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

RecruitingPhase 3Ages 55 Years - 90 YearsAllBristol-Myers Squibb
NCT06937229 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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.
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What it tests

  • KarXT
  • KarX-EC
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Where

252 sites
Local Institution - 2609
Chandler, United States
Imaging Endpoints
Scottsdale, United States
Local Institution - 1657
Anaheim, United States
Local Institution - 1668
Fresno, United States
Local Institution - 2625
Long Beach, United States
Local Institution - 2642
Long Beach, United States
Local Institution - 2649
Orange, United States
Local Institution - 2613
Pasadena, United States

…and 244 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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