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.

Start Date01 Aug 2026

Sponsor / Collaborator-

NCT06790394

/ Not yet recruitingPhase 1

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.

Start Date01 Jun 2025

Sponsor / Collaborator

Life Molecular Imaging Ltd.

[+1]

ChiCTR2500099173

/ RecruitingNot ApplicableIIT

Application of 18F-AV-45 and 18F-AV-1451 PET/CT in Alzheimer's Disease: A Cross-Sectional, Diagnostic Clinical Study.

Start Date12 Aug 2024

Sponsor / Collaborator

The First Affiliated Hospital of Nanchang University

100 Clinical Results associated with Florbetapir F-18

100 Translational Medicine associated with Florbetapir F-18

100 Patents (Medical) associated with Florbetapir F-18

428

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 Feb 2025·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

Author: Laraib, Azka ; Feng, Yuxue ; Li, Qin ; 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.

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 ; Shields, Trevor ; Loas, Gwénolé ; 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 ; Roussel, Martine ; Godefroy, Olivier

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.

News (Medical) associated with Florbetapir F-18

15 May 2025

·www.globenewswire.com

Journal of Clinical Nuclear Medicine Publishes Results of Tiziana’s Nasal Foralumab in Study Treating Moderate Alzheimer's Disease

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/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/doi/10.1073/pnas.2220272120 [2] https://www.pnas.org/doi/10.1073/pnas.2309221120 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cd486638-7caa-40f2-8c97-1c9c48a3ea9e

Phase 2Clinical ResultImmunotherapy

29 Apr 2025

·www.prnewswire.com

The ADDF's Diagnostics Accelerator (DxA) Advances AI-Enabled Digital Cognitive Assessment Tool MoCA Solo with Investment to Aid in Early Identification of Alzheimer's Disease

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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

12 Mar 2025

·www.prnewswire.com

The ADDF's Diagnostics Accelerator Authors New Paper on Ocular Biomarker Landscape, Highlighting Ocular Tests as a Tool for Early Detection of Alzheimer's Disease

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. Continue Reading ADDF x DxA Logo "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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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	European Union	Eli Lilly Nederland BV	14 Jan 2013
Alzheimer Disease	Iceland	Eli Lilly Nederland BV	14 Jan 2013
Alzheimer Disease	Liechtenstein	Eli Lilly Nederland BV	14 Jan 2013
Alzheimer Disease	Norway	Eli Lilly Nederland BV	14 Jan 2013
Contrast agents	United States	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	China	JYAMS PET Research & Development Ltd.	20 Oct 2022
Cognitive Dysfunction	Phase 3	United States	Avid Radiopharmaceuticals, Inc.	01 Jul 2011
Mild cognitive disorder	Phase 3	-	Avid Radiopharmaceuticals, Inc.	01 Feb 2011
Chronic Traumatic Encephalopathy	Phase 2	United States	Avid Radiopharmaceuticals, Inc.	01 Jun 2014
Lewy Body Disease	Phase 2	United States	Avid Radiopharmaceuticals, Inc.	01 Mar 2010
Frontotemporal Dementia	Phase 2	United Kingdom	Avid Radiopharmaceuticals, Inc.	01 Sep 2009
Parkinson Disease	Phase 2	United States	Avid Radiopharmaceuticals, Inc.	01 Jan 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04118764 (CTgov)	Not Applicable	Alzheimer Disease	6	Neuronavigation-guided single-element focused ultrasound transducer+Amyvid+Definity	yalavhijej = lyvslgbfgf gtwdoqbzjr (nwoppfimgn, ocsrwjfgox - pmfsmmdqcg) View more	-	26 Aug 2024
SNMMI2024	Not Applicable	-	-	Active tACS	odkoafxhwr(gopadbtsth) = gspijlpdzv yrhmqqghja (dzgczqxsfh )	-	09 Jun 2024
				Sham tACS	odkoafxhwr(gopadbtsth) = npxqywwjyx yrhmqqghja (dzgczqxsfh )
SNMMI2022	Not Applicable	-	-	Random Forest	qfrhrgrqgv(nqcofhocds) = pjzomboxeb ohwcwpgrbr (zmbnokscjb ) View more	-	08 Aug 2022
				Random Forest (K-Means Clustering)	qfrhrgrqgv(nqcofhocds) = snuqyoinan ohwcwpgrbr (zmbnokscjb ) View more
NCT01683825 (CTgov)	Phase 4	Senile cardiac amyloidosis	23	florbetapir+F	hfplkjkwrg(nfolpditil) = whvckewlcw peopwpqryd (akghqtdxhv, ceizgikvhq - yvqmfsondc) View more	-	13 Apr 2022
NCT01767493 (CTgov)	Phase 4	Multiple Sclerosis, Relapsing-Remitting	19	[18F]Florbetapir PET imaging	rmhbyirvzs = rvqtjfugkg agnrknmmiw (fsqvvmorrv, pbjfekyykb - elmccdwkbi) View more	-	27 Aug 2021
AAIC2018	Not Applicable	Alzheimer Disease amyloid beta (Aβ)	-	[18F]FLORBETAPIR (AD patients)	dwugtfinoh(becflevvcy) = avekboblbc azokivseuh (gcdrpmzwam )	-	01 Jul 2018
				[18F]FLORBETAPIR (Controls)	dwugtfinoh(becflevvcy) = vsfwnedpdm azokivseuh (gcdrpmzwam )
NCT01518374 (CTgov)	Phase 2	Alzheimer Disease \| Mild cognitive disorder	1,768	Florbetapir F 18	bvcnncgvzo = ipflmennzb nfkucysifl (acsmbvstev, tyauplvcsj - zhzwepyyry) View more	-	14 Jun 2018
First Experience of 100 Clinical F-18 Florbetapir (Amyvid) PET/CTScans (EANM2016)	Not Applicable	Cognitive Dysfunction F-18 florbetapir	100	F-18 Florbetapir PET/CT positive scans	vmgisujfax(lwicrpdejr) = nybcfladiw ufjruxxlvg (paszuwbulk )	Positive	21 Sep 2016
				F-18 Florbetapir PET/CT negative scans	vmgisujfax(lwicrpdejr) = vrgqhfeghm ufjruxxlvg (paszuwbulk )
SNMMI2016	Not Applicable	Alzheimer Disease	-	Amyloid PET Tracer (AD Patients)	rxellgjvxz(whkjbtthvt) = 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 micjfkglqz (dxaqnlchco ) View more	-	24 May 2016
ISC2016	Not Applicable	Cerebral Amyloid Angiopathy	-	Florbetapir (CAA patients)	pgcsqsuzff(hetyssqpcg) = yixklvodox swtrnwwddp (raslnsqoue )	-	01 Feb 2016
				Florbetapir (HTN-ICH patients)	pgcsqsuzff(hetyssqpcg) = bvfbxvtqig swtrnwwddp (raslnsqoue )

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