预约演示
更新于：2025-05-16
Florbetapir F-18
氟贝他吡[18F]
更新于：2025-05-16
概要
基本信息
原研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2012-04-06), |
最高研发阶段(中国)无进展 |
特殊审评- |
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结构/序列
分子式C20H25FN2O3 |
InChIKeyYNDIAUKFXKEXSV-CRYLGTRXSA-N |
CAS号956103-76-7 |
关联
79
项与 氟贝他吡[18F] 相关的临床试验NCT06600880
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.
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2026-08-01 |
申办/合作机构- |
NCT06790394
A Test-retest Study to Evaluate the Reproducibility of [18F]Florbetaben PET Imaging in Patients With Cardiac Amyloidosis and Control Patients
This study is an open-label study to evaluate and characterize test-retest reliability of [18F]florbetaben PET in subjects with AL-CA and ATTR-CA compared to non-CA subjects. Quantification of the [18F]florbetaben parameters related to the deposition of amyloid in the heart (such as Myocardial Tracer Retention (MTR) or Retention Index (RI)), and the variability in these parameters after repeated imaging will be evaluated. Measurement of blood metabolites and comparison of invasive with non-invasive quantification of [18F]florbetaben uptake in the heart will be performed.
开始日期2025-06-01 |
申办/合作机构 |
ChiCTR2500099173
Application of 18F-AV-45 and 18F-AV-1451 PET/CT in Alzheimer's Disease: A Cross-Sectional, Diagnostic Clinical Study.
开始日期2024-08-12 |
申办/合作机构 |
100 项与 氟贝他吡[18F] 相关的临床结果
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100 项与 氟贝他吡[18F] 相关的转化医学
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100 项与 氟贝他吡[18F] 相关的专利（医药）
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429
项与 氟贝他吡[18F] 相关的文献（医药）2025-05-04·Journal of Sulfur Chemistry
Small molecule heterocycles: design and synthesis of novel fluorescent Benzothiazoles for early detection of Alzheimer’s disease
作者: Sharma, Vijay ; Sundaram, G.S.M.
Diagnostic agents capable of imaging β-amyloid (Aβ) plaques at prodromal stages could provide noninvasive tools to assess plaque burden and assist in determining efficacy of disease-modifying therapeutic interventions in vivo.To accomplish this goal, FDA approved 18F-incorporated tracers, such as Florbetapir, Flutemetamol, and Florbetaben may allow quant. anal. of therapeutic efficacy of disease-modifying treatments that attenuate Aβ pathophysiol. in vivo.Although promising, these tracers show high off-target binding.Importantly, current anti-amyloid therapy also targets diffuse amyloid plaques (included in revised NIAAA criteria for detecting AD) and other forms of amyloid plaques.Therefore, mols. capable of detecting both diffuse and fibrillar plaque pathol. can potentially offer better quant. tools for interrogating efficacy of anti-amyloid therapy.To achieve this goal, herein, we report synthesis and characterization of new small organic mols.: ((Z,E)-4-(2-(6-(2-Fluoroethoxy)benzo[d]thiazol-2-yl)vinyl)-N,N-dimethylaniline) , ((Z)-4-(2-(6-(2-(2-(3-Fluoropropoxy)ethoxy)ethoxy)benzo[d]thiazol-2-yl)vinyl)-N,N-dimethylaniline) and ((E)-4-(2-(6-(2-(2-(3-Fluoropropoxy)ethoxy)ethoxy)benzo[d]thiazol-2-yl)vinyl)-N,N-dimethylaniline) We also report preliminary investigations on binding affinity in vitro.While demonstrated a relatively higher affinity, both and showed moderate affinity for Aβ1-42 aggregates in vitro.Furthermore, all 3 agents showed ability to detect Aβ fibrillar and diffuse plaque pathol. in brain sections of APP/PS1 transgenic mice and post-mortem confirmed AD human brain tissue sections.
2025-02-01·Journal of Nutrition Health & Aging
Impact of diabetes on the progression of Alzheimer’s disease via trajectories of amyloid–tau–neurodegeneration (ATN) biomarkers
Article
作者: Kim, Eosu ; Kim, Eun Woo ; 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.
2025-02-01·EUROPEAN ARCHIVES OF PSYCHIATRY AND CLINICAL NEUROSCIENCE
Associations of tau, Aβ, and brain volume of the Papez circuit with cognition in Alzheimer’s disease
Article
作者: Laraib, Azka ; Li, Qin ; Feng, Yuxue ; Li, Xiaofeng ; Lin, Xiuqi ; Zhan, Jiehong
This study aimed to investigate the cross-sectional associations between regional Alzheimer's disease (AD) biomarkers, including tau, β-amyloid (Aβ), and brain volume, within the Papez circuit, and neuropsychological functioning across the preclinical and clinical spectrum of AD. We utilized data from the Alzheimer's Disease Neuroimaging Initiative (ADNI) database, including 251 Aβ-positive participants. Participants were categorized into three groups based on the Clinical Dementia Rating (CDR): 73 individuals with preclinical AD (CDR = 0), 114 with prodromal AD (CDR = 0.5), and 64 with clinical AD dementia (CDR ≥ 1). Linear regression analyses, adjusted for age, gender, and education years, were employed to evaluate the associations between five regions of interest (the hippocampus, para-hippocampus, entorhinal cortex, posterior cingulate cortex, and thalamus) and five neuropsychological tests across the three imaging modalities. In the preclinical stage of AD, flortaucipir PET was associated with impaired global cognition and episodic memory (range standardized β = 0.255-0.498, p < 0.05 corrected for multiple comparisons), while florbetapir PET and brain volume were marginally related to global cognition (range standardized β = 0.221-0.231, p < 0.05). In the clinical stages of AD (prodromal and dementia), both increased flortaucipir uptake and decreased brain volume were significantly associated with poorer global neuropsychological and episodic memory performance (range standardized β = 0.222-0.621, p < 0.05, most regions of interest survived correction for multiple comparisions). However, a slight relationship was observed between florbetapir uptake and poorer global cognitive function. The regions most affected by flortaucipir PET were the hippocampus, para-hippocampus, and posterior cingulate cortex. During the clinical stages, the hippocampus and entorhinal cortex exhibited the most significant volumetric changes. Tau PET and brain volume measurements within the Papez circuit are more sensitive indicators of early cognitive deficits in AD than Aβ PET. Furthermore, during the clinical stages of AD, both flortaucipir PET and brain volume of the Papez circuit are closely correlated with cognitive decline. These findings underscore the importance of integrating multiple biomarkers for the comprehensive evaluation of AD pathology and its impact on cognition.
69
项与 氟贝他吡[18F] 相关的新闻（医药）2025-05-15
NEW YORK, May 15, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the publication of a new study in the Journal of ‘Clinical Nuclear Medicine’ demonstrating that intranasal administration of foralumab significantly dampened microglial activation in a 78-year old patient with moderate Alzheimer's disease (AD) treated as part of a Food and Drug Administration (FDA) expanded access program. The findings, published in the prestigious ‘Clinical Nuclear Medicine’ journal, highlight a promising avenue in the treatment of neurological disorders. This case represents the first use of 18F-PBR06-PET in a patient with moderate AD dementia and the first published report of an AD patient treated with nasal-foralumab. The study, led by Dr. Tarun Singhal and Dr. Howard Weiner of Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, utilized advanced PET imaging with the [F-18]PBR06 tracer to assess microglial activation before and after treatment. The findings revealed a notable reduction in neuroinflammation following intranasal foralumab administration. Figure 1.
