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NCT Number: NCT06937229

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 completed the parent studies CN012-0023 or CN012-0024.

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Key information

Conditions

Alzheimer Disease Aberrant Motor Behavior in Dementia Agitation Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms Tauopathies

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 2005, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KarXT

Drug

Specified dose on specified days

Other names: Xanomeline and Trospium Chloride capsule, BMS-986510

KarX-EC

Drug

Specified dose on specified days

Other names: Xanomeline enteric capsules, BMS-986519

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately Week 30

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Up to approximately Week 30

  2. Number of Participants With Serious AEs (SAEs)

    Time frame: Up to approximately Week 30

  3. Number of Participants With TEAEs Leading to Study Withdrawal

    Time frame: Up to approximately Week 30

  4. Number of Participants With TEAEs Leading to Death

    Time frame: Up to approximately Week 30

  5. Number of Participants with Adverse Events of Special Interest (AESI)

    Time frame: Up to approximately Week 30

  6. Change From Baseline in Barnes Akathisia Rating Scale (BARS)

    Time frame: Up to approximately Week 26

  7. Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)

    Time frame: Up to approximately Week 26

  8. Change From Baseline in Body Weight

    Time frame: Up to approximately Week 26

  9. Change From Baseline in Body Mass Index (BMI)

    Time frame: Up to approximately Week 26

  10. Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Heart Rate (HR)

    Time frame: Up to approximately Week 30

    This includes measuring of HR, both supine and standing or seated and upon standing after 2 minutes.

  11. Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP)

    Time frame: Up to approximately Week 30

    This includes measuring of systolic and diastolic BP, both supine and standing or seated and upon standing after 2 minutes.

  12. Number of Participants With Clinically Significant Changes in Laboratory Evaluations

    Time frame: Up to approximately Week 30

  13. Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)

    Time frame: Up to approximately Week 26

  14. Number of Participants With Suicidal Ideations as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to approximately Week 30

  15. Number of Participants With Cognitive Impairment as Assessed by Mini-mental State Examination (MMSE)

    Time frame: Up to approximately Week 26

  16. Number of Participants With Cognitive Impairment as Assessed by 13-item Variation of ADAS-Cog Scale (ADAS-Cog-13)

    Time frame: Up to approximately Week 26

  17. Change From Baseline in the Severity of Benign Prostatic Hyperplasia as Assessed by International Prostate Symptom Score (IPSS)

    Time frame: Up to approximately Week 26

    This analysis is done in male participants.

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 22, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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