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)
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.
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
- NCT07011732
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Bristol-Myers Squibb
- Industry
- Enrollment
- 352 participants
Conditions and interventions
Conditions
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 9, 2025
- Primary completion
- Nov 23, 2028
- Completion
- Dec 7, 2028
- Last update posted
- Apr 29, 2026
2025 – 2028
United States locations
- U.S. sites
- 40
- U.S. states
- 19
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Imaging Endpoints | Scottsdale | Arizona | 85258 | Recruiting |
| Advanced Research Center (ARC) - Anaheim | Anaheim | California | 92805 | Recruiting |
| Kaizen Brain Center | La Jolla | California | 92037 | Recruiting |
| The Neurology Group | Pomona | California | 91767 | Recruiting |
| Torrance Clinical Research | Torrance | California | 90505 | 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| Local Institution - 1630 | Colorado Springs | Colorado | 80907 | Withdrawn |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 - 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 | Active, not recruiting |
| 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 - 1661 | Savannah | Georgia | 31406 | Not yet 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 |
| Local Institution - 1665 | Bloomfield Hills | Michigan | 48302 | Not yet recruiting |
| Oakland Medical Research | Troy | Michigan | 48085 | Recruiting |
| Redbird Research | Las Vegas | Nevada | 89119 | Recruiting |
| Patient First MD | Middletown | New Jersey | 07748 | Recruiting |
| Local Institution - 1664 | Princeton | New Jersey | 08540 | Not yet 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 |
| Local Institution - 1659 | Centerville | Ohio | 45459 | Not yet recruiting |
| 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 112 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 Apr 29, 2026 · Synced May 8, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07011732 live on ClinicalTrials.gov.