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]

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]

CTR20221832 / CompletedPhase 3

一项评价氟[18F]洛贝平注射液（Florbetapir（18F））在中国健康志愿者、轻度认知障碍（MCI）患者、阿尔茨海默病（AD）性痴呆患者中的安全性和成像特征的开放、平行、多中心研究

[Translation] An open, parallel, multicenter study to evaluate the safety and imaging characteristics of 18F-Florbetapir in healthy Chinese volunteers, patients with mild cognitive impairment (MCI), and patients with Alzheimer's disease (AD) dementia

1.评价氟[18F]洛贝平注射液正电子发射计算机断层扫描（PET）视觉分析及标准摄取数值比率（SUVR）鉴别中国认知功能正常的志愿者、MCI患者和AD患者的辅助诊断价值； 2.评估氟[18F]洛贝平注射液PET成像在中国受试者中的安全性。

[Translation]

1. To evaluate the auxiliary diagnostic value of positron emission tomography (PET) visual analysis and standard uptake value ratio (SUVR) of fluorine [18F] lobepine injection in differentiating Chinese volunteers with normal cognitive function, MCI patients and AD patients; 2. To evaluate the safety of PET imaging of fluorine [18F] lobepine injection in Chinese subjects.

Start Date20 Oct 2022

Sponsor / Collaborator

JYAMS PET Research & Development Ltd.

100 Clinical Results associated with Florbetapir F-18

100 Translational Medicine associated with Florbetapir F-18

100 Patents (Medical) associated with Florbetapir F-18

218

Literatures (Medical) associated with Florbetapir F-18

01 Mar 2024·Current medicinal chemistry

Simple Synthesis of [18F] AV-45 and its Clinical Application in the Diagnosis of Alzheimer's Disease

Article

Author: Li, Yu-Bin ; Qin, Yong-De ; Li, Xiao-Hong ; Yilihamu, Nazi ; Zhang, Qi-Zhou

Objective::

[18F] AV-45 can be produced in a simple, stable, and repeatable manner on the Tracerlab FXF-N platform using a self-editing synthetic procedure and solid-phase extraction purification method. This technique is applied to positron emission tomography (PET) imaging of Alzheimer's disease (AD) to observe its distribution and characteristics in various brain regions and its diagnostic efficiency for the disease.

Methods::

The precursor was subjected to nucleophilic radiofluorination at 120 °C in anhydrous dimethyl sulfoxide, followed by acid hydrolysis of the protecting groups. The neutralized reaction mixture was purified by solid phase extraction to obtain a relatively pure [18F] AV-45 product with a high specific activity. A total of 10 participants who were diagnosed with Alzheimer's disease (AD group) and 10 healthy controls (HC group) were included retrospectively. All of them underwent [18F] AV-45 brain PET/CT imaging. The distribution of [18F] AV-45 in the AD group was analyzed visually and semi-quantitatively.

Results::

Six consecutive radiochemical syntheses were performed in this experiment. The average production time of [18F] AV-45 was 52 minutes, the radiochemical yield was 14.2 % ± 2.7% (n = 6), and the radiochemical purity was greater than 95%. When used with PET/CT imaging, the results of the visual analysis indicated increased [18F] AV-45 radioactivity uptake in the frontal, temporal, and parietal lobes in AD patients. Semiquantitative analysis showed the highest diagnostic efficacy in the posterior cingulate gyrus compared with other brain regions (P < 0.001).

Conclusion::

Intravenous [18F] AV-45 was successfully prepared on the Tracerlab FXF-N platform by solid-phase extraction of crude product and automated radiochemical synthesis. PET/CT imaging can be used to diagnose and evaluate AD patients and provide a more robust basis for clinicians to diagnose AD.

01 Nov 2023·JACC. Cardiovascular imaging

Cardiac Amyloid Quantification Using 124I-Evuzamitide (124I-P5+14) Versus 18F-Florbetapir

Article

Author: Dorbala, Sharmila ; Clerc, Olivier F ; Falk, Rodney H ; Di Carli, Marcelo F ; Bianchi, Giada ; Neri, Jocelyn Canseco ; Cuddy, Sarah A M ; Chemburkar, Vaidehi ; Vijayakumar, Shilpa ; Kijewski, Marie Foley ; Robertson, Matthew

BACKGROUND:

Cardiac amyloid quantification could advance early diagnosis of amyloid cardiomyopathy (CMP) and treatment monitoring. However, current imaging tools are based on indirect measurements. ¹²⁴I-evuzamitide is a novel pan-amyloid radiotracer binding to amyloid deposits from multiple amyloidogenic proteins. Its ability to quantify cardiac amyloid has not yet been investigated.

