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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 3Sponsored by Bristol-Myers Squibb
Actively Recruiting
PhasePhase 3
SponsorBristol-Myers Squibb
Started2025-12-02
Est. completion2029-06-22
Eligibility
Age55 Years – 90 Years
Healthy vol.Accepted
Locations47 sites
View on ClinicalTrials.gov →
NCT06937229
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
Age: 55 Years – 90 YearsHealthy volunteers accepted
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.
Conditions3
AgitationAlzheimer DiseaseAlzheimer's Disease
Interventions2
Locations47 sites
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Related trials
- A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5) — Bristol-Myers Squibb
- A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2) — Bristol-Myers Squibb
- A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease — Bristol-Myers Squibb
- A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1) — Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3) — Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2) — Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) — Karuna Therapeutics, Inc., a Bristol Myers Squibb company
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Actively Recruiting
PhasePhase 3
SponsorBristol-Myers Squibb
Started2025-12-02
Est. completion2029-06-22
Eligibility
Age55 Years – 90 Years
Healthy vol.Accepted
Locations47 sites
View on ClinicalTrials.gov →
NCT06937229