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Study on Brain Changes in Alzheimer's Disease Using Flutemetamol (18F) and Fludeoxyglucose (18F) in ALFA Project Participants

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What is this trial about?

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

This clinical trial focuses on studying Alzheimer's Disease, a condition that affects memory and other important mental functions. The study uses two special imaging techniques to understand changes in the brain. The first technique involves a substance called Flutemetamol (18F), which is used in a type of brain scan called a PET scan to detect amyloid deposits in the brain. Amyloid deposits are protein buildups that are often found in the brains of people with Alzheimer's Disease. The second technique uses Fludeoxyglucose (18F), another substance used in PET scans, to study how the brain uses glucose, a type of sugar that is an important energy source for brain cells.

The purpose of the study is to determine how common and how these amyloid deposits progress in individuals who are part of a larger research project called the ALFA project. Participants will receive injections of the substances Vizamyl and Barnascan, which contain the active substances Flutemetamol (18F) and Fludeoxyglucose (18F), respectively. These substances are given through an injection into a vein, known as intravenous administration. The study will help researchers understand the relationship between amyloid deposits and glucose metabolism in the brain, which could provide insights into the development and progression of Alzheimer's Disease.

Throughout the study, participants will undergo PET scans to visualize and measure the presence of amyloid deposits and glucose metabolism in their brains. The results will be analyzed to see how these factors vary with age, sex, genetic factors, and family history of Alzheimer's Disease. This research aims to improve understanding of Alzheimer's Disease and potentially lead to better ways to diagnose and monitor the condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Signing the consent form
The first step involves signing the informed consent form. This form confirms your agreement to participate in the study and that you understand the procedures involved.
Step 2
Initial assessment
An initial assessment will be conducted to ensure eligibility. This includes confirming that you are part of the STUDY 45-65 FPM/2012 and that your cognition is within normal ranges. A Mini Mental State Examination (MMSE) score of 26 or higher and a Verbal Semantic Fluency score of 12 or higher are required.
A Clinical Dementia Rating (CDR) score of 0 is also necessary. Additionally, a cerebral MRI will be reviewed to ensure there are no findings that would exclude participation.
Step 3
Language and literacy check
Participants must have a good knowledge of Spanish or Catalan and be literate to ensure clear communication throughout the study.
Step 4
Pregnancy test for female participants
Female participants must be post-menopausal or have a negative pregnancy test at the time of the PET scan to ensure safety during the procedure.
Step 5
PET scan with 18F-Flutemetamol
You will undergo a PET scan using 18F-Flutemetamol. This involves an intravenous injection of the solution, which helps visualize cerebral amyloid deposition. The scan will determine if the mean cortex activity is above a certain level, indicating a positive result for amyloid deposition.
Step 6
PET scan with 18F-FDG
A second PET scan will be conducted using 18F-FDG to assess glucose metabolism in the brain. This also involves an intravenous injection of the solution.
Step 7
Completion of study
After the scans, the study is complete. The results will be analyzed to determine the prevalence and progression of amyloid deposition and glucose metabolism in participants.

Who can join the trial?

7 criteria

Sign the study informed consent form approved by the corresponding authorities.
Be a man or woman who was enrolled in the STUDY 45-65 FPM/2012.
Have a brain MRI (magnetic resonance imaging) that does not show unexpected findings that would exclude you from the study. An MRI is a scan that uses magnets and radio waves to create pictures of the inside of your body.
Have normal thinking and memory abilities, shown by a score of at least 26 on the MMSE (Mini Mental State Examination) and at least 12 on the Verbal Semantic Fluency test (naming animals) at the start of the study. These are tests that check your memory and thinking skills.
Have a score of 0 on the CDR scale (Clinical Dementia Rating) at the start of the study. This scale measures the severity of symptoms of dementia.
Have a good understanding of Spanish or Catalan and be able to read and write.
If you are a woman, you should be post-menopausal or have a negative pregnancy test at the time of the PET scan. A PET scan is a type of imaging test that helps doctors see how your tissues and organs are functioning.

Who cannot join the trial?

3 criteria

Individuals who do not have a diagnosis of Alzheimer's Disease.
Individuals who are not within the specified age range for the study.
Individuals who are part of a vulnerable population, which means people who might need special protection or care.

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Barcelonabeta Brain Research Center
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Barcelona, Spain

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Investigated drugs

18F-Flutemetamol
is a special type of imaging agent used in brain scans. It helps doctors see amyloid plaques in the brain, which are often found in people with Alzheimer's disease. By using this agent in a PET scan, doctors can get a clearer picture of how much amyloid is in the brain and where it is located. This information can help in understanding the progression of Alzheimer's disease and in making decisions about treatment.
18F-FDG
is another imaging agent used in PET scans to look at how the brain uses glucose, which is a type of sugar that provides energy. This agent helps doctors see how active different parts of the brain are. By understanding glucose metabolism in the brain, doctors can learn more about brain function and detect any abnormalities that might be related to diseases like Alzheimer's.

What is already known about the treatment

18F-Flutemetamol – This medication is administered through an injection and is used in a PET scan to help visualize amyloid plaques in the brain, which are associated with Alzheimer's Disease. It is currently used in clinical settings to aid in the diagnosis of Alzheimer's by providing images that show the presence of these plaques. The main therapeutic indication is to assist in the detection of Alzheimer's Disease. At the molecular level, 18F-Flutemetamol binds to amyloid plaques, allowing them to be seen on a PET scan. It is classified as a radiopharmaceutical diagnostic agent.

Investigated diseases

Alzheimer's Disease – Alzheimer's Disease is a progressive neurological disorder that leads to the degeneration of brain cells, causing memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, which gradually worsen over time. As the disease progresses, individuals may experience difficulties with language, disorientation, mood swings, and behavioral changes. In advanced stages, individuals may lose the ability to carry out daily activities and require full-time care. The disease is associated with the accumulation of amyloid plaques and tau tangles in the brain. It primarily affects older adults, with symptoms usually appearing after age 65.