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Study of [18F]MC225 to Assess P-glycoprotein Function in Patients with Alzheimer's, Mild Cognitive Impairment, and Parkinson's Disease

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What is this trial about?

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

This clinical trial is focused on studying certain brain conditions, specifically Alzheimer's disease, Mild Cognitive Impairment, and Parkinson's disease. The study will use a special substance called [18F]MC225, which is a solution for injection. This substance is designed to help researchers measure the function of a protein in the brain known as P-glycoprotein. Understanding how this protein works in these conditions may provide valuable insights into the diseases.

The purpose of the study is to evaluate how well [18F]MC225 can measure the activity of P-glycoprotein in the brain. Participants in the study will receive an injection of the substance, and then researchers will use imaging techniques to observe how it behaves in the brain. This process will help determine how the protein is functioning in individuals with the mentioned conditions.

Throughout the study, participants will undergo various imaging tests, such as PET scans, to track the uptake and movement of [18F]MC225 in the brain. These tests are non-invasive and will provide important data on cerebral blood flow and other brain functions. The study aims to gather information that could lead to better understanding and potentially improved treatments for these neurodegenerative diseases.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria related to Alzheimer's disease, Mild Cognitive Impairment, or Parkinson's disease.

    Informed consent is obtained, ensuring understanding of the study's purpose and procedures.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to document cognitive and physical health status.

    This may include cognitive tests and medical evaluations to establish a baseline for comparison.

  3. Step 3

    Administration of [18F]MC225

    The medication [18F]MC225 is administered as a solution for injection through an intravenous route.

    This step is crucial for measuring the function of a protein called P-glycoprotein in the brain.

  4. Step 4

    PET scan procedure

    A PET scan is performed to observe the uptake and distribution of the tracer [18F]MC225 in the brain.

    This imaging helps in evaluating the function of P-glycoprotein in relation to neurodegenerative diseases.

  5. Step 5

    Follow-up assessments

    Follow-up assessments are conducted to monitor any changes in cognitive and physical health.

    These assessments help in understanding the effects of the tracer and the progression of the disease.

  6. Step 6

    Completion of the study

    Upon completion of the study, a final evaluation is conducted to summarize findings and provide feedback.

    Participants may receive information about the study's outcomes and any relevant health insights.

Who can join the trial?

14 criteria

  • Must have a diagnosis of Alzheimer's disease, Mild Cognitive Impairment (MCI), or Parkinson's disease.
  • For Alzheimer's disease:
    • Must show a decline in thinking abilities.
    • Must have a progressive decline in thinking abilities.
    • Must have issues with memory, language, understanding space, or planning and organizing.
    • No signs of other brain diseases except Alzheimer's.
    • Must have specific brain changes seen in tests like low Aβ42 in spinal fluid or positive amyloid imaging, and increased tau protein in spinal fluid or other specific brain changes.
    • For Mild Cognitive Impairment (MCI):
      • Must show a decline in one or more areas of thinking abilities.
      • Symptoms should not interfere with daily life.
      • No signs of other brain diseases except MCI.
      • For Parkinson's disease:
        • Must have slow movement (bradykinesia) and one of the following: muscle stiffness (rigidity), shaking (tremor), or balance problems not related to other issues.
        • No other explanation for these symptoms on an MRI scan.
        • No signs of other brain diseases except Parkinson's.
        • Must be between the ages of 18 and 65.
        • Both males and females can participate.

Who cannot join the trial?

3 criteria

  • Patients with Parkinson's disease cannot participate.
  • Patients with Alzheimer's disease cannot participate.
  • Patients with Mild Cognitive Impairment cannot participate.
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Investigated drugs

[18F]MC225 is a special type of imaging agent used in this clinical trial. It helps doctors see how a protein called P-glycoprotein is working in the brain. This protein is important because it helps protect the brain by pumping out harmful substances. In people with neurodegenerative diseases like Alzheimer's, Mild Cognitive Impairment, and Parkinson's, this protein might not work properly. By using [18F]MC225, doctors can take pictures of the brain and see how well this protein is functioning. This can help them understand more about these diseases and how they affect the brain. The information gathered from these images can be crucial for developing better treatments in the future.

What is already known about the treatment

[18F]MC225 – This medication is administered as an injection and is used in a PET scan to evaluate brain function. It is currently being studied in clinical trials to understand its role in measuring P-glycoprotein function in neurodegenerative diseases like Alzheimer's, Parkinson's, and Mild Cognitive Impairment. The main therapeutic indication is to help diagnose and monitor these conditions by providing detailed images of the brain. At the molecular level, it works by binding to P-glycoprotein, a protein that helps protect the brain by pumping out harmful substances, allowing doctors to see how well this protein is functioning. It is classified as a radiopharmaceutical, which means it is a radioactive compound used for diagnosis or treatment.

Investigated diseases

  • Parkinson's Disease

    Parkinson's Disease is a progressive neurological disorder that affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. The disease progresses gradually, often starting with a barely noticeable tremor in one hand. As it advances, individuals may experience slower movement, muscle rigidity, and impaired posture. Over time, speech may become soft or slurred, and automatic movements such as blinking or smiling may decrease. The progression varies among individuals, with symptoms worsening over time.

  • Alzheimer's Disease

    Alzheimer's Disease is a progressive neurodegenerative disorder that affects memory and cognitive function. It begins with mild memory loss and confusion, often mistaken for normal aging. As the disease progresses, individuals may experience significant memory impairment, difficulty in recognizing familiar people, and challenges in communication. Over time, it leads to severe cognitive decline, affecting the ability to perform daily tasks. Behavioral changes, such as mood swings and disorientation, are common as the disease advances. The progression is gradual, with symptoms worsening over several years.

  • Mild Cognitive Impairment

    Mild Cognitive Impairment (MCI) is a condition characterized by noticeable changes in cognitive abilities, such as memory and thinking skills, that are greater than expected for a person's age. It is considered an intermediate stage between normal age-related cognitive decline and more serious conditions like dementia. Individuals with MCI may experience forgetfulness, difficulty concentrating, and challenges in decision-making. Unlike dementia, these changes do not significantly interfere with daily life and activities. MCI can remain stable, improve, or progress to dementia over time. The progression varies, and not all individuals with MCI will develop more severe cognitive disorders.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518865-85-00Estimated enrolment30 patientsSponsorUniversitair Medisch Centrum Groningen

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