This project is aimed at improvement of glioblastoma (GBM) diagnostic strategies for discrimination of tumor progression and chemo- and radiotherapeutic treatment-related changes in brain tissue. The study will elucidate the diagnostic value of PET imaging with use of amyloid-β radioisotope tracer Amyvid (Florbetapir F18) for GBM. The results of the study will provide data for development of new approach for GBM diagnostics.

Start Date01 Jul 2024

Sponsor / Collaborator

Universidad Central del Caribe, Inc.

[+1]

ChiCTR2400091472 / RecruitingNot ApplicableIIT

Evaluation of the association of 18F-AV45 PET / CT imaging and the clinical severity of Alzheimer's disease patients: a prospective, single-center clinical cohort study

Start Date23 Feb 2024

Sponsor / Collaborator

Peking University Shenzhen Hospital

NCT05464368 / RecruitingPhase 1IIT

Comparison of 18F-RO948, 18F-MK6240, and 18F-GTP1 Radiopharmaceuticals in Patients With Alzheimer Disease and Older Controls

This is an open label study to compare three new generation TAU radioligands, 18F-RO948 (formerly known as 18F-6958948), 18F-MK6240, and [18F]GTP1for imaging of taupathy and demonstrate their absence of off-target binding in patients with Alzheimer disease (AD) and older healthy controls (OC). The study will directly compare AD and OC with these three next-generation TAU radioligands and compare each of them with historical data of the current most widely used first generation radioligand, 18F-AV1451. Upto38 (30 AD (Amyloid +)and 8 OC (Amyloid -), matched for age and sex with A+ subjects) male and female subjects aged 50-100 will be enrolled in this study protocol: up to 8 for Cohort 1, up to 8 for Cohort 2, and up to 22 for Cohort 3. The study consists of three cohorts: Cohort 1: Up to8 AD subjects (A+; CDR 0.5 and 1)will receive two PET scans in random order, with receiving either18F-RO948 or18F-MK6240 at the first scan. A third scan with 18F-GTP1is possible, depending on timing and radiotracer availability Cohort 2:Up to8 OC (A-; CDR=0)subjects will receive two PET scans in random order, with receiving either18F-RO948or 18F-MK6240 at the first scan. A third scan with 18F-GTP1is possible, depending on timing and radiotracer availability Cohort 3:Up to 22 (A+; CDR = 0, .5 and 1) subjects will receive three PET scans in random order, with receiving 18F-RO94818F-MK6240 or18F-GTP1at the first scan. Efforts will be made to include about 1/3 CDR = 0, 1/3 CDR .5, and 1/3 CDR 1 in Cohort 3.

Start Date01 Feb 2023

Sponsor / Collaborator

Washington University School of Medicine

[+1]

100 Clinical Results associated with Florbetapir F-18

100 Translational Medicine associated with Florbetapir F-18

100 Patents (Medical) associated with Florbetapir F-18

226

Literatures (Medical) associated with Florbetapir F-18

01 Feb 2025·Journal of Nutrition Health & Aging

Impact of diabetes on the progression of Alzheimer’s disease via trajectories of amyloid–tau–neurodegeneration (ATN) biomarkers

Article

Author: Kim, Eun Woo ; Kim, Eosu ; Kim, Keun You

BACKGROUND:

Alzheimer's disease (AD) is characterized by the accumulation of abnormal proteins, such as β-amyloid and tau, in the brain, which precedes cognitive impairment. Although diabetes mellitus (DM) is a well-established risk factor for AD, few studies have investigated how the presence of DM affects the sequential pathogenesis of AD, specifically within the amyloid-tau-neurodegeneration (ATN) and cognition framework.

OBJECTIVES:

This study aims to investigate the trajectories of ATN biomarkers in relation to the presence of DM in the preclinical and prodromal stages of AD.

DESIGN:

Participants with normal cognition (CN) or mild cognitive impairment (MCI) at baseline were included. Subjects were followed for 12-192 months, with neuroimaging and cognitive assessments conducted at every 12 or 24 months.

SETTING:

This study utilized data from the Alzheimer's Disease Neuroimaging Initiative (ADNI) database.

PARTICIPANTS:

A total of 603 participants aged 55-90 years were included, comprising 284 CN (25 with DM, 259 without DM) and 319 MCI (39 with DM, 280 without DM) individuals.

MEASUREMENTS:

ATN biomarkers were identified using florbetapir positron emission tomography (PET), flortaucipir PET, and magnetic resonance imaging (MRI), respectively. Cognition was assessed using the Clinical Dementia Rating-Sum of Boxes (CDR-SB) and Mini-Mental State Examination (MMSE). Moderation analysis was conducted to investigate the effect of DM on the association between ATN biomarkers of AD.

RESULTS:

Elevated amyloid standardized uptake value ratios (SUVRs) were associated with increased tau levels in the hippocampus, and this association was significantly enhanced by the presence of DM in MCI participants (p = 0.021). DM also strengthened the association between increased tau SUVR levels and neurodegeneration (indicated by decreased entorhinal cortical volumes; p = 0.005) in those with MCI. Furthermore, DM enhanced the association of decreased entorhinal (p = 0.012) and middle temporal cortex (p = 0.031) volumes with increased (worsened) CDR-SB scores in MCI participants. However, DM did not predict significant longitudinal changes in ATN pathology or cognitive decline in CN participants.

CONCLUSIONS:

Our study suggests that DM may increase the risk of AD by accelerating each step of the A-T-N cascade in the prodromal stage of AD, underscoring the importance of DM management in preventing the MCI conversion to AD.

01 Jan 2025·STROKE

Do Amyloid Cerebral Deposits Influence the Long-Term Poststroke Cognitive Outcome?: The IDEA3 Study

Article

Author: Wollenweber, Frank A. ; Deramond, Hervé ; Marchal, Etienne ; Loas, Gwénolé ; Shields, Trevor ; Diouf, Momar ; Courselle-Arnoux, Audrey ; Picard, Carl ; Berrissoul, Hassan ; Despretz-Wannepain, Sandrine ; Barbay, M. ; Meyer, Marc-Etienne ; Trinchard, Niels ; Leclercq, Claire ; Constans, Jean-Marc ; Lamy, Chantal ; Canaple, Sandrine ; Godefroy, Olivier ; Roussel, Martine

BACKGROUND::

Although the presence of amyloid deposits is associated with a more severe cognitive status in patients with stroke at baseline, its influence on the subsequent cognitive outcome has not been extensively assessed. The primary objective of the present study of the IDEA3 (Imagerie des dépôts amyloïdes cérébraux par florbetapir AV-45 et diagnostic des déficits cognitifs et démence post Accident Vasculaire Cérébral) cohort was to determine the influence of amyloid positron emission tomography (PET) status on the 5-year cognitive outcome.

METHODS::

This longitudinal study performed in Amiens University Hospital (inclusions: October 2014 to October 2019; last visits: October 2018 to February 2023) has included 91 patients with stroke (ischemic stroke, 89%; hemorrhagic stroke, 11%) with florbetapir PET data at baseline (positive, n=14). Patients underwent annually comprehensive clinical and cognitive assessments for 5 years after the PET scan. The primary outcome was incident dementia; secondary outcomes were incident cognitive impairment, total prevalence of cognitive impairment, and modified Rankin Scale score.

RESULTS::

A survival analysis (mean poststroke follow-up, 80.4±27 months) showed that the incidence of incident dementia was higher in the PET-positive patients (odds ratio, 9.6 [95% CI, 2.5–36.9]; P =0.001), as was the incidence of incident cognitive impairment (odds ratio, 10 [95% CI, 1.9–52.3]; P =0.003). A Cox regression analysis showed that the association between amyloid status and the incidences of dementia ( P =0.001) and cognitive impairment ( P =0.007) was still significant after adjustment for age, education, prestroke modified Rankin Scale score and cognitive impairment, stroke type, and the PET status×stroke type interaction. Considering the overall prevalence at the last follow-up in the whole study population (n=91 patients), PET positivity was associated with an elevated risk of dementia (odds ratio, 6 [95% CI, 1.76–20.5]; P =0.002) and poststroke cognitive impairment (odds ratio, 6.25 [95% CI, 1.77–22]; P =0.002). The final modified Rankin Scale score did not differ ( P =0.3) according to PET status.

