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Looking for participantsPhase3

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

Sponsor: Bristol-Myers Squibb

NCT ID: NCT06947941

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
KarXT (drug), KarX-EC (drug), KarXT + KarX-EC Arm Matching Placebo (drug)
How long the study runs
Study runs about 24 months (dates as stated)
About the drug or intervention
KarXT — drug: Specified dose on specified days · KarX-EC — drug: Specified dose on specified days · KarXT + KarX-EC Arm Matching Placebo — drug: Specified dose on specified days
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing whether a treatment called KarXT + KarX-EC is safe and works well for psychosis (seeing, hearing, or believing things that are not real) in people with Alzheimer's disease. It is run by Bristol-Myers Squibb and is known as the ADEPT-5 study. The treatment involves psychosis associated with Alzheimer's disease.

Who can take part

  • Aged 55 to 90 at screening
  • Diagnosed with Alzheimer's disease using the 2024 revised criteria from the Alzheimer's Association Workgroup
  • Has had a brain scan (magnetic resonance imaging, MRI, or computed tomography, CT) in the past 5 years, taken after dementia started, to rule out other brain conditions
  • Has had psychotic symptoms for at least 2 months before screening (symptoms of agitation may or may not also be present)

Who may not be able to

  • Psychotic symptoms mainly caused by something other than Alzheimer's disease, such as schizophrenia, schizoaffective disorder, delusional disorder, or a mood disorder with psychotic features
  • A major depressive episode with psychotic features in the 12 months before screening, or a history of bipolar disorder, schizophrenia, or schizoaffective disorder
  • Certain safety concerns, including some unusual laboratory test results
  • Other study rules may also apply — ask the trial team

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
55 Years to 90 Years
Who
All
Number of participants
325
Started
2026-03-25
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for alzheimer disease
  • • Phase3 - 325 participants
  • • The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease

Who can take part?

  • • Ages 55 Years to 90 Years
  • • Diagnosed with alzheimer disease

Where?

  • • Exeter - Local Institution - 0005
  • • London - Local Institution - 0023
  • • Oxford - Local Institution - 0015
  • • Chertsey - Local Institution - 0009
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Alzheimer DiseasePsychosis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 55 Years - 90 Years
  • Who can join: All genders

What the study is looking for

  • ✓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...

Who cannot take part

  • ✗Participants must not have certain safety concerns, including certain laboratory test irregularities.
  • ✗Other protocol-defined Inclusion/Exclusion criteria apply.
See the full criteria
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.

Where Is This Study? (8 UK sites)

Local Institution - 0005

Exeter EX12LU, United Kingdom

NOT_YET_RECRUITING

Local Institution - 0023

London W1G 8TA, United Kingdom

NOT_YET_RECRUITING

Local Institution - 0015

Oxford OX3 7JX, United Kingdom

WITHDRAWN

Local Institution - 0009

Chertsey KT160PZ, United Kingdom

NOT_YET_RECRUITING

Local Institution - 0017

Sheffield S47QQ, United Kingdom

NOT_YET_RECRUITING

Local Institution - 0018

Crowborough TN6 1NY, United Kingdom

WITHDRAWN

Local Institution - 0024

London WC1N3BG, United Kingdom

NOT_YET_RECRUITING

Local Institution - 0004

Motherwell ML1 4UF, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

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

Sponsor contact

CONTACT

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

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

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-06