Actively Recruiting
LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome
Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2026-01-12
120
Participants Needed
5
Research Sites
131 weeks
Total Duration
On this page
Sponsors
F
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead Sponsor
F
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Down Syndrome by karyotype or compatible phenotype
- Age over 40 years at screening
- Symptomatic Alzheimer's disease dementia confirmed by functional and neuropsychological tests
- Willing and able caregiver with daily contact
- Ability to comply with study treatment and biannual in-person visits
- Stable concurrent Alzheimer's disease treatment approved by EMA for 30 days prior to screening and 60 days before study start
- Ability of subjects and/or caregivers to provide informed consent
You will not qualify if you...
- Cognitive changes caused by conditions other than Alzheimer's disease
- History of adult-onset epileptic seizures (over 18 years old)
- Treatment with antiepileptic drugs, benzodiazepines, or narcotics
- Significant unstable or clinically important medical conditions affecting safety or study evaluation
- Severe renal dysfunction (creatinine clearance < 30 mL/min)
- Psychiatric or neurological disorders unrelated to Alzheimer's disease
- Significant suicide risk based on C-SSRS assessment
- Clinically significant abnormal lab values as judged by investigator
- Participation in another clinical trial within 3 months prior to screening
- Hypersensitivity to levetiracetam, pyrrolidone derivatives, or excipients
- Pregnant or breastfeeding patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Hospital Virgen de las Nieves
Granada, Andalusia, Spain, 18014
Not Yet Recruiting
2
Fundación CITA Alzheimer
Donostia / San Sebastian, Basque Country, Spain, 20009
Not Yet Recruiting
3
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Not Yet Recruiting
4
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain, 08041
Actively Recruiting
5
Hospital La Princesa
Madrid, Spain, 28006
Not Yet Recruiting
Research Team
M
María Carmona Iragui, Doctor
CONTACT
D
Diego Real de Asúa Cruzat, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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