RECRUITINGPhase 3INTERVENTIONAL
A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Participants must have completed study CN012-0023 or CN012-0024 per protocol.
- Participants must have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more).
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Participants must have completed study CN012-0023 or CN012-0024 per protocol.
* Participants must have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more).
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.
Treatments Being Tested
DRUG
KarXT
Specified dose on specified days
DRUG
KarX-EC
Specified dose on specified days
Locations (20)
Local Institution - 2609
Chandler, Arizona, United States
Imaging Endpoints
Scottsdale, Arizona, United States
Local Institution - 1657
Anaheim, California, United States
Local Institution - 2620
Canoga Park, California, United States
Local Institution - 1637
La Jolla, California, United States
Local Institution - 2625
Long Beach, California, United States
Local Institution - 2607
Long Beach, California, United States
Local Institution - 2642
Long Beach, California, United States
Local Institution - 2613
Pasadena, California, United States
Local Institution - 1662
Pomona, California, United States
Local Institution - 1651
Walnut Creek, California, United States
Local Institution - 2602
Bonita Springs, Florida, United States
Local Institution - 2626
Hialeah, Florida, United States
Local Institution - 1602
Miami, Florida, United States
Local Institution - 1618
Miami, Florida, United States
Local Institution - 1609
Miami, Florida, United States
Nuovida Research Center
Miami, Florida, United States
Local Institution - 1635
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
IPTB Clinical Research
Tampa, Florida, United States