NCT06937229

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

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 Alzheimer's Disease (ADAGIO-3)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer Disease
• Agitation

Interventions

Type	Name	Description
DRUG	KarXT	Specified dose on specified days
DRUG	KarX-EC	Specified dose on specified days

Timeline

• Start date: 2025-12-02
• Primary completion: 2029-06-22
• Completion: 2029-07-20
• First posted: 2025-04-22
• Last updated: 2026-04-06

Locations

240 sites across 25 countries: United States, Argentina, Brazil, Bulgaria, Canada, Chile, Croatia, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Portugal, Romania, South Korea, Spain, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study