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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)

NCT07011732 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Xanomeline/Trospium Chloride Capsule

Specified dose on specified days

DRUG

Xanomeline Enteric Capsule

Specified dose on specified days

DRUG

Placebo

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-10
Primary Completion
2028-11-24
Completion
2028-12-08
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Croatia
  • Greece
  • India
  • Japan
  • Mexico
  • Portugal
  • Romania
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07011732 on ClinicalTrials.gov