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

Study acronym: LESS-AD
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 24, 2025 to Dec 22, 2025
    • Site details revised at 5 of 5 sites
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07234695
Lead Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital Universitario Marqués de Valdecilla, Fundación CITA Alzheimer, University Hospital Virgen de las Nieves
Conditions
(from sponsor)		 Down Syndrome, Down Syndrome (DS), Down Syndrome (Trisomy 21), Alzheimer Dementia, Alzheimer Dementia (AD), Alzheimer Disease, Alzheimer Disease (AD), Alzheimer Blood Biomarkers +2 more
Related terms Alzheimer Disease, Dementia, Down Syndrome, Epilepsy, Epilepsy, Tonic-Clonic, Seizures
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov