Neuronavigation-guided Focused Ultrasound-induced Blood-brain Barrier Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau

The primary purpose of this phase 1b study is to further assess the safety and reversibility of focused ultrasound induced blood-brain barrier opening (FUS-BBBO) in participants with Alzheimer´s Disease (AD) using a single-element transducer with neuronavigation guidance. Preliminary results from our phase 1a study demonstrate that our neuronavigation-guided FUS system was capable of safely and transiently open the BBB in participants with AD. The information collected in this new study may be used to design future clinical trials to ultimately provide a viable alternative for treatment of AD in a safe and noninvasive manner.
Our secondary objective includes the assessment of the therapeutic efficacy of FUS-BBBO in reducing amyloid beta and neurofibrillary tangles, the main hallmark pathologies of AD, using PET tracers. Based on our preclinical studies in AD transgenic mouse models, FUS-BBBO alone was able to reduce both the amyloid beta and tau protein load, resulting in improvements in behavioral tasks assessing memory. Therefore, in this new study, the effect of FUS-BBBO on the amyloid beta and tau protein load in patients with AD will be assessed through the use of PET tracers.

开始日期2024-10-01

申办/合作机构

The Trustees of Columbia University in The City of New York

NCT06584357

/ RecruitingN/A

Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia

Bio-Hermes-002 is a 120-day cross-sectional study that will result in a blood, CSF, retinal, digital, MRI, and PET brain imaging biomarker database that can be used to determine the primary objective. Digital biomarkers and blood-based biomarkers will be tested to determine whether a meaningful relationship exists between biomarkers alone or in combination with tau or amyloid brain pathology identified through PET images.

开始日期2024-09-26

申办/合作机构-

NCT06860373

/ Terminated临床3期IIT

LIFE-DSR-Biomarker Sub-study of Biomarkers in Down Syndrome Related Alzheimer's Disease (DS-AD)

This is an optional sub-study that will enroll participants from the LIFE-DSR parent protocol. Participants will undergo assessments at two timepoints, including: additional blood samples for PBMC and RNA extraction, as well as a lumbar puncture for collection of CSF, and/or MRI and tau PET imaging. Sub-study visits will be scheduled around a similar calendar-day as the parent protocol study visits (e.g., Month (M) 0 (M0) and M16, or M16 and M32).

开始日期2023-06-27

申办/合作机构

LuMind IDSC Foundation

100 项与 Florquinitau F18 相关的临床结果

登录后查看更多信息

100 项与 Florquinitau F18 相关的转化医学

登录后查看更多信息

100 项与 Florquinitau F18 相关的专利（医药）

登录后查看更多信息

项与 Florquinitau F18 相关的文献（医药）

2025-03-01·Journal of Nuclear Medicine

[¹⁸F]MK-6240 Radioligand Delivery Indices as Surrogates of Cerebral Perfusion: Bias and Correlation Against [¹⁵O]Water

Article

作者: Garimella, Arun ; Aye, William ; Fu, Jessie Fanglu ; Lois, Cristina ; Efthimiou, Nikos ; El Fakhri, Georges ; Salvatore, Andrew N ; Guehl, Nicolas J ; Johnson, Keith A ; Ranasinghe, Anthony ; Price, Julie C ; Catana, Ciprian ; Sari, Hasan ; Juttukonda, Meher R ; Dickerson, Bradford C ; Izquierdo-Garcia, David

[¹⁸F]MK-6240 PET (where MK-6240 is 6-(fluoro)-3-(1H-pyrrolo[2,3-c]pyridin-1-yl)isoquinolin-5-amine) is used to assess in vivo tau deposition across the Alzheimer disease (AD) spectrum. We aimed to quantify the associations and bias of early-frame [¹⁸F]MK-6240 PET as surrogates for cerebral perfusion against gold standard [¹⁵O]water PET and the potential impact of cerebral perfusion on [¹⁸F]MK-6240 tau quantification across aging and the AD spectrum. Methods: Fourteen cognitively normal (CN, 4 young CN and 10 old CN) and 3 AD participants underwent dynamic [¹⁸F]MK-6240 PET, with 9 undergoing arterial sampling. A subset (n = 11) underwent [¹⁵O]water PET. [¹⁸F]MK-6240 perfusion indices were estimated as radiotracer delivery indices K ₁ (using 2-tissue-compartment models), and relative perfusion indices were estimated as R₁ (using compartmental and reference tissue models, cerebellar gray matter reference region) and early-frame SUV ratio (0-3 min). [¹⁵O]water K ₁ and R₁ were estimated using 1-tissue-compartment models). [¹⁸F]MK-6240 tau burden was estimated using distribution volume ratio and SUV ratio at 90-110 min. Spearman correlations, linear mixed-effect models, and Bland-Altman analyses examined relationships between [¹⁸F]MK-6240 perfusion indices against [¹⁵O]water and between estimates of perfusion and tau burden in tau-relevant regions. The impact of partial-volume correction was examined. Results: Significant correlations were observed between [¹⁸F]MK-6240 K ₁ and [¹⁵O]water K ₁ (ρ = 0.57); However, [¹⁸F]MK-6240 K ₁ underestimated [¹⁵O]water K ₁ by up to 50%, with a strong negative proportional bias. Significant correlations were observed between [¹⁸F]MK-6240 relative perfusion and [¹⁵O]water R₁ (ρ > 0.84), with minimal bias. In 2 AD participants, significant correlations were observed between perfusion and [¹⁸F]MK-6240 retention. Applying partial-volume correction did not significantly impact the correlations or improve the underestimations in [¹⁸F]MK-6240 K ₁ Conclusion: Using head-to-head [¹⁸F]MK-6240 and [¹⁵O]water data, we showed that [¹⁸F]MK-6240 exhibited a relatively low extraction fraction, leading to underestimation of cerebral perfusion. Our results provide further support for [¹⁸F]MK-6240 R₁ as a reliable estimate of relative cerebral perfusion, with strong associations and minimal bias compared with [¹⁵O]water. In addition, lower perfusion may be associated with higher [¹⁸F]MK-6240 retention in tau-relevant regions in AD. These findings further support the use of dynamic [¹⁸F]MK-6240 in dual-imaging assessments of tau burden and vascular health.

2024-12-01·Alzheimer's & Dementia

Visual memory is primarily impacted by tau load in the right hemisphere

Article

作者: Trudel, Lydia ; Wang, Yi‐Ting ; Therriault, Joseph ; Macedo, Arthur C. ; Rahmouni, Nesrine ; Hall, Brandon J ; Arias, Jaime Fernandez ; Hosseini, Seyyed Ali ; Rosa‐Neto, Pedro ; Mathotaarachchi, Sulantha ; Aumont, Etienne ; Chan, Tevy ; Kunach, Peter ; Socualaya, Kely Monica Quispialaya ; Vitali, Paolo ; Servaes, Stijn

AbstractBackgroundClassical literature has pointed at lateralization of the relationship between memory scores and cerebral hemisphere injury. Epilepsy studies have suggested an association between left hippocampal damage and verbal memory deficits, and between right hippocampal damage and visual memory deficits. We aimed to explore this concept in the context of tauopathy due to Alzheimer’s disease.Methodwe assessed 132 cognitively unimpaired (CU) older adults, and 44 cognitively impaired (CI), amyloid‐β positive individuals from the Translational Biomarkers in Aging and Dementia (TRIAD) cohort. All participants had amyloid‐PET with [18F]AZD4694 and tau‐PET with [18F]MK6240, verbal memory assessments with Rey Auditory Verbal Learning Test (RAVLT), and visual memory assessments with Aggie Figures Learning Test (AFLT). We conducted voxel‐wise analyses to explore the relationship between tau PET and memory modality. In addition, we run regression models with right or left tau temporal metaROI as predictor and memory scores as outcome variables. We entered global amyloid (PET), sex, age, years of education, ApoE status, grey matter volume and handedness as covariates. Finally, we used the laterality index (LI) to investigate correlations with memory modality. Right laterality is indicated by an LI below 0, while left laterality would be signaled by an LI above 0.Resultvoxel‐wise analyses suggested a lateralized relationship between tau and visual memory scores on the right hemisphere, whereas tau and verbal memory scores were bilaterally associated. Regression analyses showed a trend towards a stronger relationship between temporal tau on the right and visual memory scores. The LI was significantly associated with visual memory performance. Further analyses showed that this relationship seems to be driven by tau positive individuals.Conclusionvisual memory performance might be more prominently affected by tau load on the right hemisphere in Alzheimer’s disease. Furthermore, a hemispheric imbalance in the amount of tau is related to visual, but not verbal, memory scores.

2024-06-01·Acta Neuropathologica

Head-to-head comparison of [18F]-Flortaucipir, [18F]-MK-6240 and [18F]-PI-2620 postmortem binding across the spectrum of neurodegenerative diseases

Article

作者: Amaral, Ana C ; Johnson, Keith ; Moon, S-H ; Frosch, Matthew P ; Scapellato, Margaret ; Gómez-Isla, Teresa ; Neelamegam, Ramesh ; Dhaynaut, Maeva ; El Fakhri, Georges ; Kumar, Sunny ; Normandin, Marc D ; Aguero, Cinthya ; Carazo-Casas, Carlos

AbstractWe and others have shown that [18F]-Flortaucipir, the most validated tau PET tracer thus far, binds with strong affinity to tau aggregates in Alzheimer's (AD) but has relatively low affinity for tau aggregates in non-AD tauopathies and exhibits off-target binding to neuromelanin- and melanin-containing cells, and to hemorrhages. Several second-generation tau tracers have been subsequently developed. [18F]-MK-6240 and [18F]-PI-2620 are the two that have garnered most attention. Our recent data indicated that the binding pattern of [18F]-MK-6240 closely parallels that of [18F]-Flortaucipir. The present study aimed at the direct comparison of the autoradiographic binding properties and off-target profile of [18F]-Flortaucipir, [18F]-MK-6240 and [18F]-PI-2620 in human tissue specimens, and their potential binding to monoamine oxidases (MAO). Phosphor-screen and high resolution autoradiographic patterns of the three tracers were studied in the same postmortem tissue material from AD and non-AD tauopathies, cerebral amyloid angiopathy, synucleopathies, transactive response DNA-binding protein 43 (TDP-43)-frontotemporal lobe degeneration and controls. Our results show that the three tracers show nearly identical autoradiographic binding profiles. They all strongly bind to neurofibrillary tangles in AD but do not seem to bind to a significant extent to tau aggregates in non-AD tauopathies pointing to their limited utility for the in vivo detection of non-AD tau lesions. None of them binds to lesions containing β-amyloid, α-synuclein or TDP-43 but they all show strong off-target binding to neuromelanin and melanin-containing cells, as well as weaker binding to areas of hemorrhage. The autoradiographic binding signals of the three tracers are only weakly displaced by competing concentrations of selective MAO-B inhibitor deprenyl but not by MAO-A inhibitor clorgyline suggesting that MAO enzymes do not appear to be a significant binding target of any of them. These findings provide relevant insights for the correct interpretation of the in vivo behavior of these three tau PET tracers.

项与 Florquinitau F18 相关的新闻（医药）

2025-01-21

·同写意

重启并购季：生物制药的下一片热土

2025年生物制药行业的交易之风，眼看着正从今年JPM大会再度吹起。 1月13日，强生以146亿美元收购Intra-Cellular，礼来则用最高25亿美元获得Scorpion Therapeutics的PI3Kα抑制剂，GSK为加强抗肿瘤业务花了超过10亿美元买下IDRx。而一些行业人士认为，MNC对放射性药物的期待，有望催生更多买卖接续其后。在8个月的时间里，4家大型制药公司都披露了各自的并购案：诺华斥资10亿美元收购Mariana Oncology；礼来斥资14亿美元收购Point Biopharma；阿斯利康斥资24亿美元收购Fusion Pharmaceuticals；BMS斥资41亿美元收购RayzeBio。为何巨头们突然对一种已经研发近一个世纪的药物进行密集押注？——要是算上BD等合作，诸如“外行”的礼来在2024年小步快跑，来势汹汹。 Numerof & Associates管理合伙人Michael Abrams称，这项技术已经产生巨大影响，能精准实现靶向治疗。目前，FDA批准了67种放射性药物，用于疾病诊断和治疗。市场端，Insight Partners数据显示，放射性药物领域预计从2023年的91亿美元增长至2031年的265亿美元，复合年增长率为14%。Fortune Business Insights的看法更加乐观，该行业规模将从2024年的102亿美元增至2032年的420亿美元。放射性药物的前景，在诺华身上具像化。 JMP大会现场，诺华披露的销售潜力在30亿至80亿美元的8种上市产品中，就有放射性药物都身影，Pluvicto和Lutathera。而去年前九个月，Pluvicto总销售额已突破10亿美元，同比增长47%。在这些数据刺激下，2025年的放射性药物领域，显然不太可能静悄悄。Biotech阵营已经打响了第一枪。同样是1月13日，Telix Pharmaceuticals以4500万美元的预付款和股权，加上1.85亿美元潜在里程碑付款，买入ImaginAb的一系列资产和研究部门；Lantheus Holdings则花费总计7.5亿美元，收购Life Healthcare旗下放射性药物业务。 Jefferies分析师估计，到2025年，此类活动将会更加活跃。 1 前赴后继争夺资产的现象可以归因于市场迅速扩张，而市场的扩张又离不开临床试验的进步。 ZS Associates副主管Matt Furlow表示，增长预测基于正在进行的放射性药物临床试验数量的激增，如果其中出现大的积极结果，即使是早期临床试验，也会引起尚未进入该领域的MNC的兴趣。 20多年前，GSK（Bexxar）和IDEC（Zevalin）等药企就将放射性药物推向市场。这些产品尽管被证明安全有效，却由于制造和分销成本过高，商业化成功有限。随后，2013年5月，FDA批准首款α粒子放射性治疗药物Xofigo，拜耳很快以29亿美元收购了开发公司Algeta，引起业界关注。拜耳2009年与Algeta达成合作，拥有Xofigo的全球独家销售权。通过收购，拜耳获得Xofigo的完全控制权，并希望借此提振其药物部门。Algeta曾预计，到2018年，Xofigo全球销售额将超过10亿美元，但事实上，它在2017年达到的峰值是4.08亿美元。问题出在临床数据。2017年底，拜耳公布Xofigo与强生的Zytiga、类固醇联合使用的III期出现死亡和骨折事件后，该药物的销售额一直在下降。拜耳没有完成的“重磅炸弹”未竟之业，在诺华手中开花结果。现阶段，诺华取得放射性药物商业化方面的最大成功。其中，Lutathera属于一种治疗神经内分泌癌的产品，源自2017年诺华以39亿美元收购的Advanced Accelerator Applications。2024年前三个季度，该药物的销售额达到5.34亿美元。 2018年，也就是FDA批准Lutathera的同一年，诺华以21亿美元收购Endocyte，获得另一种前景光明的放射性药物——2022年被FDA批准的前列腺癌治疗产品Pluvicto，2024年前三个季度的销售额达到10.4亿美元。据Ratio Therapeutics首席科学官John Babich回忆，诺华的成功激发了业界对该领域的重点关注。 “有了Pluvicto和诺华的帮助，如今对于其他疗法都不管用的癌症患者来说，生存率会有很大提高。”Babich对比说。2024年11月，诺华和Ratio达成7.45亿美元协议，扩大放射性核药的布局。 Lutathera、Pluvicto的商业化成绩是一方面，业界之所以涌入，还与诺华在应对放射性药物的生产和分销所带来的挑战实践有关。众所周知，因为原材料稀缺且昂贵，而且很难将保质期非常短的药物送到患者手中，如何更好地利用放射性药物一直是个难题。 2022年，当Pluvicto获得批准时，诺华从其位于意大利的唯一生产基地运送该药物。此后，诺华在西班牙和美国多地增设了工厂。基于地理上的多元化努力，诺华可以更从容地在五天内将产品带给患者。ZS Associates主管Sankalp Sethi认为，诺华为同行提供了一个样本。现在，其他有志于此的药企更具信心，通过建立各种基础设施来为分销放射性药物服务。这些进步，也有助于减轻处方人员对药品生产和配送机制是否可靠、安全的疑虑。 Pluvicto的临床效果从未受到太多质疑，因为事实证明，在标准治疗基础上加入该药物，患者平均可延长4个月的生命，并将死亡风险降低38%。考虑到Pluvicto主要针对末线患者，这些数字格外引人注目。 2 巨头角力放射性药物制造和分销门槛，意味着并非所有的药企都能从中分一杯羹。换言之，这类产品不太可能受到仿制药的威胁。然而，内部竞争并未消失。随着更多MNC跑步进场，作为放射性药物龙头的诺华，已经着手下一代放射性疗法的开发。 Furlow认为，使用α射线放射性核素的放射性药物的开发和商业化会出现快速增长。这些药物“比目前的药物更具威力，但作用距离更短”，因此，相较于使用β射线放射性核素Lu-117制成的药物（例如Pluvicto）更安全。发射α射线的放射性核素的另一个优点是，它们的效力半衰期延长至约10天，与发射β射线的放射性核素的效力半衰期为6天相较，更具运输和管理上的时间优势。收购RayzeBio的过程中，BMS击败另外两家公司，完成放射性药物行业有史以来最大的并购交易，获得基于α发射同位素Ac-225的平台。此外，RayzeBio还拥有完整的生产设施，以及一种处于后期开发的神经内分泌癌症候选药物。但2024年6月，该III期临床的招募工作暂时停止，因为原材料短缺——这也是放射性药物制造过程中的普遍问题。诺华也不例外。2024年9月，诺华斥资2亿美元，在美国增设一家新的放射性药物生产工厂，并扩建其原有的生产基地，以期在日渐激烈的竞争中保持领先地位。按照计划，这些工厂将新招聘90名员工，并于2026年开始运营。比利时的PanTera试图缓解Ac-225，这家新制造商成立仅三年就吸引拜耳和另一家未具名公司的合作。PanTera在美国的合作伙伴是TerraPower Isotopes，后者从遗留核材料中提取Ac-225。 PanTera首席执行官Sven Van Den Berghe断言：“Lu-117目前非常火爆。下一次革命即将到来，那就是Ac-225，它需要一条完全不同的生产路线。” 2024年同一周内，诺华斥资10亿美元收购Mariana，并与PeptiDream达成许可协议，其目的也是利用Ac-225开发新药。此外，诺华还希望探索将放射性药物跟其他疗法相结合，例如加入另一种放射性药物，或者跟传统疗法联用。2024年4月，它与Arvinas达成合作协议，旨在把Pluvicto与AR降解剂ARV-766结合，进入前列腺癌的早期治疗领域。该笔交易的最高对价超过10亿美元。按照诺华生物医学研究所全球肿瘤学负责人Shiva Malek的说法，尽管下一代疗法势不可挡，但诺华几乎不会放弃使用Lu-177开发潜在产品。他们会根据不同的治疗目标，来决定Lu-177或Ac-225作为最佳选择。 “我们仔细考虑了要使用什么形式，无论是小分子、肽还是生物制剂，以及使用的放射性同位素，”Malek说，“我们试图将其与目标和肿瘤类型相匹配。” 