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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-1)

ClinicalTrials.gov ID: NCT07011732

Public ClinicalTrials.gov record NCT07011732. 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

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
NCT07011732
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 9, 2025
Primary completion
Nov 23, 2028
Completion
Dec 7, 2028
Last update posted
Aug 10, 2026

2025 – 2028

United States locations

U.S. sites
39
U.S. states
17
U.S. cities
34
Facility City State ZIP Site status
Imaging Endpoints Scottsdale Arizona 85258 Recruiting
Advanced Research Center (ARC) - Anaheim Anaheim California 92805 Recruiting
Local Institution - 1637 La Jolla California 92037 Completed
The Neurology Group Pomona California 91767 Recruiting
Local Institution - 1639 Torrance California 90505 Active, not recruiting
Sunwise Clinical Research Walnut Creek California 94596 Recruiting
Local Institution - 1630 Colorado Springs Colorado 80907 Withdrawn
Local Institution - 1622 Maitland Florida 32751 Not yet recruiting
Local Institution - 1631 Maitland Florida 32751 Not yet recruiting
Local Institution - 1666 Merritt Island Florida 32952 Not yet recruiting
Local Institution - 1602 Miami Florida 33122 Not yet recruiting
Local Institution - 1618 Miami Florida 33135 Not yet recruiting
Hope Research Network - Miami Miami Florida 33166 Recruiting
Local Institution - 1604 Miami Florida 33186 Completed
Local Institution - 1608 Ocala Florida 34471 Not yet recruiting
Combined Research Orlando (CRO) Orlando Florida 32807 Recruiting
Progressive Medical Research Port Orange Florida 32127 Recruiting
Local Institution - 1655 Marrero Louisiana 70072 Not yet recruiting
CBH Health Gaithersburg Maryland 20877 Recruiting
Local Institution - 1663 Foxborough Massachusetts 02035-1309 Not yet recruiting
Boston Center for Memory Newton Massachusetts 02459 Recruiting
Mayflower Clinical Research South Dartmouth Massachusetts 02747 Recruiting
Elixia MA Springfield Massachusetts 01103 Recruiting
NeuroBehavioral Medicine Group Bloomfield Hills Michigan 48302 Recruiting
Oakland Medical Research Troy Michigan 48085 Recruiting
Redbird Research Las Vegas Nevada 89119 Recruiting
Local Institution - 1647 Middletown New Jersey 07748 Completed
Global Medical Institutes LLC; Princeton Medical Institute Princeton New Jersey 08540 Recruiting
Local Institution - 1610 Inwood New York 11096 Not yet recruiting
Mid Hudson Medical Research New Windsor New York 12553 Recruiting
Five Towns Neurology PC -Woodmere - 923 Broadway Woodmere New York 11598-1739 Recruiting
Local Institution - 1645 Woodmere New York 11598-1739 Withdrawn
Central States Research Tulsa Oklahoma 74136 Recruiting
Local Institution - 1652 Columbia South Carolina 29205 Withdrawn
Advanced Neurology Epilepsy and Sleep Center El Paso Texas 79912 Recruiting
Wasatch Clinical Research, LLC Salt Lake City Utah 84107 Recruiting
The Memory Clinic Bennington Vermont 05201-9810 Recruiting
Local Institution - 1644 Seattle Washington 98122 Not yet recruiting
Kingfisher Cooperative Spokane Washington 99201 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 115 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07011732, 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 10, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07011732 live on ClinicalTrials.gov.

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