Actively Recruiting
Levetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome A Phase III Randomized, Double-blinded Study
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
30 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
Researchers are evaluating the use of levetiracetam to prevent epileptic seizures in adults with Alzheimer's disease associated with Down syndrome. The study aims to see if levetiracetam can delay neurodegeneration linked to this condition. This Phase III, randomized, double-blinded trial will compare levetiracetam against a placebo, assessing its effect on seizures, cognitive decline, and Alzheimer's disease markers. Participants will be randomly assigned to receive either levetiracetam or placebo for 96 weeks. Levetiracetam will be given orally at 1000 mg per day, starting with a lower dose of 500 mg per day for the first 4 weeks, and tapering down to 500 mg per day during the last 4 weeks to allow gradual withdrawal. The placebo group will receive matching tablets twice daily for the full 96 weeks. During the study, participants will attend 12 medical visits where they will undergo neuropsychological evaluations, blood tests, magnetic resonance imaging (MRI), and electroencephalograms (EEG). Researchers will measure seizure prevention, cognitive changes, plasma biomarkers, brain structure changes, and safety through adverse event monitoring. Each participant will be involved for about 2 years and 5 months in total.
CONDITIONS
Brief 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 typical phenotype
- Age over 40 years at time of screening
- Symptomatic Alzheimer's Disease dementia based on functionality changes and neuropsychological test results
- Willing and able caregiver with daily contact
- Ability to comply with study treatment and attend biannual visits
- Stable concurrent treatment for Alzheimer's disease approved by EMA for at least 30 days prior to screening
- Ability of subject and/or caregiver to provide consent before study procedures
You will not qualify if you...
- Cognitive changes due to causes other than Alzheimer's disease
- History of epileptic seizures starting after age 18
- Treatment with antiepileptic drugs, benzodiazepines, or narcotics
- Significant unstable or clinically relevant medical conditions that affect safety or study evaluation
- Severe renal dysfunction (creatinine clearance < 30 mL/min)
- Psychiatric or neurologic disorders unrelated to Alzheimer's disease
- Significant suicide risk based on C-SSRS assessment
- Clinically significant abnormal blood or biochemical test results
- Participation in another clinical trial within 3 months of screening
- Hypersensitivity to levetiracetam or related compounds
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 96 weeks
Participants take either levetiracetam or placebo twice daily to prevent seizures and monitor effects on Alzheimer's disease.
12 medical visits including neuropsychological evaluation, blood tests, MRI, and EEG
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
D
Diego Real de Asúa Cruzat, Doctor
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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