A Phase 3 interventional study of Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule in Alzheimer's Disease, sponsored by Bristol-Myers Squibb. Recruiting at 143 sites in 14 countries. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
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 in adult participants with agitation related to Alzheimer's Disease.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 426 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.
- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology:
i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.
ii) If no historical evidence available:
A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.
B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:
Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.
Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to:
i) Attend all visits and report on participant's status.
ii) Oversee participant compliance with medication and study procedures.
iii) Participate in the study assessments and provide to participate in the study.
Exclusion Criteria
- Medical Conditions.
i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.
ii) History of bipolar disorder, schizophrenia, or schizoaffective disorder.
iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
iv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR.
- Prior/Concomitant Therapy.
i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam).
A. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.
B. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1).
Note: Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).
- Other protocol-defined Inclusion/Exclusion criteria apply.
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.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Xanomeline/Trospium Chloride Capsule · Drug: Xanomeline Enteric Capsule
Drug: Placebo
Drug pages: Xanomeline · Trospium chloride
Specified dose on specified days
Also known as: KarXT, BMS-986510
Specified dose on specified days
Also known as: KarX-EC, BMS-986519
Specified dose on specified days
Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score at Week 14
Time frame: At Week 14
Change from baseline on the Clinical Global Impressions-Severity (CGI-S) at Week 14
Time frame: At Week 14
Change from baseline on CMAI-IPA Domains at Week 14
Time frame: At Week 14
Change from baseline on CMAI Total Score at Week 14
Time frame: At Week 14
Number of participants with Occurrence of Response at Week 14
As determined by CMAI-IPA changes of at least 30%, 40%, and 50% from baseline
Time frame: At Week 14
Change from baseline on the Neuropsychiatric Inventory/Neuropsychiatric Inventory -Nursing Home (NPI/NPI-NH) Total Score at Week 14
Time frame: At Week 14
Number of participants with Adverse Events (AEs)
Time frame: Up to Week 18
Number of participants with Treatment Emergent AEs (TEAEs)
Time frame: Up to Week 18
Number of participants with Serious AEs (SAEs)
Time frame: Up to Week 18
Number of participants with AEs leading to study drug withdrawal
Time frame: Up to Week 18
Number of deaths
Time frame: Up to Week 18
Number of participants with AEs of Special Interest (AESIs)
Time frame: Up to Week 18
Barnes Akathisia Rating Scale (BARS)
Time frame: Up to Week 14
Abnormal Involuntary Movement Scale (AIMS)
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 18
Number of participants with clinical laboratory abnormalities
Time frame: Up to Week 14
Number of participants with 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 18
Severity of benign prostatic hyperplasia in male participants as assessed by International Prostate Symptom Score (IPSS)
Time frame: Up to Week 18
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Showing the first 100 of 143 sites across 14 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 Myers 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
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.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Xanomeline · Trospium chloride