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

NCT07234695 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-01-12

No results posted yet for this study

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.

Conditions

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

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

Sponsors & Collaborators

  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    collaborator OTHER

  • Hospital Universitario Marqués de Valdecilla

    collaborator OTHER

  • Fundación CITA Alzheimer

    collaborator UNKNOWN

  • University Hospital Virgen de las Nieves

    collaborator OTHER

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-22
Primary Completion
2027-12-31
Completion
2028-07-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07234695 on ClinicalTrials.gov