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

Sex: All

Ages: 55 Years – 90 Years

Healthy volunteers: No

Phase: PHASE3

Enrollment: 650

Sponsor: Bristol-Myers Squibb

Summary

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.

Eligibility 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06937229). StuddyBuddy aggregates publicly available trial information.