RecruitingPhase 3

A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Psychosis Associated With Alzheimer's Disease

Lead sponsor

Bristol-Myers Squibb

Assets

Xanomeline / Xanomeline / trospium

Listed sites

Recruiting sites

Enrollment

325

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Neuropsychiatric Inventory (NPI)

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 ID2025-521057-16EU CTR

Org study IDCN012-0034

NCT IDNCT06947941

Secondary IDU1111-1318-5718WHO

Timeline

Milestones

Study first posted2025-04-27actual

Study start2026-03-25actual

Last update posted2026-06-30actual

Primary completion2028-02-21estimated

Study completion2028-03-20estimated

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 be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).

•Participants must be diagnosed with Alzheimer's disease in accordance with the 2024 revised criteria for diagnosis and staging of Alzheimer's Disease: Alzheimer's Association Workgroup.

•Participants must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma.

•Participants must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation)

Exclusion criteria

•Participants must not have psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.

•Participants must not have history of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.

•Participants must not have certain safety concerns, including certain laboratory test irregularities.

•Other protocol-defined Inclusion/Exclusion criteria apply.

Endpoints (32)

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)

Behavior / neuropsychiatric

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 14

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 14

ADAS-Cog

event count, event

Behavior / neuropsychiatric

8 endpoints

Primary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score

Time frame:Up to approximately Week 14

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory-Clinician Rating Scale (NPI-C) Core Score

Time frame:Up to approximately Week 14

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI-C: Agitation Score

Time frame:Up to approximately Week 14

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in NPI-C Core Score: Caregiver Distress Scale

Time frame:Up to approximately Week 14

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Responder Rate

Time frame:Up to approximately Week 14

Neuropsychiatric Inventory (NPI)

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Cohen-Mansfield Agitation Inventory International Psychogeriatric Association (CMAI-IPA) Score

Time frame:Up to approximately Week 14

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CMAI Total Score

Time frame:Up to approximately Week 14

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Up to approximately Week 14

event count, event

Safety / tolerability / PK

7 endpoints

Secondary/protocol endpoint

Number of Participants With Adverse Events (AEs)

Time frame:Up to approximately Week 14

event count, event

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame:Up to approximately Week 14

event count, event

Secondary/protocol endpoint

Number of Participants With Serious Adverse Events (SAEs)

Time frame:Up to approximately Week 14

event count, event

Secondary/protocol endpoint

Number of Participants With AEs of Special Interest (AESIs)

Time frame:Up to approximately Week 14

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 14

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 14

event count, event

Secondary/protocol endpoint

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

Time frame:Up to approximately Week 14

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Number of Participants With Spontaneously Reported Anticholinergic Symptoms

Time frame:Up to approximately Week 14

event count, event

Other (unclassified)

14 endpoints

Secondary/protocol endpoint/low confidence

Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score

Time frame:Up to approximately Week 14

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of Participants With TEAEs Leading to Discontinuation

Time frame:Up to approximately Week 14

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants With Spontaneously Reported Procholinergic Symptoms

Time frame:Up to approximately Week 14

event count, event

Secondary/protocol endpoint/low confidence

Barnes Akathisia Rating Scale (BARS) Score

Time frame:Up to approximately Week 14

descriptive

Secondary/protocol endpoint/low confidence

Abnormal Involuntary Movement Scale (AIMS) Score

Time frame:Up to approximately Week 14

descriptive

Secondary/protocol endpoint/low confidence

International Prostate Symptom Score (IPSS)

Time frame:Up to approximately Week 14

descriptive

Secondary/protocol endpoint/low confidence

Body Weight

Time frame:Up to approximately Week 14

descriptive

Secondary/protocol endpoint/low confidence

Body Mass Index (BMI)

Time frame:Up to approximately Week 14

descriptive

Secondary/protocol endpoint/low confidence

Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Hematology

Time frame:Up to approximately Week 14

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Clinical Chemistry

Time frame:Up to approximately Week 14

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Coagulation Parameters

Time frame:Up to approximately Week 14

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Prolactin Levels

Time frame:Up to approximately Week 14

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Urinalysis

Time frame:Up to approximately Week 14

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Drug Screening

Time frame:Up to approximately Week 14

event count, event

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.