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

Karuna Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Alzheimer Disease

Treatments: Drug: Placebo; Drug: KarXT

Study type: Interventional

Funder types: Industry

Identifiers

NCT06585787

CN012-0056

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

Enrollment: 406 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
• Patients who are diagnosed with possible AD or probable AD (refer to the appendix for the National Institute on Aging - Alzheimer's Association Guidelines for All-cause Dementia and Alzheimer's Disease).
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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406 participants in 2 patient groups

KarXT

Experimental group

Treatment:

Drug: KarXT

Placebo

Experimental group

Treatment:

Drug: Placebo