A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
Launched by BRISTOL-MYERS SQUIBB · Apr 15, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The ADAGIO-3 study is a clinical trial focused on testing a new treatment for agitation in people with Alzheimer’s Disease. This trial will specifically look at the long-term effects and safety of a combination medication called KarXT and KarX-EC in individuals who have already participated in previous studies. Agitation can include symptoms like restlessness, irritability, or emotional distress, which can be challenging for both patients and their caregivers.
To be eligible for this trial, participants must have completed one of the earlier studies (CN012-0023 or CN012-0024) and have a caregiver who can provide support and assistance for around 10 hours a week. It’s important to note that individuals with serious health issues affecting the heart, lungs, or other critical systems may not be eligible, as their safety and the reliability of the study results are top priorities. While the study is not recruiting participants yet, those interested should keep an eye out for updates on when it will begin.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participants must have completed study CN012-0023 or CN012-0024 per protocol.
- • Participants must have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more).
- 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/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
Athens, , Greece
Malaga, , Spain
Brasília, Distrito Federal, Brazil
Curitiba, Paraná, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Rio De Janeiro, , Brazil
São Paulo, , Brazil
Brno, Jihomoravský Kraj, Czechia
Olomouc, Olomoucký Kraj, Czechia
Prague, Praha 6, Czechia
Praha, Praha 8, Czechia
Chocen, , Czechia
Plzeň, , Czechia
Prague, , Czechia
Praha 10, , Czechia
Toulouse, Haute Garonne, France
Villeurbanne, Rhône, France
Lille, , France
Limoges, , France
Paris, , France
Strasbourg Cedex, , France
Erbach, Hessen, Germany
Düsseldorf, , Germany
Halle /Saale, , Germany
Westerstede, , Germany
Patras, Achaḯa, Greece
Athens, Attiki, Greece
Athens, Attiki, Greece
Athens, , Greece
Athens, , Greece
Athens, , Greece
Ioannina, , Greece
Thessaloniki, , Greece
Győr, Győr Moson Sopron, Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Petch Tikva, Il, Israel
Jerusalem, , Israel
Ramat Gan, , Israel
Napoli, Campania, Italy
Roma, Lazio, Italy
Roma, Lazio, Italy
Milano, Lombardia, Italy
Pisa, Pi, Italy
Brescia, , Italy
Isernia, , Italy
Roma, , Italy
Hadano, Kanagawa, Japan
Kawasaki, Kanagawa, Japan
Sakai, Osaka, Japan
Karatsu Shi, Saga Ken, Japan
Kanzaki Gun Yoshinogari Cho, Saga, Japan
Bunkyo Ku, Tokyo, Japan
Fukuoka, , Japan
Okayama, , Japan
Incheon, , Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Deagu, Taegu Kwangyǒkshi, Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Saltillo, Coahuila, Mexico
Guadajalara, Jalisco, Mexico
Monterrey, Nuevo León, Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
San Luis Potosi, , Mexico
Tlalnepantla De Baz, , Mexico
Lublin, , Poland
Poznan, , Poland
Coimbra, , Portugal
Guimaraes, , Portugal
Lisboa, , Portugal
Senhora Da Hora, , Portugal
Torres Vedras, , Portugal
Elche (Alicante), , Spain
Madrid, , Spain
Madrid, , Spain
Malaga, , Spain
Pamplona, , Spain
Salamanca, , Spain
Sevilla, , Spain
Terrassa, , Spain
Valladolid, , Spain
Zaragoza, , Spain
London, Greater London, United Kingdom
Chertsey, Surrey, United Kingdom
Cambridge, , United Kingdom
London, , United Kingdom
Preston, , United Kingdom
Redruth, , United Kingdom
Sheffield, , United Kingdom
Stafford, , United Kingdom
Wolverhampton, , United Kingdom
Chandler, Arizona, United States
Scottsdale, Arizona, United States
Canoga Park, California, United States
Long Beach, California, United States
Long Beach, California, United States
Pasadena, California, United States
San Diego, California, United States
Walnut Creek, California, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Troy, Michigan, United States
Saint Paul, Minnesota, United States
Las Vegas, Nevada, United States
West Long Branch, New Jersey, United States
Staten Island, New York, United States
Monroe, North Carolina, United States
Morehead City, North Carolina, United States
Blue Ash, Ohio, United States
Tulsa, Oklahoma, United States
Columbia, South Carolina, United States
Carrollton, Texas, United States
Cypress, Texas, United States
El Paso, Texas, United States
Mesquite, Texas, United States
San Antonio, Texas, United States
Bennington, Vermont, United States
Seattle, Washington, United States
Spokane, Washington, United States
Gyöngyös, Heves, Hungary
Budapest, , Hungary
Rishon Le'tzion, Central, Israel
Netanya, , Israel
Bydgoszcz, Kujawsko Pomorskie, Poland
Katowice, , Poland
Lublin, , Poland
Sochaczew, , Poland
Chorzów, śląskie, Poland
Zagreb, Grad Zagreb, Croatia
Rijeka, , Croatia
Split, , Croatia
Varazdin, , Croatia
Zagreb, , Croatia
Rychnov Nad Kneznou, , Czechia
Bucuresti, București, Romania
Bucuresti, , Romania
Getxo, Bizkaia, Spain
Bucharest, București, Romania
Bucuresti, București, Romania
Bucuresti, București, Romania
Bucuresti, București, Romania
Bucuresti, București, Romania
Bucuresti, București, Romania
Bucuresti, București, Romania
Constanta, , Romania
Iasi, , Romania
Sanpetru /Brasov, , Romania
Sibiu, , Romania
La Jolla, California, United States
Gaithersburg, Maryland, United States
Hyderabad, Andhra Pradesh, India
Hyderabad, Telangana, India
Varanasi, Uttar Pradesh, India
Kolkata, West Bengal, India
New Delhi, , India
Bonita Springs, Florida, United States
Ann Arbor, Michigan, United States
Ramat Gan, , Israel
Motherwell, , United Kingdom
Curitiba, , Brazil
Curitiba, , Brazil
Brno, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Praha, , Czechia
Villeurbanne, , France
Patras, , Greece
Győr, , Hungary
Incheon, Incheon Gwang'yeogsi, Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Deagu, , Korea, Republic Of
Monterrey, , Mexico
Chorzów, , Poland
Bucharest, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Kalocsa, , Hungary
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported