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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

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 Sep 2, 2026, 6:39 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 (ADAGIO-2)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

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

Conditions and interventions

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
Aug 25, 2026

2025 – 2028

United States locations

U.S. sites
42
U.S. states
20
U.S. cities
38
Facility City State ZIP Site status
Chandler Clinical Trials, LLC Chandler Arizona 85224 Recruiting
Local Institution - 2631 Chandler Arizona 85226-3732 Not yet recruiting
Local Institution - 2646 Chandler Arizona 85286 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 - 2649 Orange California 92866 Not yet recruiting
Local Institution - 2613 Pasadena California 91105 Not yet recruiting
Local Institution - 2614 San Diego California 92108 Not yet recruiting
Local Institution - 2620 West Hills California 91307 Completed
Local Institution - 2601 Basalt Colorado 81621 Withdrawn
Local Institution - 2632 Norwalk Connecticut 06851 Not yet recruiting
Local Institution - 2648 Aventura Florida 33180 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
Miami Jewish health Miami Florida 33137 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
Local Institution - 2618 Ann Arbor Michigan 48105 Completed
Local Institution - 2630 Saint Paul Minnesota 55130 Not yet recruiting
Hattiesburg Clinic Hattiesburg Mississippi 39402 Recruiting
Local Institution - 2603 Ozark Missouri 65721 Completed
Las Vegas Clinical Trials Las Vegas Nevada 89030 Recruiting
Local Institution - 2650 Toms River New Jersey 08755 Not yet recruiting
Local Institution - 2647 Brooklyn New York 11229 Not yet recruiting
Richmond Behavioral Associates Staten Island New York 10312 Recruiting
Walnut Clinical Research Valley Stream New York 11580 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 77429 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
EvergreenHealth Medical Center Kirkland Washington 98034 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 Aug 25, 2026 · Synced Sep 2, 2026

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Open the official record

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

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