Phase 3 Study of KarXT Plus KarX-EC for Treating Psychosis in Alzheimers Disease Patients Aged 55 to 90

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining KarXT and KarX-EC as a treatment for psychosis associated with Alzheimers disease. This Phase 3 randomized, double-blind, placebo-controlled trial aims to address psychotic symptoms such as hallucinations and delusions in patients aged 55 to 90 diagnosed with Alzheimers disease according to recent criteria. The study is sponsored by Bristol-Myers Squibb and uses a parallel group design to compare the investigational drug combination against placebo. Participants will be randomly assigned to receive either the combination of KarXT plus KarX-EC or a matching placebo, with specified doses given on set days. The treatment period lasts approximately 14 weeks, during which safety and efficacy are closely monitored. The trial assesses changes from baseline in neuropsychiatric symptoms and other clinical measures using standardized scales and questionnaires. During the study, participants will undergo various assessments including clinical evaluations, laboratory tests, brain imaging review, and symptom rating scales such as the Neuropsychiatric Inventory-Clinician and Clinical Global Impressions-Severity. Researchers will also monitor adverse events and other health indicators up to about week 14. The total participation duration spans from screening through treatment completion and safety follow-up to evaluate the overall impact and safety profile of the treatments.

A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)