CONCLUSIONS::

Our results demonstrate the major impact of amyloid deposition on the stroke outcome and emphasized the need for comprehensive etiologic workup in patients with poststroke cognitive impairment.

REGISTRATION::

URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02813434.

01 Sep 2024·CURRENT PROBLEMS IN CARDIOLOGY

Advancements and challenges in cardiac amyloidosis imaging: A comprehensive review of novel techniques and clinical applications

Review

Author: Jawa, Zabah ; Hovseth, Chad ; Albulushi, Arif ; Sallam, Mansour ; Al Hajri, Ruqaya ; Al-Mukhaini, Mohammed ; El Hadad, Mohamed Gamal

Cardiac amyloidosis, characterized by amyloid fibril deposition in the myocardium, leads to restrictive cardiomyopathy and heart failure. This review explores recent advancements in imaging techniques for diagnosing and managing cardiac amyloidosis, highlighting their clinical applications, strengths, and limitations. Echocardiography remains a primary, non-invasive imaging modality but lacks specificity. Cardiac MRI (CMR), with Late Gadolinium Enhancement (LGE) and T1 mapping, offers superior tissue characterization, though at higher costs and limited availability. Scintigraphy with Tc-99m-PYP reliably diagnoses transthyretin (TTR) amyloidosis but is less effective for light chain (AL) amyloidosis, necessitating complementary diagnostics. Amyloid-specific PET tracers, such as florbetapir and flutemetamol, provide precise imaging and quantitative assessment for both TTR and AL amyloidosis. Challenges include differentiating between TTR and AL amyloidosis, early disease detection, and standardizing imaging protocols. Future research should focus on developing novel tracers, integrating multimodality imaging, and leveraging AI to enhance diagnostic accuracy and personalized treatment. Advancements in imaging have improved cardiac amyloidosis management. A multimodal approach, incorporating echocardiography, CMR, scintigraphy, and PET tracers, offers comprehensive assessment. Continued innovation in tracers and AI applications promises further enhancements in diagnosis, early detection, and patient outcomes.

News (Medical) associated with Florbetapir F-18

14 Nov 2024

·www.prnewswire.com

New Investment from the Alzheimer's Drug Discovery Foundation's Diagnostics Accelerator (DxA) Leads Efforts to Develop Standardization Materials for Leading Diagnostic Biomarker

