Kutna Hora 1

This trial studies adults aged 55 to 90 who have psychosis linked to Alzheimers Disease. It is a Phase 3, 38-week, randomized, double-blind, placebo-controlled outpatient study. Its main goal is to assess how well KarXT capsules prevent relapse of psychosis compared to placebo. Additional goals include evaluating time to treatment discontinuation or relapse, and monitoring safety and tolerability. Participants receive either KarXT capsules at various doses or placebo capsules. The study involves a randomized assignment and is conducted under quadruple masking. The treatment period lasts 38 weeks during which KarXT or placebo is taken three times daily. Assessments continue up to approximately 42 weeks to monitor adverse events and other safety measures. Throughout the study, participants attend outpatient visits for evaluations including cognitive tests, assessments of psychosis severity, caregiver reports, lab tests, vital signs, and safety monitoring. Researchers measure relapse timing, treatment discontinuation, neuropsychiatric symptoms, movement scales, weight, and signs related to heart and urinary health. Safety is closely tracked with various assessments until about week 42.

Researchers are evaluating ITI-1284, a drug being studied for agitation associated with Alzheimers dementia. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess the efficacy, safety, and tolerability of ITI-1284 in patients aged 55 years and older who experience agitation related to Alzheimers disease. The study is sponsored by Intra-Cellular Therapies, Inc. and follows strict clinical criteria for diagnosis and agitation severity. Participants are randomly assigned in equal numbers to receive either ITI-1284 or a placebo. ITI-1284 is given as a rapidly disintegrating tablet taken once daily under the tongue at doses of 10 mg or 20 mg. The study consists of three periods a screening period lasting up to 4 weeks to assess eligibility, a 12-week double-blind treatment period where the assigned study drug is taken daily, and a 30-day safety follow-up period after the last dose to monitor any effects. During the study, participants will have assessments including the Cohen-Mansfield Agitation Inventory CMAI to measure agitation levels at Week 12. Other evaluations include the Clinical Global Impression-Severity CGI-S score and cognitive testing with the Mini-Mental State Examination. Safety monitoring occurs throughout the treatment and follow-up periods. Overall, participation lasts approximately 16 to 17 weeks, covering screening, treatment, and safety checks.

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.