A Phase 3 interventional study of KarXT and KarX-EC in Alzheimer's Disease, sponsored by Bristol-Myers Squibb. Recruiting at 128 sites in 17 countries. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 10 studies testing xanomeline in Alzheimer Disease — 10 open to participants now, 10 under way, 10 of them phase 3. xanomeline · Alzheimer Disease.
Among the 10 studies testing xanomeline in Alzheimer Disease, this one is the 3rd largest by planned enrollment, is one of 5 that started in 2025, is one of 10 in phase 3, and was the 7th registered.
3,967 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →10 of the 10 studies testing xanomeline in Alzheimer Disease are open now, in 12 countries. Recruiting first, the newest first:
Bristol-Myers Squibb · Sites in United States, Australia, Canada and 2 more countries
Ages 55–90
Bristol-Myers Squibb · Sites in United States, Argentina, Brazil and 23 more countries
Ages 55–90
Bristol-Myers Squibb · Sites in United States, Argentina, Chile and 11 more countries
Ages 55–90
Bristol-Myers Squibb · Sites in United States, Argentina, Australia and 16 more countries
Ages 60–85
Bristol-Myers Squibb · Sites in United States, Argentina, Brazil and 12 more countries
Ages 55–90
By country, each count listing its studies:
xanomeline: first FDA approval 2024 (COBENFY). What it is approved for, and how studies give it, is on its page →
Of the 642 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 284 take healthy volunteers.
This study: 60 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2022; this study’s year is marked. 5 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 586 is above the median of 70 across 3,020 interventional studies indexed under Alzheimer Disease.
Median enrollment 463 across the 10 interventional studies. None of them has completed or been terminated yet.
This tab as a report to print or save as PDF → With an account.
10 of 10 have an industry lead sponsor. The 2 most frequent:
Bristol-Myers Squibb is the lead sponsor of 1,560 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.
26 studies in Alzheimer Disease by Bristol-Myers Squibb: 12 open now, 13 under way, 10 of them phase 3. Of 13 finished, 0 (0%) have results posted.
Among the 26 studies in Alzheimer Disease by Bristol-Myers Squibb, this one is the 3rd largest by planned enrollment, is one of 6 that started in 2025, is one of 10 in phase 3, reaches primary completion later than 8 of the 12 other live ones, and was the 22nd registered.
Bristol-Myers Squibb’s Alzheimer Disease studies by the year they started, since 2007.
3 of the studies testing xanomeline in Alzheimer Disease that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06585787Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) | 2026-11-24 |
| NCT06126224Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2) | 2026-12-09 |
| NCT05980949Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyOpen-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3) | 2027-09-07 |
Add all 3 to your calendar (.ics) → With an account.
Among the 10 studies testing xanomeline in Alzheimer Disease, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Bristol-Myers Squibb’s 26 in Alzheimer Disease:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
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:
Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment, urinary retention, active biliary disease, moderate-severe renal impairment ( of \<50 mL/min), and unstable hypertension or tachycardia.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: KarXT · Drug: KarX-EC
Other: Placebo
Drug pages: Xanomeline · Trospium
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
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 128 sites across 17 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 Jul 2025 (actual). Primary completion is estimated for Sep 2028, 37 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 37 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