Psychosis Associated with Alzheimer's Disease
Conditions
Interventions
KarXT Arm:Specified dose on specified days
Placebo:Specified dose on specified days
Sponsors
Marcus Ronald
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1). -Patients who are diagnosed with possible AD or probable AD (refer to the appendix for the National Institute on Aging - Alzheimer's Association Guidelines for All-cause Dementia and Alzheimer's Disease). -Patient 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. -Patient 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
Exclusion criteria: -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. -History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder. -Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score. (Up to Week 14) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change from baseline in Cohen- Mansfield Agitation Inventory (CMAI) total score. (Up to Week 14) - Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale. (Up to Week 14) - Change from baseline in Neuropsychiatric Inventory-Clinician (NPI-C) Core score: Hallucination Domain. (Up to Week 14) - Change from baseline in NPI-C Core score: Delusion Domain. (Up to Week 14) - Change from baseline in NPI-C Core score: Agitation Domain. (Up to Week 14) - Change from baseline in NPI-C Core score: Aggression Domain. (Up to Week 14) - Change from baseline in NPI-C Agitation score. (Up to Week 14) - Change from baseline in NPI-C Core score: Caregiver Distress Scale. (Up to Week 14) - Number of participants with a >= 40% improvement from Baseline in NPI-C: H+D score. (Up to Week 14) - Number of participants with Adverse Events (AEs). (Up to Week 14) - Number of participants with Treatment-Emergent Adverse Events (TEAEs). (Up to Week 14) - Number of participants with Serious Adverse Events (SAEs). (Up to Week 14) - Number of participants with TEAEs leading to study withdrawal. (Up to Week 14) - Number of participants with procholinergic symptoms. (Up to Week 14) - Number of participants with anticholinergic symptoms. (Up to Week 14) - Number of participants with AEs of Special Interest (AESIs). (Up to Week 14) - Barnes Akathisia Rating Scale (BARS) Score. (Up to Week 14) - Abnormal Involuntary Movement Scale (AIMS) Score. (Up to Week 14) - Body Weight. (Up to Week 14) - Body Mass Index (BMI). (Up to Week 14) - Number of participants with vital sign abnormalities. (Up to Week 14) - Number of participants with clinical laboratory abnormalities. (Up to Week 14) - Number of participants with 12-lead electrocardiogram (ECG) abnormalities. (Up to Week 14) - Number of participants with suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). (Up to Week 14) - Cognition as assessed by the Mini-Mental State Examination (MMSE). (Up to Week 1 | — |
Countries
Belgium, Bulgaria, Croatia, Czech Republic, Germany, Hungary, Italy, Japan, Poland, Portugal, Serbia, Slovakia, Spain, United Kingdom, United States
Contacts
Public ContactRonald Marcus
Bristol-Myers Squibb
Outcome results
None listed