Recruiting NCT06937229

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

Phase III Interventional Alzheimer Disease Agitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: KarXT, KarX-EC.
Who it may be relevant to: Registry conditions: Alzheimer Disease, Agitation. Basic parameters: 55 years — 90 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Brazil, Bulgaria, Canada +21
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Interventions

Drug KarXT
Specified dose on specified days
Drug KarX-EC
Specified dose on specified days

Primary outcome measures

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to approximately Week 30]

Secondary outcome measures (12)

Number of Participants With Adverse Events (AEs) [Time frame: Up to approximately Week 30]
Number of Participants With Serious AEs (SAEs) [Time frame: Up to approximately Week 30]
Number of Participants With TEAEs Leading to Study Withdrawal [Time frame: Up to approximately Week 30]
Number of Participants With TEAEs Leading to Death [Time frame: Up to approximately Week 30]
Number of Participants with Adverse Events of Special Interest (AESI) [Time frame: Up to approximately Week 30]
Change From Baseline in Barnes Akathisia Rating Scale (BARS) [Time frame: Up to approximately Week 26]
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) [Time frame: Up to approximately Week 26]
Change From Baseline in Body Weight [Time frame: Up to approximately Week 26]
Change From Baseline in Body Mass Index (BMI) [Time frame: Up to approximately Week 26]
Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Heart Rate (HR) [Time frame: Up to approximately Week 30]
Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP) [Time frame: Up to approximately Week 30]
Number of Participants With Clinically Significant Changes in Laboratory Evaluations [Time frame: Up to approximately Week 30]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Single group
Masking: Open label
Primary purpose: Treatment