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Trial ID CN012-0025  |   NCT06937229

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

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 55-90
    Age Range
  • 95
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

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 Eligibility Criteria

Inclusion Criteria

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:
  • Participants must have completed study CN012-0023 or CN012-0024 per protocol.
    1. Participants must have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more).

      Exclusion Criteria

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      :
      • 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.
        Additional Information *
        • Other protocol-defined Inclusion/Exclusion criteria apply.

          Treatment Options

          Study Arms

          ASSIGNED INTERVENTION

          Study Arms

          Experimental: KarXT+KarX-EC

          ASSIGNED INTERVENTION
          • Drug: KarXT, KarX-EC
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