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

Phase 3RecruitingNCT06947941

Bristol-Myers Squibb325 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

325

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 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.

Locations (22)

Gilbert Neurology Partners/CCT Research

Gilbert, Arizona, United States

Outcomes

Primary Outcomes

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

Time frame: Up to approximately Week 14

Secondary Outcomes

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

Time frame: Up to approximately Week 14

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 approximately Week 14

Change From Baseline in NPI-C: Agitation Score

Time frame: Up to approximately Week 14

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 approximately Week 14

Responder Rate

Responder rate is defined as improvement from baseline in NPI-C: H+D score ≥ 40%.

Time frame: Up to approximately Week 14

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

Time frame: Up to approximately Week 14

Change From Baseline in CMAI Total Score

Time frame: Up to approximately Week 14

Number of Participants With Adverse Events (AEs)

Central Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com

CONTACT

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

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

CONTACT

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Inland Psychiatric Medical Group.

Chino, California, United States

RECRUITING

Local Institution - 0001

Naples, Florida, United States

WITHDRAWN

Local Institution - 1401

Naples, Florida, United States

NOT_YET_RECRUITING

Local Institution - 0029

Cleveland, Ohio, United States

NOT_YET_RECRUITING

Local Institution - 0043

Shaker Heights, Ohio, United States

NOT_YET_RECRUITING

Local Institution - 0020

Macquarie Park, New South Wales, Australia

NOT_YET_RECRUITING

Local Institution - 0052

Nedlands, Western Australia, Australia

NOT_YET_RECRUITING

Local Institution - 0054

Toronto, Ontario, Canada

NOT_YET_RECRUITING

Local Institution - 0027

Whitby, Ontario, Canada

NOT_YET_RECRUITING

...and 12 more locations

Time frame: Up to approximately Week 14

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame: Up to approximately Week 14

Number of Participants With Serious Adverse Events (SAEs)

Time frame: Up to approximately Week 14

Number of Participants With TEAEs Leading to Discontinuation

Time frame: Up to approximately Week 14

Number of Participants With Spontaneously Reported Procholinergic Symptoms

Procholinergic symptoms include nausea, vomiting, and diarrhea.

Time frame: Up to approximately Week 14

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 14

Number of Participants With AEs of Special Interest (AESIs)

AESIs such as symptomatic orthostasis, syncope, urinary adverse events, and elevated liver enzymes will be evaluated.

Time frame: Up to approximately Week 14

Barnes Akathisia Rating Scale (BARS) Score

Time frame: Up to approximately Week 14

Abnormal Involuntary Movement Scale (AIMS) Score

Time frame: Up to approximately Week 14

International Prostate Symptom Score (IPSS)

This will be measured in males only.

Time frame: Up to approximately Week 14

Body Weight

Time frame: Up to approximately Week 14

Body Mass Index (BMI)

Time frame: Up to approximately Week 14

Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP)

This includes measuring of BP, supine or sitting and then standing after approximately 2 minutes, no later than approximately 3 minutes.

Time frame: Up to approximately Week 14

Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Heart Rate (HR)

This includes measuring of HR, supine or sitting and then standing after approximately 2 minutes, no later than approximately 3 minutes.

Time frame: Up to approximately Week 14

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

Time frame: Up to approximately Week 14

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

Time frame: Up to approximately Week 14

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

Time frame: Up to approximately Week 14

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

Time frame: Up to approximately Week 14

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

Time frame: Up to approximately Week 14

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

Time frame: Up to approximately Week 14

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

Time frame: Up to approximately Week 14

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

Number of Participants With Cognitive Impairment as Assessed by Mini-mental State Examination (MMSE)

Time frame: Up to approximately Week 14

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