A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
Phase 3
Not yet recruiting
- Conditions
- Alzheimer DiseasePsychosis
- Interventions
- Registration Number
- NCT06947941
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1046
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo KarXT + KarX-EC Arm Matching Placebo - KarXT + KarX-EC Arm KarXT - KarXT + KarX-EC Arm KarX-EC -
- Primary Outcome Measures
Name Time Method Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score Up to Week 12
- Secondary Outcome Measures
Name Time Method Number of Participants With AEs of Special Interest (AESIs) That Require Drug-induced Liver Injury (DILI) Monitoring Up to approximately Week 18 AESIs requiring DILI monitoring such as symptomatic orthostasis, syncope, and elevated liver enzymes will be evaluated.
Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score Up to approximately Week 14 Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score Up to approximately Week 14 Change From Baseline in International Prostate Symptom Score (IPSS) Up to approximately Week 14 This will be measured in males only.
Change From Baseline in Body Weight Up to approximately Week 14 Change From Baseline in Body Mass Index (BMI) Up to approximately Week 14 Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Heart Rate (HR) Up to approximately Week 14 This includes measuring of HR, both supine and standing or seated and upon standing after 2 minutes.
Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP) Up to approximately Week 14 This includes measuring of systolic and diastolic BP, both supine and standing or seated and upon standing after 2 minutes.
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Hematology Up to approximately Week 14 Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Clinical Chemistry Up to approximately Week 14 Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Coagulation Parameters Up to approximately Week 14 Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Prolactin Levels Up to approximately Week 14 Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Urinalysis Up to approximately Week 14 Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Drug Screening Up to approximately Week 14 Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Up to approximately Week 14 Number of Participants With Suicidal Ideations and Behavior as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS) Up to approximately Week 18 Number of Participants With Cognitive Impairment as Assessed by Mini-mental State Examination (MMSE) Up to approximately Week 14 Number of Participants With Cognitive Impairment as Assessed by 13-item Variation of ADAS-Cog Scale (ADAS-Cog-13) Up to approximately Week 14 Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score Up to Week 12 Change From Baseline in Neuropsychiatric Inventory-Clinician Rating Scale (NPI-C) Core Score Up to Week 12 NPI-C Core Score includes assessment for hallucinations, delusions, agitation, and aggression domains
Change From Baseline in NPI-C: Agitation Score Up to Week 12 Change From Baseline in NPI-C Core Score: Caregiver Distress Scale Up to Week 12 NPI-C Core Score: Caregiver Distress Scale includes assessment for hallucinations, delusions, agitation, and aggression domains
Responder Rate Up to Week 12 Responder rate is defined as improvement from baseline in NPI-C: H+D score ≥ 40% by the end of Week 12
Change From Baseline in Cohen-Mansfield Agitation Inventory International Psychogeriatric Association (CMAI-IPA) Score Up to Week 12 Change From Baseline in CMAI Total Score Up to Week 12 Number of Participants With Adverse Events (AEs) Up to approximately Week 18 Number of Participants With Serious Adverse Events (SAEs) Up to approximately Week 18 Number of Participants With Treatment Emergent Adverse Events (TEAEs) Up to approximately Week 18 Number of Participants With TEAEs Leading to Discontinuation Up to approximately Week 18 Number of Participants With Spontaneously Reported Procholinergic Symptoms Up to approximately Week 18 Procholinergic symptoms include nausea, vomiting, and diarrhea.
Number of Participants With Spontaneously Reported Anticholinergic Symptoms Up to approximately Week 18 Anticholinergic symptoms include dry mouth, constipation, urinary retention and blurred vision.