A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
Launched by BRISTOL-MYERS SQUIBB · May 9, 2025
Trial Information
Current as of August 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment combination called KarXT and KarX-EC to see how well it works and how safe it is for people with Alzheimer's disease who have mild to moderate cognitive impairment. The goal is to improve memory and thinking skills in participants. The study is not yet recruiting, and it will include both men and women aged between 21 and 75 years.
To participate, individuals must have a confirmed diagnosis of Alzheimer's disease, specifically in the early to middle stages, and a Mini-Mental State Examination (MMSE) score between 12 and 22, which helps measure their cognitive abilities. Each participant will need a caregiver who can be involved in the study and attend visits with them. There are some health conditions that would prevent people from joining, such as severe medical issues or certain psychiatric disorders. Participants can expect regular visits and monitoring throughout the study to ensure their safety and to assess how the treatment is affecting them.
Gender
ALL
Eligibility criteria
- • 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.
- • 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 could affect safety or interfere with study procedures.
- • Other protocol-defined Inclusion/Exclusion criteria apply.
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Newton, Massachusetts, United States
Gainesville, Georgia, United States
Merritt Island, Florida, United States
Aventura, Florida, United States
Matthews, North Carolina, United States
The Villages, Florida, United States
Long Beach, California, United States
Redlands, California, United States
Basalt, Colorado, United States
Washington, District Of Columbia, United States
Atlantis, Florida, United States
Aventura, Florida, United States
Merritt Island, Florida, United States
Ocala, Florida, United States
Stuart, Florida, United States
The Villages, Florida, United States
Columbus, Georgia, United States
Gainesville, Georgia, United States
Chicago, Illinois, United States
Elk Grove Village, Illinois, United States
Newton, Massachusetts, United States
Watertown, Massachusetts, United States
Saint Paul, Minnesota, United States
Toms River, New Jersey, United States
New York, New York, United States
Syracuse, New York, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Portland, Oregon, United States
Abington, Pennsylvania, United States
East Providence, Rhode Island, United States
Cordova, Tennessee, United States
Knoxville, Tennessee, United States
Beaumont, Texas, United States
Banfield, Buenos Aires, Argentina
Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina
Buenos Aires, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Kogarah, New South Wales, Australia
Macquarie Park, New South Wales, Australia
Sydney, New South Wales, Australia
Carlton, Victoria, Australia
Perth, Western Australia, Australia
Brasília, Distrito Federal, Brazil
Curitiba, Paraná, Brazil
Aracaju, Sergipe, Brazil
São Paulo, , Brazil
Kelowna, British Columbia, Canada
Richmond, British Columbia, Canada
Halifax, Nova Scotia, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Greenfield Park, Quebec, Canada
Victoriaville, Quebec, Canada
Quebec, , Canada
Antofagasta, An, Chile
Providencia, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Osijek, , Croatia
Rijeka, , Croatia
Zagreb, , Croatia
Brno, Brno Město, Czechia
Olomouc, Olomoucký Kraj, Czechia
Plzen, Plzeň Město, Czechia
Prague, Praha 6, Czechia
Praha, Praha 6, Czechia
Praha, Praha 8, Czechia
Rychnov Nad Kněžnou, , Czechia
München, Bayern, Germany
Westerstede, Niedersachsen, Germany
Münster, Nordrhein Westfalen, Germany
Mainz, Rheinland Pfalz, Germany
Berlin, , Germany
Bremen, , Germany
Hamburg, , Germany
Athens, Attikí, Greece
Athens, Attikí, Greece
Thessaloniki, Thessaloníki, Greece
Larissa, Thessalía, Greece
Alexandroupolis, , Greece
Bengaluru, Karnataka, India
Hyderabad, Telangana, India
Hyderabad, Telangana, India
Varanasi, Uttar Pradesh, India
Kolkata, West Bengal, India
Milano, Lombardia, Italy
Milano, Lombardia, Italy
Monza, Lombardia, Italy
Brescia, , Italy
Gwangju Si, Kwangju Kwangyǒkshi, Korea, Republic Of
Seongnam, Kyǒnggi Do, Korea, Republic Of
Gangseo Gu, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Torun, Kujawsko Pomorskie, Poland
Bialystok, Podlaskie, Poland
Gdansk, Pomorskie, Poland
Poznań, Wielkopolskie, Poland
San Juan, , Puerto Rico
Bucharest, București, Romania
Bucharest, București, Romania
Bucharest, București, Romania
Bucharest, București, Romania
Iași, , Romania
Seville, Andalucía, Spain
Sant Cugat Del Vallès, Barcelona [Barcelona], Spain
Barcelona, Catalunya [Cataluña], Spain
Lleida, Lleida [Lérida], Spain
Pamplona, Navarra, Spain
Madrid, , Spain
Curitiba, , Brazil
Providencia, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Brno, , Czechia
Olomouc, , Czechia
Plzen, , Czechia
Prague, , Czechia
Praha, , Czechia
Praha, , Czechia
Athens, , Greece
Athens, , Greece
Thessaloniki, , Greece
Larissa, , Greece
Gwangju Si, , Korea, Republic Of
Seongnam, , Korea, Republic Of
Gangseo Gu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Seville, , Spain
Sant Cugat Del Vallès, , Spain
Barcelona, , Spain
Lleida, , Spain
New York, New York, United States
New York, New York, United States
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported