Recruiting

Study on Flutemetamol (18F) for Detecting Amyloid Pathology in Cognitively Normal Elderly at Risk for Alzheimer's Disease

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Alzheimer's Disease in its early stages, specifically in individuals who are currently healthy but may be at risk. The study uses a treatment called VIZAMYL, which is a solution for injection containing the active substance Flutemetamol (18F). This substance is used to help identify amyloid plaques in the brain, which are associated with Alzheimer's Disease.

The purpose of the study is to find new ways to diagnose and predict the risk of developing Alzheimer's Disease in people who do not yet show symptoms. Participants will receive an injection of VIZAMYL and undergo imaging tests to detect amyloid plaques. The study aims to discover new markers and risk factors for Alzheimer's Disease and to understand how these plaques might lead to cognitive decline over time.

Throughout the study, participants will be monitored to see how the presence of amyloid plaques affects their cognitive health. The study will help researchers learn more about the early stages of Alzheimer's Disease and potentially lead to better diagnostic tools and treatments in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility. These assessments include cognitive tests and questionnaires to evaluate your memory and mood.
The tests will include the Telephone Interview for Cognitive Status modified (TICS-m), the Geriatric Depression Scale (GDS), the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) word list recall, and the Clinical Dementia Rating (CDR) scale.
Step 2
Medication administration
You will receive a medication called VIZAMYL, which is a solution for injection. This medication contains an active substance called flutemetamol (18f).
The medication will be administered through an intravenous bolus injection or IV infusion. This means it will be injected directly into your vein.
Step 3
Follow-up visits
After the medication administration, you will have follow-up visits. These visits are designed to monitor your health and gather data for the study.
During these visits, additional assessments may be conducted to track any changes in your cognitive status and to identify any potential markers for amyloid pathology.
Step 4
End of study
The study is expected to conclude by the end of 2025. At the end of the study, you will have a final visit to complete any remaining assessments.
The information collected during the study will be used to identify clinical markers and risk factors for amyloid pathology and cognitive decline.

Who can join the trial?

5 criteria

Age between 60 and 100 years.
Score higher than 22 on the Telephone Interview for Cognitive Status modified (TICS-m), which is a test to check memory and thinking skills.
Score less than 11 on the Geriatric Depression Scale (GDS), a questionnaire to assess mood and identify signs of depression.
Score better than -1.5 standard deviations on the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) 10-word list test, which involves remembering words immediately and after a delay, compared to what is normal for your age.
Have a Clinical Dementia Rating (CDR) scale score of 0, indicating no signs of dementia, with a memory sub-score of 0, meaning no memory problems.

Who cannot join the trial?

8 criteria

Participants must be cognitively normal, meaning they should not have any diagnosed memory or thinking problems.
Participants should not have any other significant health issues that could affect the study results.
Participants must not be part of any vulnerable population, which means they should not be in a situation where they might feel pressured to join the study.
Participants should not have any known allergies or reactions to the substances used in the study.
Participants must not be currently involved in another clinical trial.
Participants should not have a history of drug or alcohol abuse.
Participants must not be pregnant or planning to become pregnant during the study.
Participants should not have any mental health conditions that could interfere with their ability to participate in the study.

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Verified sites

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Amsterdam UMC
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Amsterdam, The Netherlands

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Investigated drugs

I'm sorry, but the provided data does not include any specific medications or therapies involved in the clinical trial. If you have more detailed information or another source that lists the medications or therapies, please provide it so I can assist you further.

Flutemetamol (18F)

What is already known about the treatment

Amyloid pathology diagnostic markers – This medication is not a traditional drug but rather a diagnostic tool used in research to identify markers related to amyloid pathology, which is associated with Alzheimer's disease. It is administered through various diagnostic tests and imaging techniques to study its presence in cognitively normal elderly individuals. Currently, it is in the research phase, focusing on understanding preclinical Alzheimer's disease, and is not yet a standard part of medical practice. The main goal is to discover new markers and risk factors for amyloid pathology and to predict cognitive decline. This tool is part of the broader pharmacological classification of diagnostic agents, aiming to improve early detection and intervention strategies for Alzheimer's disease.

Investigated diseases

Alzheimer's Disease – Alzheimer's Disease is a progressive neurological disorder that leads to the degeneration of brain cells. It begins with mild memory loss and can progress to severe cognitive impairment, affecting the ability to carry out daily activities. As the disease advances, individuals may experience confusion, disorientation, and difficulty with language and communication. Behavioral changes, such as mood swings and withdrawal from social activities, are also common. Over time, Alzheimer's Disease can lead to a complete loss of independence, requiring full-time care. The progression of the disease varies among individuals, with some experiencing a slow decline and others a more rapid deterioration.