Long-term safety study of a new treatment for psychosis in Alzheimer's disease

Plain-English translation of NCT05980949 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This is a long-term safety study of , a new medication being tested to treat psychosis (confusion, hallucinations, or unusual beliefs) that sometimes happens in people with Alzheimer's disease. If you've already completed an earlier trial of this treatment, this study invites you to continue taking the medication for up to one year so doctors can monitor how safe and tolerable it is over a longer period.

When someone has Alzheimer's disease, they may experience psychosis, which can be very difficult for them and their caregivers. This medication offers a new approach to treating these symptoms, and this study exists to make sure the treatment remains safe and effective when used long-term.

Do you qualify?

You likely qualify if…

you have completed one of the earlier KarXT trials (CN012-0026, CN012-0027, or CN012-0056)
you are between 55 and 90 years old
you are willing to provide informed consent or have a legally authorized representative who can do so
you have a caregiver who can spend about 10 hours per week with you
you understand the study requirements and can follow the study procedures

You likely don't qualify if…

you have serious medical conditions that could make the study unsafe for you
you have had abnormal heart, blood, or physical exam results at the end of your previous trial
you are planning to participate in another drug or device study at the same time
you need to move to a nursing home facility without sponsor approval
you are unable to provide or arrange informed consent

What participation looks like

You will continue taking the study medication (or start it if you were in the control group of the earlier trial) for up to 52 weeks while visiting the study site for regular check-ins. During these visits, doctors will monitor your health, check for any side effects, and assess how well the medication is working. Your caregiver will also be involved in supporting you throughout the study.

AI-generated summary from trial data · Jun 13, 2026 · Not medical advice

Trial locations(428 sites)

United States

Local Institution - 1029, Homewood, Alabama

Local Institution - 1-13H98LK9, Chandler, Arizona

Local Institution - 1227, Chandler, Arizona

Local Institution - 1116, Chandler, Arizona

Local Institution - 1247, Gilbert, Arizona