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NCT07011732 · ClinicalTrials.gov registry record · Phase 3

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)

A Phase 3 study of Alzheimer Disease, sponsored by Bristol-Myers Squibb.

Recruiting
Registry status
Phase 3
Development phase
352
Enrollment target
20
Study locations

NCT07011732 is a Phase 3 study of Alzheimer Disease that is actively recruiting participants, run by Bristol-Myers Squibb. The registered enrollment target is 352 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT07011732, a Phase 3 study of Alzheimer Disease, is actively recruiting participants, sponsored by Bristol-Myers Squibb.

RECRUITING
Registry status
Phase 3
Development phase
352 participants
Enrollment target
20
Study locations

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

Alzheimer Disease

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

FieldValue
Enrollment Target 352 participants
Start Date 2025-07-10
Est. Completion 2028-12-08
Phase Phase 3

Sponsor

Bristol-Myers Squibb

1,025 total trials

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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, categorized as Phase 3. The registered enrollment target is 352 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (87% lower). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

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.

NCT07011732 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Arizona.

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.

What interventions are being tested in trial NCT07011732?

The interventions under investigation include: Placebo (DRUG), Xanomeline/Trospium Chloride Capsule (DRUG), Xanomeline Enteric Capsule (DRUG).

Who is sponsoring clinical trial NCT07011732?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.