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

Phase 3Not Yet RecruitingNCT06947941

Bristol-Myers Squibb1,046 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,046

Conditions

Alzheimer Disease Psychosis

Interventions

KarXTDRUG

Specified dose on specified days

KarX-ECDRUG

Specified dose on specified days

KarXT + KarX-EC Arm Matching PlaceboDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 55 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Up to Week 12

Secondary Outcomes

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

Time frame: Up to Week 12

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

NPI-C Core Score includes assessment for hallucinations, delusions, agitation, and aggression domains

Time frame: Up to Week 12

Change From Baseline in NPI-C: Agitation Score

Time frame: Up to Week 12

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

NPI-C Core Score: Caregiver Distress Scale includes assessment for hallucinations, delusions, agitation, and aggression domains

Time frame: Up to Week 12

Responder Rate

Responder rate is defined as improvement from baseline in NPI-C: H+D score ≥ 40% by the end of Week 12

Time frame: Up to Week 12

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

Time frame: Up to Week 12

Change From Baseline in CMAI Total Score

Time frame: Up to Week 12

Number of Participants With Adverse Events (AEs)

Time frame: Up to approximately Week 18

Central Contacts

BMS Study Connect Contact Center, www.BMSStudyConnect.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain the NCT# and Site #.

CONTACT

Data from ClinicalTrials.gov

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Number of Participants With Serious Adverse Events (SAEs)

Time frame: Up to approximately Week 18

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame: Up to approximately Week 18

Number of Participants With TEAEs Leading to Discontinuation

Time frame: Up to approximately Week 18

Number of Participants With Spontaneously Reported Procholinergic Symptoms

Procholinergic symptoms include nausea, vomiting, and diarrhea.

Time frame: Up to approximately Week 18

Number of Participants With Spontaneously Reported Anticholinergic Symptoms

Anticholinergic symptoms include dry mouth, constipation, urinary retention and blurred vision.

Time frame: Up to approximately Week 18

Number of Participants With AEs of Special Interest (AESIs) That Require Drug-induced Liver Injury (DILI) Monitoring

AESIs requiring DILI monitoring such as symptomatic orthostasis, syncope, and elevated liver enzymes will be evaluated.

Time frame: Up to approximately Week 18

Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score