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Study of Flortaucipir (18F) PET Imaging in Healthy Elderly Twins to Investigate Early Signs of Alzheimer's Disease

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This research study focuses on investigating early signs of Alzheimer's Disease in healthy elderly individuals who have normal cognitive function. The study uses a specialized imaging technique called Tau PET scanning to examine brain changes that might occur before any symptoms of memory problems appear. The study specifically looks at twins to better understand how genetic and environmental factors influence these early brain changes.

The study involves the use of Flortaucipir, also known as LY3191748, which is given as an injection into a vein. This substance helps to create detailed images of certain proteins in the brain called tau proteins, which are associated with Alzheimer's Disease. The imaging procedure will be performed alongside another type of brain scan that looks for a different protein called amyloid.

The research aims to understand how tau and amyloid proteins accumulate in the brain of people who don't have memory problems, and how genetic factors might influence these changes over time. The study will use brain imaging to track these changes and compare them with other markers related to early Alzheimer's Disease. Participants will receive a single dose of the imaging substance through an injection into a vein during their scan.

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 verification
Your eligibility for the study requires you to be over 60 years old
You must have already completed an amyloid PET scan using [18F]flutemetamol or have known amyloid status from cerebrospinal fluid testing
Step 2
Brain imaging procedure
You will receive Flortaucipir, a special imaging solution, through an intravenous injection
The solution helps identify specific proteins in your brain called tau
A specialized camera will take detailed pictures of your brain using PET imaging (Positron Emission Tomography)
Step 3
Follow-up imaging
Additional brain scans may be performed over time to track changes
The study continues until December 31, 2025
The imaging helps monitor the relationship between two brain proteins: tau and amyloid
Step 4
Data collection
Your brain imaging results will be analyzed to understand how tau protein accumulates in the brain
If you have a twin participating in the study, your results will be compared to examine genetic factors
The collected information helps understand early changes that may occur in the brain before any memory problems develop

Who can join the trial?

5 criteria

Must be 60 years or older
Must have previously undergone an [18F]flutemetamol amyloid PET scan (a special brain imaging test that checks for protein deposits in the brain) OR have documented amyloid status from CSF (cerebrospinal fluid - the fluid that surrounds the brain and spinal cord)
Can be either male or female
Must be cognitively healthy (having normal thinking and memory abilities)
Must be able to make independent decisions (not considered a vulnerable individual)

Who cannot join the trial?

16 criteria

Presence of any neurological or psychiatric disorders that could affect brain function
History of brain injury or trauma
Current use of medications that could affect cognitive function
Metal implants or devices in the body that would interfere with brain imaging
Claustrophobia (fear of enclosed spaces) that would prevent brain scanning
Not being able to lie still for extended periods during scanning procedures
Significant medical conditions that could impact brain health
Regular use of drugs or excessive alcohol consumption
Not being a twin (as this is a twin study)
Age outside the adult range (study focuses on adults)
Known genetic conditions that could affect brain function
Inability to provide informed consent
Current participation in other clinical trials
Pregnancy or planning to become pregnant during the study period
History of Alzheimer's Disease or other forms of dementia
Significant vision or hearing impairments that would interfere with testing

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Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

Based on the provided trial data, this appears to be an observational imaging study using PET scanning technology to examine tau and amyloid proteins in the brain. No medications are being tested in this trial. The study focuses on: Tau PET tracers - These are specialized radioactive substances injected into the bloodstream before a PET scan. They bind to tau protein deposits in the brain, allowing researchers to see their location and amount. These tracers are diagnostic tools, not treatments. Amyloid PET tracers - Similar to tau tracers, these are diagnostic substances that bind to amyloid protein deposits in the brain, making them visible during PET scanning. These are also used for imaging purposes only and are not therapeutic agents.

Flortaucipir (18F)

What is already known about the treatment

Based on the provided trial data, there are two relevant imaging tracers used in PET scanning for Alzheimer's research: 18F-Flortaucipir – A radioactive diagnostic agent administered intravenously for PET imaging to detect tau protein accumulation in the brain. This tracer binds specifically to abnormal tau protein deposits, allowing visualization of potential early signs of Alzheimer's Disease in living patients. The substance is classified as a radiopharmaceutical diagnostic agent and is currently approved for clinical use in detecting tau pathology in adults being evaluated for Alzheimer's Disease. 18F-Florbetaben – An injectable radioactive diagnostic agent used in PET brain imaging to detect beta-amyloid plaques in patients being evaluated for Alzheimer's Disease. The tracer binds to beta-amyloid deposits in the brain, enabling doctors to visualize these plaques through PET scanning. This compound belongs to the radiopharmaceutical diagnostic class and is widely used in clinical practice and research to help identify potential Alzheimer's pathology in living subjects.

Investigated diseases

Alzheimer's Disease - A progressive brain disorder that gradually destroys memory, thinking skills, and the ability to carry out simple tasks. It begins with mild changes in memory and thinking abilities, often years before noticeable symptoms appear. The disease causes brain cells to degenerate and die, leading to a continuous decline in memory and cognitive function. Physical changes in the brain include abnormal buildup of proteins called amyloid plaques and tau tangles. These changes initially affect parts of the brain controlling memory, but eventually spread to areas involved in language, reasoning, and social behavior. The disease typically progresses from mild forgetfulness to severe impairment of mental and physical functions.