A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
Recruiting · NCT06976216 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Who can take part
Age range
60 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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/Exclusion criteria apply.
Where it is running
60 locations listed across 17 US states.
- Healthy Brain Clinic - Long Beach, California, United States
- Anderson Clinical Research - Redlands, California, United States
- Mountain Neurological Research Center - Basalt, Colorado, United States
- Georgetown University Medical Center - Washington D.C., District of Columbia, United States
- JEM Research Institute - Atlantis, Florida, United States
- VIN-Julie Schwartzbard - Aventura, Florida, United States
- Merritt Island Medical Research, LLC - Merritt Island, Florida, United States
- Renstar Medical Research - Ocala, Florida, United States
- Alzheimer's Research and Treatment Center - Stuart, Florida, United States
- Charter Research - Lady Lake - The Villages, Florida, United States
- Local Institution - 0016 - Columbus, Georgia, United States
- Center for Advanced Research & Education - Gainesville, Georgia, United States
- Re:Cognition Health - Chicago - Chicago, Illinois, United States
- Ascension Alexian Brothers - Elk Grove Village, Illinois, United States
- Boston Center for Memory - Newton, Massachusetts, United States
- HealthPartners Neuroscience Center - Saint Paul, Minnesota, United States
- Advanced Memory Research Institute of New Jersey - Toms River, New Jersey, United States
- NYU Langone Health - New York, New York, United States
- Local Institution - 0259 - New York, New York, United States
- SUNY Upstate Medical University - Syracuse, New York, United States
- AMC Research, LLC - Matthews, North Carolina, United States
- Ohio State University - Columbus, Ohio, United States
- NDx Clinical Research Inc. - Dayton, Ohio, United States
- Summit Headlands - Portland, Oregon, United States
- Local Institution - 0004 - Abington, Pennsylvania, United States
- Rhode Island Mood & Memory Research Institute - East Providence, Rhode Island, United States
- Neurology Clinic, P.C. - Cordova, Tennessee, United States
- Gadolin Research - Beaumont, Texas, United States
- Local Institution - 0300 - Aachen, Germany
- Local Institution - 0230 - Antofagasta, Chile
- Local Institution - 0302 - Berlin, Germany
- Local Institution - 0277 - Bremen, Germany
- Azienda Ospedaliera Spedali Civili di Brescia - Brescia, Italy
- Institutul Național de Gerontologie și Geriatrie "Ana Aslan" - Bucharest, Romania
- Centrul de Sanatate Mintala - Bucharest, Romania
- Local Institution - 0271 - Buenos Aires, Argentina
- Fundación Lennox - Instituto Modelo de Neurología - Córdoba, Argentina
- Sanatorio Morra S.A. - Córdoba, Argentina
- Instituto Kremer - Córdoba, Argentina
- St Vincent's Hospital Sydney Limited - Darlinghurst, Australia
- Local Institution - 0294 - Dijon, France
- Local Institution - 0275 - Hamburg, Germany
- Institutul de Psihiatrie Socola - Iași, Romania
- Hospital Clinico San Carlos - Madrid, Spain
- TUM Klinikum - Munich, Germany
- ALPHA Recherche Clinique - Québec, Canada
- Vestra Clinics - Rychnov nad Kněžnou, Czechia
- Instituto De Neurologia Dra. Ivonne Fraga - San Juan, Puerto Rico
- Hospital das Clinicas FMUSP - São Paulo, Brazil
- Klinika za psihijatriju "Vrapče" - Zagreb, Croatia
- Local Institution - 0295 - Nice, Alpes-Maritimes, France
- University General Hospital of Alexandroupoli - Alexandroupoli, Anatolikí Makedonía Kai Thráki, Greece
- Hospital Victoria Eugenia - Seville, Andalusia, Spain
- Local Institution - 0256 - Athens, Attikí, Greece
- Aiginiteio University Hospital - Athens, Attikí, Greece
- Local Institution - 0301 - Mannheim, Baden-Wurttemberg, Germany
- Hospital Universitari General de Catalunya - Sant Cugat del Vallès, Barcelona [Barcelona], Spain
- OCT Research ULC - Kelowna, British Columbia, Canada
- Richmond Clinical Trials - Richmond, British Columbia, Canada
- Neuro Health Centrum - Brno, Brno-město, Czechia
Showing 60 of 119 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →