CLINICAL TRIALS PROFILE FOR FLORBETAPIR F-18

All Clinical Trials for FLORBETAPIR F-18

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00857506 ↗	Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45)	Completed	Avid Radiopharmaceuticals	Phase 2	2009-01-01	The primary objective of this protocol is to determine if brain amyloid imaged with florbetapir F 18 (18F-AV-45) PET scans is predictive of progressive cognitive impairment during the subsequent 36 months for groups of: normal controls, mild cognitive impairment and Alzheimer's disease. Hypothesis 1: The probability a subject will experience progressive cognitive impairment within 36 months of imaging will be greater in subjects whose 18F-AV-45 PET scan was rated amyloid positive compared to subjects whose PET scan was rated amyloid negative. The secondary objective is to determine the stability, over 36 months of a clinical diagnosis, of AD in patients with an amyloid positive 18F-AV-45 PET. Hypothesis 2: The diagnosis of AD will remain unchanged in patients whose PET scan were rated as amyloid positive.
NCT00857532 ↗	Florbetapir F 18 PET Imaging of Beta-amyloid in Parkinson's Disease Patients	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2009-01-01	The primary aim of this study is to compare regional amyloid burden in Parkinson's disease (PD) to normal control subjects. We hypothesize that there will be significant differences in overall amyloid burden in PD patients compared to age-matched normal controls.
NCT00857532 ↗	Florbetapir F 18 PET Imaging of Beta-amyloid in Parkinson's Disease Patients	Completed	National Institutes of Health (NIH)	Phase 2	2009-01-01	The primary aim of this study is to compare regional amyloid burden in Parkinson's disease (PD) to normal control subjects. We hypothesize that there will be significant differences in overall amyloid burden in PD patients compared to age-matched normal controls.
NCT00857532 ↗	Florbetapir F 18 PET Imaging of Beta-amyloid in Parkinson's Disease Patients	Completed	Avid Radiopharmaceuticals	Phase 2	2009-01-01	The primary aim of this study is to compare regional amyloid burden in Parkinson's disease (PD) to normal control subjects. We hypothesize that there will be significant differences in overall amyloid burden in PD patients compared to age-matched normal controls.
NCT00857415 ↗	Phase III Study of the Correlation Between Florbetapir F18 PET Imaging and Amyloid Pathology in the Brain	Completed	Avid Radiopharmaceuticals	Phase 3	2008-12-01	The study is designed to test the relationship between measurements of brain amyloid using florbetapir F 18 PET imaging and true levels of amyloid by dissection of the brain at autopsy. Amyloid in the brain is a key feature of Alzheimer's Disease (AD).
NCT00702143 ↗	A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)	Completed	Avid Radiopharmaceuticals	Phase 2	2008-06-01	Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).

Clinical Trial Conditions for FLORBETAPIR F-18

Condition Name

Condition Name for FLORBETAPIR F-18
Intervention	Trials
Alzheimer's Disease	19
Alzheimer Disease	12
Mild Cognitive Impairment	7
Cardiac Amyloidosis	3

Condition MeSH

Condition MeSH for FLORBETAPIR F-18
Intervention	Trials
Alzheimer Disease	33
Cognitive Dysfunction	13
Cognition Disorders	9
Mild Cognitive Impairment	8

Clinical Trial Locations for FLORBETAPIR F-18

Trials by Country

+

−

Trials by Country for FLORBETAPIR F-18
Location	Trials
United States	138
Australia	7
Canada	6
Italy	5
Spain	5

Trials by US State

+

−

Trials by US State for FLORBETAPIR F-18
Location	Trials
California	12
New York	11
Florida	11
Arizona	11
North Carolina	8

Clinical Trial Progress for FLORBETAPIR F-18

Clinical Trial Phase

Clinical Trial Phase for FLORBETAPIR F-18
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for FLORBETAPIR F-18
Clinical Trial Phase	Trials
Completed	31
Recruiting	6
Not yet recruiting	3

Clinical Trial Sponsors for FLORBETAPIR F-18

Sponsor Name

Sponsor Name for FLORBETAPIR F-18
Sponsor	Trials
Avid Radiopharmaceuticals	27
Eli Lilly and Company	3
Biogen	2

Sponsor Type

Sponsor Type for FLORBETAPIR F-18
Sponsor	Trials
Industry	37
Other	25
NIH	5

Clinical Trials, Market Analysis, and Projections for Florbetapir F-18

Introduction

Florbetapir F-18, marketed as Amyvid, is a radiopharmaceutical diagnostic agent used in Positron Emission Tomography (PET) imaging to estimate β-amyloid neuritic plaque density in the brains of adult patients, particularly those being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Current Studies and Objectives

Florbetapir F-18 is extensively used in clinical trials to assess its efficacy and safety in diagnosing Alzheimer's Disease. For instance, in the context of trials like the one evaluating donanemab, florbetapir F-18 is used to measure changes in brain amyloid plaque deposition. The primary objectives of these trials include assessing the effect of treatments on clinical progression and amyloid deposition in early symptomatic AD patients[1].

Imaging Performance and Reliability

Studies have consistently shown that florbetapir F-18 has a wide effective dose range and high test–retest reliability for both quantitative and visual assessments of β-amyloid pathology. This reliability is crucial for longitudinal studies where consistent measurements are necessary to track disease progression and treatment effects[2][3].

Safety and Tolerability

Clinical trials have generally reported that florbetapir F-18 is safe and well-tolerated. Common adverse reactions are minimal, with no significant safety concerns noted in the majority of studies. This safety profile supports its continued use in diagnostic and research settings[5].

Market Analysis

Current Market Position

Florbetapir F-18 is a leading diagnostic agent in the field of Alzheimer's Disease, approved by the U.S. FDA for PET imaging of β-amyloid neuritic plaques. Its widespread use in research and clinical settings, such as in the Alzheimer Disease Neuroimaging Initiative, underscores its importance in diagnosing and studying AD[3][5].

Market Demand

The demand for florbetapir F-18 is driven by the increasing need for accurate diagnostic tools in the management of Alzheimer's Disease. As the global population ages, the incidence of AD is expected to rise, thereby increasing the demand for diagnostic agents like florbetapir F-18.

Competitive Landscape

The market for amyloid-imaging agents includes other radiopharmaceuticals such as 18F-flutemetamol and florbetaben. However, florbetapir F-18 remains a prominent player due to its established use and favorable pharmacokinetics. The recent FDA approval of flortaucipir F-18 for imaging tau neurofibrillary tangles also complements the use of florbetapir F-18, as both agents can provide a comprehensive view of AD pathology[4][5].

Market Projections

Growth Potential

The market for diagnostic agents in Alzheimer's Disease is expected to grow significantly over the next decade. With advancements in PET imaging technology and the increasing awareness of early diagnosis and treatment, the demand for florbetapir F-18 is likely to increase. According to industry projections, the global market for Alzheimer's diagnostic tests is anticipated to expand due to the rising prevalence of the disease and the need for precise diagnostic tools.

Technological Advancements

Future advancements in PET imaging and the integration of artificial intelligence in image analysis are expected to enhance the utility and accuracy of florbetapir F-18. These technological improvements will likely drive further adoption and expansion of its use in both clinical and research settings.

Regulatory Environment

The regulatory environment continues to support the use of florbetapir F-18. FDA approvals and guidelines that facilitate the use of diagnostic agents in clinical practice will remain crucial for the market growth of this drug. Ongoing regulatory support is expected to maintain and possibly increase the market share of florbetapir F-18.

Key Takeaways

• Clinical Trials: Florbetapir F-18 is widely used in clinical trials to assess amyloid deposition and disease progression in Alzheimer's Disease.
• Market Position: It is a leading diagnostic agent approved by the FDA for PET imaging of β-amyloid neuritic plaques.
• Safety and Tolerability: The drug has a favorable safety profile with minimal adverse reactions.
• Market Demand: Increasing demand driven by the rising incidence of Alzheimer's Disease and the need for accurate diagnostic tools.
• Competitive Landscape: Florbetapir F-18 remains a prominent player despite competition from other amyloid-imaging agents.
• Growth Potential: Expected to grow significantly due to technological advancements and increasing awareness of early diagnosis.

FAQs

What is florbetapir F-18 used for?

Florbetapir F-18 is used in Positron Emission Tomography (PET) imaging to estimate β-amyloid neuritic plaque density in the brains of adult patients, particularly those being evaluated for Alzheimer's Disease and other causes of cognitive decline[5].

How does florbetapir F-18 work?

Florbetapir F-18 binds with high affinity to β-amyloid plaques in the brain, allowing for the detection of these plaques through PET imaging. It rapidly enters the brain and has a stable pseudoequilibrium, making it ideal for imaging[3][5].

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

Common adverse reactions are minimal and include headache and injection site pain. The drug is generally well-tolerated[5].

How does florbetapir F-18 compare to other amyloid-imaging agents?

Florbetapir F-18 has a favorable pharmacokinetic profile and high test–retest reliability, making it a prominent diagnostic agent despite competition from other agents like 18F-flutemetamol and florbetaben[2][3].

What is the future outlook for the market of florbetapir F-18?

The market is expected to grow significantly due to the increasing need for accurate diagnostic tools in Alzheimer's Disease management, technological advancements, and a supportive regulatory environment.

How is florbetapir F-18 administered?

Florbetapir F-18 is administered via an intravenous injection, typically 370 MBq (10 mCi), followed by a PET scan 50 minutes later[3][5].

Sources

1. Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic AD Patients. ClinicalTrials.gov.
2. Performance Characteristics of Amyloid PET with Florbetapir F 18 in Patients with Alzheimer's Disease. Journal of Nuclear Medicine.
3. Use of Florbetapir-PET for Imaging β-Amyloid Pathology. JAMA Network.
4. Lilly Receives U.S. FDA Approval of TAUVID™ (flortaucipir F 18 injection) for Use in Patients Being Evaluated for Alzheimer's Disease. Lilly Investor Relations.
5. Florbetapir F-18: Uses, Interactions, Mechanism of Action. DrugBank.