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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CONTACT
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Healthy Brain Clinic
Long Beach, California, United States
RECRUITINGAnderson Clinical Research
Redlands, California, United States
RECRUITINGMountain Neurological Research Center
Basalt, Colorado, United States
RECRUITINGGeorgetown University Medical Center
Washington D.C., District of Columbia, United States
RECRUITINGJEM Research Institute
Atlantis, Florida, United States
RECRUITINGVIN-Julie Schwartzbard
Aventura, Florida, United States
RECRUITINGMerritt Island Medical Research, LLC
Merritt Island, Florida, United States
RECRUITINGRenstar Medical Research
Ocala, Florida, United States
RECRUITINGAlzheimer's Research and Treatment Center
Stuart, Florida, United States
RECRUITINGCharter Research - Lady Lake
The Villages, Florida, United States
RECRUITING...and 96 more locations
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