NCT06947941

Brief Summary

The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P25-P50 for phase_3 alzheimer-disease

Timeline
21mo left

Started Mar 2026

Shorter than P25 for phase_3 alzheimer-disease

Geographic Reach
5 countries

22 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

April 25, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2028

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2028

Last Updated

June 2, 2026

Status Verified

June 1, 2026

Enrollment Period

1.9 years

First QC Date

April 25, 2025

Last Update Submit

June 1, 2026

Conditions

Alzheimer DiseasePsychosis

Keywords

Alzheimer diseaseAlzheimer's diseaseAlzheimer'sDementiaPsychosisAlzheimer's disease psychosisAlzheimer's disease psychosis with or without agitation

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score

    Up to approximately Week 14

Secondary Outcomes (31)

  • Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score

    Up to approximately Week 14

  • Change From Baseline in Neuropsychiatric Inventory-Clinician Rating Scale (NPI-C) Core Score

    Up to approximately Week 14

  • Change From Baseline in NPI-C: Agitation Score

    Up to approximately Week 14

  • Change From Baseline in NPI-C Core Score: Caregiver Distress Scale

    Up to approximately Week 14

  • Responder Rate

    Up to approximately Week 14

  • +26 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: KarXT + KarX-EC Arm Matching Placebo

KarXT + KarX-EC Arm

EXPERIMENTAL
Drug: KarXTDrug: KarX-EC

Interventions

KarXTDRUG

Specified dose on specified days

Also known as: BMS-986510, Xanomeline/Trospium Chloride
KarXT + KarX-EC Arm
KarX-ECDRUG

Specified dose on specified days

Also known as: BMS-986519, Xanomeline Enteric-coated
KarXT + KarX-EC Arm
KarXT + KarX-EC Arm Matching PlaceboDRUG

Specified dose on specified days

Placebo

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Gilbert Neurology Partners/CCT Research

Gilbert, Arizona, 85297, United States

RECRUITING

Inland Psychiatric Medical Group.

Chino, California, 91710, United States

RECRUITING

Local Institution - 0001

Naples, Florida, 34105, United States

WITHDRAWN

Local Institution - 1401

Naples, Florida, 34105, United States

NOT YET RECRUITING

Local Institution - 0029

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Local Institution - 0043

Shaker Heights, Ohio, 44122-5288, United States

NOT YET RECRUITING

Local Institution - 0020

Macquarie Park, New South Wales, 2113, Australia

NOT YET RECRUITING

Local Institution - 0052

Nedlands, Western Australia, 6009, Australia

NOT YET RECRUITING

Local Institution - 0054

Toronto, Ontario, M6J1H4, Canada

NOT YET RECRUITING

Local Institution - 0027

Whitby, Ontario, L1N 5S9, Canada

NOT YET RECRUITING

Local Institution - 0025

Montreal, Quebec, H4H 1R3, Canada

NOT YET RECRUITING

Local Institution - 0040

Suita, Osaka, 565-0871, Japan

NOT YET RECRUITING

Local Institution - 0035

Nankoku-shi, 783-8505, Japan

NOT YET RECRUITING

Local Institution - 0034

Osaka, 550-0006, Japan

NOT YET RECRUITING

Local Institution - 0005

Exeter, Devon, EX12LU, United Kingdom

NOT YET RECRUITING

Local Institution - 0018

Saint Leonards-on-Sea, East Sussex, TN61HB, United Kingdom

NOT YET RECRUITING

Local Institution - 0023

London, England, W1G 8TA, United Kingdom

NOT YET RECRUITING

Local Institution - 0015

Oxford, Oxfordshire, OX3 7JX, United Kingdom

NOT YET RECRUITING

Local Institution - 0009

Chertsey, Surrey, KT160PZ, United Kingdom

NOT YET RECRUITING

Local Institution - 0017

Sheffield, Yorkshire and the Humber, S47QQ, United Kingdom

NOT YET RECRUITING

Local Institution - 0024

London, WC1N3BG, United Kingdom

NOT YET RECRUITING

Local Institution - 0004

Motherwell, ML1 4UF, United Kingdom

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Alzheimer DiseasePsychotic DisordersDementia

Interventions

xanomelinetrospium chloride

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com

CONTACT

855-907-3286Clinical.Trials@bms.com

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

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2025

First Posted

April 27, 2025

Study Start

March 25, 2026

Primary Completion (Estimated)

February 21, 2028

Study Completion (Estimated)

March 20, 2028

Last Updated

June 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See Plan Description
Access Criteria
See Plan Description
More information

Locations

GB(8)JP(3)CA(3)US(6)AU(2)