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RecruitingPhase 3

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

Bristol-Myers Squibb · NCT06937229

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55–90 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
650
US sites recruiting
11
Study start
December 2, 2025
Record last updated
October 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: KarXT; KarX-EC

Conditions: Alzheimer Disease; Agitation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Participants must have completed study CN012-0023 or CN012-0024 per protocol.
  • Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).

Exclusion Criteria

  • Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Recruiting US locations

  • Imaging Endpoints

    Scottsdale, AZ 85258

    Site contact: Nida Laurin, Site 1619 · 480-290-1547

  • Nuovida Research Center

    Miami, FL 33186

    Site contact: Jorge Betancourt, MD, Site 1604 · 786-616-9853

  • Progressive Medical Research

    Port Orange, FL 32127

    Site contact: Alexander White, Site 1612 · 386-304-7070

  • IPTB Clinical Research

    Tampa, FL 33629

    Site contact: Jamie Fernandez, Site 2621 · 813-251-1800

  • Hope Research Network - Miami

    Virginia Gardens, FL 33166

    Site contact: Jorge Jorge, Site 1609 · 786-681-4959

  • Boston Center for Memory

    Newton, MA 02459

    Site contact: Paul Solomon, Site 1638 · 413-281-0577

  • Redbird Research

    Las Vegas, NV 89119

    Site contact: Jelena Kunovac, Site 1649 · 760-758-2222

  • West Clinical Research

    Morehead City, NC 28557

    Site contact: Patrick Morgante, Site 2608 · 252-515-0050

  • Epic Medical Research, LLC - Carrolton

    Carrollton, TX 75006

    Site contact: Andrea Brown, Site 2616 · 972-782-2405

  • Horizon Clinical Research Center - Houston

    Cypress, TX 77429

    Site contact: Harpaul Gill, Site 2605 · 949-491-0710

  • Advanced Neurology Epilepsy and Sleep Center

    El Paso, TX 79902

    Site contact: Aamr Herekar, Site 1643 · 505-903-1715

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.
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A Study to Evaluate the Long-term Efficacy and Safety of KarXT +… (NCT06937229) | Bored Studies