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Study of levetiracetam to prevent seizures in adults who have both Down syndrome and Alzheimer's disease

Verified siteRegistered drugNo 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 studies the prevention of seizures in adults who have both Down syndrome and Alzheimer's disease. The study tests a medication called levetiracetam, which is given as film-coated tablets. The purpose is to determine if this medication can help prevent seizures in people who have both of these conditions.

The study will compare two groups of participants over a period of 96 weeks (about 2 years). One group will receive levetiracetam tablets (either 250 mg or 500 mg), while the other group will receive placebo tablets. Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition.

During the study, doctors will track several aspects of participants' health, including brain activity through electroencephalography (a test that records electrical signals from the brain), brain structure using MRI (a type of detailed brain scan), and various blood tests. They will particularly focus on watching for seizures and checking how well the medication is tolerated by participants.

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 assessment

    Your participation begins with confirmation that you have Down syndrome and Alzheimer's disease

    A medical evaluation will verify your eligibility, including your cognitive function and overall health status

    You must be over 40 years old to participate in the study

  2. Step 2

    Medication assignment

    You will be randomly assigned to receive either levetiracetam (medicine) or placebo (inactive tablet)

    The medication comes in the form of film-coated tablets that you take by mouth

    Two dosage options are available: 250 mg or 500 mg tablets

  3. Step 3

    Regular monitoring

    Your participation continues for 96 weeks (approximately 2 years)

    You will need to attend medical visits every 6 months

    During these visits, you will undergo:

    - Physical and neurological examinations

    - Blood tests

    - Brain imaging (MRI)

    - Brain wave recording (EEG)

    - Memory and thinking tests

  4. Step 4

    Safety monitoring

    Throughout the study, your doctor will monitor any side effects or health changes

    Regular checks of your vital signs will be performed

    Your daily caregiver must maintain contact with you and help track your health status

  5. Step 5

    Study completion

    The study ends after 96 weeks or if you experience a seizure during the study period

    A final medical evaluation will be conducted to assess your overall health status

    All test results will be recorded and analyzed

Who can join the trial?

13 criteria

  • Must be diagnosed with Down Syndrome, confirmed either through genetic testing (karyotype) or typical physical characteristics
  • Must have Alzheimer's Disease with dementia symptoms, shown by changes in daily functioning and cognitive test results
  • Must be over 40 years old at the time of initial screening
  • Must have a dedicated caregiver who has daily contact with the participant
  • Both participant and caregiver must be able to attend in-person visits every 6 months
  • If taking any approved Alzheimer's medications, must be on a stable dose for:
    • At least 30 days before screening
    • At least 60 days before the study starts
    • Other medications are allowed if the dose has remained unchanged for 30 days before screening (some medications may not be allowed)
    • Participants and/or their caregivers must be able to provide informed consent before any study procedures begin
    • For participants with mild intellectual disability, must meet specific cognitive test scores:
      • CAMCOG-DS score of 80
      • mCRT score of 29
      • For participants with moderate intellectual disability, must meet specific cognitive test scores:
        • CAMCOG-DS score of 56
        • mCRT score of 28

Who cannot join the trial?

12 criteria

  • Patients who do not have both Down syndrome and Alzheimer's disease
  • People under 18 years of age or over 65 years old
  • Individuals who have not experienced bilateral tonic-clonic seizures (seizures that affect both sides of the brain and cause loss of consciousness and muscle contractions)
  • People who are allergic to levetiracetam (the study medication) or its components
  • Pregnant or breastfeeding women
  • People taking medications that could interact with levetiracetam
  • Individuals with severe kidney problems (as the medication is cleared through kidneys)
  • People with severe liver dysfunction
  • Individuals participating in other clinical trials
  • People unable to provide informed consent either directly or through a legal representative
  • Individuals with uncontrolled psychiatric conditions that could interfere with the study
  • People with other serious medical conditions that could affect their participation in the trial
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Investigated drugs

Levetiracetam is an anti-seizure medication used to prevent and control epileptic seizures. In this trial, it is being studied as a preventive treatment for seizures in adults who have both Down syndrome and Alzheimer's disease. The medication works by decreasing abnormal brain activity that can lead to seizures. It is already commonly used to treat epilepsy in the general population, and researchers are studying if it can help prevent seizures specifically in people with Down syndrome who develop Alzheimer's disease.

What is already known about the treatment

Levetiracetam – An anticonvulsant medication administered orally in tablet or liquid form, primarily used to prevent seizures in various conditions including Alzheimer's disease and Down syndrome. This drug works by binding to a specific protein in the brain called SV2A, which helps regulate the release of neurotransmitters and reduces abnormal brain cell activity that can lead to seizures. As a well-established antiepileptic drug, levetiracetam has shown significant effectiveness in preventing bilateral tonic-clonic seizures and is particularly valuable for patients with both Down syndrome and Alzheimer's disease due to its favorable safety profile and minimal drug interactions.

Investigated diseases

  • Alzheimer's Disease

    A progressive brain disorder that gradually destroys memory and thinking abilities. It begins with mild memory loss and can progress to losing the ability to carry on conversations and respond to the environment. The disease causes brain cells to degenerate and die, leading to a decline in cognitive and physical functions. Changes in the brain may begin years before the first symptoms appear.

  • Down Syndrome

    A genetic condition caused by the presence of an extra copy of chromosome 21. It leads to developmental delays and distinct physical features, including a flattened face and upward slanting eyes. People with Down syndrome often experience slower physical development and mild to moderate intellectual disability. The condition can affect cognitive ability, physical growth, and facial features.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516148-24-00Estimated enrolment120 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).