Study on the Accuracy of Tau PET ([18F]RO6958948) and Vizamyl (Flutemetamol 18F) in Diagnosing Mild Cognitive Symptoms and Risk of Alzheimer’s Disease

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What is this study about?

The study focuses on understanding and improving the diagnosis of certain brain disorders known as neurodegenerative disorders. These include conditions like Alzheimer’s disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration, and mild cognitive impairment. The study uses two special substances, Vizamyl and [18F]RO6958948, which are injected into the body to help doctors see changes in the brain using a type of scan called PET (Positron Emission Tomography).

The purpose of the study is to see how well these substances can help identify people who are at risk of developing dementia, a condition that affects memory and thinking. Participants in the study will receive an injection of either Vizamyl or [18F]RO6958948. These substances help highlight areas in the brain that may be affected by the disorders. The study will compare the brain scans of people with these disorders to those of healthy individuals to better understand the differences.

Throughout the study, participants will undergo various tests, including brain scans and cognitive assessments, to monitor their brain health and cognitive function. The study aims to gather information over time to see how these disorders progress and how the substances used in the study can aid in early detection and diagnosis. This research hopes to provide valuable insights into the early stages of these disorders and improve the way they are diagnosed and understood.

1 initial assessment

Upon joining the study, an initial assessment is conducted to determine eligibility. This includes a review of cognitive symptoms and general cognitive performance. Participants must be between 20 and 100 years of age and fluent in Swedish.

Participants are required to agree to at least one lumbar puncture, an MRI scan of the brain, and neuropsychological testing.

2 baseline visit

During the baseline visit, participants undergo a series of tests to establish their current cognitive status. This includes cognitive tests to assess memory and thinking skills.

Participants are categorized based on their cognitive symptoms: healthy elderly with no symptoms, those with mild cognitive impairment, or those with dementia.

3 imaging procedures

Participants receive an injection of Vizamyl (400 MBq/mL solution for injection), which contains the active substance flutemetamol (18f). This is used to help visualize certain brain structures during imaging.

A PET scan is performed to detect the presence of specific signals in the brain. This helps in identifying patterns associated with neurodegenerative diseases.

4 follow-up assessments

Participants may undergo additional follow-up assessments to monitor changes in cognitive function over time. This may include repeated cognitive tests and imaging procedures.

The study aims to compare brain uptake ratios of the injected substances with other diagnostic methods, such as cerebrospinal fluid biomarkers and MRI findings.

5 completion of study

The study is estimated to conclude by February 29, 2028. Participants will be informed of the study’s findings and any relevant personal health information obtained during the trial.

The primary goal is to improve the understanding of cognitive disorders and enhance diagnostic accuracy for conditions like Alzheimer’s disease.

Who Can Join the Study?

  • Participants must be between 20 and 100 years of age.
  • Participants must be fluent in Swedish.
  • Participants must agree to undergo at least one lumbar puncture (a procedure where a small amount of fluid is taken from the spine for testing).
  • Participants must agree to have an MRI scan of the brain (a type of scan that uses magnets and radio waves to take pictures of the brain).
  • Participants must agree to neuropsychological testing (tests that measure how well the brain is working, including memory, attention, and problem-solving).
  • For healthy elderly participants: No cognitive symptoms should be reported by the participant.
  • For healthy elderly participants: Normal performance on cognitive tests is required.
  • For healthy elderly participants: General thinking and daily functioning should be preserved, meaning a doctor cannot diagnose mild cognitive impairment (MCI) or dementia at the start of the study.
  • For participants with mild cognitive impairment or dementia: Cognitive symptoms should be reported by the participant or someone who knows them well.
  • For participants with mild cognitive impairment: General thinking and daily functioning should be preserved enough that a doctor cannot diagnose dementia at the start of the study.
  • For participants with dementia: General thinking and daily functioning should meet the criteria for a dementia diagnosis at the start of the study.

Who Cannot Join the Study?

  • Patients with any other neurodegenerative disorders that involve Tau-pathology. These are diseases where certain proteins build up in the brain, affecting its function.
  • Patients with Alzheimer’s disease or conditions like progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration, or mild cognitive impairment. These are all types of brain disorders that affect memory and thinking.
  • Patients who are not at high risk of developing dementia due to Alzheimer’s disease or other similar brain disorders.

Where you can join this trial?

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Site Name City Country Status
Region Skane Malmo Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Recruiting
01.03.2017

Trial locations

Tau PET (18F-RO6958948) is a type of imaging test used in this study to help doctors see the presence of tau protein in the brain. Tau protein can build up in the brains of people with Alzheimer’s disease and other similar conditions. By using this test, doctors can better understand if someone is at risk of developing dementia in the future. This test involves a special scan that shows detailed pictures of the brain, helping to identify changes that might not be visible with other types of scans.

Vizamyl (18F-Flutemetamol) is another imaging test used in the study to detect amyloid plaques in the brain. Amyloid plaques are another type of protein that can accumulate in the brains of people with Alzheimer’s disease. This test helps doctors see if these plaques are present, which can indicate a higher risk of developing dementia. Like the Tau PET scan, Vizamyl involves a special brain scan that provides clear images, allowing doctors to assess the risk of Alzheimer’s disease and other neurodegenerative disorders.

Alzheimer’s disease – Alzheimer’s disease is a progressive neurodegenerative disorder characterized by the gradual loss of memory and cognitive functions. It begins with mild memory lapses and confusion, eventually leading to severe memory impairment and disorientation. As the disease progresses, individuals may experience difficulty in speaking, swallowing, and walking. The brain undergoes significant changes, including the accumulation of amyloid plaques and tau tangles. These changes disrupt communication between neurons, leading to their eventual death. The progression of Alzheimer’s disease varies among individuals, but it generally worsens over time.

Progressive supranuclear palsy – Progressive supranuclear palsy is a rare brain disorder that affects movement, control of walking, balance, and eye movements. It is characterized by the gradual deterioration of specific areas of the brain, leading to symptoms such as stiffness, awkward movements, and difficulty with eye movements. As the disease advances, individuals may experience problems with speech and swallowing. The condition is associated with the accumulation of abnormal tau protein in the brain. This accumulation disrupts normal brain function and leads to the symptoms observed. The progression of symptoms can vary, but they typically worsen over time.

Frontotemporal dementia – Frontotemporal dementia is a group of disorders caused by progressive nerve cell loss in the brain’s frontal and temporal lobes. This leads to changes in personality, behavior, and language. Individuals may exhibit socially inappropriate behavior, apathy, or loss of empathy. As the disease progresses, language difficulties and motor problems may develop. The condition is associated with abnormal protein accumulations, including tau, in the brain. The progression of frontotemporal dementia varies, but symptoms generally worsen over time.

Corticobasal degeneration – Corticobasal degeneration is a rare neurodegenerative disorder that affects movement and cognitive functions. It is characterized by the progressive loss of nerve cells in specific areas of the brain, leading to symptoms such as muscle stiffness, tremors, and difficulty with coordination. As the disease progresses, individuals may experience cognitive decline and speech difficulties. The condition is associated with the accumulation of abnormal tau protein in the brain. This accumulation disrupts normal brain function and leads to the observed symptoms. The progression of corticobasal degeneration varies, but symptoms typically worsen over time.

Mild cognitive impairment – Mild cognitive impairment is a condition characterized by noticeable changes in cognitive abilities, such as memory and thinking skills, that are greater than expected for a person’s age. It is considered an intermediate stage between normal age-related cognitive decline and more serious conditions like dementia. Individuals with mild cognitive impairment may experience forgetfulness, difficulty concentrating, and challenges in decision-making. However, these changes do not significantly interfere with daily life and activities. The condition may remain stable, improve, or progress to more severe cognitive disorders. The progression of mild cognitive impairment varies among individuals.

Trial ID:
2024-511842-38-00
NCT ID:
NCT03174938
Trial Phase:
Therapeutic exploratory (Phase II)

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