A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)

June 29, 2026 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

325

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia, 2113
        • Not yet recruiting
        • Local Institution - 0020
        • Contact:
          • Site 0020
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Not yet recruiting
        • Local Institution - 0052
        • Contact:
          • Site 0052
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J1H4
        • Not yet recruiting
        • Local Institution - 0054
        • Contact:
          • Site 0054
      • Whitby, Ontario, Canada, L1N 5S9
        • Not yet recruiting
        • Local Institution - 0027
        • Contact:
          • Site 0027
    • Quebec
      • Montreal, Quebec, Canada, H4H 1R3
        • Not yet recruiting
        • Local Institution - 0025
        • Contact:
          • Site 0025
  • Japan
      • Nankoku-shi, Japan, 783-8505
        • Not yet recruiting
        • Local Institution - 0035
        • Contact:
          • Site 0035
      • Osaka, Japan, 550-0006
        • Not yet recruiting
        • Local Institution - 0034
        • Contact:
          • Site 0034
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Not yet recruiting
        • Local Institution - 0040
        • Contact:
          • Site 0040
  • United Kingdom
      • Crowborough, United Kingdom, TN6 1NY
        • Withdrawn
        • Local Institution - 0018
      • London, United Kingdom, WC1N3BG
        • Not yet recruiting
        • Local Institution - 0024
        • Contact:
          • Site 0024
      • Motherwell, United Kingdom, ML1 4UF
        • Not yet recruiting
        • Local Institution - 0004
        • Contact:
          • Site 0004
    • Devon
      • Exeter, Devon, United Kingdom, EX12LU
        • Not yet recruiting
        • Local Institution - 0005
        • Contact:
          • Site 0005
    • England
      • London, England, United Kingdom, W1G 8TA
        • Not yet recruiting
        • Local Institution - 0023
        • Contact:
          • Site 0023
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7JX
        • Withdrawn
        • Local Institution - 0015
    • Surrey
      • Chertsey, Surrey, United Kingdom, KT160PZ
        • Not yet recruiting
        • Local Institution - 0009
        • Contact:
          • Site 0009
    • Yorkshire and the Humber
      • Sheffield, Yorkshire and the Humber, United Kingdom, S47QQ
        • Not yet recruiting
        • Local Institution - 0017
        • Contact:
          • Site 0017
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Recruiting
        • Gilbert Neurology Partners/CCT Research
        • Contact:
          • Jonathan Hodgson, Site 0042
          • Phone Number: 602-761-9631
    • California
      • Chino, California, United States, 91710
        • Recruiting
        • Inland Psychiatric Medical Group.
        • Contact:
          • Nandita Puchakayala, Site 0031
          • Phone Number: 909-488-9116
    • Florida
      • Naples, Florida, United States, 34105
        • Withdrawn
        • Local Institution - 0001
      • Naples, Florida, United States, 34105
        • Not yet recruiting
        • Local Institution - 1401
        • Contact:
          • Site 1401
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Local Institution - 0029
        • Contact:
          • Site 0029
      • Independence, Ohio, United States, 44131
        • Recruiting
        • Insight Clinical Trials LLC - Independence
        • Contact:
          • Mark Stillman, Site 0043
          • Phone Number: 216-444-8897

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: KarXT + KarX-EC Arm Matching Placebo
Specified dose on specified days
Experimental: KarXT + KarX-EC Arm
Drug: KarXT
Specified dose on specified days
Other Names:
  • BMS-986510
  • Xanomeline/Trospium Chloride
Drug: KarX-EC
Specified dose on specified days
Other Names:
  • BMS-986519
  • Xanomeline Enteric-coated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score
Time Frame: Up to approximately Week 14
Up to approximately Week 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Hematology
Time Frame: Up to approximately Week 14
Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Clinical Chemistry
Time Frame: Up to approximately Week 14
Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Coagulation Parameters
Time Frame: Up to approximately Week 14
Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Prolactin Levels
Time Frame: Up to approximately Week 14
Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Urinalysis
Time Frame: Up to approximately Week 14
Up to approximately Week 14
Number of Participants With Clinically Significant Changes in Laboratory Evaluations: Drug Screening
Time Frame: Up to approximately Week 14
Up to approximately Week 14
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
Time Frame: Up to approximately Week 14
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
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
Up to approximately Week 14
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score
Time Frame: Up to approximately Week 14
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
NPI-C Core Score includes assessment for hallucinations, delusions, agitation, and aggression domains
Up to approximately Week 14
Change From Baseline in NPI-C: Agitation Score
Time Frame: Up to approximately Week 14
Up to approximately Week 14
Change From Baseline in NPI-C Core Score: Caregiver Distress Scale
Time Frame: Up to approximately Week 14
NPI-C Core Score: Caregiver Distress Scale includes assessment for hallucinations, delusions, agitation, and aggression domains
Up to approximately Week 14
Responder Rate
Time Frame: Up to approximately Week 14
Responder rate is defined as improvement from baseline in NPI-C: H+D score ≥ 40%.
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
Up to approximately Week 14
Change From Baseline in CMAI Total Score
Time Frame: Up to approximately Week 14
Up to approximately Week 14
Number of Participants With Adverse Events (AEs)
Time Frame: Up to approximately Week 14
Up to approximately Week 14
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to approximately Week 14
Up to approximately Week 14
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: Up to approximately Week 14
Up to approximately Week 14
Number of Participants With TEAEs Leading to Discontinuation
Time Frame: Up to approximately Week 14
Up to approximately Week 14
Number of Participants With Spontaneously Reported Procholinergic Symptoms
Time Frame: Up to approximately Week 14
Procholinergic symptoms include nausea, vomiting, and diarrhea.
Up to approximately Week 14
Number of Participants With Spontaneously Reported Anticholinergic Symptoms
Time Frame: Up to approximately Week 14
Anticholinergic symptoms include dry mouth, constipation, urinary retention and blurred vision.
Up to approximately Week 14
Number of Participants With AEs of Special Interest (AESIs)
Time Frame: Up to approximately Week 14
AESIs such as symptomatic orthostasis, syncope, urinary adverse events, and elevated liver enzymes will be evaluated.
Up to approximately Week 14
Barnes Akathisia Rating Scale (BARS) Score
Time Frame: Up to approximately Week 14
Up to approximately Week 14
Abnormal Involuntary Movement Scale (AIMS) Score
Time Frame: Up to approximately Week 14
Up to approximately Week 14
International Prostate Symptom Score (IPSS)
Time Frame: Up to approximately Week 14
This will be measured in males only.
Up to approximately Week 14
Body Weight
Time Frame: Up to approximately Week 14
Up to approximately Week 14
Body Mass Index (BMI)
Time Frame: Up to approximately Week 14
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
This includes measuring of BP, supine or sitting and then standing after approximately 2 minutes, no later than approximately 3 minutes.
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
This includes measuring of HR, supine or sitting and then standing after approximately 2 minutes, no later than approximately 3 minutes.
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
Up to approximately Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2026

Primary Completion (Estimated)

February 21, 2028

Study Completion (Estimated)

March 20, 2028

Study Registration Dates

First Submitted

April 25, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN012-0034
  • 2025-521057-16 (Other Identifier: EU CTR)
  • U1111-1318-5718 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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