A Phase 3 interventional study of KarXT and Placebo in Alzheimer Disease, sponsored by Karuna Therapeutics, Inc., a Bristol Myers Squibb company. Recruiting at 296 sites in 25 countries. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Karuna Therapeutics, Inc., a Bristol Myers Squibb company (part of Bristol-Myers Squibb) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 406 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Karuna Therapeutics, Inc., a Bristol Myers Squibb company is the lead sponsor of 17 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
First submitted after Karuna Therapeutics, Inc. became part of Bristol-Myers Squibb.
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
- Patients will not be able to participate if they have:
i) Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.
ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Drug: KarXT
Drug: Placebo
Drug pages: Xanomeline · Trospium
Specified dose on specified days
Also known as: BMS-986510
Specified dose on specified days
Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
Time frame: Up to Week 14
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale
Time frame: Up to Week 14
Change from baseline in Neuropsychiatric Inventory-Clinician (NPI-C) Core score: Hallucination Domain
Time frame: Up to Week 14
Change from baseline in NPI-C Core score: Delusion Domain
Time frame: Up to Week 14
Change from baseline in NPI-C Core score: Agitation Domain
Time frame: Up to Week 14
Change from baseline in NPI-C Core score: Aggression Domain
Time frame: Up to Week 14
Change from baseline in NPI-C Agitation score
Time frame: Up to Week 14
Change from baseline in NPI-C Core score: Caregiver Distress Scale
Time frame: Up to Week 14
Number of participants with a ≥ 40% improvement from Baseline in NPI-C: H+D score
Time frame: Up to Week 14
Number of participants with Adverse Events (AEs)
Time frame: Up to Week 14
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 14
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to Week 14
Number of participants with TEAEs leading to study withdrawal
Time frame: Up to Week 14
Number of participants with procholinergic symptoms
Time frame: Up to Week 14
Number of participants with anticholinergic symptoms
Time frame: Up to Week 14
Number of participants with AEs of Special Interest (AESIs)
Time frame: Up to Week 14
Barnes Akathisia Rating Scale (BARS) Score
Time frame: Up to Week 14
Abnormal Involuntary Movement Scale (AIMS) Score
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 14
Number of participants with clinical laboratory abnormalities
Time frame: Up to Week 14
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Time frame: Up to Week 14
Cognition as assessed by the Mini-Mental State Examination (MMSE)
Time frame: Up to Week 14
International Prostate Symptom Score (IPSS)
Time frame: Up to Week 14
Number of participants with suicidal ideation and behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Week 14
Cognition as assessed by the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13)
Time frame: Up to Week 14
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 296 sites across 25 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 Sep 2024 (actual). Primary completion is estimated for Nov 2026, 25 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 25 months is below 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.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Xanomeline · Trospium
Karuna Therapeutics, Inc., a Bristol Myers Squibb company →