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A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
RecruitingPhase 3
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
Who can join
Ages 55 to 90 · All sexes
Full 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 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 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 the study
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.
What is being tested
- KarXT (drug)
- Placebo (drug)
Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Participants: 406 · Started: Sep 26, 2024
Contact the study team
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · Phone: 855-907-3286
Official record on ClinicalTrials.gov — NCT06585787
Locations in the U.S.
| Arizona | Gilbert Neurology Partners - PLLC - Avacare, Gilbert Banner Alzheimer's Institute, Phoenix |
| California | Advanced Research Center, Inc., Anaheim Inland Psychiatric Medical Group (IPMG)-Chino, Chino USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC), Los Angeles |
| Connecticut | University of Connecticut Health Center, Farmington |
| Florida | Envision Trials LLC, Bonita Springs Arrow Clinical Trials, Daytona Beach Local Institution - 1264, Gulf Breeze (Not yet recruiting) Aqualane Clinical Research, Naples Sensible HealthCare, LLC, Ocoee Charter Research Orlando, Orlando Combined Research Orlando Phase I-IV LLC, Orlando Nova Psychiatry, Orlando Guardian Angel Research, Tampa Interventional Psychiatry of Tampa Bay, Tampa Charter Research, The Villages Premiere Research Institute at Palm Beach Neurology, PA, West Palm Beach |
| Georgia | Agile Clinical Research Trials, LLC, Atlanta |
| Massachusetts | McLean Hospital, Belmont Tufts Medical Center - 800 Washington St - PPDS, Boston Boston Neuro Research Center, North Dartmouth Elixia Health - Springfield - Elixia - PPDS, Springfield |
| Michigan | Neurobehavioral Medicine Group (NBMG), Bloomfield Township |
| Mississippi | Precise Research Centers, Flowood |
| Missouri | Tekton Research, LLC - Saint Louis Psychiatry - PPDS, St Louis |
| New Jersey | Advanced Memory Research Institute - CenExel - PPDS, Toms River |
| New York | Mid Hudson Medical Research PLLC, New Windsor SUNY Upstate Medical University, Syracuse Five Towns Neurology, PC, Woodmere |
| North Carolina | Triad Clinical Trials - 515 College Rd, Greensboro AMC Research, LLC - Flourish - PPDS, Matthews West Clinical Research, Morehead City |
| Ohio | Local Institution - 1265, Cleveland (Not yet recruiting) Ohio State University, Columbus Local Institution - 1258, Dayton (Not yet recruiting) Insight Clinical Trials LLC - Independence, Independence |
| Oklahoma | The Rivus Wellness & Research Institute, Oklahoma City |
| Rhode Island | Alzheimer's Disease and Memory Disorders Center at Rhode Island Hospital, Providence |
| South Carolina | Local Institution - 1267, Columbia (Not yet recruiting) |
| Tennessee | Vanderbilt Psychiatric Hospital, Nashville |
| Texas | Senior Adults Specialty Research, Austin Local Institution - 1260, Dallas (Not yet recruiting) Epic Medical Research LLC - DeSoto, DeSoto Advanced Neuro Research Center - El Paso, El Paso Local Institution - 1262, Fort Worth (Not yet recruiting) Local Institution - 1261, Houston (Not yet recruiting) University Hills Clinical Research - 102 Decker Ct, Irving Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases, San Antonio |
| Virginia | Local Institution - 1266, Salem (Not yet recruiting) Conquest Research, LLC - Virginia - Vienna, Vienna |
| Washington | Northwest Clinical Research Center, Bellevue |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.