Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
Launched by KARUNA THERAPEUTICS · Jul 31, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
The ADEPT-3 trial is studying a medication called KarXT to see how safe it is for people with psychosis related to Alzheimer's Disease over a longer period. This study is specifically for individuals who have completed earlier related studies (CN012-0026 or CN012-0027) and are aged between 55 and 90 years. Participants need to be able to understand the study and provide consent, or have a caregiver who can help with that. It's also important that they have someone who can assist them regularly, as this support can be crucial throughout the study.
If eligible, participants can expect to be part of this 52-week study where they will receive KarXT. The main focus is on monitoring how well they tolerate the medication over time. The study is currently recruiting participants and aims to ensure that everyone involved is safe and able to complete the study requirements. If at any point a participant needs to move to a nursing home, their continued participation will need to be approved by the study team. Overall, this trial hopes to gather important information about KarXT’s long-term effects on individuals facing these challenging symptoms.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Must have completed study CN012-0026, CN012-0027 or CN012-0056.
- • Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent CN012-0026, CN012-0027 or CN012-0056 study.
- • Can understand the nature of the study and protocol requirements and provide a signed informed consent or, if deemed not competent to provide informed consent, the subject's legally acceptable representative must provide informed consent, and the subject must provide informed assent before any study assessments are performed.
- • At entry into this study, or any time during the study, if a subject needs to relocate from home or residential assisted-living facility to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study.
- • Have an identified or proxy caregiver (spends approximately 10 hours/week with the subject).
- Key Exclusion Criteria:
- • Significant or severe medical conditions that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results.
- • Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study CN012-0026, CN012-0027 or CN012-0056 that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject.
- • Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of CN012-0028.
About Karuna Therapeutics
Karuna Therapeutics is a biopharmaceutical company dedicated to developing innovative treatments for neuropsychiatric diseases. Focused on addressing unmet medical needs in conditions such as schizophrenia and pain, Karuna leverages its proprietary drug development platform to advance novel therapeutic candidates through rigorous clinical trials. With a commitment to scientific excellence and patient-centric solutions, the company aims to transform the treatment landscape and improve the quality of life for individuals affected by complex mental health disorders.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, , Korea, Republic Of
Miami, Florida, United States
Valladolid, , Spain
Zaragoza, , Spain
Pleven, , Bulgaria
Praha, , Czechia
Salamanca, , Spain
Orlando, Florida, United States
Daytona Beach, Florida, United States
Culiacan, Sinaloa, Mexico
Kovin, , Serbia
Beijing, Beijing, China
Miami, Florida, United States
Miami, Florida, United States
Guangzhou, Guangdong, China
Miami, Florida, United States
Chengdu, Sichuan, China
Miami, Florida, United States
West Palm Beach, Florida, United States
Miami, Florida, United States
Lafayette, California, United States
Miami, Florida, United States
Zagreb, Grad Zagreb, Croatia
Shenzhen, Guangdong, China
Miami, Florida, United States
Anaheim, California, United States
Belgrade, , Serbia
Orlando, Florida, United States
Hialeah, Florida, United States
Miami Lakes, Florida, United States
Daytona Beach, Florida, United States
Hialeah, Florida, United States
Clermont, Florida, United States
Předměstí, , Czechia
Košice, , Slovakia
Phoenix, Arizona, United States
Irvine, California, United States
Lafayette, California, United States
Pasadena, California, United States
Bonita Springs, Florida, United States
Bradenton, Florida, United States
Clermont, Florida, United States
Doral, Florida, United States
Hialeah, Florida, United States
Homestead, Florida, United States
Maitland, Florida, United States
Miami Springs, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Saint Petersburg, Florida, United States
Stony Brook, New York, United States
Houston, Texas, United States
Sofia, Sofia Grad, Bulgaria
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Praha, Praha, Hlavní Mesto, Czechia
Kutná Hora, , Czechia
Plzeň, , Czechia
Bayreuth, Bayern, Germany
Homburg, Saarland, Germany
Roma, Lazio, Italy
Ponderano (Biella), Piemonte, Italy
Firenze, Toscana, Italy
Monza, , Italy
Roma, , Italy
Kovin, , Serbia
Kragujevac, , Serbia
Dubnica Nad Váhom, , Slovakia
Košice, , Slovakia
Vranov Nad Topľou, , Slovakia
Aberdeen, , United Kingdom
Motherwell, , United Kingdom
Homewood, Alabama, United States
Anaheim, California, United States
Costa Mesa, California, United States
Encino, California, United States
Encino, California, United States
Lancaster, California, United States
Los Alamitos, California, United States
Sherman Oaks, California, United States
Colorado Springs, Colorado, United States
Stamford, Connecticut, United States
Boca Raton, Florida, United States
Bonita Springs, Florida, United States
Clermont, Florida, United States
Cutler Bay, Florida, United States
Doral, Florida, United States
Doral, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Homestead, Florida, United States
Largo, Florida, United States
Maitland, Florida, United States
Maitland, Florida, United States
Miami Gardens, Florida, United States
Miami Lakes, Florida, United States
Miami Lakes, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Okeechobee, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Port Orange, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Viera, Florida, United States
Decatur, Georgia, United States
Berwyn, Illinois, United States
Elgin, Illinois, United States
Marrero, Louisiana, United States
Flowood, Mississippi, United States
Manhasset, New York, United States
Woodmere, New York, United States
Dayton, Ohio, United States
Charleston, South Carolina, United States
Cypress, Texas, United States
Flower Mound, Texas, United States
Frisco, Texas, United States
Houston, Texas, United States
Stafford, Texas, United States
Hasselt, Limburg, Belgium
Leuven, Vlaams Brabant, Belgium
Roeselare, West Vlaanderen, Belgium
Sofia, Sofia Grad, Bulgaria
Pleven, , Bulgaria
Hamilton, Ontario, Canada
Whitby, Ontario, Canada
Providencia, Metropolitana, Chile
Antofagasta, , Chile
Las Condes, , Chile
Hefei, Anhui, China
Beijing, Beijing, China
Beijing, Beijing, China
Chongqing, Chongqing, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Shenzhen, Guangdong, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Nanchang, Jiangxi, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Praha, Praha, Hlavní Mesto, Czechia
Kutná Hora, , Czechia
Plzeň, , Czechia
Praha 4, , Czechia
Rychnov Nad Kneznou, , Czechia
Reims, Marne, France
Rouen, Seine Maritime, France
Böblingen, Baden Württemberg, Germany
Athina, Attiki, Greece
Athina, Attiki, Greece
Chaidari, Athens, Attiki, Greece
Marousi, Attiki, Greece
Heraklion, , Greece
Pécs, Baranya, Hungary
Budapest, , Hungary
Miskolc, , Hungary
Roma, Lazio, Italy
Milano, Lombardia, Italy
Baggiovara, Modena, Italy
Pisa, , Italy
Buk Gu, Daegu Gwang'yeogsi, Korea, Republic Of
Seongnam Si, Gyeonggido, Korea, Republic Of
Incheon, , Korea, Republic Of
Seongnam Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Saltillo Centro, Coahuila, Mexico
Zapopan, Jalisco, Mexico
Monterrey, Nuevo Leon, Mexico
Monterrey, Nuevo Leon, Mexico
Culiacan, Sinaloa, Mexico
Mexico, , Mexico
Miraflores, Lima, Peru
Callao, , Peru
Lublin, Lubelskie, Poland
Lódz, Lódzkie, Poland
Bydgoszcz, , Poland
Katowice, , Poland
Katowice, , Poland
Siemianowice śląskie, , Poland
łódź, , Poland
ścinawa, , Poland
Beograd, Belgrade, Serbia
Beograd, Belgrade, Serbia
Belgrade, , Serbia
Belgrade, , Serbia
Belgrade, , Serbia
Kragujevac, , Serbia
Kragujevac, , Serbia
Novi Sad, , Serbia
Vršac, , Serbia
Kosice, Košický Kraj, Slovakia
Banská Bystrica, , Slovakia
Dubnica Nad Váhom, , Slovakia
Košice, , Slovakia
Vranov Nad Topľou, , Slovakia
Madrid, , Spain
Salamanca, , Spain
Sevilla, , Spain
Zamora, , Spain
Zaragoza, , Spain
Atakum, Samsun, Turkey
Eskisehir, , Turkey
Istanbul, , Turkey
Izmir, , Turkey
Izmir, , Turkey
Ilford, Greater London, United Kingdom
Swinton, Greater Manchester, United Kingdom
Preston, Lancashire, United Kingdom
Chertsey, , United Kingdom
Leeds, , United Kingdom
Sheffield, Southyorkshire, , United Kingdom
Sherman Oaks, California, United States
Cutler Bay, Florida, United States
Delray Beach, Florida, United States
Doral, Florida, United States
Fort Myers, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Miami Gardens, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Flowood, Mississippi, United States
Cypress, Texas, United States
Red Oak, Texas, United States
Verdun, Quebec, Canada
Antofagasta, , Chile
Zona Urbana Río Tijuana, Baja California, Mexico
ścinawa, , Poland
New York, New York, United States
Sofia, Sofia Grad, Bulgaria
Calgary, Alberta, Canada
Montreal, Quebec, Canada
Barcelona, , Spain
Swindon, , United Kingdom
Hangzhou, Zhejiang, China
Miami Springs, Florida, United States
Providencia, Metropolitana, Chile
Las Condes, , Chile
Shanghai, Shanghai, China
Lublin, Lubelskie, Poland
Tianjin, Tianjin, China
Ormond Beach, Florida, United States
Port Orange, Florida, United States
Toms River, New Jersey, United States
Ciudad Autónoma De Buenos Aires, , Argentina
Alken, , Belgium
Kalyftaki N. Kifissia, Attiki, Greece
Poznan, , Poland
Oradea, Bihor, Romania
Craiova, , Romania
Sibiu, , Romania
Gornja Toponica, , Serbia
Decatur, Georgia, United States
Lódz, Lódzkie, Poland
Phoenix, Arizona, United States
Farmington, Connecticut, United States
West Palm Beach, Florida, United States
Greensboro, North Carolina, United States
Morehead City, North Carolina, United States
Providence, Rhode Island, United States
Jette, Brussels, Belgium
Kortrijk, , Belgium
Sofia, , Bulgaria
Thessaloniki, , Greece
Szeged, Csongrád, Hungary
Kielce, , Poland
Bayamon, , Puerto Rico
San Juan, , Puerto Rico
Constanta, , Romania
Miami Lakes, Florida, United States
Ocoee, Florida, United States
Atlanta, Georgia, United States
San Antonio, Texas, United States
Brasília, Distrito Federal, Brazil
Plovdiv, , Bulgaria
Ruse, , Bulgaria
Toulouse, , France
Bayamon, , Puerto Rico
San Juan, , Puerto Rico
Bucuresti, , Romania
Pezinok, , Slovakia
Majadahonda, Madrid, Spain
Lleida, , Spain
Madrid, , Spain
Rancho Cucamonga, California, United States
Miami, Florida, United States
Ormond Beach, Florida, United States
San Rafael, , Argentina
Anaheim, California, United States
Miami, Florida, United States
Lakewood, California, United States
Los Angeles, California, United States
Orange, California, United States
Atlantis, Florida, United States
Deerfield Beach, Florida, United States
Homestead, Florida, United States
Tampa, Florida, United States
Toms River, New Jersey, United States
Syracuse, New York, United States
Roma, , Italy
Koriyama, Fukushima, Japan
Toride Shi, Ibaraki, Japan
Takamatsu Shi, Kagawa, Japan
Hadano, Kanagawa, Japan
Kawasaki Shi, Kanagawa, Japan
Yokohama Shi, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Kyoto Shi, Kyoto, Japan
Sakai, Osaka, Japan
Hachioji, Tokyo, Japan
Setagaya Ku, Tokyo, Japan
Setagaya Ku, Tokyo, Japan
Kumamoto, , Japan
Yeongdeungpo Gu, Seoul Teugbyeolsi, Korea, Republic Of
Lodz, , Poland
Miami, Florida, United States
Saltillo Centro, Coahuila, Mexico
Preston, , United Kingdom
Chandler, Arizona, United States
Walnut Creek, California, United States
Homestead, Florida, United States
Homestead, Florida, United States
Rochester Hills, Michigan, United States
Columbus, Ohio, United States
Charleston, South Carolina, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Cordoba, , Argentina
Sofia, Sofia Grad, Bulgaria
Hamilton, Ontario, Canada
Ashkelon, Tel Aviv, Israel
Seoul, , Korea, Republic Of
Kosice, Košický Kraj, Slovakia
Miami, Florida, United States
Chandler, Arizona, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Desoto, Texas, United States
Plano, Texas, United States
Budapest, , Hungary
Roma, Lazio, Italy
Nagpur, Maharashtra, India
Sapporo, Hokkaido, Japan
Miami, Florida, United States
Sweetwater, Florida, United States
Guangzhou, Guangdong, China
Belmont, Massachusetts, United States
Matthews, North Carolina, United States
Lisbon, Lisboa, Portugal
Torres Vedras, Lisboa, Portugal
Chandler, Arizona, United States
Woodmere, New York, United States
Nashville, Tennessee, United States
Sofia, Sofia Grad, Bulgaria
Erbach, Hessen, Germany
Frankfurt Am Main, , Germany
Jerusalem, Yerushalayim, Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Wroclaw, Dolnoslaskie, Poland
Poznan, Wielkopolskie, Poland
Gdansk, , Poland
Ankara, , Turkey
Miami, Florida, United States
The Villages, Florida, United States
Brasília, Distrito Federal, Brazil
São Paulo, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
Rio De Janeiro, , Brazil
Tours, Indre Et Loire, France
Rouen, Seine Maritime, France
Böblingen, Baden Württemberg, Germany
Szeged, Csongrád, Hungary
Gyöngyös, , Hungary
Roma, Lazio, Italy
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, , Korea, Republic Of
Gornja Toponica, , Serbia
Pezinok, , Slovakia
Miami, Florida, United States
Miami, Florida, United States
Nice, Alpes Maritimes, France
Erbach, Hessen, Germany
Frankfurt Am Main, , Germany
Yoshinogawa, Tokushima, Japan
Ansan Si, Gyeonggido, Korea, Republic Of
São Paulo, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
Milano, Lombardia, Italy
Hiroshima, , Japan
Ciudad Autonoma De Buenos Aires, , Argentina
Lisboa, , Portugal
Himeji Shi, Hyogo, Japan
Hialeah, Florida, United States
El Paso, Texas, United States
Buenos Aires, , Argentina
Alken, , Belgium
Roma, Lazio, Italy
Brescia, Lombardia, Italy
Rome, Roma, Italy
Iizuka, Fukuoka, Japan
Toride Shi, Ibaraki, Japan
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Lodz, , Poland
Guimarães, Braga, Portugal
Matosinhos, Porto, Portugal
Lisboa, , Portugal
Hialeah, Florida, United States
Port Orange, Florida, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Gyongyos, , Hungary
Gornja Toponica, , Serbia
Gyongyos, , Hungary
Miami, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Toms River, New Jersey, United States
São Paulo, Sao Paulo, Brazil
Rio De Janeiro, , Brazil
Roma, Lazio, Italy
Brescia, Lombardia, Italy
Iizuka, Fukuoka, Japan
Kumamoto, , Japan
Gdansk, , Poland
Miami, Florida, United States
Toms River, New Jersey, United States
Gdansk, Pomorskie, Poland
Tsu Shi, Mie, Japan
Takatsuki, Osaka, Japan
Tatebayashi, , Japan
Gdansk, Pomorskie, Poland
Walnut Creek, California, United States
Hangzhou, Zhejiang, China
Carolina, , Puerto Rico
Miami Springs, Florida, United States
Izmir, , Turkey
Kolkata, West Bengal, India
Varanasi, , India
Lublin, , Poland
Hyderabad, Andhra Pradesh, India
Chaidari, Athens, Attiki, Greece
San Rafael, , Argentina
Hialeah, Florida, United States
Böblingen, , Germany
Kosice, , Slovakia
Böblingen, , Germany
Szeged, , Hungary
Szeged, , Hungary
Incheon, Incheon Gwang'yeogsi, Korea, Republic Of
Lódz, , Poland
Sofia, , Bulgaria
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported