Alzheimer DiseasePhase 3NCT06947941
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
A Phase 3 study testing KarXT and KarX-EC in people with Alzheimer Disease and Psychosis, run by Bristol-Myers Squibb at 22 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer Disease, Psychosis
- What is being tested?
- KarXT and KarX-EC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 325 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 25 Mar 2026to 20 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
- Participants must be diagnosed with Alzheimer's disease in accordance with the 2024 revised criteria for diagnosis and staging of Alzheimer's Disease: Alzheimer's Association Workgroup.
- Participants must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma.
- Participants must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).
Who cannot join
- Participants must not have 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.
- Participants must not have history of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
- Participants must not have certain safety concerns, including certain laboratory test irregularities.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
22 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com contact
First line of the email MUST contain NCT # and Site #. contact
22 sites in 5 countries
United Kingdom8 sites, 6 recruiting
- Not yet recruiting
Local Institution - 0009
Chertsey, Surrey, KT160PZ
Site 0009
- Withdrawn
Local Institution - 0018
Crowborough, TN6 1NY
- Not yet recruiting
Local Institution - 0005
Exeter, Devon, EX12LU
Site 0005
- Not yet recruiting
Local Institution - 0023
London, England, W1G 8TA
Site 0023
- Not yet recruiting
Local Institution - 0024
London, WC1N3BG
Site 0024
- Not yet recruiting
Local Institution - 0004
Motherwell, ML1 4UF
Site 0004
- Withdrawn
Local Institution - 0015
Oxford, Oxfordshire, OX3 7JX
- Not yet recruiting
Local Institution - 0017
Sheffield, Yorkshire and the Humber, S47QQ
Site 0017
United States6 sites, 5 recruiting
- Recruiting
Inland Psychiatric Medical Group.
Chino, California, 91710
Nandita Puchakayala, Site 0031, 909-488-9116
- Not yet recruiting
Local Institution - 0029
Cleveland, Ohio, 44195
Site 0029
- Recruiting
Gilbert Neurology Partners/CCT Research
Gilbert, Arizona, 85297
Jonathan Hodgson, Site 0042, 602-761-9631
- Recruiting
Insight Clinical Trials LLC - Independence
Independence, Ohio, 44131
Mark Stillman, Site 0043, 216-444-8897
- Withdrawn
Local Institution - 0001
Naples, Florida, 34105
- Not yet recruiting
Local Institution - 1401
Naples, Florida, 34105
Site 1401
Canada3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0025
Montreal, Quebec, H4H 1R3
Site 0025
- Not yet recruiting
Local Institution - 0054
Toronto, Ontario, M6J1H4
Site 0054
- Not yet recruiting
Local Institution - 0027
Whitby, Ontario, L1N 5S9
Site 0027
Japan3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0035
Nankoku-shi, 783-8505
Site 0035
- Not yet recruiting
Local Institution - 0034
Osaka, 550-0006
Site 0034
- Not yet recruiting
Local Institution - 0040
Suita, Osaka, 565-0871
Site 0040
Australia2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0020
Macquarie Park, New South Wales, 2113
Site 0020
- Not yet recruiting
Local Institution - 0052
Nedlands, Western Australia, 6009
Site 0052
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Psychosis Associated With Alzheimer's Disease
The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
- Conditions
- Alzheimer Disease, Psychosis
- Being tested
- KarXT, KarX-EC, KarXT + KarX-EC Arm Matching Placebo
- Keywords
- Alzheimer disease, Alzheimer's disease, Alzheimer's, Dementia, Psychosis, Alzheimer's disease psychosis, Alzheimer's disease psychosis with or without agitation
- Medical subject headings
- Alzheimer Disease, Psychotic Disorders, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KarXTDrug
Also called BMS-986510, Xanomeline/Trospium Chloride
Specified dose on specified days
KarX-ECDrug
Also called BMS-986519, Xanomeline Enteric-coated
Specified dose on specified days
KarXT + KarX-EC Arm Matching PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: KarXT + KarX-EC Arm Matching Placebo |
| KarXT + KarX-EC Arm | Experimental | Not described Receives: Drug: KarXT; Drug: KarX-EC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score
Measured: Up to approximately Week 14
Secondary outcomes (31)
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score
Measured: Up to approximately Week 14
Change From Baseline in Neuropsychiatric Inventory-Clinician Rating Scale (NPI-C) Core Score
NPI-C Core Score includes assessment for hallucinations, delusions, agitation, and aggression domains
Measured: Up to approximately Week 14
Change From Baseline in NPI-C: Agitation Score
Measured: Up to approximately Week 14
Change From Baseline in NPI-C Core Score: Caregiver Distress Scale
NPI-C Core Score: Caregiver Distress Scale includes assessment for hallucinations, delusions, agitation, and aggression domains
Measured: Up to approximately Week 14
Responder Rate
Responder rate is defined as improvement from baseline in NPI-C: H+D score ≥ 40%.
Measured: Up to approximately Week 14
Change From Baseline in Cohen-Mansfield Agitation Inventory International Psychogeriatric Association (CMAI-IPA) Score
Measured: Up to approximately Week 14
Change From Baseline in CMAI Total Score
Measured: Up to approximately Week 14
Number of Participants With Adverse Events (AEs)
Measured: Up to approximately Week 14
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to approximately Week 14
Number of Participants With Serious Adverse Events (SAEs)
Measured: Up to approximately Week 14
Number of Participants With TEAEs Leading to Discontinuation
Measured: Up to approximately Week 14
Number of Participants With Spontaneously Reported Procholinergic Symptoms
Procholinergic symptoms include nausea, vomiting, and diarrhea.
Measured: Up to approximately Week 14
Number of Participants With Spontaneously Reported Anticholinergic Symptoms
Anticholinergic symptoms include dry mouth, constipation, urinary retention and blurred vision.
Measured: Up to approximately Week 14
Number of Participants With AEs of Special Interest (AESIs)
AESIs such as symptomatic orthostasis, syncope, urinary adverse events, and elevated liver enzymes will be evaluated.
Measured: Up to approximately Week 14
Barnes Akathisia Rating Scale (BARS) Score
Measured: Up to approximately Week 14
Abnormal Involuntary Movement Scale (AIMS) Score
Measured: Up to approximately Week 14
International Prostate Symptom Score (IPSS)
This will be measured in males only.
Measured: Up to approximately Week 14
Body Weight
Measured: Up to approximately Week 14
Body Mass Index (BMI)
Measured: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP)
This includes measuring of BP, supine or sitting and then standing after approximately 2 minutes, no later than approximately 3 minutes.
Measured: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Heart Rate (HR)
This includes measuring of HR, supine or sitting and then standing after approximately 2 minutes, no later than approximately 3 minutes.
Measured: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Hematology
Measured: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Clinical Chemistry
Measured: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Coagulation Parameters
Measured: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Prolactin Levels
Measured: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Urinalysis
Measured: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Drug Screening
Measured: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
Measured: Up to approximately Week 14
Number of Participants With Suicidal Ideations and Behavior as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to approximately Week 14
Number of Participants With Cognitive Impairment as Assessed by Mini-mental State Examination (MMSE)
Measured: Up to approximately Week 14
Number of Participants With Cognitive Impairment as Assessed by 13-item Variation of ADAS-Cog Scale (ADAS-Cog-13)
Measured: Up to approximately Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start25 Mar 2026
- Primary completion21 Feb 2028 (estimated)
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947941
- Sponsor's protocol ID
- CN012-0034
- Other IDs
- 2025-521057-16, U1111-1318-5718, 2025
- Status last verified
- Jun 2026
- First submitted
- 25 Apr 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Psychosis Associated With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06947941
- Acronym / sponsor ID
- CN012-0034
- Conditions
- Alzheimer Disease, Psychosis
- Keywords
- Alzheimer disease, Alzheimer's disease, Alzheimer's, Dementia, Psychosis, Alzheimer's disease psychosis, Alzheimer's disease psychosis with or without agitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 21 Feb 2028 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: KarXT + KarX-EC Arm Matching Placebo |
| KarXT + KarX-EC Arm | Experimental | Drug: KarXT, Drug: KarX-EC |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
- Participants must be diagnosed with Alzheimer's disease in accordance with the 2024 revised criteria for diagnosis and staging of Alzheimer's Disease: Alzheimer's Association Workgroup.
- Participants must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma.
- Participants must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).
Key exclusion criteria (4 listed)
- Participants must not have 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.
- Participants must not have history of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
- Participants must not have certain safety concerns, including certain laboratory test irregularities.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KarXTAlso: BMS-986510, Xanomeline/Trospium ChlorideSpecified dose on specified days | Drug | KarXT + KarX-EC Arm |
| KarX-ECAlso: BMS-986519, Xanomeline Enteric-coatedSpecified dose on specified days | Drug | KarXT + KarX-EC Arm |
| KarXT + KarX-EC Arm Matching PlaceboSpecified dose on specified days | Drug | Placebo |
Primary outcome
Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score
Time frame: Up to approximately Week 14
31 secondary outcomes
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score
Time frame: Up to approximately Week 14
Change From Baseline in Neuropsychiatric Inventory-Clinician Rating Scale (NPI-C) Core Score
Time frame: Up to approximately Week 14
Change From Baseline in NPI-C: Agitation Score
Time frame: Up to approximately Week 14
Change From Baseline in NPI-C Core Score: Caregiver Distress Scale
Time frame: Up to approximately Week 14
Responder Rate
Time frame: Up to approximately Week 14
Change From Baseline in Cohen-Mansfield Agitation Inventory International Psychogeriatric Association (CMAI-IPA) Score
Time frame: Up to approximately Week 14
Change From Baseline in CMAI Total Score
Time frame: Up to approximately Week 14
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately Week 14
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately Week 14
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to approximately Week 14
Number of Participants With TEAEs Leading to Discontinuation
Time frame: Up to approximately Week 14
Number of Participants With Spontaneously Reported Procholinergic Symptoms
Time frame: Up to approximately Week 14
Number of Participants With Spontaneously Reported Anticholinergic Symptoms
Time frame: Up to approximately Week 14
Number of Participants With AEs of Special Interest (AESIs)
Time frame: Up to approximately Week 14
Barnes Akathisia Rating Scale (BARS) Score
Time frame: Up to approximately Week 14
Abnormal Involuntary Movement Scale (AIMS) Score
Time frame: Up to approximately Week 14
International Prostate Symptom Score (IPSS)
Time frame: Up to approximately Week 14
Body Weight
Time frame: Up to approximately Week 14
Body Mass Index (BMI)
Time frame: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP)
Time frame: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Heart Rate (HR)
Time frame: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Hematology
Time frame: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Clinical Chemistry
Time frame: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Coagulation Parameters
Time frame: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Prolactin Levels
Time frame: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Urinalysis
Time frame: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Drug Screening
Time frame: Up to approximately Week 14
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
Time frame: Up to approximately Week 14
Number of Participants With Suicidal Ideations and Behavior as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately Week 14
Number of Participants With Cognitive Impairment as Assessed by Mini-mental State Examination (MMSE)
Time frame: Up to approximately Week 14
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 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KarXT and KarX-EC in people with Alzheimer Disease and Psychosis, run by Bristol-Myers Squibb at 22 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, United States, Canada, Japan, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score (time frame: Up to approximately Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.