A Phase 3 interventional study of KarXT and KarX-EC in Alzheimer's Disease, sponsored by Bristol-Myers Squibb. Recruiting at 119 sites in 19 countries. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 586 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Drug: KarXT · Drug: KarX-EC
Other: Placebo
Specified dose on specified days
Also known as: BMS-986510
Specified dose on specified days
Also known as: BMS-986519
Specified dose on specified days
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
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
Showing the first 100 of 119 sites across 19 countries.
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Sap, Csr
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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