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A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

NCT06937229

RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Alzheimer Disease, Agitation

Interventions: KarXT, KarX-EC

Countries: United States, Argentina, Brazil, Bulgaria, Canada, Chile, China, Croatia

The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.

Eligibility overview

Sex: ALL

Age: 55 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (258)
  • Chandler, Arizona, United States
  • Scottsdale, Arizona, United States
  • Anaheim, California, United States
  • Canoga Park, California, United States
  • La Jolla, California, United States
  • Long Beach, California, United States
  • Long Beach, California, United States
  • Long Beach, California, United States
  • Orange, California, United States
  • Pasadena, California, United States
  • Pomona, California, United States
  • Torrance, California, United States
  • Walnut Creek, California, United States
  • Bonita Springs, Florida, United States
  • Hialeah, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Port Orange, Florida, United States
  • Tampa, Florida, United States
  • Virginia Gardens, Florida, United States
  • Atlanta, Georgia, United States
  • Gaithersburg, Maryland, United States
  • Newton, Massachusetts, United States
  • Worcester, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Troy, Michigan, United States
  • Saint Paul, Minnesota, United States
  • Hattiesburg, Mississippi, United States
  • Las Vegas, Nevada, United States
  • + 228 more on CT.gov