Shaker Heights

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC as a treatment for psychosis linked to Alzheimer's disease. This Phase 3 clinical trial focuses on people aged 55 to 90 years diagnosed with Alzheimer's disease and experiencing psychotic symptoms, such as hallucinations and delusions. The study aims to understand how this treatment affects these neuropsychiatric symptoms over approximately 14 weeks. Participants will receive either KarXT plus KarX-EC or a matching placebo at specified doses on designated days. The study is double-blind and placebo-controlled, meaning neither the participants nor the researchers know who receives the active treatment or placebo during the trial. This parallel group design helps compare the treatment's impact against no active drug. During the study, participants will be monitored for changes in hallucinations and delusions using the Neuropsychiatric Inventory-Clinician scale up to about week 14. They will also undergo brain imaging review from recent MRI or CT scans to confirm eligibility and rule out other causes of dementia. Safety and efficacy will be carefully assessed throughout the trial period, ensuring close observation of any side effects or improvements.

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.