Levetiracetam to prevent seizures in adults with Down syndrome and Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled Phase 3 trial giving levetiracetam or matching placebo for 96 weeks to adults with Down syndrome who have symptomatic Alzheimer's dementia. Participants are randomly assigned to active drug or placebo and followed for clinical seizure outcomes, cognitive measures, and Alzheimer’s disease biomarkers. The primary outcome is prevention of bilateral tonic-clonic seizures at 96 weeks, with secondary outcomes including time to first seizure, changes in cognition, and safety. The trial uses standard dosing of levetiracetam and regular clinic visits at participating Spanish centers.

Why it matters

Who can join: the full rules

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 dose is stable for 30 days prior to screening.
* Subjects and/or their caregivers must be able to provide their consent before participating in any study-related procedures.

Exclusion Criteria:

* Cognitive changes attributable to causes other than AD (for example, but not limited to, uncorrected visual or hearing deficit, severe, untreated sleep apnea or uncontrolled thyroid disorders).
* Previous history of adult-onset epileptic seizures (over 18 years old).
* Treatment with any kind of antiepileptic drugs, benzodiazepines, narcotics.
* Significant comorbidities or analytical abnormalities, such as:
* Any unstable and/or clinically significant medical condition likely to hamper the evaluation of safety and/or efficacy of the study (eg, moderate and/or severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions), as per investigator's judgement.
* Severe renal dysfunction (creatinine clearance \< 30 mL/min), which would affect serum levetiracetam levels, or any other medical condition which is determined by the investigators to potentially create an undue risk for an adverse effect.
* Concomitant or past history psychiatric or neurologic disorder other than those considered to be related to AD (eg, head injury with loss of consciousness, symptomatic stroke, Parkinson's disease, severe carotid occlusive disease, transient ischemic attacks \[TIAs\]).
* Significant risk of suicide, defined using the C-SSRS as the subject answering "yes" to suicidal ideation questions 4 or 5 or answering "yes" to suicidal behavior within the past 12 months.
* Deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, judged to be clinically significant by the investigator.
* Participation in another clinical trial within 3 months of screening.
* Hypersensitivity to the active ingredient, other pyrrolidone derivatives, or any of the excipients
* Pregnant and breastfeeding patients

Where it's running

• Hospital de la Santa Creu i Sant Pau
  Barcelona, Catalonia, Spain Recruiting
• Hospital Virgen de las Nieves
  Granada, Andalusia, Spain Not yet recruiting
• Fundación CITA Alzheimer
  Donostia / San Sebastian, Basque Country, Spain Not yet recruiting
• Hospital Universitario Marqués de Valdecilla
  Santander, Cantabria, Spain Not yet recruiting
• Hospital La Princesa
  Madrid, Spain Not yet recruiting

Study contacts

• Study coordinator: María Carmona Iragui, Doctor
• Email: mcarmonai@santpau.cat
• Phone: +34 93 556 59 56

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gut methane and Parkinson's: measuring if a probiotic helps people with Parkinson's, REM sleep behavior disorder, or cognitive concerns

  This study tests whether a probiotic containing Limosilactobacillus reuteri can help people with Parkinson's disease, those at high risk for PD, and related cognitive issues by potentially improving gut methane levels and overall symptoms.

  Recruiting University of Cambridge · Cambridge, CB2 · NCT07786116

• Brain stimulation plus methylphenidate for apathy in Alzheimer's

  This trial will test whether combining short sessions of noninvasive brain stimulation (intermittent theta burst) with methylphenidate can reduce apathy in people with Alzheimer's disease or mixed Alzheimer's/vascular dementia.

  Recruiting Phase 2 Sunnybrook Health Sciences Centre · Toronto, Ontario · NCT07279740

• Home-based gamma-tACS with personalized cognitive training for mild Alzheimer's disease

  This study tests a home-delivered combination of gamma-frequency tACS and individualized memory training to see if it helps people with mild Alzheimer's disease.

  Recruiting IRCCS Centro San Giovanni di Dio Fatebenefratelli · Brescia, Brescia and 1 other locations · NCT07839650

• Low-Dose Radiation Therapy to See if It Helps Alzheimer's and Inflammatory Dementias

  Researchers will test whether giving small amounts of whole-brain radiation over a short course, then monthly boosts for a year, is tolerable and safe in people over 50 with Alzheimer's or dementia with inflammatory features.

  Recruiting Phase 1/2 Renaissance Institute of Precision Oncology and Radiosurgery · Winter Park, Florida · NCT07693140

• Predicting pre-dementia progression in APOE‑ε4 carriers

  This project will try a combined genetic, blood, and wearable-monitoring model to see if it can predict which cognitively normal or very mildly impaired adults aged 55+ with an APOE‑ε4 gene will develop biomarker-confirmed MCI within 24 months.

  Recruiting Prevention Research Consortium Corp. · San Diego, California · NCT07516119

• Using a blood test to detect Alzheimer's in hospitalized older adults with sudden confusion

  This will test whether the Quest AD-Detect blood test can identify underlying Alzheimer's disease in hospitalized patients aged 60–90 who have new confusion, delirium, or encephalopathy.

  Recruiting at 6 sites Covenant Health, US · Crossville, Tennessee and 5 other locations · NCT07222280

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.