AzTrials
AzTrials

Alzheimer DiseasePhase 3NCT06585787

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

A Phase 3 study testing KarXT in people with Alzheimer Disease, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 296 sites in 25 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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 more about this study

Who is it for?
Ages 55 to 90 years
Conditions the study is for
Alzheimer Disease
What is being tested?
KarXT
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
406 participants
Where
296 sitesin 25 countries
Study dates
26 Sep 2024to 22 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • Patients will not be able to participate if they have:
  • 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.
  • History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
  • Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

296 sites in 25 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

296 sites in 25 countries

United States102 sites, 52 recruiting

  • Advanced Research Center, Inc.

    Anaheim, California, 92805-5854

    Steven Macina, Site 1104, 714-999-6688

    Recruiting

  • Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30328-5532

    Vasundhara Cheekati, Site 1206, 404-382-8660

    Recruiting

  • Local Institution - 1225

    Atlantis, Florida, 33462

    Completed

  • Senior Adults Specialty Research

    Austin, Texas, 78757-7566

    John Bertelson, Site 1263, 512-407-8628

    Recruiting

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007-4879

    Wisam Al Jumaili, Site 1253, 425-453-0404

    Recruiting

  • McLean Hospital

    Belmont, Massachusetts, 02478-1064

    Arkadiy Stolyar, Site 1223, 617-855-2136

    Recruiting

  • Neurobehavioral Medicine Group (NBMG)

