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A study using [18F]RO6958948 PET imaging to examine brain tau protein deposits in people at risk 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 study focuses on Alzheimer's Disease, a progressive brain disorder that affects memory and thinking skills. The research aims to examine specific protein deposits called tau aggregates in the brain using a special imaging substance called [18F]RO6958948. This substance helps to create detailed pictures of these protein deposits using a special type of scan called PET (Positron Emission Tomography).

During the study, participants will receive the imaging substance [18F]RO6958948 through an injection into a vein. The maximum amount given will be 370 MBq (a measure of radioactivity) as a single dose. The substance allows researchers to see the buildup of tau proteins in the brain, which is important in understanding how Alzheimer's Disease develops and progresses.

The research will look at how these protein deposits relate to other brain changes that occur in Alzheimer's Disease. Participants will undergo brain imaging both at a single point in time and over a longer period to track any changes. The study includes people who have previously participated in related research programs at the research center and will continue for several years to monitor changes in the brain over time.

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 medical assessment

    A review of your cognitive status based on previous assessments from the past 12 months will be conducted

    Your existing brain MRI scan from the last 12 months will be evaluated

    Your current amyloid and tau status will be reviewed

  2. Step 2

    Pre-imaging preparation

    Female participants must confirm post-menopausal status or undergo a pregnancy test before imaging

    Your medical history and eligibility will be verified

  3. Step 3

    PET imaging procedure

    You will receive an injection of 18F-RO6958948 (a radioactive substance that helps detect tau proteins in the brain)

    The substance will be administered through an intravenous injection or infusion

    A PET scan (specialized brain imaging) will be performed to measure the retention of the tracer in your brain

  4. Step 4

    Follow-up assessments

    Your brain images will be analyzed to measure both overall and specific areas of tracer retention

    The results will be evaluated in relation to your amyloid levels

    The study may continue with follow-up assessments until March 2029

Who can join the trial?

13 criteria

  • Must sign an approved informed consent form for the study
  • Must be a previous participant in one of these research studies:
    • ALFA project
    • ALFA+ cohort study
    • ALFA cognition study
    • BarcelonaBeta Dementia Prevention Research Clinic study
    • βETA-AARC study
    • Age must be between 45 and 80 years old at the time of inclusion in previous studies
    • Must have had a brain MRI (Magnetic Resonance Imaging) scan within the last 12 months without any disqualifying findings
    • Must have documented cognitive status (mental function assessment) from previous participation within the last 12 months
    • Must have known amyloid beta (AB) and tau status (proteins associated with brain changes)
    • Must have good language skills and ability to read and write
    • For female participants:
      • Must be post-menopausal, or
      • Must have a negative pregnancy test before PET (Positron Emission Tomography) scan

Who cannot join the trial?

10 criteria

  • History of brain surgery, severe head trauma, or stroke
  • Contraindications (medical reasons not to use) for MRI scanning, such as having metal implants or claustrophobia (fear of enclosed spaces)
  • Current participation in other clinical trials or use of investigational drugs within 30 days before this study
  • Presence of any significant medical conditions that could interfere with brain imaging procedures
  • History of alcohol or substance abuse within the past 2 years
  • Severe allergic reactions to medications or contrast agents used in imaging
  • Inability to lie still for the duration of brain imaging procedures (approximately 45 minutes)
  • Psychiatric disorders that could interfere with study participation
  • Pregnancy or breastfeeding
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

Based on the provided trial data, I can only identify one medication: 18F-RO6958948 is a radioactive tracer used in PET (Positron Emission Tomography) imaging. This substance helps doctors see tau protein aggregates in the brain. Tau proteins are important markers in studying brain conditions. When injected into the bloodstream, this tracer binds to tau proteins in the brain, making them visible during a PET scan. This allows researchers to study how these proteins accumulate in different brain regions.

What is already known about the treatment

18F-RO6958948 – A radioactive diagnostic imaging agent administered intravenously for Positron Emission Tomography (PET) scanning, specifically designed to detect and visualize tau protein aggregates in the brain. This novel radiopharmaceutical tracer is currently being investigated in clinical trials for its ability to identify tau deposits in patients with Alzheimer's Disease, helping to understand the relationship between tau protein accumulation and disease progression. The compound belongs to the class of diagnostic radiopharmaceuticals and works by binding to tau protein aggregates in the brain, allowing them to be visualized through PET imaging technology, which is particularly valuable for early detection and monitoring of Alzheimer's Disease progression.

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 memory problems and confusion, which slowly become more severe over time. The disease causes brain cells to degenerate and die, leading to a decline in cognitive and functional abilities. Changes in the brain include abnormal buildup of proteins called amyloid plaques and tau tangles. People with Alzheimer's may experience difficulties with language, problem-solving, and behavior. The condition typically affects older adults, though early-onset cases can occur in younger people.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516209-21-00Protocol codetau-PET/BBRC2019Estimated enrolment200 patientsSponsorBarcelonabeta Brain Research Center

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