A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of KarXT KarX-EC for Agitation in Alzheimers Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who experience agitation linked to Alzheimers Disease. This phase 3 trial aims to understand how these treatments impact agitation symptoms in this population. The study is sponsored by Bristol-Myers Squibb and uses rigorous methods to compare the investigational drugs against a placebo. Participants will receive either the combination of XanomelineTrospium Chloride capsules KarXT KarX-EC or a placebo, with doses given on specified days. The study is randomized, double-blind, and placebo-controlled, ensuring objective assessment of treatment effects over a 14-week period. The trial includes a parallel group design where participants are assigned to either the experimental treatment group or placebo group. During the study, participants will be assessed for changes in agitation using the Cohen-Mansfield Agitation Inventory and other related scales at week 14. Researchers will monitor safety through adverse event reports, clinical labs, vital signs, ECGs, and specific rating scales up to week 18. Caregivers will assist by attending visits and reporting on participant status. Total participation involves regular visits and assessments over the course of the trial.

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)