The DxA partners with Dr's Henrik Zetterberg and Nicholas Ashton to create critical standardized reference materials for leading Alzheimer's blood biomarker, p-Tau217, to ensure consistency across global research and clinical settings NEW YORK, Nov. 14, 2024 /PRNewswire/ -- The Alzheimer's Drug Discovery Foundation (ADDF)'s Diagnostics Accelerator today announced a $1.18M investment in the University of Gothenburg (Sweden) to develop standardization reference materials for phosphorylated tau 217 (p-tau217) blood tests, the leading diagnostic blood biomarker for Alzheimer's disease. The project will be led by Henrik Zetterberg, MD, PhD and Nicholas Ashton, PhD, from the University of Gothenburg and Banner Health, who are both internationally recognized for their leadership and advancement of fluid biomarkers for central nervous system diseases such as Alzheimer's. The primary objective of the project is to create a certified reference material that assay developers can use as a baseline to test against when developing a p-tau217 blood test. Continue Reading Diagnostics Accelerator "Blood tests are emerging as one of the most transformative developments in Alzheimer's diagnosis and treatment," said Howard Fillit, MD, Co-Founder and Chief Science Officer at the ADDF. "With science accelerating at an unprecedented pace, it is critical that we develop tools that provide a consistent benchmark across all clinical settings. This investment will enhance the accuracy and comparability of test results so patients across the globe have access to reliable diagnostics so they can get the right treatment options for this debilitating disease." Similar efforts to standardize amyloid beta 1-42 (Aβ42) and total tau (t-tau) in cerebrospinal fluid (CSF), along with advances in imaging and amyloid testing, have significantly advanced Alzheimer's research and diagnosis. These biomarkers are crucial for understanding the disease's underlying biology as well as treating the disease. Applying these insights to standardizing p-tau in blood has the potential to become essential to diagnosing Alzheimer's, offering a unique opportunity to move the process forward for more patients. "Providing researchers with evidence-based certified guidelines will help companies calibrate more uniform assays," said Henrik Zetterberg, MD, PhD, Chief Physician and Professor at Institute of Neuroscience and Physiology at University of Gothenburg in Sweden as well as the 2024 Goodes Prize winner. "There is an urgent need to standardize p-tau217 for global clinical implementation. Support from the DxA is critical to project success and is indicative of its leadership in the biomarker diagnostics field." The DxA has invested more than $70 million in nearly 70 projects, underscoring its commitment to bringing accessible, affordable, and scalable diagnostics to patients struggling with Alzheimer's disease. Along with blood tests, the DxA's diverse portfolio includes retinal scans and digital tools that will not only provide patients with early and accurate diagnoses, but also have the potential to be used for screening, prognostic, and prevention efforts. As the Alzheimer's field continues to evolve rapidly, the way the disease is perceived, diagnosed, and treated will also mature. Adding the parameters built into standardized guidelines will ensure that meaningful momentum continues in the pursuit of accurate, accessible, and effective diagnostics. "Blood-based biomarkers like p-tau217 will be one of the many novel biomarkers that will be essential to laying the foundation for combination therapies and a precision medicine approach, representing the future of Alzheimer's treatment. These new tools will move Alzheimer's diagnostics closer to those of other diseases of aging, such as cancer, where personalized treatments are used based on each patient's unique biomarker profile," said Dr. Fillit. About The Alzheimer's Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $290 million to fund over 750 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 20 countries. To learn more, please visit: . About The Diagnostics Accelerator (DxA) The Diagnostics Accelerator, created in July 2018, is a $100 million global research initiative from partners including ADDF Co-Founder Leonard A. Lauder, Bill Gates, Jeff Bezos, MacKenzie Scott, the Dolby family, the Charles and Helen Schwab Foundation, The Association for Frontotemporal Degeneration, among others, to develop novel biomarkers for the early detection of Alzheimer's disease and related dementias. This research initiative is dedicated to accelerating the development of affordable and accessible biomarkers to diagnose Alzheimer's disease and related dementias and advance the clinical development of more targeted treatments. Through translational research awards and access to consulting support from industry experts, this program will challenge, assist and fund the research community in both academia and industry to develop novel peripheral and digital biomarkers. SOURCE Alzheimer's Drug Discovery Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Diagnostic Reagents

07 Oct 2024

·www.prnewswire.com

New Considerations for Accelerating Combination Therapy Trials to be Showcased at 2024 Clinical Trials on Alzheimer's Disease Conference

