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NCT06937229 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

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

Recruiting
Registry status
Phase 3
Development phase
600
Enrollment target
20
Study locations

NCT06937229 is a Phase 3 study of Alzheimer Disease and Agitation that is actively recruiting participants, run by Bristol-Myers Squibb. The registered enrollment target is 600 participants, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 3 states.

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The verdict

NCT06937229, a Phase 3 study of Alzheimer Disease and Agitation, is actively recruiting participants, sponsored by Bristol-Myers Squibb.

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

Study Summary

The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.

Conditions Studied

Alzheimer Disease Agitation

Interventions

  • DRUG KarXT
  • DRUG KarX-EC

Study Locations (20)

California

  • Local Institution - 1657 - Anaheim
  • Local Institution - 2620 - Canoga Park
  • Local Institution - 1637 - La Jolla
  • Local Institution - 2625 - Long Beach
  • Local Institution - 2607 - Long Beach
  • Local Institution - 2642 - Long Beach
  • Local Institution - 2613 - Pasadena
  • Local Institution - 1662 - Pomona
  • Local Institution - 2614 - San Diego
  • Local Institution - 1651 - Walnut Creek

Florida

  • Local Institution - 2602 - Bonita Springs
  • Local Institution - 2626 - Hialeah
  • Local Institution - 1602 - Miami
  • Local Institution - 1618 - Miami
  • Local Institution - 1609 - Miami
  • Nuovida Research Center - Miami
  • Local Institution - 1635 - Orlando
  • Progressive Medical Research - Port Orange

Arizona

  • Local Institution - 2609 - Chandler
  • Imaging Endpoints - Scottsdale

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2025-12-02
Est. Completion 2029-07-20
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 NCT06937229

The ClinicalTrials.gov registry entry for NCT06937229 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (78% lower). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which KarXT is the first listed.

NCT06937229 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT06937229 about?

NCT06937229 is a clinical study titled "A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)". The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who co...

What is the current status of trial NCT06937229?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2025-12-02. Estimated completion is 2029-07-20.

What conditions does trial NCT06937229 study?

This clinical trial studies the following conditions: Alzheimer Disease, Agitation.

What interventions are being tested in trial NCT06937229?

The interventions under investigation include: KarXT (DRUG), KarX-EC (DRUG).

Who is sponsoring clinical trial NCT06937229?

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

Where is trial NCT06937229 being conducted?

This trial has 20 study locations across Arizona, California, Florida. 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.