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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.

  1. 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

  2. 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)

  3. 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

  4. 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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Investigated drugs

  • 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.

What is already known about the treatment

  • 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.
Trial detailsLast updated 27 Oct 2026
Age65+ yearsPhasePhase IITrial ID2024-517634-17-01Estimated enrolment80 patientsSponsorAmsterdam UMC Stichting

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