CLINICAL TRIALS PROFILE FOR FLORBETABEN F-18

All Clinical Trials for FLORBETABEN F-18

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01020838 ↗	Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology	Completed	Life Molecular Imaging SA	Phase 3	2009-11-01	To determine the sensitivity and specificity of the visual assessment of tracer uptake in the Florbetaben PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth
NCT01020838 ↗	Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology	Completed	Piramal Imaging SA	Phase 3	2009-11-01	To determine the sensitivity and specificity of the visual assessment of tracer uptake in the Florbetaben PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth
NCT00928304 ↗	Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.	Completed	Life Molecular Imaging SA	Phase 2	2009-06-01	To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.
NCT00928304 ↗	Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.	Completed	Piramal Imaging SA	Phase 2	2009-06-01	To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.
NCT00750282 ↗	Phase II Study of Florbetaben (BAY 94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers	Completed	Life Molecular Imaging SA	Phase 2	2008-08-01	The aim of this study is to evaluate the efficacy, safety of a single dose of BAY 94-9172 (ZK 6013443) as an investigational medicinal product (IMP) in detecting cerebral protein-plaque (amyloid beta) with positron emission tomography (PET). IMP binds to amyloidal beta protein accumulating in brain tissue already from early stages of Alzheimer's disease (AD). IMP is therefore a potential tracer to be used for detecting amyloid plaques. For each subject it is required to visit the study centre during the screening phase, on the PET imaging day and for 1 follow-up visit on the next day. A telephone call for safety follow-up will be performed 7 days after IMP administration. During the screening phase the subject's medical, neurological and surgical history, specific laboratory tests related to AD, MRI of the brain and certain neuro-psychiatric tests will be performed. Clinical safety measures (physical examinations, vital signs, electrocardiogram (ECG) and laboratory tests) will be performed on the PET imaging day before IMP injection and monitored during and after two PET imaging sessions. Clinical safety measures will be performed again on the follow-up visit next day. The results of PET imaging with IMP will be compared between probable AD patients and healthy volunteers (HV). The clinical diagnosis is based on international validated and accepted criteria and established after comprehensive clinical and neuro-psychiatric examinations
NCT00750282 ↗	Phase II Study of Florbetaben (BAY 94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers	Completed	Piramal Imaging SA	Phase 2	2008-08-01	The aim of this study is to evaluate the efficacy, safety of a single dose of BAY 94-9172 (ZK 6013443) as an investigational medicinal product (IMP) in detecting cerebral protein-plaque (amyloid beta) with positron emission tomography (PET). IMP binds to amyloidal beta protein accumulating in brain tissue already from early stages of Alzheimer's disease (AD). IMP is therefore a potential tracer to be used for detecting amyloid plaques. For each subject it is required to visit the study centre during the screening phase, on the PET imaging day and for 1 follow-up visit on the next day. A telephone call for safety follow-up will be performed 7 days after IMP administration. During the screening phase the subject's medical, neurological and surgical history, specific laboratory tests related to AD, MRI of the brain and certain neuro-psychiatric tests will be performed. Clinical safety measures (physical examinations, vital signs, electrocardiogram (ECG) and laboratory tests) will be performed on the PET imaging day before IMP injection and monitored during and after two PET imaging sessions. Clinical safety measures will be performed again on the follow-up visit next day. The results of PET imaging with IMP will be compared between probable AD patients and healthy volunteers (HV). The clinical diagnosis is based on international validated and accepted criteria and established after comprehensive clinical and neuro-psychiatric examinations

Clinical Trial Conditions for FLORBETABEN F-18

Condition Name

Condition Name for FLORBETABEN F-18
Intervention	Trials
Alzheimer Disease	7
Cardiac Amyloidosis	4
Alzheimer's Disease	3
Amyloid Beta-Protein	3

Condition MeSH

Condition MeSH for FLORBETABEN F-18
Intervention	Trials
Alzheimer Disease	13
Amyloidosis	9
Cognitive Dysfunction	3
Brain Diseases	2

Clinical Trial Locations for FLORBETABEN F-18

Trials by Country

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−

Trials by Country for FLORBETABEN F-18
Location	Trials
United States	48
Germany	7
Australia	6
Japan	6
France	4

Trials by US State

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−

Trials by US State for FLORBETABEN F-18
Location	Trials
New York	9
Pennsylvania	4
California	4
Arizona	4
Florida	3

Clinical Trial Progress for FLORBETABEN F-18

Clinical Trial Phase

Clinical Trial Phase for FLORBETABEN F-18
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for FLORBETABEN F-18
Clinical Trial Phase	Trials
Completed	9
Recruiting	7
Enrolling by invitation	3

Clinical Trial Sponsors for FLORBETABEN F-18

Sponsor Name

Sponsor Name for FLORBETABEN F-18
Sponsor	Trials
National Institute on Aging (NIA)	6
Life Molecular Imaging SA	5
Piramal Imaging SA	4

Sponsor Type

Sponsor Type for FLORBETABEN F-18
Sponsor	Trials
Other	31
Industry	13
NIH	8

Florbetaben F-18: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

Florbetaben F-18, marketed as Neuraceq®, is a radioactive diagnostic agent used in Positron Emission Tomography (PET) imaging to estimate β-amyloid neuritic plaque density in the brain. Initially approved for diagnosing Alzheimer's disease and other causes of cognitive decline, Florbetaben F-18 is now being explored for its potential in diagnosing cardiac amyloidosis. Here, we provide an update on its clinical trials, market analysis, and future projections.

Clinical Trials Update

Alzheimer's Disease

Florbetaben F-18 has been extensively studied and approved for use in diagnosing Alzheimer's disease. It binds to β-amyloid plaques in the brain, allowing for the non-invasive detection of amyloid deposits. Clinical studies have shown high sensitivity and specificity in distinguishing patients with Alzheimer's disease from those with other neurodegenerative diseases such as frontotemporal lobar degeneration (FTLD) and dementia with Lewy bodies (DLB)[5].

Cardiac Amyloidosis

A significant development is the ongoing Phase 3 clinical trial, CArdiag, which is evaluating the diagnostic efficacy of [18F]florbetaben PET imaging in patients with suspected cardiac AL amyloidosis. This study, conducted in multiple centers across Germany, Spain, the UK, and the US, aims to enroll approximately 200 patients globally. The primary objective is to determine the sensitivity and specificity of [18F]florbetaben PET images compared to standard clinical diagnoses. This trial also explores the possibility of differential diagnosis between AL and ATTR types of cardiac amyloidosis using [18F]florbetaben PET[1].

Mechanism of Action and Pharmacology

Florbetaben F-18 is a fluorine-18-labeled stilbene derivative that crosses the blood-brain barrier and binds to β-amyloid plaques. The positron signal produced by the F-18 isotope is detected by a PET scanner, allowing for the visualization of amyloid deposits. In the context of cardiac amyloidosis, initial clinical data suggest that [18F]florbetaben can detect amyloid deposits in the heart, similar to its action in the brain[2].

Safety and Adverse Reactions

Clinical trials have identified the most common adverse reactions associated with Florbetaben F-18 as injection site reactions, including erythema, irritation, and pain. These reactions are generally mild and transient. The drug has a half-life of approximately one hour and is primarily excreted in the urine[2].

Market Analysis

Current Market Position

Florbetaben F-18 is approved and marketed in several countries, including the US, Europe, Japan, and Korea. It is widely used in the diagnostic workup of patients with cognitive impairment and suspected Alzheimer's disease. The integration of Florbetaben PET into clinical practice has been successful, with studies showing consistent usage patterns and high diagnostic utility[4].

Market Trends

The Alzheimer's disease diagnostic market is growing, driven by the increasing prevalence of the disease and the need for accurate diagnostic tools. Florbetaben F-18, with its established track record and expanding indications, is well-positioned to capture a significant share of this market. The potential expansion into cardiac amyloidosis diagnosis further broadens its market potential[3].

Competitive Landscape

The diagnostic market for Alzheimer's and other neurodegenerative diseases is competitive, with several other radiotracers and diagnostic tools available. However, Florbetaben F-18's approval and widespread use give it a strong market presence. The ongoing Phase 3 trial for cardiac amyloidosis could further differentiate it from competitors and expand its market reach[3].

Projections and Future Outlook

Expanding Indications

The successful completion of the CArdiag Phase 3 trial could lead to the approval of Florbetaben F-18 for diagnosing cardiac AL amyloidosis, significantly expanding its market. This would not only enhance its diagnostic capabilities but also provide an earlier and more accurate diagnosis for patients with this rare and life-threatening condition[1].

Integration with Treatment Selection and Monitoring

Beyond its diagnostic utility, Florbetaben PET is increasingly recognized for its role in measuring the biological responses to newly approved disease-modifying drugs (DMDs) for Alzheimer's. This integration with treatment selection and monitoring is expected to further solidify its position in the market and contribute to improved patient outcomes[4].

Regulatory Support

The orphan drug designation granted by the European Commission and the U.S. Food and Drug Administration for AL amyloidosis underscores the regulatory support for Florbetaben F-18. This designation can facilitate faster approval processes and provide market exclusivity, which would be beneficial for its future market position[1].

Key Takeaways

• Florbetaben F-18 is a well-established diagnostic agent for Alzheimer's disease, with a strong market presence.
• The ongoing CArdiag Phase 3 trial aims to expand its indication to cardiac AL amyloidosis.
• The drug has a favorable safety profile with mild and transient adverse reactions.
• Market trends indicate a growing demand for accurate diagnostic tools, positioning Florbetaben F-18 for continued market growth.
• Regulatory support, such as orphan drug designation, is expected to facilitate its expansion into new indications.

FAQs

What is Florbetaben F-18 used for?

Florbetaben F-18 is used for Positron Emission Tomography (PET) imaging to estimate β-amyloid neuritic plaque density in the brain, primarily for diagnosing Alzheimer's disease and other causes of cognitive decline.

What is the current status of the CArdiag Phase 3 trial?

The CArdiag Phase 3 trial has started, with the first patient imaged with [18F]florbetaben. The trial aims to evaluate the diagnostic efficacy of [18F]florbetaben PET imaging in patients with suspected cardiac AL amyloidosis.

What are the common adverse reactions associated with Florbetaben F-18?

The most common adverse reactions are injection site reactions, including erythema, irritation, and pain.

How does Florbetaben F-18 work?

Florbetaben F-18 binds to β-amyloid plaques in the brain, producing a positron signal that is detected by a PET scanner.

What is the market potential of Florbetaben F-18?

The market potential is significant, given its established use in Alzheimer's diagnosis and the potential expansion into cardiac amyloidosis diagnosis, along with its role in treatment selection and monitoring.

Sources

1. Life Molecular Imaging Announces Start of Phase 3 Study with [18F]Florbetaben in Cardiac Amyloid Light Chain (AL) Amyloidosis - Life Molecular Imaging.
2. Florbetaben F-18: Uses, Interactions, Mechanism of Action - DrugBank.
3. Alzheimer's Disease Insight Report: Current Therapies, Drug Pipeline, and Outlook - Biospace.
4. Experiences from Clinical Research and Routine Use of [18F]Florbetaben Amyloid PET - MDPI.
5. Amyloid Imaging with 18F-Florbetaben in Alzheimer Disease and Other Neurodegenerative Diseases - Journal of Nuclear Medicine.