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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

Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Participants: 406 · Started: Sep 26, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06585787

Locations in the U.S.

ArizonaGilbert Neurology Partners - PLLC - Avacare, Gilbert
Banner Alzheimer's Institute, Phoenix
CaliforniaAdvanced 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
ConnecticutUniversity of Connecticut Health Center, Farmington
FloridaEnvision 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
GeorgiaAgile Clinical Research Trials, LLC, Atlanta
MassachusettsMcLean Hospital, Belmont
Tufts Medical Center - 800 Washington St - PPDS, Boston
Boston Neuro Research Center, North Dartmouth
Elixia Health - Springfield - Elixia - PPDS, Springfield
MichiganNeurobehavioral Medicine Group (NBMG), Bloomfield Township
MississippiPrecise Research Centers, Flowood
MissouriTekton Research, LLC - Saint Louis Psychiatry - PPDS, St Louis
New JerseyAdvanced Memory Research Institute - CenExel - PPDS, Toms River
New YorkMid Hudson Medical Research PLLC, New Windsor
SUNY Upstate Medical University, Syracuse
Five Towns Neurology, PC, Woodmere
North CarolinaTriad Clinical Trials - 515 College Rd, Greensboro
AMC Research, LLC - Flourish - PPDS, Matthews
West Clinical Research, Morehead City
OhioLocal Institution - 1265, Cleveland (Not yet recruiting)
Ohio State University, Columbus
Local Institution - 1258, Dayton (Not yet recruiting)
Insight Clinical Trials LLC - Independence, Independence
OklahomaThe Rivus Wellness & Research Institute, Oklahoma City
Rhode IslandAlzheimer's Disease and Memory Disorders Center at Rhode Island Hospital, Providence
South CarolinaLocal Institution - 1267, Columbia (Not yet recruiting)
TennesseeVanderbilt Psychiatric Hospital, Nashville
TexasSenior 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
VirginiaLocal Institution - 1266, Salem (Not yet recruiting)
Conquest Research, LLC - Virginia - Vienna, Vienna
WashingtonNorthwest 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.