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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
KarXT
DrugSpecified dose on specified days
KarX-EC
DrugSpecified dose on specified days
Treatment groups
650 Participants
are divided into 1 treatment groupGroup A: KarXT+KarX-ECExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame
Up to approximately Week 30Secondary outcomes
1
Number of Participants With Adverse Events (AEs)
Time frame
Up to approximately Week 302
Number of Participants With Serious AEs (SAEs)
Time frame
Up to approximately Week 303
Number of Participants With TEAEs Leading to Study Withdrawal
Time frame
Up to approximately Week 304
Number of Participants With TEAEs Leading to Death
Time frame
Up to approximately Week 30Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov