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Comparison of Three PET Tau Tracers ([18F]RO948, [18F]PI2620, and [18F]MK-6240) in People with Cognitive Impairment

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 study focuses on comparing different imaging methods for detecting tau proteins in the brain of people with various forms of cognitive disorders. The study will use three different radioactive substances: [18F]RO6958948, [18F]PI-2620, and [18F]MK-6240, which are special tracers that can help visualize tau proteins in the brain using PET scanning. Additionally, Vizamyl will be used as a complementary imaging agent.

The research aims to understand how these different imaging tracers work in people with various cognitive conditions, including Mild Cognitive Impairment, Alzheimer's Disease, Frontotemporal Dementia, Progressive Supranuclear Palsy, Corticobasal Degeneration, Dementia with Lewy Bodies, and Down's Syndrome. Each participant will receive the imaging substances through an injection into a vein.

During the study, participants will undergo several brain scans. The imaging substances will be given in very small amounts and are designed to attach to tau proteins in the brain, making them visible during the scanning procedure. These scans will help researchers compare how well each tracer works in showing tau protein buildup in different brain areas over time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial PET scan session

    You will receive an intravenous injection of one of the three imaging substances: Florquinitau F-18, VIZAMYL, or PI-2620.

    A PET scan (a special type of brain imaging) will be performed to create detailed pictures of your brain.

    The scan will focus on measuring tau protein levels in your brain tissue.

  2. Step 2

    Brain structure imaging

    An MRI scan (detailed brain structure imaging) will be performed.

    The MRI images will be used together with the PET scan results for accurate analysis.

  3. Step 3

    Blood sample collection

    Blood samples will be taken to measure specific proteins related to brain health.

    The blood test will check for different forms of tau protein in your blood.

  4. Step 4

    Follow-up visits

    Multiple visits will occur between July 2024 and May 2027.

    Each visit will include similar procedures to track changes over time.

    The study will measure how tau protein levels change in your brain during this period.

  5. Step 5

    Cognitive assessments

    Regular memory and thinking tests will be conducted.

    These tests will help track any changes in cognitive function over time.

Who can join the trial?

16 criteria

  • For healthy individuals without memory problems:
    • Must be over 18 years old
    • At least 5 young participants aged 18-28 years needed
    • Must have normal cognitive function (CDR score of 0)
    • For individuals with Mild Cognitive Impairment (MCI):
      • Age between 50-90 years
      • Must meet NIA-AA 2018 diagnostic criteria
      • Memory test score (MMSE) between 22-28 points
      • For individuals with Alzheimer's Disease:
        • Age between 50-90 years
        • Must meet NIA-AA 2018 diagnostic criteria
        • Memory test score (MMSE) between 11-24 points
        • For individuals with other conditions:
          • Age between 50-90 years for:
            • Frontotemporal Dementia
            • Primary Progressive Aphasia (speech problems)
            • Progressive Supranuclear Palsy
            • Corticobasal Degeneration
            • Dementia with Lewy Bodies
            • For individuals with Down's Syndrome:
              • Must be over 18 years old
              • Both men and women can participate in the study

Who cannot join the trial?

12 criteria

  • History of severe allergic reactions or hypersensitivity to any PET tracer components
  • Presence of any metallic implants that would interfere with brain imaging (such as pacemakers, surgical clips)
  • Current pregnancy or breastfeeding
  • Inability to lie still for approximately 90 minutes during the scanning procedure
  • Severe claustrophobia (fear of confined spaces) that would prevent completion of the scanning
  • Participation in other clinical trials involving investigational drugs within 30 days prior to this study
  • Any medical condition that, in the investigator's opinion, makes the person unsuitable for the study
  • Known severe kidney or liver dysfunction
  • History of significant head trauma or brain surgery
  • Unable to provide informed consent
  • Weight exceeding the scanning equipment's maximum capacity (usually 350 pounds/160 kg)
  • Active substance abuse or dependence within the past year
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Investigated drugs

  • [18F]RO948

    is a specialized radioactive tracer used in PET brain imaging. It helps doctors see abnormal protein deposits called tau in the brain. This tracer allows visualization of brain changes that may be related to various neurological conditions.

  • [18F]PI2620

    is a radioactive imaging agent used in PET scans of the brain. It binds to tau protein accumulations, helping doctors to see these deposits in living patients. This tracer is designed to provide detailed images of tau distribution in the brain.

  • [18F]MK-6240

    is a radioactive substance used in PET brain imaging. Like the other tracers, it attaches to tau protein deposits in the brain, allowing doctors to see their location and amount. This helps in studying brain changes and potential neurological conditions.

What is already known about the treatment

  • [18F]RO948

    A radioactive tracer used in Positron Emission Tomography (PET) imaging to detect tau protein deposits in the brain. This second-generation imaging agent is administered through intravenous injection and helps visualize the accumulation of tau proteins, which are associated with cognitive impairment and neurodegenerative diseases. The tracer binds specifically to tau protein aggregates in the brain, allowing doctors to assess the progression of cognitive disorders and evaluate treatment effectiveness.

  • [18F]PI2620

    A specialized radioactive imaging agent administered intravenously for PET scanning to detect abnormal tau protein accumulation in the brain. This second-generation tracer provides detailed visualization of tau protein deposits, helping clinicians diagnose and monitor cognitive impairment and related neurological conditions. The compound has shown promising results in clinical research for its ability to accurately bind to tau proteins and produce clear brain images.

  • [18F]MK-6240

    An advanced radioactive tracer designed for PET imaging that specifically targets tau protein aggregates in the brain. Administered through intravenous injection, this second-generation imaging agent helps healthcare providers visualize and quantify tau protein buildup associated with cognitive decline and neurodegenerative disorders. The tracer demonstrates high selectivity for tau proteins, enabling accurate assessment of disease progression and potential treatment responses.

Investigated diseases

Cognitive Impairment - A condition that affects mental abilities, including memory, learning, concentration, and decision-making. It ranges from mild to severe forms and can affect one or multiple cognitive functions. The condition may develop gradually over time, impacting daily activities and social interactions. Cognitive impairment can affect people's ability to process information, understand complex tasks, or remember important details. While some individuals experience stable symptoms, others may notice progressive changes in their cognitive abilities over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510508-31-01Protocol codeIIBSP-HEA-2022-145Estimated enrolment150 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

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