Clinical Trial

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

Study acronym: LESS-AD
Recruiting Phase 3
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-14.
Status change: Not Yet Recruiting → Recruiting 2026-01-08
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 Down Syndrome, Down Syndrome (DS), Down Syndrome (Trisomy 21), Alzheimer Dementia, Alzheimer Dementia (AD), Alzheimer Disease, Alzheimer Disease (AD), Alzheimer Blood Biomarkers +2 more
Enrollment 120 participants
Start Date 2025-12-22
Primary Completion 2027-12 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-01-12