KarXT Tested for Psychosis in People With Alzheimer's Disease
Tests KarXT against placebo in adults with Alzheimer's and psychosis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
Key facts
- Where
- Anaheim, Atlanta, Atlantis, Austin, Bellevue, Belmont, Bloomfield Township, Bonita Springs, Boston, Chandler, Chino, Cleveland, Columbia, Columbus, Cutler Bay, Dallas, Dayton, Daytona Beach, Deerfield Beach, DeSoto, Doral, El Paso, Farmington, Flowood, Fort Worth, Gilbert, Greensboro, Gulf Breeze, Hialeah, Homestead, Houston, Independence, Irving, Kirkland, Lady Lake, Long Beach, Los Angeles, Matthews, Miami, Miami Gardens, Miami Lakes, Morehead City, Naples, Nashville, New Windsor, North Dartmouth, Ocoee, Oklahoma City, Orange, Orlando, Ormond Beach, Pasadena, Phoenix, Plano, Port Orange, Providence, Rancho Cucamonga, Salem, San Antonio, Scottsdale, Shelby, South Dartmouth, Springfield, St Louis, Stafford, Sweetwater, Syracuse, Tampa, The Villages, Toms River, Vienna, Wellington, West Palm Beach, and Woodmere, United StatesSee the 102 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 90 years old?
- Has a doctor told you that you have Alzheimer's disease?
- Do you have hallucinations or delusions caused by Alzheimer's disease?
- Has a doctor ever told you that you have bipolar disorder, schizophrenia or schizoaffective disorder?
Source: NCT06585787, who can take part
Where in United States
- Advanced Research Center, Inc.Anaheim, United StatesTaking people
- Agile Clinical Research Trials, LLCAtlanta, United StatesTaking people
- AtlantisAtlantis, United StatesNo longer taking part
- Senior Adults Specialty ResearchAustin, United StatesTaking people
- Northwest Clinical Research CenterBellevue, United StatesTaking people
- McLean HospitalBelmont, United StatesTaking people
- Neurobehavioral Medicine Group (NBMG)Bloomfield Township, United StatesTaking people
- Envision Trials LLCBonita Springs, United StatesTaking people
- Tufts Medical Center - 800 Washington St - PPDSBoston, United StatesTaking people
- ChandlerChandler, United StatesNo longer taking part
- Inland Psychiatric Medical Group (IPMG)-ChinoChino, United StatesTaking people
- ClevelandCleveland, United StatesNot yet recruiting
- ColumbiaColumbia, United StatesNot yet recruiting
- Ohio State UniversityColumbus, United StatesTaking people
- Cutler BayCutler Bay, United StatesNo longer taking part
- DallasDallas, United StatesNot yet recruiting
- DaytonDayton, United StatesNot yet recruiting
- Arrow Clinical TrialsDaytona Beach, United StatesTaking people
- Deerfield BeachDeerfield Beach, United StatesNo longer taking part
- Epic Medical Research LLC - DeSotoDeSoto, United StatesTaking people
- DoralDoral, United StatesNo longer taking part
- Advanced Neuro Research Center - El PasoEl Paso, United StatesTaking people
- University of Connecticut Health CenterFarmington, United StatesTaking people
- Precise Research CentersFlowood, United StatesTaking people
- Fort WorthFort Worth, United StatesNot yet recruiting
- Gilbert Neurology Partners - PLLC - AvacareGilbert, United StatesTaking people
- Triad Clinical Trials - 515 College RdGreensboro, United StatesTaking people
- Gulf BreezeGulf Breeze, United StatesNot yet recruiting
- HialeahHialeah, United StatesNo longer taking part
- HialeahHialeah, United StatesNo longer taking part
- HomesteadHomestead, United StatesNo longer taking part
- HoustonHouston, United StatesNot yet recruiting
- Insight Clinical Trials LLC - IndependenceIndependence, United StatesTaking people
- University Hills Clinical Research - 102 Decker CtIrving, United StatesTaking people
- KirklandKirkland, United StatesNo longer taking part
- Lady LakeLady Lake, United StatesNo longer taking part
- Long BeachLong Beach, United StatesNo longer taking part
- USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)Los Angeles, United StatesTaking people
- Los AngelesLos Angeles, United StatesNo longer taking part
- AMC Research, LLC - Flourish - PPDSMatthews, United StatesTaking people
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- Miami GardensMiami Gardens, United StatesNo longer taking part
- Miami LakesMiami Lakes, United StatesNo longer taking part
- Miami LakesMiami Lakes, United StatesNo longer taking part
- West Clinical ResearchMorehead City, United StatesTaking people
- Morehead CityMorehead City, United StatesNo longer taking part
- Aqualane Clinical ResearchNaples, United StatesTaking people
- Vanderbilt Psychiatric HospitalNashville, United StatesTaking people
- Mid Hudson Medical Research, PLLCNew Windsor, United StatesTaking people
- Boston Neuro Research CenterNorth Dartmouth, United StatesTaking people
- Sensible Healthcare, LLCOcoee, United StatesTaking people
- The Rivus Wellness & Research InstituteOklahoma City, United StatesTaking people
- OrangeOrange, United StatesNo longer taking part
- OrangeOrange, United StatesNo longer taking part
- Charter Research - OrlandoOrlando, United StatesTaking people
- Combined Research Orlando Phase I-IV LLCOrlando, United StatesTaking people
- Nova PsychiatryOrlando, United StatesTaking people
- Ormond BeachOrmond Beach, United StatesNo longer taking part
- PasadenaPasadena, United StatesNo longer taking part
- Banner Alzheimer's InstitutePhoenix, United StatesTaking people
- PlanoPlano, United StatesNo longer taking part
- Port OrangePort Orange, United StatesNo longer taking part
- Alzheimer's Disease and Memory Disorders Center at Rhode Island HospitalProvidence, United StatesTaking people
- Rancho CucamongaRancho Cucamonga, United StatesNo longer taking part
- SalemSalem, United StatesNot yet recruiting
- Glenn Biggs Institute for Alzheimer's & Neurodegenerative DiseasesSan Antonio, United StatesTaking people
- ScottsdaleScottsdale, United StatesNo longer taking part
- ShelbyShelby, United StatesNo longer taking part
- South DartmouthSouth Dartmouth, United StatesNo longer taking part
- Elixia Health - Springfield - Elixia - PPDSSpringfield, United StatesTaking people
- Tekton Research, LLC - Saint Louis Psychiatry - PPDSSt Louis, United StatesTaking people
- StaffordStafford, United StatesNo longer taking part
- SweetwaterSweetwater, United StatesNo longer taking part
- SUNY Upstate Medical UniversitySyracuse, United StatesTaking people
- SyracuseSyracuse, United StatesNo longer taking part
- Guardian Angel ResearchTampa, United StatesTaking people
- Interventional Psychiatry of Tampa BayTampa, United StatesTaking people
- TampaTampa, United StatesNo longer taking part
- Charter ResearchThe Villages, United StatesTaking people
- Advanced Memory Research Institute - CenExel - PPDSToms River, United StatesTaking people
- Toms RiverToms River, United StatesNo longer taking part
- Conquest Research, LLC - Virginia - ViennaVienna, United StatesTaking people
- WellingtonWellington, United StatesNo longer taking part
- Premiere Research Institute at Palm Beach Neurology, PAWest Palm Beach, United StatesTaking people
- Five Towns Neurology, PCWoodmere, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Trial code
- NCT06585787EU 2024-516363-92-00
- Record updated
- 27 October 2026
- Original description
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.Read full original descriptionShow less
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
Inclusion: 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 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup; 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: History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder; 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; Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities; Patients will not be able to participate if they have:; Other protocol-defined Inclusion/Exclusion criteria apply.