Alzheimer Disease, Psychosis
Conditions
Keywords
Alzheimer disease, Alzheimer's disease, Alzheimer's, Dementia, Psychosis, Alzheimer's disease psychosis, Alzheimer's disease psychosis with or without agitation
Brief summary
The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
Interventions
DRUGKarXT
Specified dose on specified days
DRUGKarX-EC
Specified dose on specified days
DRUGKarXT + KarX-EC Arm Matching Placebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score | Up to approximately Week 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score | Up to approximately Week 14 | — |
| Change From Baseline in Neuropsychiatric Inventory-Clinician Rating Scale (NPI-C) Core Score | Up to approximately Week 14 | NPI-C Core Score includes assessment for hallucinations, delusions, agitation, and aggression domains |
| Change From Baseline in NPI-C: Agitation Score | Up to approximately Week 14 | — |
| Change From Baseline in NPI-C Core Score: Caregiver Distress Scale | Up to approximately Week 14 | NPI-C Core Score: Caregiver Distress Scale includes assessment for hallucinations, delusions, agitation, and aggression domains |
| Responder Rate | Up to approximately Week 14 | Responder rate is defined as improvement from baseline in NPI-C: H+D score ≥ 40%. |
| Change From Baseline in Cohen-Mansfield Agitation Inventory International Psychogeriatric Association (CMAI-IPA) Score | Up to approximately Week 14 | — |
| Change From Baseline in CMAI Total Score | Up to approximately Week 14 | — |
| Number of Participants With Adverse Events (AEs) | Up to approximately Week 14 | — |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to approximately Week 14 | — |
| Number of Participants With Serious Adverse Events (SAEs) | Up to approximately Week 14 | — |
| Number of Participants With TEAEs Leading to Discontinuation | Up to approximately Week 14 | — |
| Number of Participants With Spontaneously Reported Procholinergic Symptoms | Up to approximately Week 14 | Procholinergic symptoms include nausea, vomiting, and diarrhea. |
| Number of Participants With Spontaneously Reported Anticholinergic Symptoms | Up to approximately Week 14 | Anticholinergic symptoms include dry mouth, constipation, urinary retention and blurred vision. |
| Number of Participants With AEs of Special Interest (AESIs) | Up to approximately Week 14 | AESIs such as symptomatic orthostasis, syncope, urinary adverse events, and elevated liver enzymes will be evaluated. |
| Barnes Akathisia Rating Scale (BARS) Score | Up to approximately Week 14 | — |
| Abnormal Involuntary Movement Scale (AIMS) Score | Up to approximately Week 14 | — |
| International Prostate Symptom Score (IPSS) | Up to approximately Week 14 | This will be measured in males only. |
| Body Weight | Up to approximately Week 14 | — |
| Body Mass Index (BMI) | Up to approximately Week 14 | — |
| Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP) | Up to approximately Week 14 | This includes measuring of BP, supine or sitting and then standing after approximately 2 minutes, no later than approximately 3 minutes. |
| Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Heart Rate (HR) | Up to approximately Week 14 | This includes measuring of HR, supine or sitting and then standing after approximately 2 minutes, no later than approximately 3 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 14 | — |
| 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 | — |
Countries
Australia, Canada, Japan, United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed