Alzheimer's Disease
Conditions
Keywords
Dementia, Cognitive Impairment, Kar-XT, KarX-EC, Mild Alzheimer's Disease, Moderate Alzheimer's Disease
Brief summary
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Interventions
DRUGKarXT
Specified dose on specified days
DRUGKarX-EC
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach. * Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening. * Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities. * Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.
Exclusion criteria
* Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment, urinary retention, active biliary disease, moderate-severe renal impairment (eGFR of \<50 mL/min), and unstable hypertension or tachycardia. * Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion. * Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening. * Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that reflect significant pathology other than AD or could affect safety or interfere with study procedures. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) | At week 24 |
| Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+) | At week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL) | At week 24 |
| Change from baseline in neuro psychiatric inventory (NPI) total score | At week 24 |
| Number of participants with adverse events (AEs) | At week 24 |
| Number of participants with serious adverse events (SAEs) | At week 24 |
| Number of participants with adverse event of special interest (AESIs) | At week 24 |
| Number of participants with AEs leading to study intervention discontinuation | At week 24 |
| Number of participants with AEs leading to study discontinuation | At week 24 |
| Number of participants with AEs leading to death | At week 24 |
| Number of participants with clinically significant changes in vital signs | At week 24 |
| Number of participants with clinically significant changes in electrocardiogram (ECG) tests | At week 24 |
| Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale (C-SSRS) tests | At week 24 |
| Number of participants with clinically significant changes in weight | At week 24 |
| Number of participants with clinically significant changes in safety laboratory tests | At week 24 |
Countries
Argentina, Australia, Brazil, Canada, Chile, Croatia, Czechia, France, Germany, Greece, India, Italy, Netherlands, Poland, Puerto Rico, Romania, South Korea, Spain, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed