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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Must have completed study KAR-031 (CN012-0026), KAR-032(CN012-0027), or CN012-0056. This Inclusion criterion is not applicable for Protocol Amendment 07 or later versions.
* Can understand the nature of the study and protocol requirements and provide a signed informed consent (IC) form before any study assessments are performed. If the subject is deemed not competent to provide IC, both the following requirements for consent must be met:

  1. The subject's legally acceptable representative (LAR) must provide IC
  2. The subject must provide informed assent
* Must have stable living environment. At entry into this study, or any time during the study, if a subject needs to relocate from home, a residential assisted-living facility, or other stable location to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study.

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 KAR-031 (Visit 19), Study KAR-032 (Visit 12), Study CN012-0056 (Visit 12) 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 KAR-033.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where it's running

• Advanced Research Center, Inc.
  Anaheim, California, United States Recruiting
• USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)
  Los Angeles, California, United States Recruiting
• SC3 Research - Pasadena - 960 E. Green St
  Pasadena, California, United States Recruiting
• Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS
  Walnut Creek, California, United States Recruiting
• University of Connecticut Health Center
  Farmington, Connecticut, United States Recruiting
• Envision Trials LLC
  Bonita Springs, Florida, United States Recruiting

+382 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ML-007C-MA for hallucinations and delusions in Alzheimer's disease

  This will test whether ML-007C-MA reduces hallucinations and delusions in people aged 55–90 with Alzheimer's-related psychosis.

  Recruiting at 61 sites Phase 2 MapLight Therapeutics · Phoenix, Arizona and 61 other locations · NCT06887192

• KarXT for psychosis in people with Alzheimer's disease

  This Phase 3 test will see if KarXT reduces hallucinations and delusions in people aged 55–90 who have Alzheimer's-related psychosis.

  Recruiting at 7 sites Phase 3 Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Chandler, Arizona and 156 other locations · NCT06126224

• Evaluating KarXT for treating psychosis in Alzheimer's patients

  This study is testing a new treatment called KarXT to see if it can help people with Alzheimer's who are experiencing psychosis and prevent them from getting worse.

  Recruiting at 36 sites Phase 3 Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Homewood, Alabama and 128 other locations · NCT05511363

• Multiple-dose safety and tolerability test of LY03020 in healthy adults and people with stable schizophrenia

  This test will see if taking repeated oral doses of LY03020 is safe and tolerated by healthy Chinese adults and people with stable schizophrenia.

  Recruiting Phase 1 Luye Pharma Group Ltd. · Beijing · NCT07230652

• Testing ACP-204 for treating psychosis in Alzheimer's patients

  This study is testing a new medication called ACP-204 to see if it can help reduce psychotic symptoms in people with Alzheimer's disease.

  Recruiting at 73 sites Phase 2/3 ACADIA Pharmaceuticals Inc. · Chandler, Arizona and 154 other locations · NCT06159673

• Understanding brain mechanisms of psychosis in Alzheimer's disease

  This study is trying to understand how changes in the brain related to tau protein might cause psychotic symptoms in people with Alzheimer's disease.

  Recruiting Northwell Health · Manhasset, New York · NCT05847192

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.