NCT06937229 · Phase 3 · RECRUITING
A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
This Phase 3 trial is testing two drug formulations — KarXT and KarX-EC, both containing the same active ingredient xanomeline — for long-term management of agitation in people with Alzheimer's disease. It is an extension study, meaning only participants who finished one of two earlier trials can enroll. Phase 3 means the drug is being evaluated at a larger scale before potential approval, but it is not yet approved for this use.
You may qualify if
- Participants must have completed study CN012-0023 or CN012-0024 per protocol.
- Participants must have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more).
You're excluded if
- Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
- Other protocol-defined Inclusion/Exclusion criteria apply.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-06-02