Image Source: Singhal T et al. Dampening of Microglial Activation with Nasal Foralumab Administration in Moderate Alzheimer’s Disease Dementia. Clinical Nuclear Medicine 2025 May 13. doi: 10.1097/RLU.0000000000005955. Online ahead of print.A, 18F-PBR06-PET shows significant decreased standardized uptake value (SUV) after 3 months of treatment (bottom row) with nasal-foralumab as compared to baseline (top row). B, SUV-ratio (SUVR) images demonstrate a decrease in PET signal following treatment, particularly in bilateral precuneus, posterior cingulate, bilateral parietal cortices and cerebellum (bottom row) as compared with pre-treatment baseline (top row). C, A baseline amyloid-positive 18F-Florbetapir-PET scan in the patient D, z-score maps of 18F-PBR06-PET focusing on the precuneus, posterior cingulate, and anterior cingulate regions show abnormally increased microglial activation in these regions (left) before treatment, which decreased following treatment with nasal-foralumab (right). “The marked decrease in microglial PET signal following nasal-foralumab treatment provides preliminary evidence that intranasal foralumab can modulate microglial activity in Alzheimer's disease. This supports the potential efficacy of nasal foralumab in targeting microglial activation in AD,” said Tarun Singhal, M.B.B.S., M.D., Associate Professor of Neurology at Harvard Medical School, Director of the PET Imaging Program in Neurologic Diseases, and Associate neurologist and nuclear medicine physician at Brigham and Women’s Hospital. “Given the role of microglia in neurodegeneration, these results are encouraging and warrant further investigation in larger, controlled studies with additional quantitative approaches.” “These findings from Dr. Singhal et al, are consistent with our previously reported effects of nasal- foralumab in decreasing microglial activation in non-active secondary progressive multiple sclerosis patients,” Commented Ivor Elrifi, CEO of Tiziana Life Sciences. “There are currently no approved disease-modifying therapies for moderate Alzheimer’s Disease, and it is clearly an area of unmet need. A phase-2a study of nasal-foralumab in mild Alzheimer’s is being initiated.” Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development for intranasal delivery. By modulating T cell function, it aims to reduce inflammation in the central nervous system. Previous studies have shown its potential in multiple sclerosis and other neuroinflammatory conditions. The full study is available online in Clinical Nuclear Medicine at: https://journals-lww-com.libproxy1.nus.edu.sg/nuclearmed/Fulltext/9900/dampening_of_microglial_activation_with_nasal.1721.aspx. About Foralumab Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923). Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.[1],[2] About Tiziana Life Sciences Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications. For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com. Forward-Looking Statements Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Tiziana’s Annual Report on Form 20-F for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority. For further inquiries: Tiziana Life Sciences LtdPaul Spencer, Business Development, and Investor Relations+44 (0) 207 495 2379email: info@tizianalifesciences.com [1] https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2220272120 [2] https://www-pnas-org.libproxy1.nus.edu.sg/doi/10.1073/pnas.2309221120 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cd486638-7caa-40f2-8c97-1c9c48a3ea9e
临床2期临床结果免疫疗法
2025-04-29
Standardized digital test will expand early diagnosis capabilities to more primary care physicians
NEW YORK, April 29, 2025 /PRNewswire/ -- The Alzheimer's Drug Discovery Foundation (ADDF)'s Diagnostics Accelerator (DxA) today announced a significant investment that will support clinical validation for the digital version of the Montreal Cognitive Assessment (MoCA), MoCA Solo, an automatically scored test for tablet devices utilizing AI-enabled avatars, requiring only minimal supervision. The original MoCA is a one-page 30-point pen-and-paper cognitive test that is administered in ten minutes and used worldwide by trained professionals. MoCA Solo does not require trained administration, and if successful, MoCA Solo could be more widely used as a scalable tool for assessing mild cognitive impairment (MCI), especially in primary care clinical settings.
"Combining the MoCA Solo assessment with blood biomarkers has the potential to enable earlier detection of Alzheimer's disease by identifying individuals with MCI who are most likely to benefit from specialist care," said Howard Fillit, MD, Co-Founder and Chief Science Officer of the ADDF. "A scalable, accessible, and standardized assessment that can be easily administered across a variety of clinical settings empowers primary care physicians to play a more prominent role in the front lines of diagnosing and treating Alzheimer's. As the Alzheimer's population continues to grow, exceeding the capacity of specialists, conducting assessments at the primary care level is a critical step towards getting patients and their families the support they need sooner."
Given the success of recently approved Alzheimer's drugs, Leqembi and Kisunla, comprehensive diagnosis and evaluation require both biomarker testing and cognitive testing to provide a holistic assessment of a patient's Alzheimer's and disease progression. While blood-based biomarkers are most likely to become the gold standard for the early diagnosis and detection of Alzheimer's-related biology, the addition of digital standardized cognitive assessment will provide complementary information on a patient's cognitive state, helping to determine which individuals are in the earliest stages of the disease and would benefit from referral to specialist care.
Development of and access to standardized assessment and diagnostic tools is a foundational goal of the ADDF's Diagnostics Accelerator. Pairing cognitive assessment with individual biomarkers paves the way for early diagnosis and helps inform combination therapies that will allow us to treat Alzheimer's via precision medicine.
"As new Alzheimer's therapies come to market, it's more important than ever to have reliable, standardized, easy-to-deploy tools for early detection," said Niranjan Bose, Managing Director of Health and Life Sciences at Gates Ventures. "Digitizing the widely used MoCA test empowers primary care physicians to detect cognitive decline earlier and reduce bottlenecks with specialist referrals. When paired with blood biomarker testing, the information gives doctors a more complete picture of an individual's condition, enabling timely and targeted intervention."
