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

Phase 3

Not yet recruiting

• Conditions: Alzheimer Disease; Agitation
• Interventions: Drug: KarXT; Drug: KarX-EC

• Registration Number: NCT06937229
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-15
• Study First Posted: 2025-04-22
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-19
• Last Update Posted: 2025-08-20
• Study Start: 2025-11-21
• Primary Completion: 2029-06-22
• Study Completion: 2029-07-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KarXT+KarX-EC	KarXT	-
KarXT+KarX-EC	KarX-EC	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Up to approximately Week 30

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight	Up to approximately Week 26
Number of Participants With Suicidal Ideations as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to approximately Week 30
Number of Participants With Cognitive Impairment as Assessed by Mini-mental State Examination (MMSE)	Up to approximately Week 26
Number of Participants With Cognitive Impairment as Assessed by 13-item Variation of ADAS-Cog Scale (ADAS-Cog-13)	Up to approximately Week 26
Number of Participants With TEAEs Leading to Study Withdrawal	Up to approximately Week 30
Number of Participants With TEAEs Leading to Death	Up to approximately Week 30
Number of Participants with Adverse Events of Special Interest (AESI)	Up to approximately Week 30
Change From Baseline in Barnes Akathisia Rating Scale (BARS)	Up to approximately Week 26
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)	Up to approximately Week 26
Change From Baseline in Body Mass Index (BMI)	Up to approximately Week 26
Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Heart Rate (HR)	Up to approximately Week 30	This includes measuring of HR, both supine and standing or seated and upon standing after 2 minutes.
Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP)	Up to approximately Week 30	This includes measuring of systolic and diastolic BP, both supine and standing or seated and upon standing after 2 minutes.
Number of Participants With Clinically Significant Changes in Laboratory Evaluations	Up to approximately Week 30
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)	Up to approximately Week 26
Change From Baseline in the Severity of Benign Prostatic Hyperplasia as Assessed by International Prostate Symptom Score (IPSS)	Up to approximately Week 26	This analysis is done in male participants.
Number of Participants With Adverse Events (AEs)	Up to approximately Week 30
Number of Participants With TEAEs	Up to approximately Week 30
Number of Participants With Serious AEs (SAEs)	Up to approximately Week 30

Trial Locations

Locations (202)

Local Institution - 2609; 🇺🇸 Chandler, Arizona, United States

Local Institution - 1619; 🇺🇸 Scottsdale, Arizona, United States

Local Institution - 2620; 🇺🇸 Canoga Park, California, United States

Local Institution - 1637; 🇺🇸 La Jolla, California, United States

Local Institution - 2625; 🇺🇸 Long Beach, California, United States

Local Institution - 2607; 🇺🇸 Long Beach, California, United States

Local Institution - 2613; 🇺🇸 Pasadena, California, United States

Local Institution - 2614; 🇺🇸 San Diego, California, United States

Local Institution - 1651; 🇺🇸 Walnut Creek, California, United States

Local Institution - 2602; 🇺🇸 Bonita Springs, Florida, United States

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