LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome
Recruiting
Phase 3
Interventional Study
Down Syndrome
Down Syndrome (DS)
Down Syndrome (Trisomy 21)
Alzheimer Dementia
Alzheimer Dementia (AD)
Alzheimer Disease
Alzheimer Disease (AD)
Alzheimer Blood Biomarkers
Epilepsy
Seizures
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 40 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 120 (estimated)
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Other
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About This Trial
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 p…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Diagnosed with Down Syndrome (DS), either with a karyotype or a compatible typical phenotype.
* Age over 40 years at time of screening.
* Symptomatic Alzheimer's Disease (AD) dementia, based on change in functionality and neuropsychological tests' results. Different cut-off po…
Contacts