Long-term KarXT plus KarX-EC treatment for agitation in Alzheimer’s disease

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 interventional trial enrolls participants who completed parent studies CN012-0023 or CN012-0024 to receive a combined regimen of immediate-release KarXT and enteric KarX-EC capsules over an extended treatment period. Efficacy for agitation symptoms will be tracked alongside systematic safety monitoring, including cardiovascular and other adverse events, with regular clinic visits and caregiver-reported outcomes. An identified caregiver with approximately 10 hours per week contact is required to provide collateral information and support study procedures. The trial is sponsored by Bristol-Myers Squibb and conducted at selected U.S. clinical sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants must have completed study CN012-0023 or CN012-0024 per protocol.
* Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).

Exclusion Criteria:

* 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.

Where it's running

• Imaging Endpoints
  Scottsdale, Arizona, United States Recruiting
• Nuovida Research Center
  Miami, Florida, United States Recruiting
• Progressive Medical Research
  Port Orange, Florida, United States Recruiting
• IPTB Clinical Research
  Tampa, Florida, United States Recruiting
• Hope Research Network - Miami
  Virginia Gardens, Florida, United States Recruiting
• Boston Center for Memory
  Newton, Massachusetts, United States Recruiting

+202 more sites. See ClinicalTrials.gov for the full list.

Study contacts

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

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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.