Phase
Condition
Schizophrenia And Schizoaffective Disorders (Pediatric)
Schizotypal Personality Disorder (Spd)
Psychosis
Treatment
KarX-EC
KarXT + KarX-EC Arm Matching Placebo
KarXT
Clinical Study ID
Ages 55-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 2024NIA-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 orsubsequent 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 InternationalPsychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).
Exclusion
Exclusion Criteria:
Participants must not have psychotic symptoms that are primarily attributable to acondition other than the AD causing the dementia, eg, schizophrenia, schizoaffectivedisorder, delusional disorder, or mood disorder with psychotic features.
Participants must not have history of major depressive episode with psychoticfeatures 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 laboratorytest irregularities.
Other protocol-defined Inclusion/Exclusion criteria apply.