Clinical 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)

Name: 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) — clinical trial record (NCT07011732)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Recruiting Phase 3

View on ClinicalTrials.gov →

Summary

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

Protocol Amendment History 1 change

notable Enrollment increased: 352 -> 426 participants 2026-07-01

Trial Details

NCT Number	NCT07011732
Lead Sponsor	Bristol-Myers Squibb
Conditions	Alzheimer Disease
Enrollment	426 participants
Start Date	2025-07-10
Primary Completion	2028-11-24 (estimated)
Study Completion	2028-12-08 (estimated)
Updated on ClinicalTrials.gov	2026-08-11