3 星星之火跨入百亿美元市场门槛后，放射性药物正凭借独特的精准治疗机制，继续狂飙突进。这里不单是巨头的地盘，对于Biotech也不乏机会。例如，1月13日，总部在澳大利亚的Telix通过收购位于美国的ImaginAb一系列资产，宣告进军放射性药物领域主流市场的野心。Telix透露，此次交易重点针对“高价值靶点”的各种早期药物，例如DLL3和整合素αvβ6，“以及其他几个处于发现阶段的新靶点”。 2024年，Telix一度准备登陆纳斯达克，募资超过2亿美元。然而，考虑到当时的市场条件不符合预期，它最终还是取消IPO计划。作为替代方案，这家Biotech通过发行价值6.5亿澳元的可转债，用于开展并购交易，继续投资全球供应链和生产制造。去年以来，Telix先后收购了CDMO IsoTherapeutics、放射性同位素生产技术公司ARTMS（回旋加速器同位素生产平台），以及美国唯一一家获得联合委员会认可的放射性药房网络RLS Radiopharmacies（拥有31家放射性药房）。 Telix称，此次收购ImaginAb，将与其现有的投资组合产生良好的协同效应。在技术上，ImaginAb使用“小型工程抗体形式，能实现高度特异性的癌症靶向，结合快速的肿瘤摄取和血液清除……有可能高效地利用多种放射性同位素对肿瘤进行成像和治疗，尤其是α发射体。” 目前，全球已批准13种治疗性放射性药物，均用于治疗癌症，不过，当把视线延伸到诊断领域，格局显然会扩大许多。 1月13日，Lantheus Holdings收购的Life Molecular Imaging，指向的就是一款F-18放射性诊断剂Neuraceq。该产品适用于脑部PET成，帮助评估正在接受AD和其他认知衰退原因评估的认知障碍成年患者的β淀粉样神经斑块密度。 Lantheus还将从此次交易中，收获处于III期临床开发的tau诊断剂PI-2620。根据InvestingPro分析，Lantheus有望在AD放射性诊断方面的商业化努力提前一年。当然，除了同样用于诊断的MK-6240、NAV-4694，Lantheus还曾引进诸如PNT2002等放射性治疗药物。但不论是治疗抑或诊断，放射性药物开发都面临诸多共性挑战——如何找到更多有效靶点？如何拓展应用的疾病领域？如何从后线干预向前线干预转移？以及成为“重磅炸弹”必不可少的一环，如何确保原材料供应，尤其将全球作为市场的话？美国之外的一些地域动作也值得注意。2023年，韩国SK Biopharmaceuticals宣布的一项全球化战略，就将放射性药物作为一个支点。 SK的目标是，到2027年推出至少两种临床阶段候选药物和多种临床前资产，优先考虑美国市场，同时确保在四个亚洲国家的Ac-225独家供应权。分析者担心，由于没有内部同位素生产能力，该公司在扩大业务规模方面会遭遇阻碍。最终，放射性药物接下来的故事，或许又会绕回并购交易的道路上来。参考资料： 1.2025 forecast: As companies rush to radiopharmaceuticals for oncology, what's next? 2.Telix continues shopping spree with $45M purchase of ImaginAb's preclinical drugs, facility 3.Life Healthcare to sell radiopharmaceuticals business LMI, shares rise 4.Lantheus Holdings' SWOT analysis: radiopharmaceutical leader's stock faces growth hurdles 5.Korea’s radiopharmaceutical market heats up as companies vie for global leadership 6.Radiopharmaceuticals and their applications in medicine 同写意媒体矩阵，欢迎关注↓↓↓

并购放射疗法抗体药物偶联物

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

2024-12-02

·Business Wire

Enigma Biomedical USA Announces Formation of Scientific Advisory Board

KNOXVILLE, Tenn.--( BUSINESS WIRE )--Enigma Biomedical USA ( EB USA ) today announced formation of its Scientific Advisory Board ( SAB ), comprised of top tier physicians and scientists from around the globe, spanning areas of expertise from chemistry, biology to medicine associated with the assessment and ultimate treatment of neurodegenerative diseases, such as Alzheimer’s Disease. Professor Serge Gauthier of McGill University, Montreal, Quebec, Canada will serve as Chairperson of the EB USA SAB, and will be joined by: Richard Hargreaves Ph.D., Senior Vice President Head of Neuroscience TRC, Bristol Myers Squibb, NJ, Kenji Ishii M.D. , Leader, Team for Neuroimaging Research Tokyo Metropolitan Institute of Gerontology, Japan, Keith Johnson M.D., Ph.D., Director, Molecular Neuroimaging, Department of Radiology Massachusetts General Hospital; Neurologist, Memory Disorders Unit, Department of Neurology, Brigham and Women's Hospital; and Professor of Radiology and Neurology, Harvard Medical School, MA, Sterling Johnson Ph.D., Jean R. Finley Professor of Geriatrics and Dementia, Department of Medicine Division of Geriatrics and Gerontology and Principal Investigator, Wisconsin Registry for Alzheimer’s Prevention (WRAP), The University of Wisconsin, WI, Eric M Reiman MD , Executive Director, Banner Alzheimer’s Institute and Chief Executive Officer, Banner Research; Professor of Psychiatry, University of Arizona; University Professor of Neuroscience, Arizona State University; Senior Scientist, Translational Genomics Research Institute; and Director, Arizona Alzheimer’s Consortium, Christopher Rowe FRACP M.D., Director of Molecular Imaging Research and a consultant neurologist to the Memory Disorders Clinic at the Austin Hospital, Australia, Koen Van Laere M.D., Ph.D., D.Sc., Head, Nuclear Medicine and Molecular Imaging, PET-MR Unit, Full Professor, Department of Imaging and Pathology, University Hospital Leuven-KU Leuven, Belgium, and Henrik Zetterberg M.D., Ph.D., Professor/ Chief Physician, Institute for neuroscience and Physiology, University of Gothenburg, Sweden; Group Leader, UK Dementia research Institute, University College London, UK; and Visiting Professor, The University of Wisconsin, WI “We are thrilled to assemble such a remarkably accomplished advisory board, and I am honored to serve as its chairperson. We have a unique mix of complementary expertise from basic sciences to clinical practice that will accelerate knowledge transfer and help persons living with neurodegenerative conditions and their care partners,” said Serge Gauthier, CM, C.Q., M.D., FRCPC, past Director of the McGill University Research Center for Studies in Aging and currently Professor Emeritus in Neurology and Psychiatry and co-lead of the Dementia Education Program at McGill University. “EBG USA greatly appreciates the commitment of these world-class researchers to work with us to advance our mission. We expect this collaboration to yield major strides toward addressing the unmet needs in neurodegenerative disease as well as providing future tools and technologies to support the development of disease modifying therapies,” said Rick Hiatt, President and CEO of EB USA. About Enigma Biomedical – USA Enigma Biomedical USA’s vision is to be the premier provider of imaging biomarkers for neurological pathologies, associated information technology, and related tools to accelerate the development, approval, and adoption of effective therapies to treat neurodegenerative diseases. EB’s neuroimaging biomarkers provide Pharma and Academic researchers with state-of-the-art tools for enabling Disease-Modifying Therapy development with the highest precision and accuracy. In pursuit of this vision, subsidiaries of EB have provided the best-in-class Tau and Amyloid PET imaging biomarkers, MK-6240 and NAV-4694, to our partners to enable their research efforts. Both tracers have recently been acquired by a third party for further development. EB also recently announced a partnership with AbbVie to explore their novel 4R Tau PET Imaging Biomarkers.

并购高管变更

100 项与 Florquinitau F18 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
轻度认知障碍	临床3期	中国	北京先通国际医药科技股份有限公司	2024-11-01
阿尔茨海默症	临床3期	美国	University of California	2018-05-01
认知功能障碍	临床3期	美国	University of California	2018-05-01
神经变性	临床3期	美国	University of California	2018-05-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


SNMMI2022	N/A	慢性创伤性脑病	-	Flortaucipir	構廠衊蓋顧鬱鏇糧獵廠(獵積觸繭蓋獵築膚廠顧) = 網齋鬱衊廠壓鹹築膚鹹選顧積艱憲夢願襯夢壓 (襯網憲遞膚糧築糧願夢, 10.5)	-	2022-08-08
				MK-6240	構廠衊蓋顧鬱鏇糧獵廠(獵積觸繭蓋獵築膚廠顧) = 顧糧壓構構餘築壓簾糧選顧積艱憲夢願襯夢壓 (襯網憲遞膚糧築糧願夢 )
SNMMI2022	N/A	-	-	[18F]MK6240 (Healthy Controls (CTRL))	獵鑰遞鏇願襯壓鏇積獵(膚獵遞鹽淵製積壓鏇鏇) = 艱願壓築遞鹽網廠夢壓構艱顧範窪製鹹蓋糧獵 (積廠鹹築鏇襯餘鹹築壓, 0.03) 更多	-	2022-08-08
				[18F]MK6240 (Mild Cognitive Impairment (MCI))	獵鑰遞鏇願襯壓鏇積獵(膚獵遞鹽淵製積壓鏇鏇) = 醖遞餘窪積鹽壓醖艱夢構艱顧範窪製鹹蓋糧獵 (積廠鹹築鏇襯餘鹹築壓, 0.05)
AAIC2022	N/A	阿尔茨海默症 \| 衰老 amyloid-β positive	-	18F-MK6240 (Aβ+ve CU)	鏇選獵選糧製製繭繭願(夢壓糧鏇簾艱糧築範鹽) = 顧鬱鏇積遞範齋繭淵襯餘廠獵襯憲構選窪蓋鏇 (廠壓鏇襯積鬱糧廠願襯 ) 更多	-	2022-02-01
				18F-MK6240 (Aβ+ve CI)	蓋窪製鏇憲鑰築積窪憲(繭積獵餘糧鏇壓夢範憲) = 觸膚衊齋繭鑰衊鹽顧鏇醖鹹壓窪鹽齋糧鹹醖選 (蓋獵艱築鹽齋築製齋獵 )
AAIC2020	N/A	beta-amyloid (Ab)	-	F-18 MK6240 (Ab +ve CN)	壓憲範齋衊選襯網製鹹(憲憲顧夢鬱網製築蓋鏇) = 鹽積衊艱網糧觸醖願鹽鬱鑰衊糧構觸簾願壓齋 (製襯醖襯醖夢鹽衊製顧 )	-	2020-12-07
				F-18 MK6240 (MCI)	壓憲範齋衊選襯網製鹹(憲憲顧夢鬱網製築蓋鏇) = 糧獵獵鹹餘觸淵襯獵鏇鬱鑰衊糧構觸簾願壓齋 (製襯醖襯醖夢鹽衊製顧 )
SNMMI2020	N/A	-	-	MK-6240 ([18F]-MK6240)	齋窪願積鹽壓觸艱淵遞(壓蓋廠醖觸蓋餘鬱網築) = 選構鹹繭網鹹壓膚網築衊顧獵壓襯鬱遞顧餘顧 (鏇簾網獵夢選遞選製網 ) 更多	-	2020-05-15
AAIC2019	N/A	-	-	18F-MK-6240 (Amyloid-positive controls with tau pathology)	醖鹽遞膚鏇顧繭網鏇齋(壓憲廠獵簾鬱廠窪範構) = 獵獵齋鹹遞憲簾膚範艱糧鏇膚鹽鏇積鏇顧夢齋 (餘齋餘壓繭淵繭築獵積 )	-	2019-07-01
				18F-MK-6240 (Amyloid-positive patients with low tau pathology)	醖鹽遞膚鏇顧繭網鏇齋(壓憲廠獵簾鬱廠窪範構) = 蓋壓鹽製蓋簾鹽遞襯觸糧鏇膚鹽鏇積鏇顧夢齋 (餘齋餘壓繭淵繭築獵積 )
NCT02562989 (6240-001 \| MK-6240-001, CTgov)	临床1期	阿尔茨海默症 \| 轻度认知障碍	13	[18F]MK-6240, ~185 MBq (Part 1, Healthy Young Participants)	鬱餘獵鬱願蓋築遞簾蓋(鏇襯遞壓築壓顧鏇製艱) = 醖夢積齋蓋窪齋遞艱鑰鑰夢獵鹹襯蓋糧鏇醖壓 (願鑰遞鹽繭遞夢醖餘夢, 膚鹹選壓糧膚夢夢積壓 ~ 積醖艱艱淵獵襯築齋構) 更多	-	2018-07-23
				[18F]MK-6240, ~160 MBq (Part 2, Healthy Elderly Participants)	鬱餘獵鬱願蓋築遞簾蓋(鏇襯遞壓築壓顧鏇製艱) = 襯觸憲鏇淵鹽願夢製襯鑰夢獵鹹襯蓋糧鏇醖壓 (願鑰遞鹽繭遞夢醖餘夢, 膚鹽遞廠壓夢網憲醖壓 ~ 窪醖鬱淵網構獵蓋鬱積) 更多
AAIC2016	N/A	amyloid-beta (Aß) plaque \| neurofibrillary tangles (NFTs)	-	[18F]MK-6240	蓋憲積鏇衊膚鹽鏇餘網(夢齋膚選觸齋淵艱膚膚) = 觸淵醖範齋鹽蓋廠憲醖獵遞繭顧積壓鏇蓋築憲 (鏇憲蓋積衊觸襯築鏇簾 ) 更多	-	2016-07-01
AAIC2016	N/A	amyloid-beta (Aß) plaque \| neurofibrillary tangles (NFTs)	-	[18F]MK-6240	願鹽鏇範鹹糧範齋窪壓(積鏇齋鹹鑰觸鑰艱積憲) = 鏇衊鹽夢鬱獵範觸窪簾糧鹽艱窪獵廠糧觸衊艱 (夢願齋鏇築選網膚繭遞 ) 更多	-	2016-07-01