This study involves people who have Alzheimer’s disease and are experiencing agitation, which means they may have behaviors such as restlessness, aggression, or emotional distress that are related to their condition. The treatments being tested in this study are KarXT, which is a capsule containing two substances called xanomeline tartrate and trospium chloride, and KarX-EC, which is a capsule containing only xanomeline tartrate. Some people in the study will receive these medications while others will receive placebo. The medications are also known by their code names BMS-986510 for KarXT and BMS-986519 for KarX-EC.
The purpose of this study is to find out if KarXT combined with KarX-EC works better than placebo in reducing agitation in people with Alzheimer’s disease. During the study, the effectiveness of the treatment will be measured using a rating scale that tracks agitation behaviors, such as physical and verbal aggression, and how often these behaviors occur. Doctors will also assess the overall severity of agitation symptoms to see if there is improvement with the treatment.
People taking part in this study will need to have a caregiver who spends enough time with them each week to observe their symptoms and help them follow the study requirements. The caregiver will attend study visits and provide information about the person’s agitation and overall condition. The study will involve taking the study medication or placebo in capsule form by mouth over a period of time, with regular visits to monitor safety and measure changes in agitation symptoms.
Czechia 
France 
Hungary 
Italy 
Poland 
