The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.
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).
None
Parallel
KarXT
DrugSpecified dose on specified days
Placebo
DrugSpecified dose on specified days
Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale
Change from baseline in Neuropsychiatric Inventory-Clinician (NPI-C) Core score: Hallucination Domain
Change from baseline in NPI-C Core score: Delusion Domain
Change from baseline in NPI-C Core score: Agitation Domain
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