drugset / Trial / NCT06937229

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

NCT06937229

Phase 3 Recruiting 650 enrolled Bristol-Myers Squibb
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.

Timeline

Start
2025-12-02
Primary completion
2029-06-22
Completion
2029-07-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Trospium Small molecule
Subject Xanomeline Small molecule

Indications