ADAGIO 3

A study to evaluate the long-term efficacy and safety of KarXT + KarX-EC for agitation associated with Alzheimer's disease

Conditions

Sponsor

Bristol-Myers Squibb

Clinical Trial

Phase III

Status

Enrolling by invitation

Drug

KarXT + KarX-EC

Countries

United Kingdom

This study is an open-label extension study.

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?

All participants will receive one an oral administration of KarXT + KarX-EC.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of this study is to evaluate the long-term efficacy and safety of KarXT + KarX-EC in people with agitation related to Alzheimer's disease, who completed the ADAGIO-1 or ADAGIO-2 study.

How long will the treatment last?

26 weeks

What your involvement will entail?

During the study, participants will be asked to complete tests that will assess their memory, activities of daily living, 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:

Have completed the ADAGIO-1 or ADAGIO-2 study
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.

Who cannot participate in the study?

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

A medical condition that may interfere with the safety and/or efficacy of the study (e.g. •untreated or unstable hypertension, clinically significant tachycardia, pulmonary, renal, hematologic, GI e.g. obstructive disorders, endocrine, immunologic, dermatologic, neurologic, or oncologic disease)
All grades of hepatic impairment
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

2024-519994-20-00

Clinicaltrials.gov identifier

NCT06937229

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.

Link to public registries

https://clinicaltrials.gov/study/NCT06937229