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

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. According to ClinicalTrials.gov, the official US trial registry.

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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
Bristol-Myers Squibb

1,025 total trials

What NCT06937229 shows while recruiting

NCT06937229 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (78% lower).

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 names 20 study sites across 3 states, led by 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.

Learn More About Clinical Trials

Similar trials for Alzheimer Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06937229's enrollment target sits among peer trials

600 46th of 306 higher than 259 of 306 other Alzheimer Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06937229

Source: ClinicalTrials.gov NCT06937229, the US trial registry maintained by the National Library of Medicine. NCT06937229 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.