Agitation, Alzheimer Disease
Conditions
Keywords
Agitation, Alzheimer disease, KarXT, KarX-EC
Brief summary
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
DRUGKarXT
Specified dose on specified days
DRUGKarX-EC
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to approximately Week 30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to approximately Week 30 | — |
| Number of Participants With Serious AEs (SAEs) | Up to approximately Week 30 | — |
| Number of Participants With TEAEs Leading to Study Withdrawal | Up to approximately Week 30 | — |
| Number of Participants With TEAEs Leading to Death | Up to approximately Week 30 | — |
| Number of Participants with Adverse Events of Special Interest (AESI) | Up to approximately Week 30 | — |
| Change From Baseline in Barnes Akathisia Rating Scale (BARS) | Up to approximately Week 26 | — |
| Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) | Up to approximately Week 26 | — |
| Change From Baseline in Body Weight | Up to approximately Week 26 | — |
| Change From Baseline in Body Mass Index (BMI) | Up to approximately Week 26 | — |
| Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Heart Rate (HR) | Up to approximately Week 30 | This includes measuring of HR, both supine and standing or seated and upon standing after 2 minutes. |
| Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP) | Up to approximately Week 30 | This includes measuring of systolic and diastolic BP, both supine and standing or seated and upon standing after 2 minutes. |
| Number of Participants With Clinically Significant Changes in Laboratory Evaluations | Up to approximately Week 30 | — |
| Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) | Up to approximately Week 26 | — |
| Number of Participants With Suicidal Ideations as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to approximately Week 30 | — |
| Number of Participants With Cognitive Impairment as Assessed by Mini-mental State Examination (MMSE) | Up to approximately Week 26 | — |
| Number of Participants With Cognitive Impairment as Assessed by 13-item Variation of ADAS-Cog Scale (ADAS-Cog-13) | Up to approximately Week 26 | — |
| Change From Baseline in the Severity of Benign Prostatic Hyperplasia as Assessed by International Prostate Symptom Score (IPSS) | Up to approximately Week 26 | This analysis is done in male participants. |
Countries
Argentina, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Portugal, Romania, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed