ADAGIO 2

Information about the drug that will be tested in the study

Name of the drugs

KarXT + KarX-EC

• 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 this study is to evaluate the efficacy and safety of KarXT + KarX-EC in people with agitation related to Alzheimer's disease.

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 agitation and aggression
• To 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 between 55 and 90 years old
• Have a confirmed diagnosis of Alzheimer’s disease, in accordance with the 2024 Alzheimer's Association criteria
• Have a score between 5 and 22 in the MMSE test (a test about your thinking skills)
• Have a study partner who has a sufficient contact with the participant (10 hours/week), is willing to participate in study procedures throughout the study duration.
• History of agitation.

Who cannot participate in the study?

People cannot take part in the study if they have or have experienced:

• Agitation symptoms that are primarily attributable to a condition other than the Alzheimer’s disease causing dementia
• History of bipolar disorder, schizophrenia or schizoaffective disorder
• History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma
• Risk of suicidal behaviour.

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

EuCT Number

2025-520612-34-00

Clinicaltrials.gov identifier

NCT07011745

Study contact information

Clinical.Trials@bms.com

Link to full text

https://euclinicaltrials.eu/ctis-public/view/2025-520612-34-00 

https://clinicaltrials.gov/study/NCT07011745 

Study's website

https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT07011745?id=NCT07011745 

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) in April 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.