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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
410
KarXT 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 Capsules
Local Institution - 1029
Homewood, Alabama, United States
ACTIVE_NOT_RECRUITINGLocal Institution - 1044
Phoenix, Arizona, United States
COMPLETEDLocal Institution - 1033
Encino, California, United States
COMPLETEDLocal Institution - 1031
Irvine, California, United States
WITHDRAWNTime from randomization to relapse during the 38-week study
Time frame: Week 38
Time from randomization to first occurrence of treatment discontinuation for any reason or relapse during the 38-week study
Time frame: Week 38
Change in Neuropsychiatric Inventory-Clinician rating scale (NPI-C) Core Caregiver Distress score
NPI-C score includes assessment for hallucinations, delusions, agitation, and aggression domains.
Time frame: Up to approximately Week 38
Number of participants with Adverse Events (AEs)
Time frame: Up to approximately Week 42
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately Week 42
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to approximately Week 42
Number of participants with TEAEs leading to study withdrawal
Time frame: Up to approximately Week 42
Number of participants with AEs including procholinergic and anticholinergic symptoms
Procholinergic symptoms include nausea, vomiting, and diarrhea and anticholinergic symptoms include dry mouth, constipation, urinary retention and blurred vision.
Time frame: Up to approximately Week 42
Number of participants with Adverse Events of Special Interest (AESIs)
AESIs include symptomatic orthostasis, syncope, urinary adverse events, and elevated liver enzymes requiring drug-induced liver injury (DILI) monitoring.
Time frame: Up to approximately Week 42
Barnes Akathisia Rating Scale (BARS)
Time frame: Up to approximately Week 38
Abnormal Involuntary Movement Scale (AIMS)
Time frame: Up to approximately Week 38
Body weight
Time frame: Up to approximately Week 38
BMI
Time frame: Up to approximately Week 38
Number of participants with clinically significant orthostatic vital signs
Time frame: Up to approximately Week 38
Number of participants with clinically significant laboratory evaluations
Laboratory evaluations include hematology, clinical chemistry, coagulation, prolactin levels, urinalysis, and drug screen
Time frame: Up to approximately Week 38
Number of participants with clinically significant 12-lead electrocardiogram (12-lead ECG)
Time frame: Up to approximately Week 38
Number of participants with suicidal ideation as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately Week 38
Assessment of cognition as measured by Mini-Mental State Examination (MMSE)
Time frame: Up to approximately Week 38
International Prostate Symptom Score (IPSS) (males only)
Time frame: Up to approximately Week 38
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ATP Clinical Research-302 W La Veta Ave
Orange, California, United States
RECRUITINGLocal Institution - 1043
Pasadena, California, United States
COMPLETEDLocal Institution - 1047
San Marcos, California, United States
ACTIVE_NOT_RECRUITINGSunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS
Walnut Creek, California, United States
RECRUITINGLocal Institution - 1014
Colorado Springs, Colorado, United States
COMPLETEDLocal Institution - 1013
Stamford, Connecticut, United States
COMPLETED...and 106 more locations