A Phase 3 interventional study of KarXT and KarX-EC in Alzheimer Disease and Agitation, sponsored by Bristol-Myers Squibb. Recruiting at 252 sites in 26 countries. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 650 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: KarXT · Drug: KarX-EC
Drug pages: Xanomeline · Trospium
Specified dose on specified days
Also known as: Xanomeline and Trospium Chloride capsule, BMS-986510
Specified dose on specified days
Also known as: Xanomeline enteric capsules, BMS-986519
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately Week 30
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately Week 30
Number of Participants With Serious AEs (SAEs)
Time frame: Up to approximately Week 30
Number of Participants With TEAEs Leading to Study Withdrawal
Time frame: Up to approximately Week 30
Number of Participants With TEAEs Leading to Death
Time frame: Up to approximately Week 30
Number of Participants with Adverse Events of Special Interest (AESI)
Time frame: Up to approximately Week 30
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
Time frame: Up to approximately Week 26
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
Time frame: Up to approximately Week 26
Change From Baseline in Body Weight
Time frame: Up to approximately Week 26
Change From Baseline in Body Mass Index (BMI)
Time frame: Up to approximately Week 26
Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Heart Rate (HR)
This includes measuring of HR, both supine and standing or seated and upon standing after 2 minutes.
Time frame: Up to approximately Week 30
Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP)
This includes measuring of systolic and diastolic BP, both supine and standing or seated and upon standing after 2 minutes.
Time frame: Up to approximately Week 30
Number of Participants With Clinically Significant Changes in Laboratory Evaluations
Time frame: Up to approximately Week 30
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
Time frame: Up to approximately Week 26
Number of Participants With Suicidal Ideations as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately Week 30
Number of Participants With Cognitive Impairment as Assessed by Mini-mental State Examination (MMSE)
Time frame: Up to approximately Week 26
Number of Participants With Cognitive Impairment as Assessed by 13-item Variation of ADAS-Cog Scale (ADAS-Cog-13)
Time frame: Up to approximately Week 26
Change From Baseline in the Severity of Benign Prostatic Hyperplasia as Assessed by International Prostate Symptom Score (IPSS)
This analysis is done in male participants.
Time frame: Up to approximately Week 26
Not enrolling at this site — choose another above.
Showing the first 100 of 252 sites across 26 countries. Choose a country and city above to see the rest.
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, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Started Dec 2025 (actual). Primary completion is estimated for Jun 2029, 42 months after the start.
Of 75 industry-sponsored phase 3 interventional studies under Alzheimer Disease, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 61. This study's planned 42 months is close to that.
Counting every sponsor, half of 101 studies reached it within 47 months; a quarter within 28 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drugs tested here: Xanomeline · Trospium