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 a combination treatment called KarXT and KarX-EC for adults aged 55 to 90 who have agitation linked to Alzheimers Disease. This Phase 3 study aims to understand how this treatment may help manage agitation symptoms in this population, with careful monitoring of side effects and overall safety. Participants will receive either the KarXT plus KarX-EC treatment or a placebo, with doses given on specified days as capsules. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active treatment or placebo. The treatment period lasts 14 weeks, during which participants are closely observed. During the study, participants will undergo various assessments including the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association CMAI-IPA score to measure agitation changes at week 14. Additional evaluations include clinical global impressions, neuropsychiatric inventories, safety monitoring through lab tests, vital signs, body measurements, and assessment of side effects up to week 18. Caregivers will also report on participants status, and safety will be closely followed throughout 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-2)