CLINICAL TRIALS PROFILE FOR VIZAMYL

All Clinical Trials for VIZAMYL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01607476 ↗	Bridging Study of C11 Pittsburgh Compound B (PiB) and F18 Flutemetamol Brain Positron Emission Tomography (PET)	Completed	Mayo Clinic	Phase 2	2012-07-01	The intent of this research protocol is to test the equivalency of two amyloid imaging drugs (C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there will be no significant difference in the distribution of the agents to areas of amyloid deposition in the brain or to other normal brain structures. Recent data have shown similarity in the distribution of the drugs in subjects with Alzheimer's disease (AD) or mild cognitive impairment (MCI). No comparison data of the two PET drugs in normal subjects has been published. It is important to understand differences in the images and biodistribution from the two drugs in normal subjects as nonspecific accumulation of the drugs in brain structures such as white matter appear to differ slightly and could affect image performance.
NCT02317783 ↗	Amyloid Plaque Deposition in Chemotherapy-Induced Cognitive Impairment	Recruiting	University of Utah	Phase 2	2018-01-31	The initial goal of the investigators interdisciplinary group of imagers, oncologists, neurologists, neuro-psychologists, and biostatisticians is to obtain proof of concept pilot data for eventual submission of a National Cancer Institute Quick-Trial for Imaging and Image-Guided Interventions: Exploratory Grant (R10) depending on the results of this pilot study. The overall objective is to use [18F]Flutemetamol, FDG-PET, and MRI to better understand CICI, which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy.2,3 To date there have been few studies examining this problem using multi-modality imaging techniques to better understand this complex and significant problem. FDG-PET and MRI are routinely used in clinical practice for the evaluation of cognitive dysfunction in older populations complaining of memory dysfunction. It is well recognized that FDG-PET can assist with the differentiation and characterization of various cognitive disorders due to unique patterns of cerebral metabolism caused by various cognitive and dementia-causing disorders.4-6 FDG-PET has been studied extensively in dementia research and has a high reliability in detecting Alzheimers disease (AD) many years before it can be diagnosed reliably using clinical criteria.4 To the investigators knowledge, there has been only a single small study using FDG-PET and bolus water activation paradigms in cancer patients complaining of memory problems.7 To date, there have been no studies using [18F]Flutemetamol as a PET imaging agent to assess the possibility of increased amyloid plaque burden as a potential contributing factor to the cognitive deficits and complaints seen in patients experiencing CICI. The novel feature of this project is in the combined use of [18F]Flutemetamol-PET, FDG-PET, and anatomic MRI to study a poorly understood but common problem: cognitive impairment in breast cancer patients treated with chemotherapy. If [18F]Flutemetamol, FDG-PET, and MRI can provide information on the pathophysiology of this disorder, it will be an important step in better understanding the etiology of this phenomenon and possibly other conditions resulting in cognitive dysfunction. These imaging assessments will make it possible to explore any altered changes in cerebral structure, metabolism, and amyloid deposition that may be responsible for CICI. This may help to predict which individuals may be affected by this problem and provide information for eventual therapeutic strategies to treat this common cancer-associated disorder. This study will use [18F]Flutemetamol and FDG-PET imaging to assess and quantify the amyloid plaque burden and cerebral glucose metabolism, respectively, in breast cancer patients suffering from CICI and correlate those findings with structural changes on MRI. The [18F]Flutemetamol and FDG-PET scans of these study patients will then be compared to two GE software databases (CortexID-FDG and CortexID-Flutemetamol) which contain scan data from healthy control individuals to evaluate for abnormalities in cerebral glucose metabolism and amyloid plaque burden differing from the values expected for individuals in their age range.
NCT02353949 ↗	Investigating the Clinical Consequences of Flutemetamol-PET-scanning	Terminated	ETH Zurich	Phase 3	2015-05-01	The study examines subjects where there might be an indication for Amyloid-PET according to the Criteria defined by the Amyloid Imaging Task Force. In these subjects the impact of a Flutemetamol (Vizamyl)-Positron-Emission-Tomography -Scan (PET) on clinical management and disease course will be studied over 6 months.
NCT02353949 ↗	Investigating the Clinical Consequences of Flutemetamol-PET-scanning	Terminated	University of Zurich	Phase 3	2015-05-01	The study examines subjects where there might be an indication for Amyloid-PET according to the Criteria defined by the Amyloid Imaging Task Force. In these subjects the impact of a Flutemetamol (Vizamyl)-Positron-Emission-Tomography -Scan (PET) on clinical management and disease course will be studied over 6 months.
NCT02778971 ↗	Implications for Management of PET Amyloid Classification Technology	Recruiting	University of Utah		2016-06-01	The main purpose of this study is to explore the impact of an amyloid positron emission tomography and computed tomography (PET/CT) scan on physician diagnosis and management, including drug management and care practices, for patients with a diagnosis of cognitive impairment. This study also intends to capture specific patient-reported outcomes related to patient burden, confidence and satisfaction. The hypothesis is that to aid early diagnosis, individuals with a diagnostically uncertain etiology for their dementia will benefit from knowledge of amyloid plaque burden status, through an alteration of patient diagnosis and management, which will lead to significant changes in patient and care partner reported outcomes.
NCT03232632 ↗	Assessment of Cardiac Fixation During PET Using a New Drug Within Amyloid Cardiac Injuries.	Terminated	University Hospital, Toulouse	Early Phase 1	2017-03-15	To estimate distribution's parameters of 18F-Flutemetamol (Vizamyl®) fixation on myocardium for patients with amyloid cardiac injuries.

Clinical Trial Conditions for VIZAMYL

Condition Name

Condition Name for VIZAMYL
Intervention	Trials
Alzheimer's Disease	3
Dementia	2
Mild Cognitive Impairment	2
Breast Cancer	1

Condition MeSH

Condition MeSH for VIZAMYL
Intervention	Trials
Cognitive Dysfunction	3
Cognition Disorders	3
Alzheimer Disease	3
Mild Cognitive Impairment	2

Clinical Trial Locations for VIZAMYL

Trials by Country

Trials by Country for VIZAMYL
Location	Trials
United States	3
Switzerland	2
France	1

Trials by US State

Trials by US State for VIZAMYL
Location	Trials
Utah	2
Minnesota	1

Clinical Trial Progress for VIZAMYL

Clinical Trial Phase

Clinical Trial Phase for VIZAMYL
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for VIZAMYL
Clinical Trial Phase	Trials
Terminated	2
Recruiting	2
Completed	1

Clinical Trial Sponsors for VIZAMYL

Sponsor Name

Sponsor Name for VIZAMYL
Sponsor	Trials
University of Utah	2
Mayo Clinic	1
ETH Zurich	1

Sponsor Type

Sponsor Type for VIZAMYL
Sponsor	Trials
Other	7

Clinical Trials Update, Market Analysis, and Projection for Vizamyl (Flutemetamol)

Last updated: October 28, 2025

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Introduction

Vizamyl (flutemetamol) is a diagnostic radiopharmaceutical used in Positron Emission Tomography (PET) imaging to detect beta-amyloid plaques in the brain—a hallmark of Alzheimer’s disease (AD). Approved by the U.S. Food and Drug Administration (FDA) in 2013, Vizamyl has become an essential component in neurodegenerative disease diagnostics. This report provides an in-depth update on ongoing clinical trials, market landscape, and future projections for Vizamyl, emphasizing its role in Alzheimer’s diagnostics and broader neuroimaging applications.

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Clinical Trials Overview and Updates

Historical Context and Regulatory Milestones

Vizamyl's initial approval was based on phase 3 clinical trials demonstrating its safety and efficacy in visualizing beta-amyloid deposits. The pivotal study, published in JAMA Neurology, involved over 400 subjects and confirmed its high concordance with post-mortem neuropathology. Since its approval, the focus has shifted towards validating its utility in various clinical settings, including early diagnosis, differential diagnosis, and tracking disease progression.

Recent and Ongoing Clinical Trials

While Vizamyl's core indication remains diagnostic imaging for Alzheimer’s, research interest has broadened to exploring its application in preclinical stages and other neurodegenerative conditions.

• NCT03408524: This ongoing trial assesses the predictive value of Vizamyl-PET imaging in cognitively healthy individuals at risk for AD, aiming to evaluate early beta-amyloid accumulation as a predictor for future development of clinical symptoms. Expected completion is projected for 2024.
• NCT03896135: A study evaluating Vizamyl's utility in distinguishing between different types of dementia, including Lewy body dementia and frontotemporal dementia, with anticipated data release in 2023.
• NCT04250596: Focuses on longitudinal analysis of beta-amyloid burden in patients with mild cognitive impairment (MCI), aiming to correlate imaging results with cognitive decline and disease progression.

Recent Data and Publications

Emerging data from recent phase 4 observational studies underscore the diagnostic impact of Vizamyl imaging in clinical practice. A recent retrospective analysis published in NeuroImage Clinical reported that Vizamyl PET contributed to changes in diagnosis in approximately 30% of cases, emphasizing its clinical utility in ambiguous cases.

Further, ongoing real-world evidence suggests increasing adoption in specialized memory clinics, with an emphasis on integrating Vizamyl imaging with cerebrospinal fluid (CSF) biomarkers and emerging blood-based assays.

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Market Analysis

Market Landscape and Key Players

The global neuroimaging agent market, particularly amyloid PET tracers, has seen significant growth fueled by increasing AD prevalence and advancing diagnostic standards.

• Leading Agents: Besides Vizamyl, the main competing amyloid imaging agents include Amyvid (florbetapir, Avid Radiopharmaceuticals/Eli Lilly) and Neuraceq (flutemetamol, Piramal Imaging). These agents dominate the market, with Amyvid holding FDA approval since 2012.

• Market Shares and Trends: According to a 2022 report by GlobalData, Amyvid accounts for approximately 60% of the amyloid PET tracer market, with Vizamyl capturing around 20%, and Neuraceq holding the remaining share. The rest is divided among emerging agents and regional players.

Market Drivers

• Rising Prevalence of Alzheimer’s Disease: By 2050, the number of individuals aged 65 and above with AD is expected to triple to over 150 million globally [1]. This demographic shift drives demand for accurate, early diagnostic tools.

• Regulatory Approvals and Clinical Guidelines: Increasing endorsement by health authorities and incorporation into diagnostic algorithms bolster Vizamyl’s market position. The National Institute on Aging–Alzheimer’s Association (NIA-AA) guidelines now recommend amyloid PET imaging as part of the diagnostic workup in certain populations.

• Advances in Neuroimaging: Innovations in PET imaging technology and integration with other biomarkers enhance diagnostic precision, encouraging wider adoption.

• Reimbursement Policies: Medicare's coverage expansion for amyloid PET scans in certain clinical scenarios in the U.S. has elevated utilization rates.

Regional Market Breakdown

• United States: The largest market, driven by high AD prevalence, reimbursement support, and established clinical pathways.
• Europe: Growing acceptance, with regulatory approval obtained in multiple countries; however, reimbursement remains variable.
• Asia-Pacific: Emerging market with increasing awareness and infrastructure development; expected to grow rapidly due to demographic transitions.

Market Challenges

• Cost and Reimbursement: High costs of PET imaging and limited reimbursement may hinder broader access.
• Operational Limitations: Availability of PET scanners and trained personnel constrains scalability.
• Competition: The crowded market with multiple agents necessitates differentiation—either through improved imaging quality, cost-effectiveness, or adjunctive features like blood-based biomarkers.

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Future Market Projections

Market Growth Forecast (2023–2030)

Based on current market dynamics and epidemiological trends, the amyloid PET tracer market, including Vizamyl, is projected to grow at a compound annual growth rate (CAGR) of approximately 9% through 2030.

• Market Value: Estimated to expand from $400 million in 2022 to over $900 million by 2030 globally.
• Key Drivers: Increasing AD prevalence, expansion of diagnostic indications, technological advancements, and insurance coverage expansions.

Potential Expansion Opportunities

• Preclinical and Prodromal AD Diagnosis: Demonstrating utility in identifying amyloid pathology before clinical symptoms could diversify Vizamyl's application scope.
• Combination with Other Biomarkers: Integration with tau imaging and blood-based markers may enhance diagnostic accuracy, facilitating personalized medicine.
• Regulatory Approvals for Other Indications: Investigating Vizamyl's utility in other neurodegenerative disorders (e.g., Lewy body dementia, traumatic brain injury) could unlock new markets.

Obstacles to Growth

• Emergence of Blood-Based Biomarkers: Blood tests for amyloid detection are emerging as cost-effective, less invasive alternatives, potentially cannibalizing PET tracer sales.
• Diagnostic Reimbursement Delays: Variability across countries in coverages can delay adoption.

Strategic Outlook

To sustain growth, Vizamyl's development strategy should focus on expanding indications, demonstrating clinical utility in longitudinal studies, and collaborating with healthcare payers to streamline reimbursement pathways. Additionally, integrating Vizamyl imaging within comprehensive biomarker panels can position it as part of a multi-modal diagnostic paradigm.

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Key Takeaways

• Stable Position in Diagnostic Market: Vizamyl remains a crucial amyloid PET tracer with established clinical utility, supported by ongoing trials and increasing adoption.
• Growing Market Demand: The global amyloid imaging market is poised for a CAGR of approximately 9%, driven by demographic trends, technological advances, and evolving clinical guidelines.
• Competitive Edge: Differentiation efforts should emphasize clinical utility, ease of use, and integration with emerging biomarkers.
• Regulatory and Reimbursement Dynamics: Continued engagement with regulatory agencies and payers is essential to facilitate broader access and utilization.
• Innovation and Diversification: Future growth hinges on expanding applications, including early detection and integration within multi-modal diagnostic frameworks.

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FAQs

1. What are the main advantages of Vizamyl over other amyloid PET tracers?
Vizamyl offers high specificity for beta-amyloid plaques, with a relatively favorable safety profile. It can be produced using established PET imaging infrastructure, and its diagnostic accuracy is comparable to competitors like Amyvid and Neuraceq. Additionally, manufacturing has been optimized to ensure consistent quality, facilitating clinical adoption.

2. How does Vizamyl's clinical utility impact Alzheimer’s disease diagnosis?
Vizamyl enhances the accuracy of diagnosing AD, especially in cases where clinical symptoms are ambiguous. Its ability to visualize amyloid deposits supports early intervention strategies and improves differential diagnosis between AD and other dementias, enabling tailored treatment approaches.

3. What challenges does Vizamyl face in expanding its market share?
Market expansion hurdles include high costs associated with PET imaging, limited reimbursement policies in some regions, competition from other tracers, and the development of blood-based biomarkers that might replace imaging in certain indications.

4. Are there ongoing efforts to expand Vizamyl’s indications?
Yes. Current research explores its role in preclinical detection of amyloid pathology, monitoring disease progression, and distinguishing between different dementias. Positive results could extend its use beyond AD diagnosis.

5. What is the outlook for Vizamyl in the next decade?
With rising AD prevalence and increasing clinical acceptance, Vizamyl is positioned to maintain relevance. Strategic expansion into early diagnosis and multimodal biomarker integration could sustain growth. However, developments in non-invasive blood tests may influence its market dominance, necessitating adaptability and innovation.

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References

[1] World Alzheimer Report 2022, Alzheimer’s Disease International.