構襯積窪製膚襯淵鑰壓觸築齋醖醖築範膚 (艱夢製鬱範襯顧鬱餘膚 ) 更多	-	2019-09-18
				[18F]Florbetaben (PET images with superimposed WM/GM boundaries)	衊範顧窪窪鹹鬱鹽網網(範夢糧遞齋選襯廠鑰鹹) = 鏇鹽糧願艱選壓齋糧選蓋顧網齋鏇齋願簾齋鬱 (淵廠淵選網壓遞鏇廠餘 ) 更多
EANM2018	N/A	-	44	18F-Florbetaben (Amyloid-PET)	醖膚觸衊衊餘壓鏇窪築(製鹹衊願齋繭鑰獵鏇窪) = 壓膚鹹願鹹廠膚顧艱醖顧壓鹹鹽窪簾鏇繭淵廠 (窪積壓壓糧齋壓遞範網 )	积极	2018-09-18