RecruitingPhase 3

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

A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)

Lead sponsor

Bristol-Myers Squibb

Assets

Xanomeline / Xanomeline / trospium

Listed sites

256

Recruiting sites

Enrollment

650

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Treatment Emergent Adverse Events (TEAEs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Secondary ID2024-519994-20EU CTR

Org study IDCN012-0025

NCT IDNCT06937229

Secondary IDU1111-1316-3903WHO

Timeline

Milestones

Study first posted2025-04-22actual

Study start2025-12-02actual

Last update posted2026-07-01actual

Primary completion2029-06-22estimated

Study completion2029-07-20estimated

Assets

Drug assets

Xanomeline Xanomeline / trospium

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

Global cognition

Other clinical outcomes

Global cognition

2 endpoints

Secondary/protocol endpoint

Number of Participants With Cognitive Impairment as Assessed by Mini-mental State Examination (MMSE)

Time frame:Up to approximately Week 26

Mini-Mental State Examination (MMSE)

event count, event

Secondary/protocol endpoint

Number of Participants With Cognitive Impairment as Assessed by 13-item Variation of ADAS-Cog Scale (ADAS-Cog-13)

Time frame:Up to approximately Week 26

ADAS-Cog

event count, event

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame:Up to approximately Week 30

event count, event

Secondary/protocol endpoint

Number of Participants With Adverse Events (AEs)

Time frame:Up to approximately Week 30

event count, event

Secondary/protocol endpoint

Number of Participants with Adverse Events of Special Interest (AESI)

Time frame:Up to approximately Week 30

event count, event

Secondary/protocol endpoint

Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Heart Rate (HR)

Time frame:Up to approximately Week 30

event count, event

Secondary/protocol endpoint

Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP)

Time frame:Up to approximately Week 30

event count, event

Secondary/protocol endpoint

Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)

Time frame:Up to approximately Week 26

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Number of Participants With TEAEs Leading to Death

Time frame:Up to approximately Week 30

event count, event

Other (unclassified)

9 endpoints

Secondary/protocol endpoint/low confidence

Number of Participants With Serious AEs (SAEs)

Time frame:Up to approximately Week 30

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants With TEAEs Leading to Study Withdrawal

Time frame:Up to approximately Week 30

event count, event

Secondary/protocol endpoint/low confidence

Change From Baseline in Barnes Akathisia Rating Scale (BARS)

Time frame:Up to approximately Week 26

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)

Time frame:Up to approximately Week 26

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Body Weight

Time frame:Up to approximately Week 26

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Body Mass Index (BMI)

Time frame:Up to approximately Week 26

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of Participants With Clinically Significant Changes in Laboratory Evaluations

Time frame:Up to approximately Week 30

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants With Suicidal Ideations as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame:Up to approximately Week 30

event count, event

Secondary/protocol endpoint/low confidence

Change From Baseline in the Severity of Benign Prostatic Hyperplasia as Assessed by International Prostate Symptom Score (IPSS)

Time frame:Up to approximately Week 26

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.