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Recruiting Phase 3 Interventional

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)

ClinicalTrials.gov ID: NCT07011745

Public ClinicalTrials.gov record NCT07011745. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 8, 2026, 8:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease

Study identification

NCT ID
NCT07011745
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
352 participants

Conditions and interventions

Interventions

  • Placebo Drug
  • Xanomeline Enteric Capsule Drug
  • Xanomeline/Trospium Chloride Capsule Drug

Drug

Eligibility (public fields only)

Age range
55 Years to 90 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 15, 2025
Primary completion
Nov 2, 2028
Completion
Nov 12, 2028
Last update posted
Apr 29, 2026

2025 – 2028

United States locations

U.S. sites
38
U.S. states
19
U.S. cities
35
Facility City State ZIP Site status
Chandler Clinical Trials, LLC Chandler Arizona 85224 Recruiting
Local Institution - 2631 Chandler Arizona 85226-3732 Not yet recruiting
National Institute of Clinical Research Garden Grove California 92844 Recruiting
Local Institution - 2607 Long Beach California 90805 Not yet recruiting
Accellacare Long Beach California 90807 Recruiting
Local Institution - 2627 Napa California 94558 Not yet recruiting
Local Institution - 2613 Pasadena California 91105 Not yet recruiting
Local Institution - 2614 San Diego California 92108 Not yet recruiting
Alliance Clinical -West Hills West Hills California 91307 Recruiting
Local Institution - 2601 Basalt Colorado 81621 Withdrawn
Local Institution - 2635 Colorado Springs Colorado 80907 Not yet recruiting
Local Institution - 2632 Norwalk Connecticut 06851 Not yet recruiting
Envision Trials LLC Bonita Springs Florida 34134-4154 Recruiting
Key Clinical Research Bradenton Florida 34207 Recruiting
Local Institution - 2636 Doral Florida 33122 Not yet recruiting
Local Institution - 2606 Homestead Florida 33032 Not yet recruiting
Local Institution - 2633 Miami Florida 33137 Not yet recruiting
Local Institution - 2637 Miami Florida 33165 Not yet recruiting
Local Institution - 2634 Orlando Florida 32806 Not yet recruiting
IPTB Clinical Research Tampa Florida 33629 Recruiting
Agile Clinical Research Trials, LLC Atlanta Georgia 30328 Recruiting
Vitalix Clinical Worcester Massachusetts 01608 Recruiting
Michigan Clinical Research Institute PC Ann Arbor Michigan 48105 Recruiting
Local Institution - 2630 Saint Paul Minnesota 55130 Not yet recruiting
Hattiesburg Clinic Hattiesburg Mississippi 39402 Recruiting
Local Institution - 2603 Ozark Missouri 65721 Active, not recruiting
Las Vegas Clinical Trials Las Vegas Nevada 89030 Recruiting
Richmond Behavioral Associates Staten Island New York 10312 Recruiting
Local Institution - 2644 Valley Stream New York 11580 Not yet recruiting
West Clinical Research Morehead City North Carolina 28557 Recruiting
Velocity Clinical Research - Blue Ash Blue Ash Ohio 45242 Recruiting
Epic Medical Research, LLC - Carrolton Carrollton Texas 75006 Recruiting
Horizon Clinical Research Center - Houston Cypress Texas 77065 Recruiting
Epic Medical Research, LLC - Mesquite Mesquite Texas 75150 Recruiting
UT Health - San Antonio San Antonio Texas 78229 Recruiting
Local Institution - 2612 Bountiful Utah 84010 Active, not recruiting
Local Institution - 2638 Kirkland Washington 98034 Not yet recruiting
Local Institution - 2610 Milwaukee Wisconsin 53226 Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 102 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07011745, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 29, 2026 · Synced May 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07011745 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →