A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age55-90
SponsorBristol-Myers Squibb
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- KarXT
- KarX-EC
Treatment groups
650 Participants
are divided into 1 treatment groupLocations
256Argentina
Local Institution - 20051058, Ciudad Autonoma de Buenos AiresBuenos Aires, Argentina
Local Institution - 10011900, La PlataBuenos Aires, Argentina
Local Institution - 1002B7602CBM, Mar del PlataBuenos Aires, Argentina
Local Institution - 20061133, Buenos AiresBuenos Aires F.D., Argentina
Sponsors and collaborators
Bristol-Myers Squibb
Lead sponsor
Source ClinicalTrials.gov