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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
406
Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
Time frame: Up to Week 14
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale
Time frame: Up to Week 14
Change from baseline in Neuropsychiatric Inventory-Clinician (NPI-C) Core score: Hallucination Domain
Time frame: Up to Week 14
Change from baseline in NPI-C Core score: Delusion Domain
Time frame: Up to Week 14
Change from baseline in NPI-C Core score: Agitation Domain
Time frame: Up to Week 14
Change from baseline in NPI-C Core score: Aggression Domain
Time frame: Up to Week 14
Change from baseline in NPI-C Agitation score
Time frame: Up to Week 14
Change from baseline in NPI-C Core score: Caregiver Distress Scale
Time frame: Up to Week 14
Number of participants with a ≥ 40% improvement from Baseline in NPI-C: H+D score
Time frame: Up to Week 14
Change from baseline in Cohen- Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score
Time frame: Up to Week 14
Change from baseline in Cohen- Mansfield Agitation Inventory (CMAI) total score
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Chandler Clinical Trials, LLC
Chandler, Arizona, United States
RECRUITINGGilbert Neurology Partners - PLLC - Avacare
Gilbert, Arizona, United States
RECRUITINGBanner Alzheimer's Institute
Phoenix, Arizona, United States
RECRUITINGScottsdale Clinical Trials
Scottsdale, Arizona, United States
RECRUITINGAdvanced Research Center, Inc.
Anaheim, California, United States
RECRUITINGInland Psychiatric Medical Group (IPMG)-Chino
Chino, California, United States
RECRUITINGLong Beach Research Institute, LLC
Long Beach, California, United States
RECRUITINGUSC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)
Los Angeles, California, United States
RECRUITINGLocal Institution - 1219
Los Angeles, California, United States
WITHDRAWNATP Clinical Research-302 W La Veta Ave
Orange, California, United States
RECRUITING...and 264 more locations
Time frame: Up to Week 14
Number of participants with Adverse Events (AEs)
Time frame: Up to Week 14
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 14
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to Week 14
Number of participants with TEAEs leading to study withdrawal
Time frame: Up to Week 14
Number of participants with procholinergic symptoms
Time frame: Up to Week 14
Number of participants with anticholinergic symptoms
Time frame: Up to Week 14
Number of participants with AEs of Special Interest (AESIs)
Time frame: Up to Week 14
Barnes Akathisia Rating Scale (BARS) Score
Time frame: Up to Week 14
Abnormal Involuntary Movement Scale (AIMS) Score
Time frame: Up to Week 14
Body Weight
Time frame: Up to Week 14
Body Mass Index (BMI)
Time frame: Up to Week 14
Number of participants with vital sign abnormalities
Time frame: Up to Week 14
Number of participants with clinical laboratory abnormalities
Time frame: Up to Week 14
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Time frame: Up to Week 14
Number of participants with suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Week 14
Cognition as assessed by the Mini-Mental State Examination (MMSE)
Time frame: Up to Week 14
Cognition as assessed by the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13)
Time frame: Up to Week 14