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  • NCT06937229

Not Yet Recruiting

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) - CN012-0025

Updated: 27 May, 2025   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.
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Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 55-90

    Age Range

  • 92

    Location(s)

  • Not Yet Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: KarXT+KarX-EC
Drug: KarXT, KarX-EC

Key Eligibility Criteria

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

If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information

466-DK-2200001