RecruitingPhase 3

LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome

Spain120 participantsStarted 2025-12-22

Plain-language summary

The purpose of this study is to evaluate whether levetiracetam can prevent epileptic seizures in patients with Alzheimer's disease associated with Down syndrome. It will also analyze whether it can delay the neurodegeneration associated with this disease. Patients will be randomly assigned to one of two groups: one group will receive the active drug (levetiracetam), and the other will receive a placebo. Both groups will receive the treatment for 96 weeks. Each patient will participate for a total of 2 years and 5 months.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosed with Down Syndrome (DS), either with a karyotype or a compatible typical phenotype. * Age over 40 years at time of screening. * Symptomatic Alzheimer's Disease (AD) dementia, based on change in functionality and neuropsychological tests' results. Different cut-off points will be established to diagnose dementia depending on the level of intellectual disability of the individual, according to previous experience (Benejam et al; 2020): in adults with mild intellectual disability, a CAMCOG-DS score of 80 and an mCRT score of 29 will be chosen, whereas values of 56 and 28, respectively, will be used in subjects with moderate intellectual disability. Doubtful cases (e.g., with compromised functionality, but without alteration in the neuropsychological assessment) or those unable to complete the evaluation will be categorized by consensus among expert clinicians, using all available clinical information. * Willing and able caregiver who has daily contact with the study subject. * Subjects and caregivers must be able to comply with the prescribed regimen of study treatment throughout the course of the study and meet a minimum required time commitment of biannual in-person visits. * Any concurrent treatment for AD approved by the European Medicines Agency (EMA) must be stable for at least 30 days prior to screening and at least 60 days prior to study day 1. Other medications (except for those listed under exclusion criteria) are allowed as long as the…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 3 trial testing levetiracetam specifically to *prevent* seizures before they start in people with Down syndrome and Alzheimer's disease — does my loved one's current situation, including whether they've already had seizures or not, affect whether this trial might be worth discussing with their care team?
2Since levetiracetam is already an approved anti-seizure medication used in other conditions, what do we know so far about its safety profile in adults with Down syndrome, and are there any behavioral or mood-related side effects that are especially important to watch for in someone who may have difficulty communicating how they feel?
3This trial is actively recruiting right now — what would the commitment actually look like in terms of visit frequency, monitoring, and any blood biomarker testing, and is that realistic given our caregiving situation?
4Because the trial is studying prevention rather than treatment of seizures that have already occurred, how does my doctor weigh the potential benefit of starting a preventive medication now against the option of waiting and only treating seizures if and when they happen?
5Are there standard-of-care approaches already available for managing seizure risk in adults with Down syndrome and Alzheimer's disease that we should consider first, or alongside discussing this trial?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy of Levetiracetam as a preventive treatment for epileptic seizures in adults with Alzheimer's disease associated with Down syndrome.

Timeframe: From enrollment to the end of treatment at 96 weeks

Trial details

NCT IDNCT07234695

SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

María Carmona Iragui, Doctor

+34 93 556 59 56 mcarmonai@santpau.cat

View on ClinicalTrials.gov More Down Syndrome trials