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Study on [18F]MNI-659 to Track Huntington's Disease Progression in Symptomatic and Pre-symptomatic Patients

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 focuses on Huntington's disease, a genetic disorder that causes the progressive breakdown of nerve cells in the brain. The study aims to explore innovative ways to predict the progression of this disease using advanced imaging techniques and cognitive tests. The treatment being studied involves a special solution for injection called [18F]MNI-659, which is administered intravenously. This solution is designed to help researchers identify specific markers in the body that can indicate how the disease is progressing.

The purpose of the study is to find reliable markers, known as biomarkers, that can be used to measure the progression of Huntington's disease from its early stages. Participants in the study will include both individuals who have symptoms of the disease and those who are in the pre-symptomatic stages, meaning they have the genetic mutation but do not yet show symptoms. The study will take place over a period of time, with participants receiving the injection and undergoing various tests and assessments to track changes in their condition.

Throughout the study, researchers will collect data at different intervals to analyze how the disease progresses in each participant. This information will help in understanding the effectiveness of the biomarkers in predicting disease progression. The ultimate goal is to improve the ability to monitor and treat Huntington's disease more effectively in the future. Participants will be closely monitored, and their health and safety will be a top priority throughout the study.

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 visit

    Upon joining the study, participants will attend an initial visit. During this visit, eligibility will be confirmed based on specific criteria such as age and health status.

    Participants will provide written consent to participate in the study. This consent is necessary to proceed with the trial activities.

  2. Step 2

    Baseline assessment

    Participants will undergo a baseline assessment. This includes various tests and evaluations to establish initial health and cognitive status.

    The assessment will help in tracking changes over time and may involve questionnaires, physical exams, and cognitive tests.

  3. Step 3

    Imaging procedure

    Participants will receive an injection of a solution called [18F]MNI-659. This is a special imaging agent used to help visualize certain areas of the brain.

    The injection is administered through a vein, a process known as intravenous administration.

  4. Step 4

    Follow-up visits

    Participants will attend follow-up visits at various intervals, including at 1 month, 12 months, and 24 months after the initial visit.

    These visits will involve repeating some of the initial assessments to monitor changes and progression over time.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment will be conducted. This will include a comprehensive evaluation similar to the baseline assessment.

    The final assessment aims to gather data on the progression of the condition and the effectiveness of the imaging agent in tracking changes.

Who can join the trial?

18 criteria

  • Age between 18 and 65 years.
  • Must provide written consent to participate.
  • Must be part of a social security plan or be a beneficiary.
  • For healthy volunteers (control group):
    • Functional score of 13 on the UHDRS scale, which measures daily living abilities.
    • Motor score of less than 6 on the UHDRS scale, which measures movement abilities.
    • No known genetic diseases and no direct family connection to someone with Huntington's disease.
    • For symptomatic Huntington's disease patients:
      • Genetic marker (GAC) count of 40 or more.
      • CAP score of 250 or more, which is a measure related to the genetic risk of the disease.
      • Functional score between 10 and 13 on the UHDRS scale.
      • Motor score greater than 5 if the functional score is 13.
      • High confidence in the diagnosis of Huntington's disease.
      • Age of disease onset must be over 20 years.
      • Must be physically able to sign consent.
      • For pre-symptomatic Huntington's disease patients:
        • Genetic marker (GAC) count of 40 or more.
        • CAP score of 250 or more.
        • Functional score of 13 on the UHDRS scale.
        • Motor score of less than 6 on the UHDRS scale.
        • Must be physically able to sign consent.

Who cannot join the trial?

3 criteria

  • Patients who do not have Huntington's disease, whether they show symptoms or not, cannot participate.
  • Individuals who are not within the specified age range for the study cannot participate.
  • Participants must not belong to any vulnerable population groups.
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Investigated drugs

The provided data does not include specific medications or therapies involved in the clinical trial. Therefore, I am unable to list or describe any medications or therapies based on the given information. If you have additional details or another source of information, please provide them so I can assist you further.

What is already known about the treatment

[trade name of the medication] – This medication is administered to patients with symptomatic and pre-symptomatic Huntington's disease. It is currently being studied in clinical trials to identify biomarkers that can measure the progression of Huntington's disease. The main therapeutic indication is to help manage and track the progression of Huntington's disease. The medication works at the molecular level by targeting specific pathways involved in the disease's progression, although the exact mechanism is still under investigation. It is classified pharmacologically as a treatment for neurodegenerative disorders.

Investigated diseases

Huntington's disease – Huntington's disease is a genetic disorder that affects the brain, leading to the progressive degeneration of nerve cells. It typically begins with subtle changes in mood, cognition, and movement, which gradually worsen over time. As the disease progresses, individuals may experience involuntary movements, known as chorea, along with difficulties in coordination and balance. Cognitive decline is also common, affecting memory, judgment, and the ability to plan and organize. Emotional and behavioral changes, such as depression and irritability, often accompany the physical symptoms. The progression of Huntington's disease varies among individuals, but it generally leads to increasing disability over the years.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516022-63-00Protocol codeAPHP210360Estimated enrolment100 patientsSponsorAssistance Publique Hopitaux De Paris

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