Combination Therapy Approach Stemming from ADDF Advisory Board Expected to Shape the Next Generation of Alzheimer's Treatments Novel Therapies Guided by the Biology of Aging Take Center Stage at CTAD, Reflecting the Evolution of the Drug Pipeline NEW YORK, Oct. 7, 2024 /PRNewswire/ -- The Alzheimer's Drug Discovery Foundation (ADDF) will be leading a roundtable, "Advancing Combination Therapy: Discussion on Key Considerations, Perspectives, and Promising Avenues for the Future of Alzheimer's Treatments," at the 2024 Clinical Trials on Alzheimer's Disease (CTAD) conference, which will be held October 29th through November 1st in Madrid, Spain. Moderated by Jeffrey Cummings, MD, ScD, Joy Chambers-Grundy Professor of Brain Science at the School of Integrated Health Sciences at University of Nevada, Las Vegas (UNLV), the panel will feature Howard Fillit, MD, Co-Founder and Chief Science Officer of the ADDF alongside leading experts from industry, academia, and clinical research. The panel takes place on Wednesday, October 30th at 1:45pm CET and will expand upon the recommendations of an expert advisory board—convened by the ADDF at the beginning of the year—that recently provided key considerations on how best to approach and accelerate combination therapy trials for Alzheimer's. "Decades of research has brought us to a pivotal point in the field where the learnings and advances we've gained can now be applied to a robust and diverse pipeline, create a promising path forward for combination therapy trials. These more complex trials—that will look to combine anti-amyloids with novel therapies—are critical to developing the next generation of treatments that will enable precision medicine approach," notes Dr. Fillit. "The patients and families living with this debilitating disease cannot afford for us to take our foot off the gas, we must maintain the momentum toward developing a much-needed personalized and multi-pronged solution." Dr. Fillit will also chair a session, "Emerging Solutions: Novel Approaches to Treating Alzheimer's Disease," on Thursday, October 31st at 11:25am CET. This session will highlight several promising therapeutic programs exploring the underlying aging pathologies contributing to the onset of Alzheimer's, which are indicative of the larger drug pipeline where nearly 75% of Alzheimer's drugs in clinical trials are exploring novel targets beyond amyloid and tau. CTAD will feature several key sessions from ADDF-funded investigators, whose work in drug development and biomarkers is shaping and leading the field towards the holy grail of Alzheimer's treatments—combination therapy and precision medicine, similar to cancer care. Dr. Fillit will participate in several sessions around timely developments: Roundtable: "Forging the Path Forward: Capitalizing on Recent Alzheimer's Momentum through Strategic Investments in Novel Therapeutics" on Wednesday, October 30th at 1:45pm CET Moderator: Jeffrey Cummings, MD, ScD (UNLV) Panelists: Howard Fillit, MD (ADDF), Michael Gold, MD (Compass Pathways), Suzanne Hendrix, PhD (Pentara), Mark Mintun, MD, (Eli Lilly), and Jin Zhou, PhD (Eisai) Session: "Emerging Solutions: Novel Approaches to Treating Alzheimer's Disease" on Thursday, October 31st at 11:25 am CET Chair: Howard Fillit, MD Additional sessions from ADDF-funded investigators include: Oral Communication: "Results from COG0201: a Randomized, Placebo-controlled, Double-blind, International, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Adults with Mild-to-Moderate Alzheimer's Disease" with Cognition Therapeutics on Tuesday, October 29th at 5:55pm CET Late Breaker: "Safety and Preliminary Efficacy of AAV Gene Therapy (LX1001) in Patients with APOE4 Homozygote Alzheimer's Disease – Interim Data from a Phase 1/2, Open-Label, 52-Week, Multicenter Study" with Lexeo on Wednesday, October 30th at 10:50am CET Late Breaker: "Plasma p-tau217 and related CSF proteomic markers of pathological progression are slowed by p75NTR modulation: A Phase 2a trial of LM11A31 in Alzheimer's disease" with PharmatophiX on Thursday, October 31st at 8:30am CET To view the full program for the 2024 CTAD conference, visit the conference webpage. About The Alzheimer's Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $290 million to fund over 750 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 20 countries. To learn more, please visit: . SOURCE Alzheimer's Drug Discovery Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2

25 Sep 2024

·www.businesswire.com

C2N Receives Funding from Diagnostics Accelerator to Develop a Decentralized Clinical Mass Spectrometry Solution to Enable High-Performance Alzheimer’s Disease Testing Worldwide

ST. LOUIS--( BUSINESS WIRE )-- C2N Diagnostics, LLC , an international leader with its Precivity blood tests to help diagnose Alzheimer’s disease, aims to create a fully automated, standardized, high resolution liquid chromatography-mass spectrometry (LC-MS) platform to enable the local deployment of the precise innovation at the core of its clinical and research biomarkers in clinical labs around the world. C2N has received a groundbreaking investment up to $7.025 million from the Alzheimer’s Drug Discovery Foundation’s (ADDF) Diagnostics Accelerator initiative, which is focused on efforts to develop cutting-edge biomarkers and novel diagnostic technologies that aid in the early detection and diagnosis of Alzheimer’s and clinical trial design. C2N seeks to transform Alzheimer’s disease diagnosis and inform medical management and treatment decisions by addressing an unmet clinical need through its high-performance LC-MS solution. The company says it will create an end-to-end platform, including instruments and diagnostic kits, that will enable leading research and clinical labs around the world to aid healthcare providers in the detection of fluid biomarkers that reflect core brain pathologies of Alzheimer's disease. The initiative will accommodate multiple assays tracking both amyloid and tau pathology and enable a framework for adding future C2N assays targeting different measures of neuropathology implicated in multiple brain diseases. C2N believes this decentralized process for high-performance testing, developed and qualified in a regulatory-compliant manner, is a requisite to address the growing global demand for early and accurate disease detection. Landmark Research Highlights Effectiveness of C2N’s Precivity Blood Tests for Alzheimer’s Disease Diagnosis The Journal of the American Medical Association recently published research that showed the PrecivityAD2™ test delivered a highly statistically significant accuracy of over 90% at a pre-defined, single binary cutoff compared to cerebrospinal fluid (CSF) analysis or amyloid PET analysis; the company’s LC-MS platform played an essential role in this outcome. Dr. Howard Fillit, Co-Founder and Chief Science Officer of ADDF, says, “C2N’s Precivity blood tests answer a critical need for less costly and more accessible diagnostic testing in memory and dementia care. Their tests are highly sensitive and accurate clinical tools that aid healthcare providers in the diagnosis and treatment of Alzheimer’s disease. This new investment in C2N’s LC-MS clinical testing platform brings us closer to the day when even more patients will be able to rely on blood tests to help diagnose Alzheimer’s disease.” Niranjan Bose, PhD, B Pharm, Managing Director, Health and Life Sciences at Gates Ventures, says, “C2N’s impressive track record includes establishing itself as a leading innovator in the field of high-performance blood biomarkers that are playing a pivotal role in the early diagnosis of Alzheimer’s disease. This investment furthers our aim to address the global burden of Alzheimer’s disease by supporting efforts to diagnose the disease earlier, catalyze a more diverse drug pipeline, accelerate clinical trial enrollment, and facilitate data sharing. The approach to develop and validate a clinical lab workstation along with Precivity diagnostic test kits could be a game-changer.” C2N CEO Dr. Joel Braunstein says, “Early and accurate detection represents the greatest chance for transforming the trajectory of Alzheimer’s disease through early treatment and prevention. We thank the Diagnostics Accelerator for their trust and confidence in our approach. This project aims to truly redefine what it means to offer high-performance Alzheimer’s disease testing on a global scale. We believe the potential reach of our scale-up achievable through an LC-MS clinical analyzer that can run our proprietary portfolio of Precivity™ tests is significant. Many research and clinical labs at locations throughout the world have already expressed interest in adopting our tests. We look forward to working with these groups in the years ahead as we seek to make that aspiration a reality.” The global scalability project will run concurrently with existing testing at the C2N laboratory in St. Louis, which is a CLIA-certified, CAP-accredited laboratory that performs the Precivity tests as Laboratory Development Tests (LDT). This news, occurring during World Alzheimer’s Month, adds to other developments, including Unilabs and C2N signing a multi-year partnership agreement that will increase access to C2N’s Precivity™ portfolio of blood tests on an exclusive basis in Europe, including Norway, Switzerland, and the United Kingdom. The agreement will also provide access in Peru, Saudi Arabia, and the United Arab Emirates. In addition, C2N has entered into a non-exclusive agreement with Mayo Clinic Laboratories , for inclusion of C2N’s Precivity tests in Mayo Clinic Laboratories’ test offerings to its clients. C2N received a Breakthrough Device Designation from the U.S. Food and Drug Administration in 2018. C2N is a preferred diagnostics provider by many of the leading biopharmaceutical companies throughout the world. All Precivity tests must be ordered by an authorized healthcare provider; patients in the United States can easily schedule a blood draw appointment from C2N’s network of over 700 patient service centers and 13,000 mobile phlebotomists. About C2N Diagnostics, LLC C2N Diagnostics is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C2N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health. C2N’s high-resolution mass spectrometry-based biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. C2N assays have been used in over 150 Alzheimer’s disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies (DMTs) that are changing the trajectory of Alzheimer’s disease. C2N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer’s Association, and other non-profits and consortiums. Over 30,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review. C2N has partnered with numerous leading clinical diagnostic labs throughout the world to offer expanded Precivity™ testing access to providers and patients, including Unilabs across 75 countries, Grupo Fleury in Brazil and Healius Pathology in Australia for clinical use, and with Mediford Corporation in Japan for research purposes. C2N also recently announced it has entered into a non-exclusive agreement with Mayo Clinic Laboratories. The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, Alzheimer’s Association and BrightFocus Foundation. For more information visit www.C2N.com . About Precivity™ Tests The Precivity™ tests are innovative new blood tests intended for use in patients 55 and older with signs or symptoms of mild cognitive impairment or dementia. These tests aid healthcare providers in the detection of amyloid plaques in the brain, a pathological hallmark of Alzheimer's disease, and inform medical management and treatment decisions. About Mass Spectrometry A mass spectrometer is a device that produces charged particles (ions) from biological substances and biomarkers present in complex tissues and fluids like blood. The platform then uses electric and magnetic fields to measure the mass of the charged particles. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) offers advantages of true multiplexing, quantitative accuracy, high sensitivity, high specificity, and wide dynamic range, enabling definitive identification and quantification of Alzheimer’s disease biomarkers at both low and high abundance. High resolution LC-MS/MS is an ideal platform to evaluate multiple complex biomarkers simultaneously to help optimize diagnostic accuracy. About The Alzheimer’s Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $290 million to fund over 750 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 20 countries. To learn more, please visit: http://www.alzdiscovery.org/ . About The Diagnostics Accelerator (DxA) The Diagnostics Accelerator, created in July 2018, is a $100 million global research initiative from partners including ADDF Co-Founder Leonard A. Lauder, Bill Gates, Jeff Bezos, MacKenzie Scott, the Dolby family, the Charles and Helen Schwab Foundation, The Association for Frontotemporal Degeneration, among others, to develop novel biomarkers for the early detection of Alzheimer's disease and related dementias. This research initiative is dedicated to accelerating the development of affordable and accessible biomarkers to diagnose Alzheimer's disease and related dementias and advance the clinical development of more targeted treatments. Through translational research awards and access to consulting support from industry experts, this program will challenge, assist and fund the research community in both academia and industry to develop novel peripheral and digital biomarkers.

