Phase III Study of Levetiracetam to Prevent Seizures and Slow Alzheimers Progression in Adults Over 40 With Down Syndrome

What this Trial Is About

Researchers are evaluating the use of levetiracetam to prevent epileptic seizures in adults with Alzheimers 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 Alzheimers 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.

LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome