A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
Launched by KARUNA THERAPEUTICS · Aug 30, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
The ADEPT-4 clinical trial is studying a new treatment called KarXT for individuals with Alzheimer's Disease (AD) who are experiencing psychosis, which includes symptoms like hallucinations or delusions. This study is open to adults aged 55 to 90 who have been diagnosed with mild to severe Alzheimer's and have had psychotic symptoms for at least two months. To ensure the treatment is safe and effective, participants will need to have undergone a brain scan in the last five years to rule out other health issues.
If you or a loved one qualifies for this trial, you can expect to be part of a study that aims to improve the understanding and treatment of Alzheimer's-related psychosis. Throughout the trial, participants will be closely monitored for their safety and health. It’s important to note that certain medical histories, such as severe mental health disorders or specific health concerns identified through lab tests, may prevent someone from joining the study. This trial is currently recruiting participants, so it could be a valuable opportunity for those affected by Alzheimer's Disease.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- • Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
- • Patients who are diagnosed with AD based on the 2024 National Institute on Aging - Alzheimer's Association criteria with AD biomarker confirmation.
- • Patient must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma.
- • Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).
- • Exclusion Criteria
- • - Patients will not be able to participate if they have:.
- • i) Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.
- • ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
- • iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.
- • Other protocol-defined Inclusion/Exclusion criteria apply.
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
Columbus, Ohio, United States
Seoul, , Korea, Republic Of
Farmington, Connecticut, United States
Madrid, , Spain
Salamanca, , Spain
Kortrijk, , Belgium
Toms River, New Jersey, United States
Seoul, , Korea, Republic Of
Costa Mesa, California, United States
Miami, Florida, United States
Port Orange, Florida, United States
Novi Sad, , Serbia
Valladolid, , Spain
Sapporo, Hokkaido, Japan
Setagaya Ku, Tokyo, Japan
Yokohama, Kanagawa, Japan
Majadahonda, Madrid, Spain
Miami Lakes, Florida, United States
Petah Tikva, , Israel
Hialeah, Florida, United States
Miami, Florida, United States
Anaheim, California, United States
Orlando, Florida, United States
Roma, , Italy
Atlanta, Georgia, United States
Zagreb, Grad Zagreb, Croatia
Kovin, , Serbia
Sevilla, , Spain
Sakai, Osaka, Japan
Lleida, , Spain
Sibiu, , Romania
Hachioji, Tokyo, Japan
Koriyama, Fukushima, Japan
Miami, Florida, United States
Seoul, , Korea, Republic Of
Kragujevac, , Serbia
Miami, Florida, United States
Rancho Cucamonga, California, United States
Belmont, Massachusetts, United States
Long Beach, California, United States
Miami, Florida, United States
Anaheim, California, United States
Belgrade, , Serbia
Morehead City, North Carolina, United States
Desoto, Texas, United States
Wroclaw, Dolnoslaskie, Poland
Scottsdale, Arizona, United States
Himeji Shi, Hyogo, Japan
Daytona Beach, Florida, United States
Miami Lakes, Florida, United States
Pasadena, California, United States
Bonita Springs, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Woodmere, New York, United States
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Homburg, Saarland, Germany
Ponderano (Biella), Piemonte, Italy
Kovin, , Serbia
Dubnica Nad Váhom, , Slovakia
Košice, , Slovakia
Vranov Nad Topľou, , Slovakia
Valladolid, , Spain
Anaheim, California, United States
Doral, 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
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Woodmere, New York, United States
Roeselare, West Vlaanderen, Belgium
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Zagreb, Grad Zagreb, Croatia
Athina, Attiki, Greece
Chaidari, Athens, Attiki, Greece
Pécs, Baranya, Hungary
Budapest, , Hungary
Seoul, , Korea, Republic Of
Lublin, Lubelskie, Poland
Belgrade, , Serbia
Belgrade, , Serbia
Kragujevac, , Serbia
Novi Sad, , Serbia
Kosice, Košický Kraj, Slovakia
Dubnica Nad Váhom, , Slovakia
Košice, , Slovakia
Vranov Nad Topľou, , Slovakia
Salamanca, , Spain
Sevilla, , Spain
Eskisehir, , Turkey
Istanbul, , Turkey
Izmir, , Turkey
Cutler Bay, Florida, United States
Doral, Florida, United States
Hialeah, Florida, United States
Miami Gardens, 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
Flowood, Mississippi, United States
Stafford, Texas, United States
Homestead, Florida, United States
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Princeton, New Jersey, United States
Costa Mesa, California, United States
Cutler Bay, Florida, United States
Daytona Beach, Florida, United States
Doral, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Ormond Beach, Florida, United States
Port Orange, Florida, United States
Toms River, New Jersey, United States
Columbus, Ohio, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Ciudad Autónoma De Buenosaires, Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Córdoba, , Argentina
Alken, , Belgium
Chaidari, Attiki, Greece
Kalyftaki N. Kifissia, Attiki, Greece
Jerusalem, Yerushalayim, Israel
Ashkelon, , Israel
Petah Tikva, , Israel
Lublin, Lubelskie, Poland
Poznan, , Poland
Wroclaw, , Poland
Oradea, Bihor, Romania
Craiova, , Romania
Sibiu, , Romania
Gornja Toponica, , Serbia
Banska Bystrica, , Slovakia
Dubnica Nad Vahom, , Slovakia
Košice, , Slovakia
Vranov Nad Toplou, , Slovakia
Lisbon, Lisboa, Portugal
Roeselare, West Vlaanderen, Belgium
Costa Mesa, California, United States
Cutler Bay, Florida, United States
Miami, Florida, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Los Angeles, California, United States
Farmington, Connecticut, United States
West Palm Beach, Florida, United States
Belmont, Massachusetts, United States
Flowood, Mississippi, United States
Greensboro, North Carolina, United States
Matthews, North Carolina, United States
Morehead City, North Carolina, United States
Providence, Rhode Island, United States
Stafford, Texas, United States
Ciudad Autónoma De Buenos Aires, Ciudad Autonoma De Buenosaires, Argentina
Jette, Brussels, Belgium
Kortrijk, , Belgium
Roeselare, , Belgium
Rio De Janeiro, , Brazil
Sao Paulo, , Brazil
Sao Paulo, , Brazil
Sofia, , Bulgaria
Berlin, , Germany
Erbach, , Germany
Frankfurt Am Main, , Germany
Athens, Attiki, Greece
Thessaloniki, , Greece
Szeged, Csongrád, Hungary
Gyöngyös, , Hungary
Ramat Gan, Tel Aviv, Israel
Gdansk, Pomorskie, Poland
Kielce, , Poland
Lisbon, Lisboa, Portugal
Lisbon, , Portugal
Bayamon, , Puerto Rico
San Juan, , Puerto Rico
Constanta, , Romania
Homestead, Florida, United States
Miami Lakes, Florida, United States
Ocoee, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
El Paso, Texas, United States
San Antonio, Texas, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Brasília, Distrito Federal, Brazil
Plovdiv, , Bulgaria
Ruse, , Bulgaria
Sofia, , Bulgaria
Toulouse, Haute Garonne, France
Toulouse, , France
Tours Cedex 9, , France
Boblingen, Baden Wurttemberg, Germany
Heraklion, Irakleio, Greece
Budapest, , Hungary
Ponderano, Piemonte, Italy
Brescia, , Italy
Milano, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
Lisbon, , Portugal
Senhora Da Hora, , Portugal
Torres Vedras, , Portugal
Bayamon, , Puerto Rico
Carolina, , Puerto Rico
San Juan, , Puerto Rico
Bucuresti, , Romania
Iasi, , Romania
Pezinok, , Slovakia
Majadahonda, Madrid, Spain
Lleida, , Spain
Madrid, , Spain
Ankara, , Turkey
Rancho Cucamonga, California, United States
Doral, Florida, United States
Hialeah, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Ormond Beach, Florida, United States
Nashville, Tennessee, United States
Stafford, Texas, United States
San Rafael, , Argentina
Nice, , France
Tsu Shi, Mei, Japan
Yoshinogawa, Tokusima, Japan
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Lakewood, California, United States
Los Angeles, California, United States
Orange, California, United States
Atlantis, Florida, United States
Daytona Beach, Florida, United States
Deerfield Beach, Florida, United States
Doral, Florida, United States
Homestead, Florida, United States
Homestead, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Ocoee, Florida, United States
Tampa, Florida, United States
The Villages, Florida, United States
Wellington, Florida, United States
Toms River, New Jersey, United States
Syracuse, New York, United States
Greensboro, North Carolina, United States
Brugge, , Belgium
Sao Paulo, , Brazil
Roma, , Italy
Koriyama, Fukushima, Japan
Tatebayashi Shi, Gunma, Japan
Hiroshima, Hirosima, Japan
Sapporo, Hokkaido, Japan
Iizuka, Hukuoka, Japan
Himeji Shi, Hyogo, 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
Kanzaki Gun Yoshinogari Cho, Saga, Japan
Wako Shi, Saitama, Japan
Hachioji, Tokyo, Japan
Setagaya Ku, Tokyo, Japan
Setagaya Ku, Tokyo, Japan
Kumamoto, , Japan
Takatsuki, ôsaka, Japan
Yeongdeungpo Gu, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, , Korea, Republic Of
Lodz, , Poland
Bayamon, , Puerto Rico
San Juan, , Puerto Rico
Beograd, Belgrade, Serbia
Atakum, Samsun, Turkey
Eskisehir, , Turkey
Istanbul, , Turkey
Izmir, , Turkey
Izmir, , Turkey
Pécs, Baranya, Hungary
Budapest, , Hungary
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Cordoba, , Argentina
Ashkelon, Tel Aviv, Israel
Kosice, Košický Kraj, Slovakia
Zagreb, Grad Zagreb, Croatia
Ponderano (Biella), Piemonte, Italy
Chandler, Arizona, United States
Atlantis, Florida, United States
Hialeah, Florida, United States
Homestead, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
The Villages, Florida, United States
Flowood, Mississippi, United States
Toms River, New Jersey, United States
Lawrence, New York, United States
Desoto, Texas, United States
El Paso, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Budapest, , Hungary
Roma, Lazio, Italy
Fukuoka, Hukuoka, Japan
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Ansan Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Creixomil, Braga, Portugal
San Juan, , Puerto Rico
Oradea, , Romania
Belgrade, , Serbia
Miami Lakes, Florida, United States
Sweetwater, Florida, United States
San Antonio, Texas, United States
Nagpur, Maharashtra, India
Sapporo, Hokkaido, Japan
Kanzaki Gun Yoshinogari Cho, Saga, Japan
Miami, Florida, United States
Sweetwater, Florida, United States
Athina, Attiki, Greece
Hialeah, Florida, United States
Miami, Florida, United States
West Palm Beach, Florida, United States
Belmont, Massachusetts, United States
Matthews, North Carolina, United States
Lisbon, Lisboa, Portugal
Torres Vedras, Lisboa, Portugal
Senhora Da Hora, Porto, Portugal
Bayamon, , Puerto Rico
Kovin, , Serbia
Matthews, North Carolina, United States
Nashville, Tennessee, United States
Sofia, Sofia Grad, Bulgaria
Jerusalem, Yerushalayim, Israel
Petah Tikva, , Israel
Wroclaw, Dolnoslaskie, Poland
Ankara, , Turkey
Tours, Indre Et Loire, France
Böblingen, Baden Württemberg, Germany
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, , Korea, Republic Of
Long Beach, California, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Ocoee, Florida, United States
Greensboro, North Carolina, United States
Nice, Alpes Maritimes, France
Erbach, Hessen, Germany
Frankfurt Am Main, , Germany
Heraklion, Irakleio, Greece
Roma, , Italy
Roma, , Italy
Yoshinogawa, Tokushima, Japan
Ansan Si, Gyeonggido, Korea, Republic Of
Wroclaw, Dolnoslaskie, Poland
Gornja Toponica, , Serbia
Lady Lake, Florida, United States
São Paulo, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
Ramat Gan, , Israel
Milano, Lombardia, Italy
Hadano, Kanagawa, Japan
Hiroshima, , Japan
Seoul, , Korea, Republic Of
Phoenix, Arizona, United States
Deerfield Beach, Florida, United States
Miami, Florida, United States
West Palm Beach, Florida, United States
Ciudad Autonoma De Buenos Aires, , Argentina
Toulouse, , France
Takamatsu Shi, Kagawa, Japan
Yokohama Shi, Kanagawa, Japan
Takatsuki, Osaka, Japan
Yoshinogawa, Tokushima, Japan
Fukuoka, , Japan
Lisboa, , Portugal
Orange, California, United States
El Paso, Texas, United States
Iizuka, Fukuoka, Japan
Himeji Shi, Hyogo, Japan
Lisboa, , Portugal
Jerusalem, Yerushalayim, Israel
Setagaya Ku, Tokyo, Japan
Buenos Aires, , Argentina
Rome, Roma, Italy
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Guimarães, Braga, Portugal
Lisboa, , Portugal
Gornja Toponica, , Serbia
Toms River, New Jersey, United States
Toride Shi, Ibaraki, Japan
Kawasaki Shi, Kanagawa, Japan
Yokohama, Kanagawa, Japan
San Juan, , Puerto Rico
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Hialeah, Florida, United States
The Villages, Florida, United States
Heraklion, , Greece
Gyongyos, , Hungary
Ashkelon, Tel Aviv, Israel
San Juan, , Puerto Rico
Miami, Florida, United States
Pasadena, California, United States
São Paulo, Sao Paulo, Brazil
Rio De Janeiro, , Brazil
Roma, Lazio, Italy
Brescia, Lombardia, Italy
Miami, Florida, United States
Toms River, New Jersey, United States
Tsu Shi, Mie, Japan
Kumamoto, , Japan
Gdansk, , Poland
Rancho Cucamonga, California, United States
Tatebayashi Shi, Gunma, Japan
Gdansk, Pomorskie, Poland
Chandler, Arizona, United States
Orange, California, United States
Homestead, Florida, United States
Port Orange, Florida, United States
Springfield, Massachusetts, United States
Morehead City, North Carolina, United States
Providence, Rhode Island, United States
Alken, , Belgium
Erbach, Hessen, Germany
Kolkata, West Bengal, India
Hyderabad, , India
Varanasi, , India
Roma, Lazio, Italy
Kyoto Shi, Kyoto, Japan
Hiroshima, , Japan
Tatebayashi, , Japan
Lodz, , Poland
Torres Vedras, Lisboa, Portugal
Matosinhos, Porto, Portugal
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Banska Bystrica, , Slovakia
Thessaloniki, , Greece
Gyöngyös, Heves, Hungary
Lublin, , Poland
Poznan, , Poland
Beograd, Belgrade, Serbia
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Yongin Si, , Korea, Republic Of
Gdansk, Pomorskie, Poland
Guimarães, Braga, Portugal
Toulouse, , France
Hyderabad, Andhra Pradesh, India
Pezinok, , Slovakia
Homburg, Saarland, Germany
Oradea, Bihor, Romania
Chaidari, Athens, Attiki, Greece
Syracuse, New York, United States
Arlington, Virginia, United States
Nice, Alpes Maritimes, France
Heraklion, Irakleio, Greece
Gyöngyös, Heves, Hungary
Roma, Lazio, Italy
Brescia, Lombardia, Italy
Yeongdeungpo Gu, Seoul Teugbyeolsi, Korea, Republic Of
Gangwon Do, , Korea, Republic Of
Craiova, , Romania
Oklahoma City, Oklahoma, United States
Thessaloniki, , Greece
Milano, Lombardia, Italy
Ilawa, Warminsko Mazurskie, Poland
Bucuresti, , Romania
Constanta, , Romania
San Rafael, , Argentina
Jette, Brussels, Belgium
Budapest, , Hungary
Kosice, , Slovakia
Böblingen, , Germany
Szeged, , Hungary
Chaidari, Athens, Attiki, Greece
Miami Lakes, Florida, United States
Tampa, Florida, United States
Sofia, Sofia Grad, Bulgaria
Salerno, Campania, Italy
Yongin Si, Gyeonggido, Korea, Republic Of
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported