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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (8 UK sites)
Local Institution - 0005
Exeter EX12LU, United Kingdom
Local Institution - 0023
London W1G 8TA, United Kingdom
Local Institution - 0015
Oxford OX3 7JX, United Kingdom
Local Institution - 0009
Chertsey KT160PZ, United Kingdom
Local Institution - 0017
Sheffield S47QQ, United Kingdom
Local Institution - 0018
Crowborough TN6 1NY, United Kingdom
Local Institution - 0024
London WC1N3BG, United Kingdom
Local Institution - 0004
Motherwell ML1 4UF, United Kingdom
How to Get in Touch
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
Sponsor contactCONTACT
First line of the email MUST contain NCT # and Site #.
Sponsor contactCONTACT
