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RECRUITING
NCT07234695
PHASE3

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

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

View on ClinicalTrials.gov

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.

Official title: 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).

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-12-22

Completion Date

2028-07

Last Updated

2026-01-12

Healthy Volunteers

No

Interventions

DRUG

Levetiracetam 500mg

Use of Levetiracetam to prevent Seizures in Symptomatic Alzheimer's Disease in adults with Down syndrome (the LESS-AD trial)

DRUG

Placebo

Comparator

Locations (5)

Hospital Virgen de las Nieves

Granada, Andalusia, Spain

Fundación CITA Alzheimer

Donostia / San Sebastian, Basque Country, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Hospital La Princesa

Madrid, Spain