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
Study ID
NCT07234695
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Levetiracetam 500mg — DRUG
    Use of Levetiracetam to prevent Seizures in Symptomatic Alzheimer's Disease in adults with Down syndrome (the LESS-AD trial)
  • Placebo — DRUG
    Comparator

Study Details

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.

Key Dates

First listed
Nov 18, 2025
Start date
Dec 22, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Levetiracetam 500 mg/12h
    Tablets for twice daily administration for 96 weeks. During the first 4 weeks of the treatment period, LEV, treatment will be administered 500mg/d (250mg/12h) to facilitate the compliance. During the last 4 weeks of the treatment period, LEV will be administered 500mg/d (250mg/12h) to enable a gradual withdrawal.
  • Placebo Comparator: Placebo
    Tablets for twice daily administration for 96 weeks.

Primary Outcome Measure

Efficacy of Levetiracetam as a preventive treatment for epileptic seizures in adults with Alzheimer's disease associated with Down syndrome. [ Time Frame: From enrollment to the end of treatment at 96 weeks ]

Central Contacts

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