Okeechobee

This research focuses on people with psychosis linked to Alzheimers Disease who have completed earlier studies CN012-0026, CN012-0027, or CN012-0056. It is a Phase 3 global, multicenter, open-label extension study lasting 52 weeks that aims to evaluate the long-term safety and tolerability of KarXT in this population. Participants will receive KarXT capsules containing Xanomeline and Trospium Chloride. The study includes various dosing levels ranging from 202 mg to 66.76.67 mg taken three times daily. This open-label extension follows completion of previous studies and continues for up to 54 weeks from the initial dose, including a 14-day safety follow-up after the final dose. During the study, participants will be monitored for treatment-emergent adverse events and serious adverse events. Safety assessments include clinical evaluations throughout the treatment and 14 days after the last dose. The total participation time is approximately one year, allowing researchers to understand long-term effects of KarXT in this group.

Researchers are evaluating ALTO-300, a drug taken as a capsule once daily in the evening, for adults with moderate to severe major depressive disorder MDD. The study aims to compare the effects of ALTO-300 versus a placebo when added to an antidepressant, focusing on how patient characteristics may influence treatment outcomes. This is a randomized, double-blind trial with a phase 2 design. Participants will be randomly assigned to receive either ALTO-300 or a matching placebo capsule once daily for 42 days during the double-blind period. Those who qualify may then enter an open-label extension period lasting up to 8 weeks, during which all participants receive ALTO-300 once daily. The trial includes careful monitoring throughout both treatment periods. During the study, participants will undergo assessments to measure changes in depression symptoms using the Montgomery-sberg Depression Rating Scale MADRS up to week 6. Safety evaluations include tracking adverse events, heart rate, weight, blood pressure, and suicidality over the course of up to 15 weeks. The total participation duration may extend to 14 weeks, including both blinded and open-label phases, with regular visits and evaluations.