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2013-06-01

申办/合作机构

Navidea Biopharmaceuticals, Inc.

NCT01812213

/ Terminated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.

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项与 Flutafuranol F-18 相关的文献（医药）

2024-12-01·Alzheimers & Dementia

Plasma Aβ42/Aβ40 and phospho‐tau217 concentration ratios increase the accuracy of amyloid PET classification in preclinical Alzheimer’s disease

Article

作者: Rissman, Robert A

Abstract:

Background:

Our data from several clinical trials of individuals with asymptomatic AD demonstrates that plasma Aβ42/40 quantification by mass spectrometry can serve as a reliable biomarker for predicting elevated brain amyloid as detected by PET. We investigated how adding plasma p‐tau measures to our plasma Aβ42/40 algorithm to streamline identification of eligible participants and reduce burden and trial cost. To determine if the addition of plasma p‐tau181 and/or p‐tau217 concentrations can improve plasma Aβ42/40 algorithms to correctly identify participants with amyloid burden of >20 centiloids with the NAV4694 tracer among individuals screening for participation in the AHEAD preclinical AD trial.

Method:

Plasma amyloid and tau were measured using C2N Diagnostics mass spectrometry. Participant samples (N = 1085) collected prior to the incorporation of plasma Aβ42/40 testing during screening were used. Plasma samples consisted of those with adequate amyloid PET levels (n = 364; 33%) to be eligible for AHEAD and those who did not and screen failed (n = 747; 67%). We quantified Aβ (Aβ42/40) and tau species, including the phosphorylated (p‐tau) and non‐phosphorylated (np‐tau) forms of tau181 and tau217. A ratio of p‐tau to np‐tau was calculated (p‐tau181r and p‐tau217r) to normalize inter‐individual differences in np‐tau. We conducted Receiver Operating Characteristic (ROC) curve analyses fagainst amyloid PET status (>20 centiloids). We fit a Mixture of Experts model and included p‐tau181r and p‐tau217r in the predictive algorithm (Aβ42/40, Age and APOE) for amyloid PET status.

Result:

Plasma samples from N = 1085 composed of 67% Female, 13.5% Hispanic, 3.7% Black or African American with a mean age of 67.6 (SD = 6.1) years. 45% of participants had at least one APOE4 allele. The Area Under the Curve (AUC) for Aβ42/40 was 0.87 (95% CI; 0.84, 0.89), consistent with prior reports. For plasma tau, we found AUCs of 0.74 (95% CI; 0.71, 0.77) with p‐tau181, to 0.91 (95% CI; 0.90, 0.93) with p‐tau217r. The model including covariates p‐tau217r, Aβ42/40, Age and APOE improved AUC to 0.95 (95% CI; 0.93, 0.96).

Conclusion:

Our data suggests that plasma p‐tau217r in addition to Aβ42/40 ratio can significantly improve anti‐amyloid clinical trial screening burden and timelines for recruitment.

2024-12-01·Alzheimers & Dementia

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

Article

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

Abstract:

Background:

Classical 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.

Method:

we 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.

Result:

voxel‐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.

Conclusion:

visual 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.

2024-02-01·Alzheimers & Dementia

Plasma pTau-217 and N-terminal tau (NTA) enhance sensitivity to identify tau PET positivity in amyloid-β positive individuals.

Article

作者: Lantero-Rodriguez, Juan ; Zetterberg, Henrik ; Gauthier, Serge ; Pascoal, Tharick A ; Hosseini, Seyyed Ali ; Kobayashi, Eliane ; Triana-Baltzer, Gallen ; Servaes, Stijn ; Woo, Marcel S ; Macedo, Arthur C ; Rosa-Neto, Pedro ; Lussier, Firoza Z ; Tissot, Cécile ; Arias, Jaime Fernandez ; Mayer, Christina ; Friese, Manuel A ; Snellman, Anniina ; Blennow, Kaj ; Therriault, Joseph ; Benedet, Andrea L ; Karikari, Thomas K ; Stevenson, Jenna ; Massarweh, Gassan ; Wang, Yi-Ting ; Chamoun, Mira ; Kolb, Hartmuth C ; Ashton, Nicholas J ; Rahmouni, Nesrine

INTRODUCTION:

We set out to identify tau PET-positive (A+T+) individuals among amyloid-beta (Aβ) positive participants using plasma biomarkers.

METHODS:

In this cross-sectional study we assessed 234 participants across the AD continuum who were evaluated by amyloid PET with [¹⁸ F]AZD4694 and tau-PET with [¹⁸ F]MK6240 and measured plasma levels of total tau, pTau-181, pTau-217, pTau-231, and N-terminal tau (NTA-tau). We evaluated the performances of plasma biomarkers to predict tau positivity in Aβ+ individuals.

RESULTS:

Highest associations with tau positivity in Aβ+ individuals were found for plasma pTau-217 (AUC [CI_95% ] = 0.89 [0.82, 0.96]) and NTA-tau (AUC [CI_95% ] = 0.88 [0.91, 0.95]). Combining pTau-217 and NTA-tau resulted in the strongest agreement (Cohen's Kappa = 0.74, CI_95% = 0.57/0.90, sensitivity = 92%, specificity = 81%) with PET for classifying tau positivity.

DISCUSSION:

The potential for identifying tau accumulation in later Braak stages will be useful for patient stratification and prognostication in treatment trials and in clinical practice.

HIGHLIGHTS:

We found that in a cohort without pre-selection pTau-181, pTau-217, and NTA-tau showed the highest association with tau PET positivity. We found that in Aβ+ individuals pTau-217 and NTA-tau showed the highest association with tau PET positivity. Combining pTau-217 and NTA-tau resulted in the strongest agreement with the tau PET-based classification.

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2025-01-17

·Business Wire

Neuraly and Enigma Biomedical USA announce a Research License and Commercialization Option Agreement for PET Imaging Biomarker, PMI04

KNOXVILLE, Tenn.--( BUSINESS WIRE )--On January 16, 2025, Neuraly Inc. (Neuraly), a wholly owned subsidiary of D&D Pharmatech Inc., and Enigma Biomedical USA, Inc. (Enigma) announced the signing of a research license and commercialization option agreement for PMI04, a PET (Positron Emission Tomography) imaging biomarker of neuroinflammation developed by Neuraly. Under the agreement, Enigma acquires an exclusive research license for PMI04, as well as the option to negotiate commercialization rights based on the research results. PMI04 is a PET imaging biomarker that selectively binds to CSF-1R (Colony Stimulating Factor 1 Receptor) expressed in activated microglia. It enables visualization of the pathological activity of microglia, the fundamental contributors to neuroinflammatory responses, aiding in the diagnosis of various neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis. Enigma plans to focus its development efforts on utilizing PMI04 for the assessment of neurodegenerative diseases. Currently, PET imaging targeting TSPO (Translocator Protein) is used in neuro research, but exhibits limited specificity, leading to challenging interpretation and quantitative assessment. In contrast, CSF-1R specifically binds to activated microglia, directly correlating with microglial proliferation and survival. This makes PMI04 a next-generation PET imaging biomarker capable of quantifying assessment, early detection, and pathological analysis of inflammation-related neurodegenerative diseases, which may ultimately benefit the development of therapeutics. With successful conclusion of the research, a commercialization license agreement will be established between the two companies, granting Enigma exclusive development and commercialization rights for PMI04. Neuraly will receive an upfront payment and milestone payments based on development and commercialization progress, along with sales royalties upon the commercial sales in the future. Seulki Lee, CEO of Neuraly stated "We hope this partnership will represent a significant step forward in providing alternatives for the diagnosis and treatment of neurodegenerative diseases. We will do our utmost to ensure that PMI04 is commercialized swiftly through close collaboration with Enigma." “We are delighted to have been selected as a development partner by Neuraly,” said Rick Hiatt, President and CEO of Enigma. “We will build on demonstrated successes with the best-in-class neuroimaging biomarkers MK-6240 (Cerveau Technologies) and NAV-4694 (Meilleur Technologies). We believe the Neuraly CSF-1R PET imaging biomarker has unique properties and will prove useful in developing current and future therapeutics for neurodegenerative disease. Our commitment is to expand the availability of this novel investigational imaging agent to the broader scientific community.” About Enigma Biomedical USA, Inc. 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. Enigma’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 Enigma 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. Enigma also recently announced a partnership with AbbVie to explore their novel 4R Tau PET Imaging Biomarkers. About D&D Pharmatech, Inc. and Neuraly Inc. D&D Pharmatech Inc. (D&D) , listed on the KOSDAQ in Korea, specializes in the development of GLP-1 receptor agonists. The company has established a long-term partnership with the Johns Hopkins University School of Medicine to develop imaging biomarkers related to neurodegenerative diseases. Additionally, D&D is conducting clinical trials for GLP-1 candidates in various indications, including a completion of a Phase 2 trial in the U.S. for the weekly injectable GLP-1 receptor agonist pegsebrenatide (NLY01) in Parkinson’s disease patients in 2023. Neuraly Inc. (Neuraly) , D&D's wholly-owned subsidiary located in Gaithersburg, Maryland, USA, specializes in IND-enabling studies and clinical development for D&D’s programs targeting neurodegenerative, metabolic, and fibrotic diseases. Neuraly has successfully cleared multiple INDs and conducted five clinical trials to date, including four completed studies and an ongoing Phase 2 trial of DD01 for metabolic dysfunction-associated steatohepatitis (MASH).

临床2期并购引进/卖出

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.

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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	美国	Navidea Biopharmaceuticals, Inc.	2013-06-01
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	-	阿斯利康制药有限公司	-
认知功能障碍	临床2期	-	Cerveau Technologies, Inc.初创企业	-

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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


NCT01812213 (NAV4-04, CTgov)	临床2期	阿尔茨海默症 \| 轻度认知障碍	76	[18F]NAV4694	製網鹽繭蓋獵餘膚製餘(襯鑰繭餘鏇蓋艱範夢製) = 築壓繭淵鏇簾餘鑰膚築夢醖觸選糧鑰廠衊鏇糧 (鹽鏇窪憲窪鹽糧積膚範, 淵鬱醖襯襯糧齋構鹽衊 ~ 願選餘網憲衊製醖醖選) 更多	-	2024-08-14
AAIC2013	N/A	阿尔茨海默症	-	[18F]NAV4694	鹹鏇糧網觸淵觸願衊範(顧簾齋蓋繭範憲繭糧糧) = 願膚願獵獵鹹壓艱顧鏇遞獵願鏇蓋糧齋鑰窪膚 (簾顧窪獵鹹衊夢構範醖 )	-	2013-07-01
AAIC2013	N/A	阿尔茨海默症	-	[11C]PIB	鹹鏇糧網觸淵觸願衊範(顧簾齋蓋繭範憲繭糧糧) = 鬱積觸積鹹衊夢蓋襯餘遞獵願鏇蓋糧齋鑰窪膚 (簾顧窪獵鹹衊夢構範醖 )	-	2013-07-01