The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
586
Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11)
Time frame: At week 24
Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+)
Time frame: At week 24
Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL)
Time frame: At week 24
Change from baseline in neuro psychiatric inventory (NPI) total score
Time frame: At week 24
Number of participants with adverse events (AEs)
Time frame: At week 24
Number of participants with serious adverse events (SAEs)
Time frame: At week 24
Number of participants with adverse event of special interest (AESIs)
Time frame: At week 24
Number of participants with AEs leading to study intervention discontinuation
Time frame: At week 24
Number of participants with AEs leading to study discontinuation
Time frame: At week 24
Number of participants with AEs leading to death
Time frame: At week 24
Number of participants with clinically significant changes in vital signs
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Time frame: At week 24
Number of participants with clinically significant changes in electrocardiogram (ECG) tests
Time frame: At week 24
Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale (C-SSRS) tests
Time frame: At week 24
Number of participants with clinically significant changes in weight
Time frame: At week 24
Number of participants with clinically significant changes in safety laboratory tests
Time frame: At week 24