This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease.
The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.
Is aged 55 to 90 years, inclusive, at Screening
Can understand the nature of the study and protocol requirements and provide a signed informed consent form before any study assessments are performed. If the subject is deemed not competent to provide consent, the following requirements for consent must be met.
Meets clinical criteria for possible or probable Alzheimer's Disease
Has 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. If not available, a non-contrast brain MRI or non-contrast head CT must be done during screening.
Psychotic symptoms that are primarily attributable to a condition other than the Alzheimer's Disease causing dementia
History of major depressive episode with psychotic features during the 12 months prior to Screening
History of a diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular or oncologic disease, or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results
Single group
KarXT
DrugKarXT 20 mg/2 mg TID KarXT 30 mg/3 mg TID KarXT 40 mg/4 mg TID KarXT 50 mg/5 mg TID KarXT 66.7/6.67 mg TID
Placebo
DrugPlacebo Capsules
Time from randomization to relapse
Time from randomization to first occurrence of treatment discontinuation for any reason or relapse
Change in NPI-C: H+D Caregiver Observed Frequency x Severity Score (NPI-C: H+D CObs)
Change in Neuropsychiatric Inventory-Clinician rating scale (NPI-C) Core score Caregiver Distress scale
NPI-C Core score includes assessment for hallucinations, delusions, agitation, and aggression domains.
Number of participants with Adverse Events (AEs)
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