Breakthrough Therapy

100 Deals associated with Florbetapir F-18

External Link

KEGG	Wiki	ATC	Drug Bank
D09617	Florbetapir F-18	V09AX05	DB09149

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Alzheimer Disease	EU	Eli Lilly Nederland BV	14 Jan 2013
Alzheimer Disease	IS	Eli Lilly Nederland BV	14 Jan 2013
Alzheimer Disease	LI	Eli Lilly Nederland BV	14 Jan 2013
Alzheimer Disease	NO	Eli Lilly Nederland BV	14 Jan 2013
Contrast agents	US	Avid Radiopharmaceuticals, Inc.	06 Apr 2012

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Dementia due to Alzheimer's disease (disorder)	Phase 3	CN	JYAMS PET Research & Development Ltd.	20 Oct 2022
Cognitive Dysfunction	Phase 3	US	Avid Radiopharmaceuticals, Inc.	01 Jul 2011
Mild cognitive disorder	Phase 3	-	Avid Radiopharmaceuticals, Inc.	01 Feb 2011
Chronic Traumatic Encephalopathy	Phase 2	US	Avid Radiopharmaceuticals, Inc.	01 Jun 2014
Lewy Body Disease	Phase 2	US	Avid Radiopharmaceuticals, Inc.	01 Mar 2010
Striatonigral Degeneration	Phase 2	US	Avid Radiopharmaceuticals, Inc.	01 Mar 2010
Frontotemporal Dementia	Phase 2	GB	Avid Radiopharmaceuticals, Inc.	01 Sep 2009
Parkinson Disease	Phase 2	US	Avid Radiopharmaceuticals, Inc.	01 Jan 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01683825 (CTgov)	Phase 4	Senile cardiac amyloidosis	23	F-18 florbetapir PET	zgqzlibkmo(anszljpgpz) = deqclrjbuj zdissjfpwq (mikstnreyu, rzeqaexwzx - txiqvhbplm) View more	-	13 Apr 2022
NCT01767493 (CTgov)	Phase 4	Multiple Sclerosis, Relapsing-Remitting	19	[18F]Florbetapir PET imaging	tmgzujpewu(ocszteeiaj) = habzdcskai viyiqvqzbo (lgrbcwyjyi, xpbldjcmnd - maolivceei) View more	-	27 Aug 2021
AAIC2018	Not Applicable	Alzheimer Disease amyloid beta (Aβ)	-	[18F]FLORBETAPIR (AD patients)	jrcpztszbk(fvdzifqwbk) = tvelrhvmnu qofkayulbo (mblhntwjhh )	-	01 Jul 2018
				[18F]FLORBETAPIR (Controls)	jrcpztszbk(fvdzifqwbk) = wzomdrltnr qofkayulbo (mblhntwjhh )
NCT01518374 (CTgov)	Phase 2	Alzheimer Disease \| Mild cognitive disorder	1,768	Florbetapir F 18	qfeuwqcnxi(boijlftfrw) = xfotyhgprb pzojhggnss (tkzjilfiur, tycqxfbcov - myotbwzajj) View more	-	14 Jun 2018
SNMMI2018	Not Applicable	-	4	18F-florbetapir	qlmwegrpgg(sgtunefidk) = hvwsdqnrye qerzddbrcp (dmebfklvrz, 0.20)	-	23 May 2018
				18F-florbetaben	qlmwegrpgg(sgtunefidk) = wccchkrwff qerzddbrcp (dmebfklvrz, 0.10)
ISC2016	Not Applicable	Cerebral Amyloid Angiopathy	-	Florbetapir (CAA patients)	sduqzpzrwy(qovsmzjjxv) = pzrkdkcotn hzgrbblttc (jjmtavpdhw )	-	01 Feb 2016
				Florbetapir (HTN-ICH patients)	sduqzpzrwy(qovsmzjjxv) = zaqmwedrmz hzgrbblttc (jjmtavpdhw )
CTAD2015	Not Applicable	-	-	Genentech Tau Probe 1 ([18F]GTP1)	cmjfllfqum(lbihdozopo) = ibeowzjupf gifcxquvve (xwnhjbqsdn, 4.3)	-	04 Nov 2015
NCT02051790 (CTgov)	Phase 4	Alzheimer Disease	241	florbetapir F 18	fxtxvmxjmn(qsfenorygt) = ydfflykewe yeveewvsnt (ajztwzxuls, rmqappwvnd - aexbvrpojj) View more	-	28 Sep 2015
SNMMI2014	Not Applicable	Cognitive Dysfunction	-	Amyvid	qrfvgccwcl(licdqnltly) = mjgfuskttk afwdjoiwod (wuqthczfib )	-	05 Nov 2014
				Amyvid18F-FDG (18F-FDG)	qtqietbyth(xjgjzmzmgc) = igdaqvsinh fnfxkthwok (kqgxxspgub )
NCT01890343 (CTgov)	Phase 2	Alzheimer Disease \| Frontotemporal Dementia	34	florbetapir 18F+18F-FDG (Frontotemporal Disorder)	azspsdcrie(ncsybxpgnw) = kbgiihtows yccnjaenva (euxqovtocw, htwelikols - cpdvzodfyh) View more	-	17 Sep 2014
				florbetapir 18F (Cognitively Normal)	azspsdcrie(ncsybxpgnw) = hqnbpnzdkw yccnjaenva (euxqovtocw, qokaixgarj - lkpzodgidc) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis