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

Purpose

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.

Condition

  • Alzheimer Disease

Eligibility

Eligible Ages
Between 55 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KarXT
  • Drug: KarXT
    Specified dose on specified days
    Other names:
    • BMS-986510
Experimental
Placebo
  • Drug: Placebo
    Specified dose on specified days

Recruiting Locations

Gilbert Neurology Partners - PLLC - Avacare
Gilbert, Arizona 85297
Contact:
Jonathan Hodgson, Site 1247
602-761-9631

Banner Alzheimer's Institute
Phoenix, Arizona 85006-2528
Contact:
Ganesh Gopalakrishna, Site 1217
602-839-6900

Advanced Research Center, Inc.
Anaheim, California 92805-5854
Contact:
Steven Macina, Site 1104
714-999-6688

Inland Psychiatric Medical Group (IPMG)-Chino
Chino, California 91710
Contact:
Nandita Puchakayala, Site 1244
909-488-9116

USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)
Los Angeles, California 90033-5313
Contact:
Lon Schneider, Site 1226
323-442-3715

University of Connecticut Health Center
Farmington, Connecticut 06030
Contact:
Neha Jain, Site 1222
860-790-7354

Envision Trials LLC
Bonita Springs, Florida 34134
Contact:
Daniel Mandri, Site 1020
305-819-2909

Arrow Clinical Trials
Daytona Beach, Florida 32117-5532
Contact:
David Billmeier, Site 1023
386-278-8000

Aqualane Clinical Research
Naples, Florida 34105
Contact:
William Justiz, Site 1246
941-436-6838

Sensible HealthCare, LLC
Ocoee, Florida 34761-2964
Contact:
Kelly Taylor, Site 1212
407-654-2724

Charter Research Orlando
Orlando, Florida 32803
Contact:
Diana Balsalobre, Site 1257

Nova Psychiatry
Orlando, Florida 32803
Contact:
David Medina, Site 1242
407-823-8421

Combined Research Orlando Phase I-IV LLC
Orlando, Florida 32807-3555
Contact:
Eric Carbonell, Site 1112
407-440-4493

Guardian Angel Research
Tampa, Florida 33614
Contact:
Sadaf Bazargan, Site 1124
813-300-3300

Interventional Psychiatry of Tampa Bay
Tampa, Florida 33629-5837
Contact:
Jamie Fernandez, Site 1110
813-251-1800

Charter Research
The Villages, Florida 32162-2698
Contact:
Jeffrey Norton, Site 1256
352-775-1000

Premiere Research Institute at Palm Beach Neurology, PA
West Palm Beach, Florida 33407-3209
Contact:
Paul Winner, Site 1216
561-845-0500

Agile Clinical Research Trials, LLC
Atlanta, Georgia 30328-5532
Contact:
Vasundhara Cheekati, Site 1206
404-382-8660

McLean Hospital
Belmont, Massachusetts 02478-1064
Contact:
Arkadiy Stolyar, Site 1223
617-855-2136

Tufts Medical Center - 800 Washington St - PPDS
Boston, Massachusetts 02111-1552
Contact:
Brent Forester, Site 1245
617-636-3202

Boston Neuro Research Center
North Dartmouth, Massachusetts 02747-2612
Contact:
Mushtaque Chachar, Site 1243
508-925-7403

Elixia Health - Springfield - Elixia - PPDS
Springfield, Massachusetts 01103
Contact:
Susan Smiga, Site 1239
413-305-1142

Neurobehavioral Medicine Group (NBMG)
Bloomfield Township, Michigan 48302-1909
Contact:
Richard Jackson, Site 1248
412-916-2425

Precise Research Centers
Flowood, Mississippi 39232
Contact:
Joseph Kwentus, Site 1132
601-420-5810

Tekton Research, LLC - Saint Louis Psychiatry - PPDS
St Louis, Missouri 63128
Contact:
Ernest Graypel, Site 1255
314-267-1075

Advanced Memory Research Institute - CenExel - PPDS
Toms River, New Jersey 08755
Contact:
Arun Singh, Site 1202
732-341-9500

Mid Hudson Medical Research PLLC
New Windsor, New York 12553-7754
Contact:
Sashi Makam, Site 1251
845-674-9398

SUNY Upstate Medical University
Syracuse, New York 13210-2306
Contact:
Tinatin Chabrashvili, Site 1240
617-636-5000

Five Towns Neurology, PC
Woodmere, New York 11598-1739
Contact:
David Steiner, Site 1025
516-239-1800

Triad Clinical Trials - 515 College Rd
Greensboro, North Carolina 27410-3311
Contact:
Richard Montgomery, Site 1221
336-235-0991

AMC Research, LLC - Flourish - PPDS
Matthews, North Carolina 28105-8336
Contact:
Mohammad Bolouri, Site 1214
704-364-4000

West Clinical Research
Morehead City, North Carolina 28557
Contact:
Patrick Morgante, Site 1215
252-515-0050

Ohio State University
Columbus, Ohio 43221
Contact:
Douglas Scharre, Site 1201
614-293-4560

Insight Clinical Trials LLC - Independence
Independence, Ohio 44131
Contact:
Mark Stillman, Site 1249
216-444-8897

The Rivus Wellness & Research Institute
Oklahoma City, Oklahoma 73112
Contact:
Marvin Peyton, Site 1016
405-317-5783

Alzheimer's Disease and Memory Disorders Center at Rhode Island Hospital
Providence, Rhode Island 02903
Contact:
Chuang-Kuo Wu, Site 1218
714-456-7002

Vanderbilt Psychiatric Hospital
Nashville, Tennessee 37212-3133
Contact:
Jo Wilson, Site 1211
615-322-4967

Epic Medical Research LLC - DeSoto
DeSoto, Texas 75115-2043
Contact:
Haresh Boghara, Site 1121
972-777-6956

Advanced Neuro Research Center - El Paso
El Paso, Texas 79912-1743
Contact:
Aamr Herekar, Site 1208
915-974-2200

University Hills Clinical Research - 102 Decker Ct
Irving, Texas 75062-2898
Contact:
Mary Ann Knesevich, Site 1259
972-717-6262

Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases
San Antonio, Texas 78229-3901
Contact:
Antonio Teixeira, Site 1210
210-567-8229

Conquest Research, LLC - Virginia - Vienna
Vienna, Virginia 22182
Contact:
Henry Tran, Site 1241
703-717-7755

Northwest Clinical Research Center
Bellevue, Washington 98007-4879
Contact:
Wisam Al Jumaili, Site 1253
425-453-0404

Instituto De Neurologia Dra. Ivonne Fraga,Psc
San Juan, Puerto Rico 00918-4502
Contact:
Ivonne De L Fraga Berrios, Site 1302
7874035534

More Details

NCT ID
NCT06585787
Status
Recruiting
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center