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Long-term safety assessment of KarXT for Alzheimer's-related psychosis

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

Phase 3 Interventional Karuna Therapeutics, Inc., a Bristol Myers Squibb company · NCT05980949

This study is testing the long-term safety of a treatment called KarXT for people with Alzheimer's-related psychosis who have already participated in earlier trials.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment800 (estimated)
Ages55 Years to 90 Years
SexAll
SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company Industry-sponsored
Locations421 sites (Homewood, Alabama and 420 other locations)
Trial IDNCT05980949 on ClinicalTrials.gov

What this trial studies

This Phase 3 global, multicenter study is an open-label extension designed for participants who have completed previous studies involving KarXT. It aims to evaluate the long-term safety and tolerability of KarXT in individuals experiencing psychosis associated with Alzheimer's Disease. Eligible subjects will be monitored over a 52-week period to gather data on the treatment's effects and any adverse reactions. The study includes both randomized and non-randomized participants from earlier trials.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 55 to 90 who have completed specific prior studies and have a caregiver available.

Not a fit: Patients with significant or severe medical conditions that could interfere with the study's outcomes may not benefit from participation.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients suffering from psychosis related to Alzheimer's Disease.

How similar studies have performed: While this approach is based on previous studies, the long-term safety assessment of KarXT in this specific context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Must have completed study CN012-0026, CN012-0027 or CN012-0056.
* Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent CN012-0026, CN012-0027 or CN012-0056 study.
* Can understand the nature of the study and protocol requirements and provide a signed informed consent or, if deemed not competent to provide informed consent, the subject's legally acceptable representative must provide informed consent, and the subject must provide informed assent before any study assessments are performed.
* At entry into this study, or any time during the study, if a subject needs to relocate from home or residential assisted-living facility to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study.
* Have an identified or proxy caregiver (spends approximately 10 hours/week with the subject).

Exclusion Criteria:

* Significant or severe medical conditions that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results.
* Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study CN012-0026, CN012-0027 or CN012-0056 that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject.
* Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of CN012-0028.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

Homewood, Alabama and 420 other locations

+371 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Psychosis Associated With Alzheimer's Disease
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.