Okeechobee

The trial investigates the long-term safety and tolerability of KarXT in people with psychosis associated with Alzheimer's Disease. This Phase 3 global, multicenter, open-label extension study lasts 52 weeks and enrolls participants who have completed earlier related studies (CN012-0026, CN012-0027, or CN012-0056). The purpose is to monitor how well patients tolerate KarXT over an extended period and to collect safety data. Participants receive KarXT in varying doses taken three times daily, ranging from 20/2 mg up to 66.7/6.67 mg per dose, corresponding to total daily doses between 60/6 mg and 200/20 mg. This treatment is provided throughout the 52-week open-label extension. The study includes only those who completed the previous related studies and continues to assess their response to KarXT over this longer timeframe. During the study, participants are closely monitored for treatment-emergent adverse events from the first dose through 14 days after the final dose, which may be up to 54 weeks. Regular assessments ensure safety and tolerability, and caregivers are involved to support participants. The study also evaluates participants' ability to continue living in their current setting and requires consent from the participant or their legal representative. Overall, the study tracks long-term safety outcomes in this specific patient group.

Researchers are evaluating the effectiveness of ALTO-300 compared to a placebo when added to an antidepressant treatment in adults with moderate to severe major depressive disorder (MDD). This Phase 2 study aims to identify differences in how well ALTO-300 works based on patient characteristics. The main goal is to measure changes in depression symptoms over six weeks using the Montgomery-Åsberg Depression Rating Scale (MADRS). Participants will receive either ALTO-300 capsules or placebo capsules once daily while continuing their current antidepressant, which must be a single SSRI, SNRI, or bupropion taken for at least six weeks without recent dose changes. The study includes a randomized, double-blind phase where neither participants nor researchers know who receives the active drug or placebo. There is also an open-label extension phase after the initial treatment period. During the study, participants will undergo regular assessments to monitor their depression symptoms and overall health. Researchers will track changes in MADRS scores up to week 6 to evaluate treatment effects. Participants must comply with all study procedures, and safety will be closely monitored throughout the trial. The study includes adults aged 18 to 70 years who meet the specific inclusion criteria and do not have any exclusion conditions.