RecruitingPhase 3NCT07234695

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

A Phase III, Randomized, Double-blinded Study of the Efficacy and Safety of LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome (the LESS-AD Trial).

Sponsor

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

Enrollment

120 participants

Start Date

Dec 22, 2025

Study Type

INTERVENTIONAL

Conditions

Epilepsy Alzheimer Disease Seizures Down Syndrome (DS)Down Syndrome Alzheimer Dementia Alzheimer Dementia (AD)Alzheimer Disease (AD)Down Syndrome (Trisomy 21)Alzheimer Blood Biomarkers

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.

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a seizure-prevention medication called levetiracetam can help adults with Down syndrome who have developed Alzheimer's disease symptoms. **You may be eligible if...** - You have been diagnosed with Down syndrome (confirmed by genetic test or typical features) - You are over 40 years old - You are showing signs of Alzheimer's disease, such as memory and thinking changes compared to your usual abilities **You may NOT be eligible if...** - You do not have Down syndrome - You do not have symptoms of Alzheimer's disease - You are 40 years old or younger Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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