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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 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Placebo
- DRUG Xanomeline/Trospium Chloride Capsule
- DRUG Xanomeline Enteric Capsule
Study Locations (20)
Florida
- Local Institution - 1622 — Maitland
- Local Institution - 1631 — Maitland
- Local Institution - 1602 — Miami
- Local Institution - 1618 — Miami
- Hope Research Network - Miami — Miami
- Nuovida Research Center — Miami
- Local Institution - 1608 — Ocala
- Combined Research Orlando (CRO) — Orlando
- Progressive Medical Research — Port Orange
California
- Advanced Research Center (ARC) - Anaheim — Anaheim
- Kaizen Brain Center — La Jolla
- The Neurology Group — Pomona
- Torrance Clinical Research — Torrance
- Sunwise Clinical Research — Walnut Creek
Arizona
- Imaging Endpoints — Scottsdale
Colorado
- Local Institution - 1630 — Colorado Springs
Georgia
- Local Institution - 1661 — Savannah
Louisiana
- Local Institution - 1655 — Marrero
Maryland
- CBH Health — Gaithersburg
Massachusetts
- Local Institution - 1663 — Foxborough
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2025-07-10 |
| Est. Completion | 2028-12-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07011732
The ClinicalTrials.gov registry entry for NCT07011732 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 352 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07011732 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07011732 about?
NCT07011732 is a clinical study titled "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)". 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.
What is the current status of trial NCT07011732?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 352 participants. The study started on 2025-07-10. Estimated completion is 2028-12-08.
What conditions does trial NCT07011732 study?
This clinical trial studies the following conditions: Alzheimer Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07011732?
The interventions under investigation include: Placebo (DRUG), Xanomeline/Trospium Chloride Capsule (DRUG), Xanomeline Enteric Capsule (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07011732?
This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07011732 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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