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RecruitingPhase 3

A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

Karuna Therapeutics, Inc., a Bristol Myers Squibb company · NCT06585787

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55–90 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
406
US sites recruiting
44
Study start
September 26, 2024
Record last updated
September 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: KarXT; Placebo

Conditions: Alzheimer Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Gilbert Neurology Partners - PLLC - Avacare

    Gilbert, AZ 85297

    Site contact: Jonathan Hodgson, Site 1247 · 602-761-9631

  • Banner Alzheimer's Institute

    Phoenix, AZ 85006-2528

    Site contact: Ganesh Gopalakrishna, Site 1217 · 602-839-6900

  • Advanced Research Center, Inc.

    Anaheim, CA 92805-5854

    Site contact: Steven Macina, Site 1104 · 714-999-6688

  • Inland Psychiatric Medical Group (IPMG)-Chino

    Chino, CA 91710

    Site contact: Nandita Puchakayala, Site 1244 · 909-488-9116

  • USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)

    Los Angeles, CA 90033-5313

    Site contact: Lon Schneider, Site 1226 · 323-442-3715

  • University of Connecticut Health Center

    Farmington, CT 06030

    Site contact: Neha Jain, Site 1222 · 860-790-7354

  • Envision Trials LLC

    Bonita Springs, FL 34134

    Site contact: Daniel Mandri, Site 1020 · 305-819-2909

  • Arrow Clinical Trials

    Daytona Beach, FL 32117-5532

    Site contact: David Billmeier, Site 1023 · 386-278-8000

  • Aqualane Clinical Research

    Naples, FL 34105

    Site contact: William Justiz, Site 1246 · 941-436-6838

  • Sensible HealthCare, LLC

    Ocoee, FL 34761-2964

    Site contact: Kelly Taylor, Site 1212 · 407-654-2724

  • Charter Research Orlando

    Orlando, FL 32803

    Site contact: Diana Balsalobre, Site 1257

  • Nova Psychiatry

    Orlando, FL 32803

    Site contact: David Medina, Site 1242 · 407-823-8421

  • Combined Research Orlando Phase I-IV LLC

    Orlando, FL 32807-3555

    Site contact: Eric Carbonell, Site 1112 · 407-440-4493

  • Guardian Angel Research

    Tampa, FL 33614

    Site contact: Sadaf Bazargan, Site 1124 · 813-300-3300

  • Interventional Psychiatry of Tampa Bay

    Tampa, FL 33629-5837

    Site contact: Jamie Fernandez, Site 1110 · 813-251-1800

  • Charter Research

    The Villages, FL 32162-2698

    Site contact: Jeffrey Norton, Site 1256 · 352-775-1000

  • Premiere Research Institute at Palm Beach Neurology, PA

    West Palm Beach, FL 33407-3209

    Site contact: Paul Winner, Site 1216 · 561-845-0500

  • Agile Clinical Research Trials, LLC

    Atlanta, GA 30328-5532

    Site contact: Vasundhara Cheekati, Site 1206 · 404-382-8660

  • McLean Hospital

    Belmont, MA 02478-1064

    Site contact: Arkadiy Stolyar, Site 1223 · 617-855-2136

  • Tufts Medical Center - 800 Washington St - PPDS

    Boston, MA 02111-1552

    Site contact: Brent Forester, Site 1245 · 617-636-3202

  • Boston Neuro Research Center

    North Dartmouth, MA 02747-2612

    Site contact: Mushtaque Chachar, Site 1243 · 508-925-7403

  • Elixia Health - Springfield - Elixia - PPDS

    Springfield, MA 01103

    Site contact: Susan Smiga, Site 1239 · 413-305-1142

  • Neurobehavioral Medicine Group (NBMG)

    Bloomfield Township, MI 48302-1909

    Site contact: Richard Jackson, Site 1248 · 412-916-2425

  • Precise Research Centers

    Flowood, MS 39232

    Site contact: Joseph Kwentus, Site 1132 · 601-420-5810

  • Tekton Research, LLC - Saint Louis Psychiatry - PPDS

    St Louis, MO 63128

    Site contact: Ernest Graypel, Site 1255 · 314-594-7785

  • Advanced Memory Research Institute - CenExel - PPDS

    Toms River, NJ 08755

    Site contact: Arun Singh, Site 1202 · 732-341-9500

  • Mid Hudson Medical Research PLLC

    New Windsor, NY 12553-7754

    Site contact: Sashi Makam, Site 1251 · 845-674-9398

  • SUNY Upstate Medical University

    Syracuse, NY 13210-2306

    Site contact: Tinatin Chabrashvili, Site 1240 · 617-636-5000

  • Five Towns Neurology, PC

    Woodmere, NY 11598-1739

    Site contact: David Steiner, Site 1025 · 516-239-1800

  • Triad Clinical Trials - 515 College Rd

    Greensboro, NC 27410-3311

    Site contact: Richard Montgomery, Site 1221 · 336-235-0991

  • AMC Research, LLC - Flourish - PPDS

    Matthews, NC 28105-8336

    Site contact: Mohammad Bolouri, Site 1214 · 704-364-4000

  • West Clinical Research

    Morehead City, NC 28557

    Site contact: Patrick Morgante, Site 1215 · 252-515-0050

  • Ohio State University

    Columbus, OH 43221

    Site contact: Douglas Scharre, Site 1201 · 614-293-4560

  • Insight Clinical Trials LLC - Independence

    Independence, OH 44131

    Site contact: Mark Stillman, Site 1249 · 216-444-8897

  • The Rivus Wellness & Research Institute

    Oklahoma City, OK 73112

    Site contact: Marvin Peyton, Site 1016 · 405-317-5783

  • Alzheimer's Disease and Memory Disorders Center at Rhode Island Hospital

    Providence, RI 02903

    Site contact: Chuang-Kuo Wu, Site 1218 · 714-456-7002

  • Vanderbilt Psychiatric Hospital

    Nashville, TN 37212-3133

    Site contact: Jo Wilson, Site 1211 · 615-322-4967

  • Senior Adults Specialty Research

    Austin, TX 78757-7566

    Site contact: John Bertelson, Site 1263 · 512-407-8628

  • Epic Medical Research LLC - DeSoto

    DeSoto, TX 75115-2043

    Site contact: Haresh Boghara, Site 1121 · 972-777-6956

  • Advanced Neuro Research Center - El Paso

    El Paso, TX 79912-1743

    Site contact: Aamr Herekar, Site 1208 · 915-974-2200

  • University Hills Clinical Research - 102 Decker Ct

    Irving, TX 75062-2898

    Site contact: Mary Ann Knesevich, Site 1259 · 972-717-6262

  • Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases

    San Antonio, TX 78229-3901

    Site contact: Antonio Teixeira, Site 1210 · 210-567-8229

  • Conquest Research, LLC - Virginia - Vienna

    Vienna, VA 22182

    Site contact: Henry Tran, Site 1241 · 703-717-7755

  • Northwest Clinical Research Center

    Bellevue, WA 98007-4879

    Site contact: Wisam Al Jumaili, Site 1253 · 425-453-0404

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.
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A Study to Evaluate KarXT as a Treatment for Psychosis Associated… (NCT06585787) | Bored Studies