This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
KarXT 20/2 mg (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg (TDD 90/9 mg) KarXT 40/4 mg (TDD 120/12 mg) KarXT 50/5 mg (TDD 150/15 mg) KarXT 66.7/6.67 mg (TDD 200/20 mg)
Placebo Capsules
Local Institution - 1116
Chandler, Arizona, United States
Local Institution - 1044
Phoenix, Arizona, United States
Local Institution - 1104
Anaheim, California, United States
Local Institution - 1119
Canoga Park, California, United States
Local Institution - 1151
Encino, California, United States
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.
Time frame: Baseline and End of Treatment (up to 14 weeks)
Change from Baseline to End of Treatment in the Cohen-Mansfield Agitation Inventory (CMAI) score
Cohen-Mansfield Agitation Inventory (CMAI) is a caregiver's rating 29-item questionnaire used to assess the frequency of manifestations of agitated behaviors in older adults. Each item is rated on a 7-point scale ranging from "1 = never" to "7 = several times per hour." Higher scores on this scale indicate worse outcomes.
Time frame: Baseline and End of Treatment (up to 14 weeks)
Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) scale
Clinical Global Impressions-Severity (CGI-S) requires the assessor to consider aspects of the psychosis (hallucinations and delusions) prior to providing a global assessment of severity. Higher scores on this scale indicate worse outcomes.
Time frame: Baseline and End of Treatment (up to 14 weeks)
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Local Institution - 1142
Lancaster, California, United States
Local Institution - 1117
Los Alamitos, California, United States
Local Institution - 1103
Sherman Oaks, California, United States
Local Institution - 1007
Walnut Creek, California, United States
Local Institution - 1156
Clermont, Florida, United States
...and 109 more locations