"This investment by the ADDF underscores their commitment to innovation in digital diagnostics and expanding access to accurate, efficient cognitive testing at a national scale," said Dr. Ziad Nasreddine, creator of the MoCA, and CEO of MoCA Cognition. "We are proud to partner with the ADDF to help address the growing challenge of Alzheimer's disease."
The gold standard pen-and-paper MoCA, developed in 1996 and clinically validated in 2005, demonstrated 90% sensitivity and 87% specificity for detecting MCI. The assessment includes questions designed to assess short-term memory, visuospatial skills, executive function, language, attention, concentration, working memory, and orientation. Today, the MoCA is the most widely used cognitive assessment for early detection and has been translated into 200+ languages and dialects. It is regularly cited in scientific articles and is used by both specialists and primary care physicians. A 2023 global Delphi consensus of experts published in Alzheimer's & Dementia ranked the MoCA as the preferred tool for detecting MCI and early AD among 53 cognition scales considered (Ellison et al., 2023). A validated and automated digital version will reduce the need for human administrators and enable further adoption, especially within primary care.
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 $370 million to fund 765 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 21 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
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2025-03-12
New findings published in Alzheimer's & Dementia suggest blood biomarkers are expected to become the standard method for diagnosing Alzheimer's, while ocular tests offer a non-invasive alternative for detecting at-risk patient populations
NEW YORK, March 12, 2025 /PRNewswire/ -- The Alzheimer's Drug Discovery Foundation's (ADDF) Diagnostics Accelerator (DxA) authored a first-of-its-kind paper, "Unlocking ocular biomarkers for early detection of Alzheimer's disease," providing a landscape review of ocular biomarkers as another tool, alongside blood biomarkers, to aid in the early detection of Alzheimer's disease. The paper, which was published in Alzheimer's & Dementia, shares an informed perspective on the role of ocular biomarkers in the broader Alzheimer's diagnostics space and what defines a true ocular biomarker, while also highlighting the potential for ocular screening to identify at-risk patients who would otherwise go undiagnosed. The authors' assessment is based on hours of in-depth interviews with leading neurologists, ophthalmologists, optometrists, and primary care physicians from across the United States.
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"Meaningful progress is being made in Alzheimer's research, with advances in novel biomarkers – including blood tests, retinal scans and digital tools – providing less invasive and more accessible ways to detect and diagnose Alzheimer's disease," said Howard Fillit, MD, Co-Founder and Chief Science Officer of the ADDF. "With the advent of these new tools, it is important to understand the appropriate context of use for each test. This paper shares a new and more nuanced perspective on the role of ocular biomarkers, which have the potential to identify at-risk individuals during routine eye exams, who otherwise may go undiagnosed."
Blood-based testing for Alzheimer's is more cost-effective, convenient, and less invasive than current diagnostic methods and blood biomarkers are most likely to emerge as the standard clinical practice for Alzheimer's diagnostics. For patients to receive an Alzheimer's blood test, they must see their primary care doctor or a neurologist, which is not always accessible to all patients. As stated in the paper, the authors categorize ocular biomarkers as an additional non-invasive and accessible option to identify people at risk for Alzheimer's disease (e.g., pre-symptomatic) outside of the traditional settings of an annual physical or an exam with a neurologist.
Ocular technologies are expected to cost between $100-200 of out-of-pocket costs and must meet minimum performance standards of 90-95% sensitivity and 75-85% specificity to qualify as a test for preclinical Alzheimer's. The authors believe focusing on these factors will help identify which of the four to eight million aging Americans who undergo an annual eye exam and who may be at risk for developing Alzheimer's.
"This paper highlights the critical requirements and path to success of retinal biomarkers in Alzheimer's disease (AD) diagnosis", says Niranjan Bose, Managing Director, Health and Life Sciences at Gates Ventures. "While blood-based biomarkers are poised to take the lead in AD diagnostic applications, retinal biomarker testing can play a vital role in detecting preclinical AD and supporting differential diagnosis in neurodegenerative conditions. However, to make a meaningful impact in the future, it must meet rigorous technical standards similar to blood-based tests and demonstrate clinical utility to ensure integration as a reliable tool in early AD detection."
Research into ocular biomarkers for detecting Alzheimer's disease is ongoing with early findings pointing to biomarkers in the retina as having the potential to provide key indicators of the disease. The retina displays similarities to the brain's cellular composition, and several neurodegenerative disorders are known to have manifestations in the retina. With ongoing technological advancements, ocular biomarkers have the potential to become a scalable, accessible tool that can be integrated into routine eye exams, making early detection of Alzheimer's disease more feasible and improving outcomes for at-risk individuals.
"The pace of innovation in the Alzheimer's field has accelerated greatly in recent years, but major gaps persist, particularly in early, pre-symptomatic patient identification. Ocular biomarkers offer a novel method to detect the earliest molecular beginnings of Alzheimer's disease, and to do so with the potential for elevated sensitivity and without the burden of more invasive tests," said Sam Ulin, a Partner at ClearView Healthcare Partners who specializes in the translation of innovative technologies into clinical application. "Our work here with the DxA can hopefully serve as a guidepost to innovators in the space, helping them understand what is needed for an ocular biomarker test to meet the needs of patients and practitioners, maximizing the impact of these technologies on AD research, development, and ultimately, patient care."
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 $370 million to fund 765 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 21 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.
ABOUT CLEARVIEW HEALTHCARE PARTNERS
ClearView is the leading independent strategy consulting firm focused on the life sciences. The Company was founded on the core belief that companies driving innovation in the life sciences need strategic partners that can combine deep scientific expertise, robust analytic approaches, and sound business instincts to create actionable and impactful results. These principles have enabled ClearView to build enduring partnerships with clients across the industry and around the globe, where we thrive in engagements where the stakes are high and the answer uncertain. ClearView meets these challenges with transparent problem-solving and dedicated thought partnership to create clarity on the path forward. For further information please visit .
SOURCE Alzheimer's Drug Discovery Foundation
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100 项与 氟贝他吡[18F] 相关的药物交易
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 阿尔茨海默症 | 欧盟 | 2013-01-14 | |
| 阿尔茨海默症 | 冰岛 | 2013-01-14 | |
| 阿尔茨海默症 | 列支敦士登 | 2013-01-14 | |
| 阿尔茨海默症 | 挪威 | 2013-01-14 | |
| 造影剂 | 美国 | 2012-04-06 |
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 阿尔茨海默病引起的痴呆症 | 临床3期 | 中国 | 2022-10-20 | |
| 认知功能障碍 | 临床3期 | 美国 | 2011-07-01 | |
| 轻度认知障碍 | 临床3期 | - | 2011-02-01 | |
| 慢性创伤性脑病 | 临床2期 | 美国 | 2014-06-01 | |
| 路易体病 | 临床2期 | 美国 | 2010-03-01 | |
| 额颞痴呆 | 临床2期 | 英国 | 2009-09-01 | |
| 帕金森病 | 临床2期 | 美国 | 2009-01-01 |
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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 |
|---|
N/A | 6 | 蓋鬱獵窪繭襯淵遞鏇獵 = 艱齋鑰構鹽顧餘願膚顧 鑰鹽夢鹽膚顧鏇鏇夢醖 (廠鹽齋鏇齋壓繭獵願壓, 簾鹽顧願淵選醖齋糧獵 ~ 鏇餘鬱糧窪鏇壓鏇繭糧) 更多 | - | 2024-08-26 | |||
N/A | - | - | Active tACS | 遞顧齋構願鹽範鬱製選(鬱願壓網鹽齋糧衊衊淵) = 艱醖艱糧範襯艱餘醖鏇 顧製遞憲鹽鬱膚蓋膚膚 (遞選鹹鏇夢簾鏇網築鬱 ) | - | 2024-06-09 | |
Sham tACS | 遞顧齋構願鹽範鬱製選(鬱願壓網鹽齋糧衊衊淵) = 糧衊憲廠襯獵鏇鏇積壓 顧製遞憲鹽鬱膚蓋膚膚 (遞選鹹鏇夢簾鏇網築鬱 ) | ||||||
N/A | - | - | Random Forest | 襯網顧顧艱鬱遞壓鹽壓(膚廠蓋製蓋選憲觸遞醖) = 醖鑰構範顧壓壓獵襯鏇 夢構顧衊鑰鹽願顧衊願 (夢積選糧艱鏇積築鑰襯 ) 更多 | - | 2022-08-08 | |
Random Forest (K-Means Clustering) | 襯網顧顧艱鬱遞壓鹽壓(膚廠蓋製蓋選憲觸遞醖) = 簾鬱齋範淵鹽簾憲遞製 夢構顧衊鑰鹽願顧衊願 (夢積選糧艱鏇積築鑰襯 ) 更多 | ||||||
临床4期 | 23 | 鏇積築糧鬱積醖衊遞繭(積壓顧衊網憲網蓋積鏇) = 築築繭鏇衊網鹽網襯遞 繭網構憲餘齋選構衊顧 (願製繭夢夢膚鏇築糧夢, 餘淵觸積構築繭廠獵醖 ~ 蓋衊糧夢艱蓋築構獵衊) 更多 | - | 2022-04-13 | |||
临床4期 | 19 | 網糧鹹淵繭壓齋構繭壓 = 製構艱襯築選餘艱餘觸 廠獵網壓獵憲顧觸獵衊 (觸範衊廠願齋憲遞鏇鑰, 遞遞獵夢鑰選繭繭願鹽 ~ 遞齋膚壓鏇築齋簾繭鹽) 更多 | - | 2021-08-27 | |||
N/A | 阿尔茨海默症 amyloid beta (Aβ) | - | (AD patients) | 醖夢鑰鑰蓋夢鹹廠蓋觸(獵構鏇襯積衊蓋鹹艱蓋) = 簾願觸獵襯鏇壓範窪範 廠憲積齋範窪糧齋襯廠 (鹽糧製鏇憲遞艱窪齋選 ) | - | 2018-07-01 | |
(Controls) | 醖夢鑰鑰蓋夢鹹廠蓋觸(獵構鏇襯積衊蓋鹹艱蓋) = 積鹽窪窪淵窪艱簾鏇艱 廠憲積齋範窪糧齋襯廠 (鹽糧製鏇憲遞艱窪齋選 ) | ||||||
临床2期 | 1,768 | 選顧醖積觸鬱艱廠襯築 = 鏇繭鬱構範醖鹽夢遞築 壓範糧遞壓淵顧壓餘餘 (壓餘獵膚淵糧憲製網夢, 蓋鹹餘壓簾艱餘鬱鹹醖 ~ 繭積醖網憲蓋遞製簾淵) 更多 | - | 2018-06-14 | |||
N/A | 认知功能障碍 F-18 florbetapir | 100 | F-18 Florbetapir PET/CT positive scans | 鏇繭艱醖獵積憲糧膚夢(糧鏇蓋醖糧憲獵鹽積襯) = 積壓窪淵艱積顧餘積製 鏇齋願獵鹽鏇繭艱醖壓 (淵鑰積窪醖衊鏇餘衊觸 ) | 积极 | 2016-09-21 | |
F-18 Florbetapir PET/CT negative scans | 鏇繭艱醖獵積憲糧膚夢(糧鏇蓋醖糧憲獵鹽積襯) = 製鹽鬱範蓋齋鬱糧鬱餘 鏇齋願獵鹽鏇繭艱醖壓 (淵鑰積窪醖衊鏇餘衊觸 ) | ||||||
N/A | - | Amyloid PET Tracer (AD Patients) | 齋鑰鏇膚鹹顧積糧鏇醖(夢簾繭齋膚製遞願窪窪) = Receiver Operating Characteristics (ROC) showed the Area-under-the-ROC-Curve of 0.90±0.018 using 3D-SSP-PCLD and 0.91±0.018 3D-SSP-SUVR, indicating a nearly identical discriminatory power for normal controls vs AD patients 餘鏇積艱觸簾鏇網築艱 (衊簾製膚壓鬱窪選構顧 ) 更多 | - | 2016-05-24 | ||
N/A | - | (CAA patients) | 構鑰願衊鑰醖鏇憲遞襯(網網膚襯鹽獵獵糧鹹鏇) = 壓壓簾衊鬱壓鏇鏇鹹選 構膚壓網鹽窪繭膚醖觸 (積鏇製壓齋鑰選廠鏇選 ) | - | 2016-02-01 | ||
(HTN-ICH patients) | 構鑰願衊鑰醖鏇憲遞襯(網網膚襯鹽獵獵糧鹹鏇) = 網窪願簾窪憲鏇觸構醖 構膚壓網鹽窪繭膚醖觸 (積鏇製壓齋鑰選廠鏇選 ) |
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