OBJECTIVES:

The objectives of this pilot study were to quantify myocardial ¹²⁴I-evuzamitide uptake and to compare its diagnostic value to ¹⁸F-florbetapir in participants with amyloid CMP and control subjects.

METHODS:

This study included 46 participants: 12 with light-chain (AL) CMP, 12 with wild-type transthyretin (ATTRwt) CMP, 2 with hereditary amyloidosis, and 20 control subjects. All amyloidosis participants underwent positron emission tomography/computed tomography with ¹²⁴I-evuzamitide and ¹⁸F-florbetapir. Control subjects underwent ¹²⁴I-evuzamitide (n = 10) or ¹⁸F-florbetapir (n = 8) positron emission tomography/computed tomography. Left ventricular percent injected dose (LV% ID) was measured as mean activity concentration × myocardial volume/injected activity. High LV %ID was defined using Youden's index.

RESULTS:

In CMP participants, median age was 74 years and 92% were men. ¹²⁴I-evuzamitide LV %ID differed across groups: median AL-CMP 1.48 (IQR: 1.12-1.89), ATTRwt-CMP 2.12 (IQR: 1.66-2.47), and control subjects 0.00 (IQR: 0.00-0.01; overall P < 0.001). High LV %ID perfectly discriminated CMP from control subjects. Discrimination performance was similar for ¹⁸F-florbetapir LV %ID. Notably, for ATTRwt-CMP, LV %ID was higher with ¹²⁴I-evuzamitide than ¹⁸F-florbetapir (P = 0.002). ¹²⁴I-evuzamitide LV %ID was correlated with interventricular septum thickness (Spearman's ρ = 0.78) and LV global longitudinal strain (ρ = 0.54) from echocardiography, and with LV mass index (ρ = 0.82) and extracellular volume (ρ = 0.51) from cardiac magnetic resonance.

CONCLUSIONS:

¹²⁴I-evuzamitide demonstrates uptake by cardiac amyloid and accurately discriminates amyloid CMP from control subjects. In AL-CMP, discrimination performance is similar to ¹⁸F-florbetapir. In ATTRwt-CMP, performance may be better with ¹²⁴I-evuzamitide. Moderate-to-strong correlations of ¹²⁴I-evuzamitide uptake with cardiac structural and functional metrics suggest valid amyloid quantification. Hence, ¹²⁴I-evuzamitide is a promising novel radiotracer to detect and quantify cardiac amyloid.

27 Oct 2023·EJNMMI research

Head-to-head comparison of relative cerebral blood flow derived from dynamic [¹⁸F]florbetapir and [¹⁸F]flortaucipir PET in subjects with subjective cognitive decline.

Article

Author: Ossenkoppele, Rik ; Tuncel, Hayel ; van der Flier, Wiesje M ; Golla, Sandeep S V ; Wolters, Emma E ; van Berckel, Bart N M ; Visser, Denise ; Boellaard, Ronald ; Timmers, Tessa

BACKGROUND:

Dynamic PET imaging studies provide accurate estimates of specific binding, but also measure the relative tracer delivery (R₁), which is a proxy for relative cerebral blood flow (rCBF). Recently, studies suggested that R₁ obtained from different tracers could be used interchangeably and is irrespective of target tissue. However, the similarities or differences of R₁ obtained from different PET tracers still require validation. Therefore, the goal of the current study was to compare R₁ estimates, derived from dynamic [¹⁸F]florbetapir (amyloid) and [¹⁸F]flortaucipir (tau) PET, in the same subjects with subjective cognitive decline (SCD).

RESULTS:

Voxel-wise analysis presented a small cluster (1.6% of the whole brain) with higher R₁ values for [¹⁸F]flortaucipir compared to [¹⁸F]florbetapir in the Aβ-negative group. These voxels were part of the hippocampus and the left middle occipital gyrus. In part of the thalamus, midbrain and cerebellum, voxels (2.5% of the whole brain) with higher R₁ values for [¹⁸F]florbetapir were observed. In the Aβ-positive group, a cluster (0.2% of the whole brain) of higher R₁ values was observed in part of the hippocampus, right parahippocampal gyrus and in the left sagittal stratum for [¹⁸F]flortaucipir compared to [¹⁸F]florbetapir. Furthermore, in part of the thalamus, left amygdala, midbrain and right parahippocampal gyrus voxels (0.4% of the whole brain) with higher R₁ values for [¹⁸F]florbetapir were observed. Despite these differences, [¹⁸F]florbetapir R₁ had high correspondence with [¹⁸F]flortaucipir R₁ across all regions of interest (ROIs) and subjects (Aβ-:r² = 0.79, slope = 0.85, ICC = 0.76; Aβ+: r² = 0.87, slope = 0.93, ICC = 0.77).

CONCLUSION:

[¹⁸F]flortaucipir and [¹⁸F]florbetapir showed similar R₁ estimates in cortical regions. This finding, put together with previous studies, indicates that R₁ could be considered a surrogate for relative cerebral blood flow (rCBF) in the cortex and may be used interchangeably, but with caution, regardless of the choice of these two tracers.

News (Medical) associated with Florbetapir F-18

25 Jun 2024

·www.biospace.com

Radiopharmaceutical Industry Outlook: Growth Trends and Future Prospects

The concept of radiopharmaceuticals has been around for several decades. The field of radiotherapeutics has seen rapid development due to advances in radioisotope-based therapies, multimodality bioimaging technology, nanotherapeutics, and interventional oncology. The success of Novartis' prostate cancer drug Pluvicto further led to the resurgence of interest among prominent players in the field, leading to numerous clinical trials testing novel radiotheranostics. What are radiopharmaceuticals, and what are some statistics about the procedures performed globally? Radiopharmaceutical is a combination of radioactive isotopes and pharmaceutical drugs. They are used to diagnose and treat life-threatening diseases such as cancer, cardiac disorders, and neurological disorders. They are utilized in 3 procedures: SPECT imaging, PET imaging and therapeutics. Radiopharmaceuticals are transforming the treatment of various diseases, especially cancers, with targeted radionuclide therapy. Radioligand therapy targets cancer cells with high doses of radiation, promising advancements in cancer treatment. The widespread use of nuclear medicines is evident from a number of procedures performed globally. According to the World Nuclear Association, the annual number of nuclear medicine procedures performed exceeds 50 million, and the need for radioisotopes is rising. Radioisotopes are employed in the medical field by more than 10,000 hospitals worldwide, with approximately 90% of the procedures being diagnostic. Technetium-99 (Tc-99m) is the most often used radioisotope in nuclear medicine diagnostics; it is utilized in approximately 80% of nuclear medicine procedures and 85% of diagnostic scans performed globally. Additionally, in the US and Europe, 20 million and about 10 million nuclear medicine procedures are performed annually, respectively, with 2 million being therapeutic. SPECT is the current major scanning technology employed to diagnose and monitor a wide range of medical conditions; however, PET is expected to be preferred in future over SPECT as it is a more precise and sophisticated technique in the diagnosis of cancers and is well-used in cardiac and brain imaging. Tc-99m and 18F- FDG are the major radiopharmaceuticals for SPECT and PET imaging, which account for 80% of all nuclear medicine procedures. However, the availability of new radiopharmaceuticals, such as PET imaging agents flutemetamol and florbetapir used in neurological conditions and cancer theranostic, drive molecular imaging in the clinical setting. Read our related market research report’s key insights: Radiopharmaceutical CDMO/CMO Services Market Key Insights 2024 Radiotheranostics Market Key Insights 2024 Radiopharmaceuticals Market Key Insights 2024 Radioligand Therapy Market Key Insights 2024 Radioactive Tracer Market Key Insights 2024 What are the different components of the radiopharmaceuticals market: Radioligand therapy, nuclear pharmacy, radiotheranostics, and radioactive tracers are various components used in radiopharmaceuticals to diagnose and treat diseases. The increasing utilization of these components drives substantial growth in the radiopharmaceutical industry. With rising demand for targeted cancer treatments, advanced diagnostic procedures, and integrated therapeutic solutions, these segments play pivotal roles in expanding the market. As technological innovations continue to enhance precision and efficiency, the radiopharmaceutical industry is poised for sustained growth and global expansion in the coming years. Radioligand Therapy/ Radiopharmaceutical Therapeutics Radioligand therapy (RLT) utilizes targeted medicines, often employing radioactive isotopes like lutetium-177, to bind to tumour targets, offering high rates of long-term tumour remission and stability, particularly for metastasized disease. Nuclear Pharmacy Nuclear pharmacy, a pharmacy subspecialty, focuses on preparing, dispensing, and managing radioactive materials used in nuclear medicine operations. Radiotheranostics Radiotheranostics uses radioactive probes to diagnose and treat specific cells, usually cancer cells. It's a combination of molecular imaging and targeted therapy that uses a ligand-linker-radioisotope design. Radioactive Tracer Radioactive tracers are diagnostic radiopharmaceuticals used to image the body and identify diseases. These are composed of tightly bonded molecules with a radioactive atom. So, what are the market dynamics of the Radiopharmaceutical industry? Key driving factors: Advancements in imaging technology Growth in PET imaging procedures driven by prostate, cardiac, and amyloid imaging due to better imaging, significantly lower false negatives and faster examination time Diagnostic and therapeutic application expansion of radiopharmaceuticals in new applications such as cardiology, neurology apart from oncology The ageing population and rising prevalence of target diseases increase the target population Availability of new products in PET and Theranostics segment Expansion of radioligand therapy into earlier lines of treatment (i.e., from 3L to include 2L, 1L and mHSPC populations) Innovative use of AI to enhance diagnostic accuracy and prognostics Rising demand for targeted cancer treatments Measures to close the gap between supply and demand for Mo-99 Market restraints: Stringent manufacturing and regulatory environment Requirement of robust raw material supply, manufacturing, and product transportation due to the short half-life of products Lack of skilled workforce Preconceived negative perceptions around the use of radioactive substances Trends - Investigation of new/ alternative radioisotopes such as 211 At, 223 Radium, and 212 Lead Supply chain advancements Integration with AI for diagnostic imaging Availability of radionuclide therapy programs in hospitals and cancer centers The radiopharmaceuticals sector is highly specialized, competitive and rapidly growing. Cardinal, GE, Novartis, Curium, and Jubilant are some of the prominent players in the industry. Major industry players are acquiring smaller companies with radiopharmaceuticals pipelines and investing in potential blockbuster products to get a foot in the door, which has resulted in significant investments, M&A, and funding. This can be attributed to the effectiveness of radiopharmaceuticals in cancer treatment and the commercial success of recently approved products such as Lutathera (Novartis) and Pluvicto (Novartis). In March 2024, AstraZeneca PLC completed the Canadian biotech Fusion Pharmaceuticals Inc. acquisition for $2 billion. In May 2024, Novartis AG acquired Mariana Oncology to enhance its research capabilities and clinical supply capacity in radioligand therapies. Similarly, in December 2023, Eli Lilly acquired POINT Biopharma Global Inc. with its lutetium-based portfolio for $ 1.4 billion. That same month, BMS purchased RayzeBio, Inc., including its Phase III actinium-based RYZ101, for $4.1 billion. Additionally, radiopharmaceuticals are being developed by significant drugmakers, a few publicly traded companies, and at least a dozen biotechnology startups. The under-development pipeline includes several PET & SPECT imaging agents, and targeted theranostic radiopharmaceuticals for diagnosing cancer and non-cancer indications. For instance, Clarity Pharmaceuticals, an innovative radiopharmaceutical with its Targeted Copper Theranostic (TCT) platform of products, has SARTATE, SAR-bisPSMA, and SAR-Bombesin, next generation, highly targeted theranostic radiopharmaceutical for cancer. GE Healthcare has two new radiopharmaceuticals in the pipeline, PET and SPECT imaging. Expanding the radiopharmaceutical pipeline presents a substantial opportunity for improved patient care with increased access to cutting-edge imaging, improved treatment options, greater personalized treatment, lower radiation exposure, and potential for future advancements. Radioligand therapy is currently used in a small number of cancers. It appears to be a promising treatment option, and its use is anticipated to increase over time to treat various cancer types. The radiopharmaceutical market growth will be further boosted by the use of radioligand therapy together with other therapies, raising patient and healthcare professional awareness of radioligand therapy, coordinating and collaborating specialities involved in providing cancer care (medical oncologists, nuclear medicine physicians, and others), planning hospital capacity—both human and physical—to deliver radioligand therapy safely and effectively, and developing efficient nuclear waste disposal protocols tailored to the various types of therapy.

AcquisitionPhase 3Radiation Therapy

14 Jun 2024

·www.biospace.com

With Donanemab on the Cusp of Approval, Proper Alzheimer’s Diagnosis Is Urgent

Pictured: Abstract visualization of human brain/iStock, bawanch An FDA advisory committee on Monday unanimously voted for the approval of Eli Lilly’s anti-amyloid antibody donanemab, concluding that the benefits outweighed the risk for Alzheimer’s disease patients. At the same time, thousands of physicians, technologists, lab professionals, scientists and others attended the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024 annual meeting in Toronto. Many of the speakers at SNMMI 2024 discussed donanemab and other anti-amyloid drugs and the urgent need to properly diagnose Alzheimer’s so these therapies will benefit patients. Despite other targets, amyloid beta and tau remain critical to the Alzheimer’s treatment landscape, with Eisai and Biogen’s Leqembi in July 2023 becoming the first ever anti-amyloid antibody and disease-altering treatment to be granted traditional FDA approval. Mary Ellen Koran, assistant professor of radiology in the Nuclear Medicine Section at the Mayo Clinic Arizona, emphasized in an SNMMI 2024 presentation that the imaging of brain pathologies is critical, particularly with the advent of anti-amyloid drugs. “It turns out that clinically diagnosing Alzheimer’s disease is very difficult,” Koran said at SNMMI 2024. “Even in specialized dementia centers, there’s a misdiagnosis of Alzheimer’s disease of over a quarter of patients. This is really important now that we have therapies that are actually targeting these pathologies.” Koran pointed to a study published in JAMA Neurology that found as many as one-third of patients clinically diagnosed with mild to moderate Alzheimer’s disease had minimal amyloid accumulation in their brains and risked having limited or no benefit from anti-amyloid treatment. “If you’re giving them a drug based on clinical diagnosis, you’re not giving these patients the right drug, and you’re not giving the right patients the drugs for the clinical trials,” she said. “This is where imaging becomes so important.” The Amyloid PET Quandary Positron emission tomography (PET) scans are a particularly critical component of the diagnosis and treatment of Alzheimer’s disease (AD). Last week, ahead of Monday’s advisory committee meeting, FDA staffers noted that donanemab treatment “demonstrated a statistically significant effect on change from baseline in brain amyloid plaque as measured by PET.” The agency also said that “the use of reduction of amyloid plaques on PET as a surrogate endpoint [is] reasonably likely to predict clinical benefit in patients with early symptomatic stages of AD.” The Alzheimer’s Drug Discovery Foundation (ADDF) has called Lilly’s TRAILBLAZER-ALZ 2 donanemab trial “emblematic of a new era” in research in which patients most likely to benefit from treatment are identified in the early stages of AD. “A unique aspect of this trial was the use of both the Amyvid and Tauvid PET scans to enroll patients with confirmed amyloid plaques, allowing investigators to confirm clearance or reduction of the pathology in later scans,” according to ADDF. At SNMMI 2024, Koran similarly commented that in Lilly’s TRAILBLAZER-ALZ 2 trial, “there were multiple amyloid PET images taken throughout the course of treatment,” which is “pretty cool” for the Alzheimer’s imaging community as such “quantification” of images “may actually inform therapy.” On the reimbursement side, an October 2023 decision by the Centers for Medicare and Medicaid Services (CMS) expanded coverage of PET imaging for diagnosing AD, potentially enabling greater access to new therapies for patients. “It makes us, as nuclear medicine physicians, very relevant to the treatment of these patients,” Koran said. However, Satoshi Minoshima, chair of the Department of Radiology and Imaging Sciences at the University of Utah, provided a sobering assessment at SNMMI 2024 of the challenges facing anti-amyloid therapy in the U.S., including limited scanner capacity, shortages of radiologists and cognitive disorder specialists and unreliable PET interpretation. “Resource limitation is a major challenge for the health system,” Minoshima said, noting it’s a problem that will only get worse as anti-amyloid antibodies like donanemab come to market. The new CMS policy to pay for amyloid PET scans beyond clinical trials is already having a big impact. Minoshima provided a chart with the latest nationwide data on patient volume in the U.S., which showed a 5- to 10-fold increase since October 2023. “Amyloid PET imaging use is really escalating nationally,” he warned. It seems the dam is about to break. Greg Slabodkin is the news editor at BioSpace. You can reach him at greg.slabodkin@biospace.com. Follow him on LinkedIn.

Drug Approval

10 Jun 2024

·www.prnewswire.com

ALZHEIMER'S DRUG DISCOVERY FOUNDATION'S (ADDF) STATEMENT ON FDA ADVISORY COMMITTEE'S ENDORSEMENT OF DONANEMAB

While the endorsement of a second anti-amyloid is emblematic of a new era, a combination therapy and precision medicine approach will be needed to guide the next generation of treatments. NEW YORK, June 10, 2024 /PRNewswire/ -- Today, the FDA Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted that donanemab shows clinical benefit for the treatment of early Alzheimer's disease. If approved, donanemab would become the second disease-modifying drug for Alzheimer's to receive full approval, expanding the arsenal of available drugs needed to treat Alzheimer's with combination therapy. "Today's vote offers hope that donanemab will be approved in the coming months, but it's important to look at this milestone in the larger treatment landscape for Alzheimer's, which will entail a combination therapy and precision medicine approach," says Dr. Howard Fillit, Co-Founder and Chief Science Officer of the Alzheimer's Drug Discovery Foundation (ADDF). "If approved, donanemab will expand the first class of disease-modifying drugs, serving as the building blocks for future generations of drugs. Anti-amyloids are not a silver bullet, but they offer opportunities for patients to modify the course of the disease while the field works towards developing more novel therapies that target the underlying biology." The donanemab trials demonstrate the field's ability to conduct innovative and rigorous biomarker-powered trials that provide a definitive answer on a drug's effectiveness. By using a "goldilocks strategy," the TRAILBLAZER-ALZ 2 trial used both amyloid and tau imaging to identify patients who were in the early stages of Alzheimer's and most likely to benefit from treatment. "It's encouraging to see that some patients essentially enter remission, where they achieve full amyloid clearance with donanemab, with no resurgence in substantial plaque buildup for nearly four years," notes Dr. Fillit. "These findings are a direct result of biomarker tests that can detect, quantify, and monitor plaque buildup in the brain. Biomarkers will continue to revolutionize clinical trial design as we move towards developing drugs that target novel pathways guided by the biology of aging." This milestone comes at a critical time when drug development is now largely driven by the biology of aging approach. In the current pipeline, nearly 75% of Alzheimer's drugs in development are exploring novel targets related to the various aging pathways like inflammation, metabolic disturbances, and vascular dysfunctions. Some of the promising drugs are from ADDF-funded companies such as Coya Therapeutics, which is developing a combination therapy targeting neuroinflammation, as well as Therini Bio, which is developing a drug to target vascular dysfunction, and PharmatrophiX, which recently completed a phase 2a trial for a neuroprotective drug now ready for phase 2b trials. Diversity in the drug pipeline coupled with recent advances in biomarkers—notably the advent of accessible and scalable blood-based biomarkers—sets the stage for a new frontier in Alzheimer's care where early detection, diagnosis, and intervention is feasible. Biomarkers will also be integral to the prevention of the disease by identifying patients in the preclinical phase before symptoms present and reducing Alzheimer's risk based on their individual biomarker profiles. "Today's advisory committee endorsement is a milestone achievement for the researchers, patients, families, and caregivers who have dedicated years to advancing new treatment options, but our work does not end here. We must continue fostering innovation and progress to move closer to the day where Alzheimer's is treated on an individual basis with the help of precision medicine, ultimately halting the progression or preventing the onset of the disease altogether," closes 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: . SOURCE Alzheimer's Drug Discovery Foundation

Phase 2Drug Approval

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
Glioblastoma	Phase 2	PR	Universidad Central del Caribe, Inc.	19 Apr 2023
Glioblastoma	Phase 2	PR	University of Puerto Rico	19 Apr 2023
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	udodzwegbw(mxgctnbcdt) = ohtxstfknp hdagdqnpte (xxlpegytwb, pgqmhxmntd - jsiqqjmuve) View more	-	13 Apr 2022
NCT01767493 (CTgov)	Phase 4	Multiple Sclerosis, Relapsing-Remitting	19	[18F]Florbetapir PET imaging	jmhmugpobe(snzbxhtato) = viwhfkiwdi fgcldvuxgc (nuuvbmeioq, xninjwwjud - kgqfzrpjjf) View more	-	27 Aug 2021
AAIC2018	Not Applicable	Alzheimer Disease	-	[18F]FLORBETAPIR (AD patients)	rlkxmyxsar(fxewnwgzee) = kgtpabupnk mwmamxpzxo (igqpvzxelf )	-	01 Jul 2018
AAIC2018	Not Applicable	Alzheimer Disease	-	[18F]FLORBETAPIR (Controls)	rlkxmyxsar(fxewnwgzee) = nopjdxtete mwmamxpzxo (igqpvzxelf )	-	01 Jul 2018
NCT01518374 (CTgov)	Phase 2	Alzheimer Disease \| Mild cognitive disorder	1,768	Florbetapir F 18	svnxduidjf(khokixgsdk) = qnlaisgmdx pvqjocgmrb (pdsnukulaj, jiitezykzd - ggwoujspub) View more	-	14 Jun 2018
ISC2016	Not Applicable	Cerebral Amyloid Angiopathy	-	Florbetapir (CAA patients)	tbrcafeset(idqxedmbpm) = blfhpbnivn zusexrsjzh (imttfftckz )	-	01 Feb 2016
ISC2016	Not Applicable	Cerebral Amyloid Angiopathy	-	Florbetapir (HTN-ICH patients)	tbrcafeset(idqxedmbpm) = pmtvxlxkri zusexrsjzh (imttfftckz )	-	01 Feb 2016
CTAD2015	Not Applicable	-	-	Genentech Tau Probe 1 ([18F]GTP1)	lyzunfilic(gidhkctoql) = zuqojqazvy ajehzaprwo (cticunmlmu, 4.3)	-	04 Nov 2015
NCT02051790 (CTgov)	Phase 4	Alzheimer Disease	241	florbetapir F 18	bvihtapveq(xwsrdyygyu) = sspxuarwhg pajedcnuam (ojxvsjkure, dmvabeiqkc - nzndiqprkf) View more	-	28 Sep 2015
NCT01890343 (CTgov)	Phase 2	Alzheimer Disease \| Frontotemporal Dementia	34	florbetapir 18F+18F-FDG (Frontotemporal Disorder)	hqwcikddtx(ronjwaulgr) = rknukrotyh ohkomzqybw (bwjejskajz, fqtvfisppx - eulxsauurj) View more	-	17 Sep 2014
NCT01890343 (CTgov)	Phase 2	Alzheimer Disease \| Frontotemporal Dementia	34	florbetapir 18F (Cognitively Normal)	hqwcikddtx(ronjwaulgr) = ermjmoxnjg ohkomzqybw (bwjejskajz, iwxxuwfvah - cibgmhuvsy) View more	-	17 Sep 2014
NCT01683825 (Pubmed \| Eur J Nucl Med Mol Imaging)	Phase 4	Senile cardiac amyloidosis	14	<sup>18</sup>F-florbetapir positron emission tomography ((18)F-florbetapir)	fnhvqvnvvv(yaudanizqx) = idfwtfzdmz vohpurenda (dmrqqgdhkv )	-	01 Sep 2014
NCT01683825 (Pubmed \| Eur J Nucl Med Mol Imaging)	Phase 4	Senile cardiac amyloidosis	14	<sup>18</sup>F-florbetapir positron emission tomography (Control subjects without amyloidosis)	fnhvqvnvvv(yaudanizqx) = uvameatoab vohpurenda (dmrqqgdhkv )	-	01 Sep 2014
INDIA-FBP (AAIC2014)	Not Applicable	Cognitive Dysfunction	250	18F-FLORBETAPIR (Patients with cognitive impairment)	kskesynbpu(gpbijlumvr) = hifaggbhai dvxqqleuft (asvtyzptyn )	-	01 Jul 2014

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