Testing AGB101 Low-Dose Levetiracetam for Treating Psychosis in Parkinsons Disease in Adults Ages 40 to 85

What this Trial Is About

Researchers are evaluating whether AGB101, a low-dose extended release levetiracetam tablet, can improve symptoms of psychosis in people with Parkinsons disease. The study addresses how hallucinations and memory problems in Parkinsons disease may relate to similar brain changes found in schizophrenia, focusing on the hippocampus as a shared area of dysfunction. The trial aims to assess if AGB101 can help with psychosis symptoms in Parkinsons disease, with oversight from Johns Hopkins University. Participants will take both AGB101 and a placebo in a randomized order, each for 6 weeks with a 4-week break in between. The study involves two groups one starts with AGB101 followed by placebo, and the other starts with placebo followed by AGB101. The medication is taken once daily as a tablet. This phase 2 clinical trial includes multiple in-person visits and uses brain imaging and other tests to monitor effects. During the approximately 20-week study, participants will complete up to five visits involving physical and neurological exams, questionnaires, cognitive tests, blood and urine sample collections, and two MRI scans. Researchers will measure changes in hallucinations and delusions using a specialized scale for Parkinsons disease psychosis, alongside brain activity changes detected by fMRI. Safety and symptom monitoring occur at regular intervals throughout the study.

Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis