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]

NCT01886820 / Unknown status临床3期

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral Beta-Amyloid When Compared With Postmortem Histopathology

To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology

开始日期2013-06-30

申办/合作机构

Navidea Biopharmaceuticals, Inc.

NCT01812213 / Unknown status临床2期

Beta-Amyloid Imaging With [18F]NAV4694 Positron Emission Tomography (PET) in Predicting Progression to Alzheimer's Disease (AD) in Subjects With Mild Cognitive Impairment (MCI)

To investigate whether [18F]NAV4694 positron emission tomography (PET) scan findings have the ability to distinguish subjects with mild cognitive impairment (MCI) who progress to Alzheimer's disease (AD) from those who do not.

开始日期2013-03-01

申办/合作机构

Navidea Biopharmaceuticals, Inc.

100 项与 Flutafuranol F-18 相关的临床结果

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100 项与 Flutafuranol F-18 相关的转化医学

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100 项与 Flutafuranol F-18 相关的专利（医药）

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项与 Flutafuranol F-18 相关的文献（医药）

2024-01-01·Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring

Inter‐scanner Aβ‐PET harmonization using barrel phantom spatial resolution matching

Article

作者: Masters, Colin L ; Davey, Catherine E ; Rowe, Christopher C ; Williams, Robert C ; Ruwanpathirana, Gihan P ; Johnston, Leigh A

AbstractINTRODUCTIONThe standardized uptake value ratio (SUVR) is used to measure amyloid beta–positron emission tomography (Aβ‐PET) uptake in the brainDifferences in PET scanner technologies and image reconstruction techniques can lead to variability in PET images across scanners. This poses a challenge for Aβ‐PET studies conducted in multiple centers. The aim of harmonization is to achieve consistent Aβ‐PET measurements across different scanners. In this study, we propose an Aβ‐PET harmonization method of matching spatial resolution, as measured via a barrel phantom, across PET scanners. Our approach was validated using paired subject data, for which patients were imaged on multiple scanners.METHODSIn this study, three different PET scanners were evaluated: the Siemens Biograph Vision 600, Siemens Biograph molecular computed tomography (mCT), and Philips Gemini TF64. A total of five, eight, and five subjects were each scanned twice with [18F]‐NAV4694 across Vision‐mCT, mCT‐Philips, and Vision‐Philips scanner pairs. The Vision and mCT scans were reconstructed using various iterations, subsets, and post‐reconstruction Gaussian smoothing, whereas only one reconstruction configuration was used for the Philips scans. The full‐width at half‐maximum (FWHM) of each reconstruction configuration was calculated using [18F]‐filled barrel phantom scans with the Society of Nuclear Medicine and Molecular Imaging (SNMMI) phantom analysis toolkit. Regional SUVRs were calculated from 72 brain regions using the automated anatomical labelling atlas 3 (AAL3) atlas for each subject and reconstruction configuration. Statistical similarity between SUVRs was assessed using paired (within subject) t‐tests for each pair of reconstructions across scanners; the higher the p‐value, the greater the similarity between the SUVRs.RESULTSVision‐mCT harmonization: Vision reconstruction with FWHM = 4.10 mm and mCT reconstruction with FWHM = 4.30 mm gave the maximal statistical similarity (maximum p‐value) between regional SUVRs. Philips‐mCT harmonization: The FWHM of the Philips reconstruction was 8.2 mm and the mCT reconstruction with the FWHM of 9.35 mm, which gave the maximal statistical similarity between regional SUVRs. Philips–Vision harmonization: The Vision reconstruction with an FWHM of 9.1 mm gave the maximal statistical similarity between regional SUVRs when compared with the Philips reconstruction of 8.2 mm and were selected as the harmonized for each scanner pair.CONCLUSIONBased on data obtained from three sets of participants, each scanned on a pair of PET scanners, it has been verified that using reconstruction configurations that produce matched‐barrel, phantom spatial resolutions results in maximally harmonized Aβ‐PET quantitation between scanner pairs. This finding is encouraging for the use of PET scanners in multi‐center trials or updates during longitudinal studies.Highlights

Question: Does the process of matching the barrel phantom‐derived spatial resolution between scanners harmonize amyloid beta–standardized uptake value ratio (Aβ‐SUVR) quantitation?

Pertinent findings: It has been validated that reconstruction pairs with matched barrel phantom‐derived spatial resolution maximize the similarity between subjects paired Aβ‐PET (positron emission tomography) SUVR values recorded on two scanners.

Implications for patient care: Harmonization between scanners in multi‐center trials and PET camera updates in longitudinal studies can be achieved using a simple and efficient phantom measurement procedure, beneficial for the validity of Aβ‐PET quantitation measurements.

2023-03-01·Journal of Nuclear Medicine

Evaluation of Tau Radiotracers in Chronic Traumatic Encephalopathy

Article

作者: Vasdev, Neil ; Varlow, Cassis

Chronic traumatic encephalopathy (CTE) is a neurologic disorder associated with head injuries, diagnosed by the perivascular accumulation of hyperphosphorylated tau protein (phospho-tau) identified at autopsy. Tau PET radiopharmaceuticals developed for imaging Alzheimer disease are under evaluation for brain injuries. The goal of this study was to conduct a head-to-head in vitro evaluation of 5 tau PET radiotracers in subjects pathologically diagnosed with CTE. Methods: Autoradiography was used to assess the specific binding and distribution of ³H-flortaucipir (also known as Tauvid, AV-1451, and T807), ³H-MK-6240 (also known as florquinitau), ³H-PI-2620, ³H-APN-1607 (also known as PM-PBB3 and florzolotau), and ³H-CBD-2115 (also known as ³H-OXD-2115) in fresh-frozen human postmortem CTE brain tissue (stages I-IV). Immunohistochemistry was performed for phospho-tau with AT8, 3R tau with RD3, 4R tau with RD4 and amyloid-β with 6F/3D antibodies. Tau target density (maximum specific binding) was quantified by saturation analysis with ³H-flortaucipir in tissue sections. Results: ³H-flortaucipir demonstrated a positive signal in all CTE cases examined, with varying degrees of specific binding (68.7% ± 10.5%; n = 12) defined by homologous blockade and to a lesser extent by heterologous blockade with MK-6240 (27.3% ± 13.6%; n = 12). The ³H-flortaucipir signal was also displaced by the monoamine oxidase (MAO)-A inhibitor clorgyline (43.9% ± 4.6%; n = 3), indicating off-target binding to MAO-A. ³H-APN-1607 was moderately displaced in homologous blocking studies and was not displaced by ³H-flortaucipir; however, substantial displacement was observed when blocking with the β-amyloid-targeting compound NAV-4694. ³H-MK-6240 and ³H-PI-2620 had negligible binding in all but 2 CTE IV cases, and binding may be attributed to pathology severity or mixed Alzheimer disease/CTE pathology. ³H-CBD-2115 showed moderate binding, displaced under homologous blockade, and aligned with 4R-tau immunostaining. Conclusion: In human CTE tissues, ³H-flortaucipir and ³H-APN-1607 revealed off-target binding to MAO-A and amyloid-β, respectively, and should be considered if these radiotracers are used in PET imaging studies of patients with brain injuries. ³H-MK-6240 and ³H-PI-2620 bind to CTE tau in severe- or mixed-pathology cases, and their respective ¹⁸F PET radiotracers warrant further evaluation in patients with severe suspected CTE.

2022-12-29·Brain Communications

Medial temporal tau predicts memory decline in cognitively unimpaired elderly

Article

作者: Chamoun, Mira ; Rosa-Neto, Pedro ; Therriault, Joseph ; Lussier, Firoza Z ; Rahmouni, Nesrine ; Arfaie, Saman ; Kwan, Angela T H ; Gauthier, Serge ; Tissot, Cecile ; Servaes, Stijn ; Stevenon, Jenna ; Azizi, Zahra ; Bezgin, Gleb ; Pallen, Vanessa

AbstractAlzheimer’s disease can be detected in living people using in vivo biomarkers of amyloid-β and tau, even in the absence of cognitive impairment during the preclinical phase. [18F]-MK-6420 is a high-affinity PET tracer that quantifies tau neurofibrillary tangles, but its ability to predict cognitive changes associated with early Alzheimer’s disease symptoms, such as memory decline, is unclear. Here, we assess the prognostic accuracy of baseline [18F]-MK-6420 tau-PET for predicting longitudinal memory decline in asymptomatic elderly individuals. In a longitudinal observational study, we evaluated a cohort of cognitively normal elderly participants (n = 111) from the translational biomarkers in ageing and dementia study (data collected between October 2017 and July 2020, with a follow-up period of 12 months). All participants underwent tau-PET with [18F]-MK-6420 and amyloid-β PET with [18F]-AZD-4694. The exclusion criteria included the presence of head trauma, stroke or other neurological disorders. There were 111 eligible participants selected based on the availability of amyloid-β PET, tau-PET, MRI and APOEɛ4 genotyping. Among these participants, the mean standard deviation age was 70.1 (8.6) years; 20 (18%) were tau-PET-positive and 71 of 111 (63.9%) were women. A significant association between the baseline Braak Stages I–II [18F]-MK-6240 standardized uptake value ratio positivity and change in composite memory score were observed at the 12-month follow-up, after correcting for age, sex and years of education [logical memory and Rey Auditory Verbal Learning Test, standardized beta = −0.52 (−0.82–0.21), P < 0.001, for dichotomized tau-PET and −1.22 (−1.84−(−0.61)], P < 0.0001, for continuous tau-PET]. Moderate cognitive decline was observed for A + T + over the follow-up period, whereas no significant change was observed for A−T+, A + T- and A-T-, although it should be noted that the A−T + group was small. Our results indicate that baseline tau neurofibrillary tangle pathology is associated with longitudinal changes in memory function, supporting the use of [18F]-MK-6420 PET to predict the likelihood of asymptomatic elderly individuals experiencing future memory decline. Overall, [18F]-MK-6420 PET is a promising tool for predicting memory decline in older adults without cognitive impairment at baseline. This is of critical relevance as the field is shifting towards a biological model of Alzheimer’s disease defined by the aggregation of pathologic tau. Therefore, early detection of tau pathology using [18F]-MK-6420 PET provides us with hope that living patients with Alzheimer’s disease may be diagnosed during the preclinical phase before it is too late.

项与 Flutafuranol F-18 相关的新闻（医药）

2024-02-13

·Business Wire

Enigma Biomedical - USA Announces Appointment of Hartmuth Kolb, PhD as Chief Scientific Officer

KNOXVILLE, Tenn.--( BUSINESS WIRE )--Enigma Biomedical USA (EB) today announced the appointment of Hartmuth Kolb, PhD as Chief Science Officer (CSO). Dr. Kolb’s passion for innovation and scientific rigor has driven his extensive career and broad recognition. He will join Enigma at the beginning of March, 2024. In his 10 year tenure at Johnson & Johnson Innovative Medicine, he served as the Vice President, Neuroscience Biomarkers and Global Head of Imaging. Before joining Johnson & Johnson, Dr. Kolb had roles as SVP Research at Avid/Lilly and was VP of Biomarker Research (PET Radiopharmaceutical Development) at Siemens Medical Solutions. In this latter role, Kolb and his team developed 18F-T807 (aka Flortaucipir), the first Tau-imaging PET biomarker, now available as Tauvid®. Prior to his tenure at Siemens, Dr. Kolb was Associate Professor of Chemistry at The Scripps Research Institute and Chief Operating Officer and Head of Chemistry at Coelacanth Corporation, a company founded by Professor Barry Sharpless to develop novel chemical technologies. In this role, Kolb became a founding Click Chemist and the first author of the foundational Click Chemistry publication which led to Barry Sharpless being awarded the 2022 Nobel Prize for Chemistry. Dr. Kolb serves as the co-chair of the Neuroscience Steering Committee of the Foundation for NIH (FNIH) biomarkers consortium, where he and the other co-chairs oversee a portfolio of pre-competitive biomarker projects related to neurodegeneration and neuropsychiatric diseases. Dr. Kolb has a PhD in Organic Chemistry from the Imperial College, London. “I am passionate about precision neuroscience, based on objective disease-related biomarkers,” said Dr. Kolb, “and am looking forward to joining the first-class Enigma team to develop new imaging biomarker solutions for diagnosis and staging of CNS disorders, which will enable the development of disease modifying therapies for patients.” “Enigma, and our affiliate companies, are focused on providing information and technologies to researchers and clinicians to enable the improvement of brain health,” said Rick Hiatt, Chief Executive Officer of Enigma Biomedical USA and President and CEO of Meilleur Technologies, Inc. “We are thrilled to have Hartmuth join our team and help us develop our long-term strategies and support our future direction. Hartmuth is joining an already strong EB team in which, along with our recently appointed Chief Medical Officer, Dr. Samantha Budd- Haeberlein, we have deep expertise in drug and biomarker development for neurodegenerative disease and a catalyst to continue to achieve our Company’s mission and vision.” 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, including NAV-4694, provide Pharma and Academic researchers with best-in-class tools for enabling Disease-Modifying Therapy development with the highest possible precision and accuracy. EB also recently announced a partnership with AbbVie for exploration of their novel 4R Tau PET Imaging Biomarkers.

高管变更

2023-12-20

·PRNewswire

Meilleur Technologies Inc. Announces Execution of Manufacturing Agreement with PharmaLogic for Production of the Next-Generation Amyloid PET Imaging Biomarker, NAV4694

KNOXVILLE, Tenn. and BOCA RATON, Fla., Dec. 20, 2023 /PRNewswire/ -- Meilleur Technologies Inc. (MTI) today announced it has signed an agreement with PharmaLogic Holdings Corporation ("PharmaLogic") granting PharmaLogic the rights to manufacture fluorine-18 [F18]NAV4694, a next-generation investigational imaging biomarker used in Positron Emission Tomography (PET) imaging studies to assess the status of amyloid plaque in the brain. Amyloid plaques are one of the pathological hallmarks of several neurodegenerative diseases, including Alzheimer's Disease (AD). Continue Reading Logo for Meilleur Technologies,. Under the terms of the agreement, PharmaLogic will manufacture [F18]NAV4694 for use in clinical trials at select United States-based radiopharmacies. "We are delighted that the NAV-694 clinical and research program will be supported by Pharmalogic's extensive PET manufacturing and dispensing expertise," said Rick Hiatt, President and CEO of Meilleur Technologies, Inc. "Meilleur is focused on enabling acceleration of technologies that have the potential to advance the fight against debilitating neurodegenerative disease. Additionally, we believe NAV4694 has unique properties that will prove useful in developing current and future therapeutic agents in neurodegenerative disease and are excited to add PharmaLogic to our growing network of pharmaceutical and academic partners. Our goal is to expand the availability of this novel investigational imaging agent to the broader scientific community." "PharmaLogic is pleased to partner with Meilleur Technologies furthering our commitment to help combat some of the world's most challenging diseases, including Alzheimer's Disease," said Steve Chilinski, CEO of PharmaLogic. About Meilleur Technologies, Inc. Meilleur'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. Meilleur's late-stage biomarker, NAV-4694, provides Pharma and Academic researchers with a 'best in class' second generation ß-Amyloid imaging biomarker capable of detecting and validating Disease Modifying Therapies with the highest possible precision and accuracy for determining the risk of Alzheimer's disease. About PharmaLogic PharmaLogic is a world-class North American contract development and manufacturing organization specializing in novel diagnostic imaging and therapeutic radiopharmaceuticals for the treatment of cancers and other diseases. In addition to an established and reliable network of radiopharmacies, PharmaLogic has decades of expertise in drug development from discovery, through manufacturing and commercialization. The Company seeks to take the lead in the advancement of radiopharmaceutical technology for the benefit of patients worldwide. For more information, visit: SOURCE PharmaLogic Holdings Corp

引进/卖出

2023-12-12

·BioSpace

Meilleur Technologies Inc. Announces Use of the Next-Generation Amyloid PET Imaging Biomarker, NAV-4694, in the Young Blood Institute’s AmβARI study on Amyloid Removal

KNOXVILLE, Tenn.--(BUSINESS WIRE)-- Meilleur Technologies, Inc. today announced a research collaboration agreement with the Young Blood Institute (YBI) on the use of Meilleur’s [F-18]NAV-4694, an investigational imaging agent, in Positron Emission Tomography (PET) scans to assess the status of amyloid plaque in the brain. Amyloid plaques are a hallmark of several neurodegenerative diseases, including Alzheimer’s Disease (AD). The collaboration is focused on using [F-18]NAV-4694 as an imaging biomarker in the YBI AmβARI (Amyloid βeta Assessment & Removal Intervention) study. The Young Blood Institute will utilize Meilleur’s [F-18]NAV-4694 tracer to aid YBI’s study of early detection and clearance of Amyloid βeta to prevent Alzheimer’s disease using Therapeutic Plasma Exchange. Colin Masters, MD, Professor of Dementia Research at the Florey Institute and the University of Melbourne, Melbourne, Australia, will lead the study as YBI Principal Investigator. According to Dr. Masters, “There are multiple tracers for PET scanning available at the moment, and I insisted that we get the scientifically preferred tracer for this clinical study so that the trials we’re planning will provide the strongest clinical evidence of how significantly plasma exchange shifts the PET signal. ref” Mark Urdahl, President & CEO of the Young Blood Institute, added, “While we plan to use the latest mass spec Aβ blood tests to screen subjects for potential Amyloid βeta accumulations in the brain, PET scanning remains the primary modality for confirmation of diagnosis. And NAV4694 provides the highest signal strength of any of the F-18 tracers ref.” “Meilleur is focused on enabling acceleration of technologies that have the potential to advance the fight against debilitating neurodegenerative diseases,” said Rick Hiatt, Chief Exécutive Officier, Meilleur Technologies, Inc. “We believe NAV4694 has unique properties that will prove useful in developing current and future therapeutic agents in neurodegenerative disease and are excited to add YBI to our growing network of pharmaceutical and academic partners, leveraging our globally validated production sites. Our goal is to expand the availability of this novel investigational imaging agent to the broader scientific community.” Ref. : Pascoal et al. 2020. PiB: Klunk et al., Alzheimer Dement, 2015. NAV: Rowe et al., J Nucl Med, 2016. FBB: Rowe et al., EJNMMI, 2017. FBP: Navitsky et al., Alzheimer Dement, 2018. FLT: Battle et al., EJNMMI Research, 2018. About Meilleur Technologies, Inc. Meilleur’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. Meilleur’s late-stage biomarker, NAV-4694, provides Pharma and Academic researchers with a ‘best in class’ second generation ß-Amyloid imaging biomarker capable of detecting and validating Disease Modifying Therapies with the highest possible precision and accuracy for determining the risk of Alzheimer’s disease. About the Young Blood Institute The Young Blood Institute was established as a non-profit clinical research organization to study new uses for Therapeutic Plasma Exchange therapies that have been used for decades to address autoimmune disorders. YBI’s study focus on age-associated disorders, as well as early pre-clinical findings and unique protocol developments for cognitively normal subjects, have led to an expansion into secondary prevention studies and strategies around dementia and dementia of the Alzheimer’s type, in particular. View source version on businesswire.com: Contacts Meilleur Technologies, Inc. Rick Hiatt, 617-906-2715 Young Blood Institute Mark Urdahl, 844-924-4648 Source: Meilleur Technologies, Inc. View this news release online at:

临床研究

100 项与 Flutafuranol F-18 相关的药物交易

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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	临床3期	-	阿斯利康制药有限公司	-
阿尔茨海默症	临床3期	-	Cerveau Technologies, Inc.初创企业	-
阿尔茨海默症	临床3期	-	Navidea Biopharmaceuticals Ltd.	-
轻度认知障碍	临床2期	美国	Navidea Biopharmaceuticals, Inc.	2013-03-01
认知功能障碍	临床2期	-	Cerveau Technologies, Inc.初创企业	-
认知功能障碍	临床2期	-	阿斯利康制药有限公司	-

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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


AAIC2013	N/A	阿尔茨海默症	-	[18F]NAV4694	鹽願艱願範壓淵選窪夢(獵觸願繭壓築選願襯膚) = 壓餘鑰醖鏇廠鹹廠糧鬱壓選鏇築壓壓選醖繭齋 (鑰鏇觸壓衊構願網選襯 )	-	2013-07-01
				[11C]PIB	鹽願艱願範壓淵選窪夢(獵觸願繭壓築選願襯膚) = 窪鹽醖築範淵廠衊製鑰壓選鏇築壓壓選醖繭齋 (鑰鏇觸壓衊構願網選襯 )
AAIC2012	N/A	痴呆	-	11C-PiB	範選膚衊餘鏇蓋膚餘膚(夢繭齋艱醖鏇選襯窪網) = 鏇壓壓製壓觸壓願餘築壓夢觸壓製選積淵鹽鑰 (壓衊網衊觸夢顧艱鹽蓋 ) 更多	-	2012-07-01
				18F-AZD4694	範選膚衊餘鏇蓋膚餘膚(夢繭齋艱醖鏇選襯窪網) = 繭鑰鏇襯積蓋窪製淵鹽壓夢觸壓製選積淵鹽鑰 (壓衊網衊觸夢顧艱鹽蓋 ) 更多