A study to evaluate safety and efficacy of KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease
Information about the drug that will be tested in the study
Name of the drugs
KarXT is the main investigational medicine that combines two agents: xanomeline (a drug that stimulates certain brain receptors important for cognition and behaviour) and trospium (a compound that helps reduce side effects outside the brain).
KarX-EC is an enteric-coated formulation of xanomeline, meaning the xanomeline is coated to be released in the intestine rather than the stomach, which can improve tolerability and the delivery profile.
Administration
Oral administration (capsules)
Is the drug already on the market for another medical condition?
KarXT is approved in the US and China for the treatment of schizophrenia in adults.
Will all participants receive the same drug?
Participants will be selected by chance to receive one of the following options:
- An oral administration of KarXT + KarX-EC
- An oral administration of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).
Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.
Information about participating in the trial
What are the researchers trying to find out?
The purpose of the study is to evaluate the safety and efficacy of KarXT + KarX-EC for the treatment of psychosis associated with Alzheimer's disease dementia.
How long will the treatment last?
- 14 weeks
What your involvement will entail?
- During the study, participants will be asked to complete tests that will assess their memory, hallucination, delusion, agitation and psychosis
- Complete some laboratory tests to evaluate the emergent adverse events (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)
- Do physical examination and an electrocardiogram (ECG), which is a test that records the electrical activity of the heart.
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be 55 to 90 years old
- Have a biomarker confirmed diagnosis of Alzheimer’s disease, in accordance with the 2024 Alzheimer's Association criteria
- Have results of brain scans (MRI, CT) consistent with the clinical diagnosis of Alzheimer's disease
- History of psychotic symptoms (according to the International Psychogeriatric Association [IPA] criteria) during the past two months.
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- Psychotic symptoms that are primarily attributable to a condition other than Alzheimer's disease-causing dementia (e.g., schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features)
- History of major depressive episode with psychotic features during the last 12 months
- A disease that may interfere with the safety or study assessments (e.g., pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease).
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
Clinicaltrials.gov identifier
NCT06947941
EU CT Number
2025-521057-16
Study contact information
Link to full text
https://clinicaltrials.gov/study/NCT06947941
Study's website
https://www.bmsclinicaltrials.com/content/studyconnect/us/en/clinical-trials/NCT06947941.html
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov) in August 2026.
This document has been reviewed by a member of the European Dementia Carers Working Group.
This document has been reviewed by the pharmaceutical company running this trial.
