A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)

Phase 3

Recruiting

• Conditions: Alzheimer Disease
• Interventions: Drug: Xanomeline/Trospium Chloride Capsule; Drug: Placebo; Drug: Xanomeline Enteric Capsule

• Registration Number: NCT07011745
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-06-02
• Study First Posted: 2025-06-10
• Study Start: 2025-07-16
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-07
• Last Update Posted: 2025-10-09
• Primary Completion: 2028-11-03
• Study Completion: 2028-11-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KarXT + KarX-EC	Xanomeline/Trospium Chloride Capsule	-
KarXT + KarX-EC	Xanomeline Enteric Capsule	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score at Week 14	At Week 14

Secondary Outcome Measures

Name	Time	Method
Number of participants with Occurrence of Response at Week 14	At Week 14	As determined by CMAI-IPA changes of 30%, 40%, and 50% from baseline
Mean change from baseline on the Neuropsychiatric Inventory/Neuropsychiatric Inventory -Nursing Home (NPI/NPI-NH) Total Score at Week 14	At Week 14
Number of participants with Adverse Events (AEs)	Up to Week 18
Number of participants with Treatment Emergent AEs (TEAEs)	Up to Week 18
Number of participants with suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to Week 18
Mean change from baseline on the Clinical Global Impressions-Severity (CGI-S) at Week 14	At Week 14
Mean change from baseline on the CMAI-IPA Domains at Week 14	At Week 14
Mean change from baseline on the CMAI Total Score at Week 14	At Week 14
Number of participants with Serious AEs (SAEs)	Up to Week 18
Number of participants with AEs leading to study drug withdrawal	Up to Week 18
Number of deaths	Up to Week 18
Number of participants with AEs of Special Interest (AESIs)	Up to Week 18
Barnes Akathisia Rating Scale (BARS)	Up to Week 18
Abnormal Involuntary Movement Scale (AIMS)	Up to Week 18
Body Weight	Up to Week 18
Body Mass Index (BMI)	Up to Week 18
Number of participants with vital sign abnormalities	Up to Week 18
Number of participants with clinical laboratory abnormalities	Up to Week 18
Number of participants with electrocardiogram (ECG) abnormalities	Up to Week 18
Severity of benign prostatic hyperplasia in male participants as assessed by International Prostate Symptom Score (IPSS)	Up to Week 18

Trial Locations

Locations (137)

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

Local Institution - 2631; 🇺🇸 Chandler, Arizona, United States

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

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

Local Institution - 2627; 🇺🇸 Napa, California, United States

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

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

Alliance Clinical -West Hills; 🇺🇸 West Hills, California, United States

Local Institution - 2601; 🇺🇸 Basalt, Colorado, United States

Local Institution - 2635; 🇺🇸 Colorado Springs, Colorado, United States

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