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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR VIZAMYL


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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.
NCT05374564 ↗ Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy Not yet recruiting Yale University Phase 1 2022-06-01 18F-Flutemetamol (Vizamyl) is a radioactive diagnostic agent indicated and FDA-approved for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) or other causes of cognitive decline. This study is designed to evaluate a novel use for 18F-Flutemetamol in cardiac amyloidosis.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

Condition MeSH for Vizamyl
Intervention Trials
Cognition Disorders 3
Alzheimer Disease 3
Cognitive Dysfunction 3
Mild Cognitive Impairment 2
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Clinical Trial Locations for Vizamyl

Trials by Country

Trials by Country for Vizamyl
Location Trials
United States 3
Switzerland 2
France 1
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Trials by US State

Trials by US State for Vizamyl
Location Trials
Utah 2
Minnesota 1
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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
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Clinical Trial Status

Clinical Trial Status for Vizamyl
Clinical Trial Phase Trials
Terminated 2
Recruiting 2
Completed 1
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Clinical Trial Sponsors for Vizamyl

Sponsor Name

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

Sponsor Type for Vizamyl
Sponsor Trials
Other 7
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Vizamyl: A Breakthrough in Alzheimer’s Diagnosis - Clinical Trials, Market Analysis, and Projections

Introduction to Vizamyl

Vizamyl, also known as Flutemetamol F18 injection, is a groundbreaking radioactive diagnostic agent approved by the U.S. Food and Drug Administration (FDA) and the European Commission for Positron Emission Tomography (PET) imaging of the brain. It is specifically designed to estimate beta amyloid neuritic plaque density, a key indicator of Alzheimer’s disease (AD)[1][2][5].

Clinical Trials and FDA Approval

The FDA approval of Vizamyl was based on a comprehensive review of pivotal and supportive data from a series of clinical trials, including Phase III brain autopsy and biopsy studies. These studies demonstrated high sensitivity and specificity for the visual interpretation of PET images compared to beta amyloid brain pathology. The clinical trials also included an electronic reader training program (ETP) developed by GE Healthcare, which was effective in training readers to accurately interpret the images[1][2][5].

Key Findings from Clinical Trials

  • High Sensitivity and Specificity: The trials showed that Vizamyl had high sensitivity and specificity for detecting beta amyloid plaques, making it a reliable tool for diagnosing Alzheimer’s disease.
  • Safety Profile: Vizamyl was generally well tolerated, with common adverse reactions such as flushing, increased blood pressure, headache, nausea, and dizziness occurring at rates of 2% or less. One serious hypersensitivity reaction was reported but resolved with treatment[1][2].

Market Availability and Expansion

Initial U.S. Markets

Vizamyl was first made available in the U.S. in the second quarter of 2014, with initial markets including areas near East Rutherford, NJ, Woburn, MA, Beltsville, MD, East Lansing, MI, Dallas, TX, Phoenix, AZ, and Colton, CA[2].

European Market

Following FDA approval, Vizamyl also received marketing authorization from the European Commission in 2014. It became commercially available in selected European countries from early 2015[5].

Market Analysis and Projections

Current Market Context

The approval and market introduction of Vizamyl occur within a broader context of growing demand for innovative healthcare solutions. The U.S. clinical trials market, for instance, is projected to grow significantly, driven by ongoing research efforts and the need to enhance patient care. The market was valued at USD 25.81 billion in 2023 and is expected to reach USD 41.57 billion by 2033[3].

Alzheimer’s Disease Market

Alzheimer’s disease is a significant health burden, with an estimated 5.2 million Americans affected and healthcare costs for 2014 estimated at $214 billion. The availability of diagnostic tools like Vizamyl is crucial for improving diagnostic accuracy and potentially reducing these costs[2].

Segment Growth

The diagnostic segment, particularly for neurologic conditions like Alzheimer’s, is expected to see substantial growth. The oncology segment, which currently holds the largest revenue share, is also anticipated to register the fastest CAGR over the forecast period. However, the autoimmune and neurology segments are also expected to be lucrative, with the autoimmune segment projected to grow at a CAGR of 5.6%[3].

Impact on Alzheimer’s Diagnosis and Treatment

Diagnostic Accuracy

Vizamyl enhances diagnostic accuracy by providing clear, color PET images that help physicians detect or exclude the presence of beta amyloid plaques in the brain. This can lead to more accurate diagnoses and better patient management strategies[1][2].

Clinical Utility

The ability to visually interpret these images, thanks to the ETP, ensures that healthcare providers can make more informed decisions about patient care. This tool is particularly valuable in distinguishing between Alzheimer’s disease and other causes of cognitive decline[1].

Future Treatment Implications

The approval of Vizamyl underscores the potential for advancing treatment options by helping to enroll the right patients into clinical trials. This could lead to the development of disease-modifying medications, a critical step in managing and potentially treating Alzheimer’s disease[1].

Key Takeaways

  • Clinical Trials Success: Vizamyl’s approval is based on robust clinical trial data showing high sensitivity and specificity.
  • Market Expansion: Initially available in select U.S. and European markets, with plans for broader distribution.
  • Diagnostic Impact: Enhances diagnostic accuracy for Alzheimer’s disease, aiding in better patient care and potential treatment advancements.
  • Market Growth: Part of a growing diagnostic market driven by the need for innovative healthcare solutions.
  • Safety Profile: Generally well tolerated with minimal adverse reactions.

FAQs

What is Vizamyl used for?

Vizamyl is used for Positron Emission Tomography (PET) imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease or other causes of cognitive decline[1][2].

How was Vizamyl approved?

Vizamyl was approved by the FDA and the European Commission based on pivotal and supportive data from a series of clinical trials, including Phase III brain autopsy and biopsy studies[1][2][5].

What are the common adverse reactions associated with Vizamyl?

Common adverse reactions include flushing, increased blood pressure, headache, nausea, and dizziness, occurring at rates of 2% or less. One serious hypersensitivity reaction has been reported[1][2].

How does Vizamyl improve diagnostic accuracy?

Vizamyl provides clear, color PET images that help physicians detect or exclude the presence of beta amyloid plaques in the brain, enhancing diagnostic accuracy and aiding in better patient management strategies[1][2].

What is the market outlook for Vizamyl and similar diagnostic tools?

The market for diagnostic tools like Vizamyl is expected to grow, driven by the increasing demand for innovative healthcare solutions and the need to enhance patient care. The U.S. clinical trials market is projected to expand significantly by 2033[3].

Sources

  1. GE Healthcare Announces FDA Approval of Vizamyl™ (Flutemetamol F18 Injection) for Detection of Beta Amyloid - GE Healthcare.
  2. GE Healthcare Announces First U.S. Markets For New Alzheimer’s Diagnostic Tool for Detection of Beta Amyloid - Business Wire.
  3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033 - BioSpace.
  4. EU Clinical Trials Register - EU Clinical Trials Register.
  5. GE Healthcare Announces European Union Approval of VIZAMYL™ (Flutemetamol 18F Solution for Injection) for PET Imaging of Beta Amyloid Plaque in Suspected Alzheimer’s Disease - Business Wire.

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