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Study on Metabolic Impairment in ALS and TIA Patients Using Hyperpolarized Pyruvate MRI

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 clinical trial is focused on studying two diseases: Amyotrophic Lateral Sclerosis (ALS) and Transient Ischemic Attack (TIA). ALS is a condition that affects nerve cells in the brain and spinal cord, leading to muscle weakness. TIA is often referred to as a "mini-stroke" and involves temporary disruption of blood flow to the brain, causing stroke-like symptoms. The treatment being studied is an injection called Hyperpolarized [1-13C]pyruvate, which is a form of pyruvic acid. This treatment is used in a special type of imaging called MRI (Magnetic Resonance Imaging) to help detect and understand changes in brain metabolism related to these diseases.

The purpose of the study is to use this new MRI technique to identify and describe metabolic changes in patients with ALS and TIA. Participants in the study will receive an injection of Hyperpolarized [1-13C]pyruvate, which will help highlight certain metabolic processes in the brain during the MRI scan. This approach aims to provide a clearer picture of how these diseases affect brain function.

Throughout the study, participants will undergo MRI scans after receiving the injection. The study will monitor how the injected substance interacts with the brain's metabolism, focusing on how it converts to other substances like bicarbonate, lactate, and alanine. This information will be gathered alongside clinical examinations and patient interviews to better understand the impact of ALS and TIA on brain health.

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. Participants must be between 18 and 85 years old. Pre-menopausal women undergo a pregnancy test to confirm non-pregnancy.

    Participants with ALS (Amyotrophic Lateral Sclerosis) must meet the 2021 Gold Coast criteria and show upper motor neuron symptoms. Participants with TIA (Transient Ischemic Attack) must have experienced a TIA within the last 10 days, with symptoms including unilateral weakness of a limb or face, lasting at least 10 minutes.

  2. Step 2

    Initial assessment

    An initial assessment is conducted, which includes a clinical examination, interviews, and review of patient records. This helps in understanding the disease characteristics.

  3. Step 3

    Medication administration

    Participants receive an injection of Hyperpolarized [1-13C]pyruvate. This is administered through an intravenous bolus injection or IV infusion. The dosage, frequency, and duration of administration are determined by the study protocol.

  4. Step 4

    MRI procedure

    Participants undergo an MRI (Magnetic Resonance Imaging) scan using the hyperpolarized pyruvate technique. This scan aims to detect and characterize metabolic impairment in the brain.

  5. Step 5

    Metabolic assessment

    The primary focus is on assessing cerebral metabolism. This involves measuring the exchange of the 13C label from hyperpolarized pyruvate to bicarbonate, lactate, and alanine.

  6. Step 6

    Follow-up and monitoring

    Participants are monitored for any changes in their condition. Follow-up assessments may include additional clinical examinations and interviews to gather further information on disease progression.

Who can join the trial?

7 criteria

  • Participants must be between the ages of 18 and 85 years old.
  • Pre-menopausal women (women who have not yet gone through menopause) must have a negative pregnancy test done at the study site.
  • For the ALS group (participants with Amyotrophic Lateral Sclerosis):
    • Must meet the 2021 Gold Coast criteria for ALS diagnosis.
    • Must have symptoms related to the upper motor neurons, which are nerve cells in the brain that help control movement.
    • For the TIA group (participants with Transient Ischemic Attack):
      • Must have experienced a TIA within the last 10 days.
      • Symptoms must include weakness on one side of the body, either in a limb or the face.
      • Symptoms must have lasted at least 10 minutes.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with ALS (Amyotrophic Lateral Sclerosis) or TIA (Transient Ischemic Attack) cannot participate.
  • Patients who are under the age of 18 or over the age of 65 cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
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Investigated drugs

Hyperpolarized Pyruvate is a special form of a naturally occurring substance in the body called pyruvate. In this clinical trial, it is used in a new type of MRI scan to help doctors see how the body's metabolism is working in patients with Amyotrophic Lateral Sclerosis (ALS) and Transient Ischemic Attack (TIA). This technique allows doctors to get a clearer picture of how these diseases affect the body's energy production and use, which can help in understanding the disease better and potentially lead to new treatments.

What is already known about the treatment

Hyperpolarized Pyruvate – This medication is administered through an injection and is used in a special type of MRI scan to help visualize metabolic changes in the brain. It is currently being studied in clinical trials to better understand its role in detecting metabolic impairments in conditions like Amyotrophic Lateral Sclerosis (ALS) and Transient Ischemic Attack (TIA). The main therapeutic use of Hyperpolarized Pyruvate is to provide clearer images of how the brain is functioning at a metabolic level, which can help in diagnosing and understanding these conditions. At the molecular level, it works by enhancing the signals in MRI scans, making it easier to see changes in brain metabolism. This medication falls under the category of diagnostic agents used in imaging techniques.

Investigated diseases

  • Amyotrophic Lateral Sclerosis

    Amyotrophic Lateral Sclerosis is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. It leads to the gradual degeneration and death of motor neurons, which are responsible for controlling voluntary muscles. As the disease progresses, individuals experience muscle weakness and atrophy, affecting their ability to move, speak, swallow, and eventually breathe. The progression of muscle weakness is typically symmetrical and can start in any part of the body. Over time, the loss of motor neurons leads to increasing disability. The exact cause of the degeneration of motor neurons in ALS is not fully understood.

  • Transient Ischemic Attack

    A Transient Ischemic Attack is a temporary period of symptoms similar to those of a stroke. It occurs when there is a brief reduction in blood supply to part of the brain, often due to a clot or blockage. The symptoms, which can include sudden numbness, weakness, confusion, or difficulty speaking, usually resolve within minutes to hours. Unlike a stroke, a TIA does not cause permanent damage to the brain. However, it serves as a warning sign that a person is at increased risk of having a stroke in the future. The underlying causes of a TIA are similar to those of a stroke, including atherosclerosis and heart disease.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516954-24-00Estimated enrolment46 patientsSponsorAarhus University

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