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Study of microglial activation and synaptic density using [18F]-DPA-714, [18F]-Ro948, [11C]-UCB-J, and [11C]PiB PET imaging in patients with 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 condition that affects memory and cognitive function. The research aims to understand how brain cell changes relate to the progression of the disease. The study will use several specialized imaging substances including [18F]RO6958948, 11C-UCB-J, 18F-DPA-714, and [11C]PiB, which are administered through injection into a vein to create detailed images of the brain.

During the study, participants will receive these imaging substances at different times to examine various aspects of brain activity. The substances will help researchers see specific changes in brain cells, particularly focusing on how certain brain cells called microglia become activated and how this affects the connections between brain cells called synapses. Each imaging session involves receiving a small amount of the imaging substance through an intravenous injection.

The imaging will be performed using a special scanning technique called Position Emission Tomography (PET), which creates detailed pictures of the brain. This allows researchers to observe and measure changes in the brain that are characteristic of Alzheimer's disease. The study will track these changes over time to better understand how the disease progresses and affects different parts of the brain.

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 PET scanning session

    You will undergo three PET scans (a type of medical imaging that uses small amounts of radioactive materials) during one session

    The following tracers will be administered through intravenous injection:

    - 11C-UCB-J to measure synaptic density in your brain

    - 18F-DPA-714 to assess microglial activation

    - [11C]PiB solution for examining brain changes

  2. Step 2

    Brain imaging procedure

    Each PET scan will require you to lie still while the scanner takes images of your brain

    The procedure is painless and non-invasive

    The radioactive materials used in the scan will naturally decay and leave your body

  3. Step 3

    Follow-up assessments

    Your participation will involve regular follow-up visits until April 2028

    During these visits, clinical evaluations and additional PET scans will be performed to track changes over time

    The same scanning procedures will be repeated as in the initial session

  4. Step 4

    Study completion

    The study will conclude with a final assessment of all collected data

    Your participation will end after the completion of all scheduled follow-up visits

    The total duration of the study is from October 2023 to April 2028

Who can join the trial?

14 criteria

  • Must be an adult (male or female)
  • Women who can become pregnant must use effective contraception
  • Must be able to provide signed consent
  • Must be at least 50 years old
  • For healthy participants (controls):
    • No memory problems
    • Normal score on Mini-Mental State Examination (MMSE) above 27
    • Adequate performance on memory tests: Free and Cued Selective Reminding Test (FCSRT) with scores greater than 25 for free recall and greater than 44 for total recall
    • For Alzheimer's Disease patients:
      • Must have early-stage disease
      • Progressive memory problems, with or without other cognitive difficulties
      • Clinical Dementia Rating (CDR) score of 0.5 or 1
      • No other medical conditions that could affect thinking abilities
      • Normal brain scan (MRI) results
      • Positive cerebrospinal fluid (CSF) markers for Alzheimer's Disease
      • Must not have any general health conditions that could interfere with brain function or imaging procedures

Who cannot join the trial?

12 criteria

  • Persons under 18 years of age
  • Pregnant or breastfeeding women
  • People with severe kidney problems (as it may affect how the imaging substances are cleared from the body)
  • Individuals with metal implants or devices that could interfere with brain imaging
  • Those who have participated in another clinical trial within the past 30 days
  • People with severe allergies or previous reactions to medical imaging substances
  • Individuals who cannot lie still for the duration of the brain imaging procedure
  • Those with claustrophobia (fear of enclosed spaces) as the imaging equipment requires lying in a confined space
  • People taking certain medications that could interfere with brain imaging results
  • Individuals with severe psychiatric conditions that could affect their ability to participate
  • Those unable to provide informed consent
  • People with conditions that make them unsuitable for radiation exposure from imaging procedures
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Investigated drugs

  • [18F]-DPA-714

    is a special imaging tracer used in PET scans that helps doctors see inflammation in the brain by showing active microglia cells. This helps understand how the brain's immune system is responding in Alzheimer's disease.

  • [18F]-Ro948

    is an imaging tracer that binds to abnormal tau protein in the brain during PET scans. This helps visualize the buildup of tau, which is one of the hallmark features of Alzheimer's disease.

  • [11C]-UCB-J

    is a newer type of imaging tracer that shows the density and health of synapses (connections between brain cells) during PET scans. This helps doctors understand how Alzheimer's disease affects the communication between brain cells.

What is already known about the treatment

  • [18F]-DPA-714

    A radioactive tracer used in Positron Emission Tomography (PET) imaging that specifically binds to activated microglia in the brain. This diagnostic agent helps visualize neuroinflammation in Alzheimer's disease by targeting the translocator protein (TSPO) expressed on activated microglial cells. It is administered intravenously during PET scanning procedures and is currently used in clinical research to study inflammatory processes in neurodegenerative conditions.

  • [18F]-Ro948

    A specialized radioactive tracer designed for PET imaging that binds to tau protein aggregates in the brain, a hallmark of Alzheimer's disease. This diagnostic compound is administered intravenously and helps researchers visualize the distribution and density of tau pathology in living patients. It represents a valuable tool in clinical research for understanding the progression of Alzheimer's disease and evaluating potential treatments.

  • [11C]-UCB-J

    A novel radioactive PET tracer that specifically binds to SV2A proteins found in synapses, allowing researchers to measure synaptic density in the living brain. Administered through intravenous injection during PET scanning, this compound helps evaluate synaptic loss in Alzheimer's disease and other neurological conditions. It serves as an important tool in clinical research for understanding how disease processes affect neural connections.

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 worsen over time. The disease causes brain cells to degenerate and die, leading to a decline in cognitive and behavioral functions. Changes in the brain include abnormal buildup of proteins called plaques and tangles. People with Alzheimer's experience increasing difficulty with daily activities as their judgment and sense of orientation become impaired. The condition affects each person differently, but typically progresses from mild to moderate to severe stages. Note: I corrected the spelling from "Alzeihmer disease" to "Alzheimer's Disease" as per the requirement to use correct, medically recognized names.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516566-11-00Protocol codeD23-P006Estimated enrolment90 patientsSponsorGroupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience

sourced from the EU Clinical Trials Register and site verification

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