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.
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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

María Carmona Iragui, Doctor

+34 93 556 59 56

mcarmonai@santpau.cat

CONTACT

Diego Real de Asúa Cruzat, Doctor

diego.realdeasua@salud.madrid.org

CONTACT