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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately Week 30
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)
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Local Institution - 2609
Chandler, Arizona, United States
NOT_YET_RECRUITINGImaging Endpoints
Scottsdale, Arizona, United States
RECRUITINGLocal Institution - 1657
Anaheim, California, United States
NOT_YET_RECRUITINGLocal Institution - 2620
Canoga Park, California, United States
NOT_YET_RECRUITINGLocal Institution - 1637
La Jolla, California, United States
NOT_YET_RECRUITINGLocal Institution - 2625
Long Beach, California, United States
NOT_YET_RECRUITINGLocal Institution - 2607
Long Beach, California, United States
NOT_YET_RECRUITINGLocal Institution - 2642
Long Beach, California, United States
NOT_YET_RECRUITINGLocal Institution - 2613
Pasadena, California, United States
NOT_YET_RECRUITINGLocal Institution - 1662
Pomona, California, United States
NOT_YET_RECRUITING...and 234 more locations
This includes measuring of HR, both supine and standing or seated and upon standing after 2 minutes.
Time frame: Up to approximately Week 30
Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP)
This includes measuring of systolic and diastolic BP, both supine and standing or seated and upon standing after 2 minutes.
Time frame: Up to approximately Week 30
Number of Participants With Clinically Significant Changes in Laboratory Evaluations
Time frame: Up to approximately Week 30
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
Time frame: Up to approximately Week 26
Number of Participants With Suicidal Ideations as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately Week 30
Number of Participants With Cognitive Impairment as Assessed by Mini-mental State Examination (MMSE)
Time frame: Up to approximately Week 26
Number of Participants With Cognitive Impairment as Assessed by 13-item Variation of ADAS-Cog Scale (ADAS-Cog-13)
Time frame: Up to approximately Week 26
Change From Baseline in the Severity of Benign Prostatic Hyperplasia as Assessed by International Prostate Symptom Score (IPSS)
This analysis is done in male participants.
Time frame: Up to approximately Week 26