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

Bristol-Myers Squibb (BMS)

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Alzheimer Disease; Psychosis

Treatments: Drug: KarXT + KarX-EC Arm Matching Placebo; Drug: KarXT; Drug: KarX-EC

Study type: Interventional

Funder types: Industry

Identifiers

NCT06947941

CN012-0034

Details and patient eligibility

About

The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.

Enrollment: 1,046 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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 NIA-AA criteria.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,046 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: KarXT + KarX-EC Arm Matching Placebo

KarXT + KarX-EC Arm

Experimental group

Treatment:

Drug: KarX-EC

Drug: KarXT