A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT KarX-EC for the Treatment of Agitation Associated With Alzheimers Disease ADAGIO-3

What this Trial Is About

Researchers are evaluating the long-term safety and effectiveness of a combined treatment using xanomeline tartratetrospium chloride in an immediate release capsule KarXT and xanomeline enteric capsules KarX-EC for people with agitation associated with Alzheimers Disease. This study includes participants who have completed previous related studies CN012-0023 or CN012-0024. The goal is to observe how well these treatments work and how safe they are over an extended period. The study involves giving participants specified doses of KarXT and KarX-EC on certain days. This is an open-label study, meaning both the researchers and participants know what treatment is being given. The trial is non-randomized and does not include a placebo group. The treatment period lasts up to about 30 weeks, during which participants take the study medications and are closely monitored. Participants will be involved in regular assessments throughout up to approximately 30 weeks. Researchers will track any treatment-emergent side effects and other adverse events, along with specific measures such as movement scales, body weight and BMI changes, heart rate and blood pressure checks, laboratory tests, ECGs, and cognitive assessments like the Mini-mental State Examination and ADAS-Cog. Safety monitoring includes assessment of suicidal thoughts and prostate symptom severity. This comprehensive monitoring aims to understand the treatment impacts and participant safety during the study.

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)