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RecruitingPhase 3

A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

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

Asset

Xanomeline / trospium

Listed sites

292

Recruiting sites

147

Enrollment

406

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 ID2024-516363-92EU CTR
Org study IDCN012-0056
NCT IDNCT06585787
Secondary IDU1111-1310-4139WHO

Timeline

Milestones

Study first posted2024-09-19actual
Study start2024-09-26actual
Last update posted2026-07-07actual
Primary completion2026-11-24estimated
Study completion2026-12-22estimated

Assets

Drug assets

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

•Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
•Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.
•Patient 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.
•Patient 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

- Patients will not be able to participate if they have:

i) 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.

ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.

iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.

* Other protocol-defined Inclusion/Exclusion criteria apply.

Endpoints (27)

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)
11
Behavior / neuropsychiatric
9
Safety / tolerability / PK
5
Global cognition
2

Global cognition

2 endpoints
Secondary/protocol endpoint

Cognition as assessed by the Mini-Mental State Examination (MMSE)

Time frame:Up to Week 14

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

Cognition as assessed by the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13)

Time frame:Up to Week 14

ADAS-Cog

descriptive

Behavior / neuropsychiatric

9 endpoints
Primary/protocol endpoint

Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score

Time frame:Up to Week 14

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Neuropsychiatric Inventory-Clinician (NPI-C) Core score: Hallucination Domain

Time frame:Up to Week 14

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in NPI-C Core score: Delusion Domain

Time frame:Up to Week 14

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in NPI-C Core score: Agitation Domain

Time frame:Up to Week 14

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in NPI-C Core score: Aggression Domain

Time frame:Up to Week 14

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in NPI-C Agitation score

Time frame:Up to 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 Week 14

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Number of participants with a ≥ 40% improvement from Baseline in NPI-C: H+D score

Time frame:Up to Week 14

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/protocol endpoint

Number of participants with suicidal ideation and behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

Time frame:Up to Week 14

event count, event

Safety / tolerability / PK

5 endpoints
Secondary/protocol endpoint

Number of participants with Adverse Events (AEs)

Time frame:Up to Week 14

event count, event

Secondary/protocol endpoint

Number of participants with Treatment-Emergent Adverse Events (TEAEs)

Time frame:Up to Week 14

event count, event

Secondary/protocol endpoint

Number of participants with Serious Adverse Events (SAEs)

Time frame:Up to Week 14

event count, event

Secondary/protocol endpoint

Number of participants with vital sign abnormalities

Time frame:Up to Week 14

event count, event

Secondary/protocol endpoint

Number of participants with 12-lead electrocardiogram (ECG) abnormalities

Time frame:Up to Week 14

event count, event

Other (unclassified)

11 endpoints
Secondary/protocol endpoint/low confidence

Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale

Time frame:Up to Week 14

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of participants with TEAEs leading to study withdrawal

Time frame:Up to Week 14

event count, event

Secondary/protocol endpoint/low confidence

Number of participants with procholinergic symptoms

Time frame:Up to Week 14

event count, event

Secondary/protocol endpoint/low confidence

Number of participants with anticholinergic symptoms

Time frame:Up to Week 14

event count, event

Secondary/protocol endpoint/low confidence

Number of participants with AEs of Special Interest (AESIs)

Time frame:Up to Week 14

event count, event

Secondary/protocol endpoint/low confidence

Barnes Akathisia Rating Scale (BARS) Score

Time frame:Up to Week 14

descriptive

Secondary/protocol endpoint/low confidence

Abnormal Involuntary Movement Scale (AIMS) Score

Time frame:Up to Week 14

descriptive

Secondary/protocol endpoint/low confidence

Body Weight

Time frame:Up to Week 14

descriptive

Secondary/protocol endpoint/low confidence

Body Mass Index (BMI)

Time frame:Up to Week 14

descriptive

Secondary/protocol endpoint/low confidence

Number of participants with clinical laboratory abnormalities

Time frame:Up to Week 14

event count, event

Secondary/protocol endpoint/low confidence

International Prostate Symptom Score (IPSS)

Time frame:Up to Week 14

descriptive

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.