    Bloomfield Township, Michigan, 48302-1909

    Richard Jackson, Site 1248, 412-916-2425

    Recruiting

  • Envision Trials LLC

    Bonita Springs, Florida, 34134

    Daniel Mandri, Site 1020, 305-819-2909

    Recruiting

  • Tufts Medical Center - 800 Washington St - PPDS

    Boston, Massachusetts, 02111-1552

    Brent Forester, Site 1245, 617-636-3202

    Recruiting

  • Local Institution - 1227

    Chandler, Arizona, 85224

    Completed

  • Inland Psychiatric Medical Group (IPMG)-Chino

    Chino, California, 91710

    Nandita Puchakayala, Site 1244, 909-488-9116

    Recruiting

  • Local Institution - 1265

    Cleveland, Ohio, 44195

    Site 1265

    Not yet recruiting

  • Local Institution - 1267

    Columbia, South Carolina, 29203-8004

    Site 1267

    Not yet recruiting

  • Ohio State University

    Columbus, Ohio, 43221

    Douglas Scharre, Site 1201, 614-293-4560

    Recruiting

  • Local Institution - 1138

    Cutler Bay, Florida, 33189-1230

    Active, not recruiting

  • Local Institution - 1260

    Dallas, Texas, 75231-6079

    Site 1260

    Not yet recruiting

  • Local Institution - 1258

    Dayton, Ohio, 45417-3445

    Site 1258

    Not yet recruiting

  • Arrow Clinical Trials

    Daytona Beach, Florida, 32117-5532

    David Billmeier, Site 1023, 386-278-8000

    Recruiting

  • Local Institution - 1224

    Deerfield Beach, Florida, 33442

    Completed

  • Epic Medical Research LLC - DeSoto

    DeSoto, Texas, 75115-2043

    Haresh Boghara, Site 1121, 972-777-6956

    Recruiting

  • Local Institution - 1164

    Doral, Florida, 33122-1620

    Active, not recruiting

  • Advanced Neuro Research Center - El Paso

    El Paso, Texas, 79912-1743

    Aamr Herekar, Site 1208, 915-974-2200

    Recruiting

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

    Neha Jain, Site 1222, 860-790-7354

    Recruiting

  • Precise Research Centers

    Flowood, Mississippi, 39232

    Joseph Kwentus, Site 1132, 601-420-5810

    Recruiting

  • Local Institution - 1262

    Fort Worth, Texas, 76104-4143

    Site 1262

    Not yet recruiting

  • Gilbert Neurology Partners - PLLC - Avacare

    Gilbert, Arizona, 85297

    Jonathan Hodgson, Site 1247, 602-761-9631

    Recruiting

  • Triad Clinical Trials - 515 College Rd

    Greensboro, North Carolina, 27410-3311

    Richard Montgomery, Site 1221, 336-235-0991

    Recruiting

  • Local Institution - 1264

    Gulf Breeze, Florida, 32561

    Site 1264

    Not yet recruiting

  • Local Institution - 1120

    Hialeah, Florida, 33012-4648

    Active, not recruiting

  • Local Institution - 1237

    Hialeah, Florida, 33013

    Completed

  • Local Institution - 1229

    Homestead, Florida, 33030

    Active, not recruiting

  • Local Institution - 1261

    Houston, Texas, 77030-1312

    Site 1261

    Not yet recruiting

  • Insight Clinical Trials LLC - Independence

    Independence, Ohio, 44131

    Mark Stillman, Site 1249, 216-444-8897

    Recruiting

  • University Hills Clinical Research - 102 Decker Ct

    Irving, Texas, 75062-2898

    Mary Ann Knesevich, Site 1259, 972-717-6262

    Recruiting

  • Local Institution - 1254

    Kirkland, Washington, 98034

    Withdrawn

  • Local Institution - 1040

    Lady Lake, Florida, 32159

    Completed

  • Local Institution - 1230

    Long Beach, California, 90805

    Completed

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

    Los Angeles, California, 90033-5313

    Lon Schneider, Site 1226, 323-442-3715

    Recruiting

  • Local Institution - 1219

    Los Angeles, California, 90095

    Withdrawn

  • AMC Research, LLC - Flourish - PPDS

    Matthews, North Carolina, 28105-8336

    Mohammad Bolouri, Site 1214, 704-364-4000

    Recruiting

  • Local Institution - 1159

    Miami, Florida, 33032

    Active, not recruiting

  • Local Institution - 1021

    Miami, Florida, 33122-1335

    Active, not recruiting

  • Local Institution - 1125

    Miami, Florida, 33135-1601

    Active, not recruiting

  • Local Institution - 1236

    Miami, Florida, 33135-2968

    Active, not recruiting

  • Local Institution - 1115

    Miami, Florida, 33135

    Active, not recruiting

  • Local Institution - 1010

    Miami, Florida, 33137

    Completed

  • Local Institution - 1143

    Miami, Florida, 33145-2455

    Completed

  • Local Institution - 1113

    Miami, Florida, 33155-6630

    Active, not recruiting

  • Local Institution - 1129

    Miami, Florida, 33165-3947

    Active, not recruiting

  • Local Institution - 1150

    Miami, Florida, 33165

    Active, not recruiting

  • Local Institution - 1006

    Miami, Florida, 33173-1474

    Active, not recruiting

  • Local Institution - 1111

    Miami, Florida, 33173

    Active, not recruiting

  • Local Institution - 1158

    Miami, Florida, 33175

    Completed

  • Local Institution - 1235

    Miami, Florida, 33176-1451

    Completed

  • Local Institution - 1147

    Miami, Florida, 33176-7947

    Completed

  • Local Institution - 1234

    Miami, Florida, 33176

    Active, not recruiting

  • Local Institution - 1105

    Miami, Florida, 33179-2537

    Completed

  • Local Institution - 1157

    Miami, Florida, 33184-1412

    Active, not recruiting

  • Local Institution - 1126

    Miami Gardens, Florida, 33056-4000

    Active, not recruiting

  • Local Institution - 1209

    Miami Lakes, Florida, 33014

    Completed

  • Local Institution - 1118

    Miami Lakes, Florida, 33016

    Active, not recruiting

  • Local Institution - 5005

    Morehead City, North Carolina, 28557

    Withdrawn

  • West Clinical Research

    Morehead City, North Carolina, 28557

    Patrick Morgante, Site 1215, 252-515-0050

    Recruiting

  • Aqualane Clinical Research

    Naples, Florida, 34105

    William Justiz, Site 1246, 941-436-6838

    Recruiting

  • Vanderbilt Psychiatric Hospital

    Nashville, Tennessee, 37212-3133

    Jo Wilson, Site 1211, 615-322-4967

    Recruiting

  • Mid Hudson Medical Research PLLC

    New Windsor, New York, 12553-7754

    Sashi Makam, Site 1251, 845-674-9398

    Recruiting

  • Boston Neuro Research Center

    North Dartmouth, Massachusetts, 02747-2612

    Mushtaque Chachar, Site 1243, 508-925-7403

    Recruiting

  • Sensible HealthCare, LLC

    Ocoee, Florida, 34761-2964

    Kelly Taylor, Site 1212, 407-654-2724

    Recruiting

  • The Rivus Wellness & Research Institute

    Oklahoma City, Oklahoma, 73112

    Marvin Peyton, Site 1016, 405-317-5783

    Recruiting

  • Local Institution - 1001

    Orange, California, 92866

    Completed

  • Local Institution - 1228

    Orange, California, 92868-2847

    Completed

  • Charter Research Orlando

    Orlando, Florida, 32803

    Diana Balsalobre, Site 1257

    Recruiting

  • Nova Psychiatry

    Orlando, Florida, 32803

    David Medina, Site 1242, 407-823-8421

    Recruiting

  • Combined Research Orlando Phase I-IV LLC

    Orlando, Florida, 32807-3555

    Eric Carbonell, Site 1112, 407-440-4493

    Recruiting

  • Local Institution - 1204

    Ormond Beach, Florida, 32174-3101

    Active, not recruiting

  • Local Institution - 1043

    Pasadena, California, 91106

    Active, not recruiting

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006-2528

    Ganesh Gopalakrishna, Site 1217, 602-839-6900

    Recruiting

  • Local Institution - 1238

    Plano, Texas, 75093-8225

    Completed

  • Local Institution - 1205

    Port Orange, Florida, 32127-5169

    Active, not recruiting

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

    Providence, Rhode Island, 02903

    Chuang-Kuo Wu, Site 1218, 714-456-7002

    Recruiting

  • Local Institution - 1213

    Rancho Cucamonga, California, 91730

    Active, not recruiting

  • Local Institution - 1266

    Salem, Virginia, 24153-6404

    Site 1266

    Not yet recruiting

  • Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases

    San Antonio, Texas, 78229-3901

    Antonio Teixeira, Site 1210, 210-567-8229

    Recruiting

  • Local Institution - 1220

    Scottsdale, Arizona, 85260-6742

    Completed

  • Local Institution - 1252

    Shelby, North Carolina, 28150-3803

    Withdrawn

  • Local Institution - 1250

    South Dartmouth, Massachusetts, 02747

    Completed

  • Elixia Health - Springfield - Elixia - PPDS

    Springfield, Massachusetts, 01103

    Susan Smiga, Site 1239, 413-305-1142

    Recruiting

  • Tekton Research, LLC - Saint Louis Psychiatry - PPDS

    St Louis, Missouri, 63128

    Ernest Graypel, Site 1255, 314-594-7785

    Recruiting

  • Local Institution - 1134

    Stafford, Texas, 77477-3929

    Completed

  • Local Institution - 1133

    Sweetwater, Florida, 33182

    Completed

  • Local Institution - 1231

    Syracuse, New York, 13203

    Withdrawn

  • SUNY Upstate Medical University

    Syracuse, New York, 13210-2306

    Tinatin Chabrashvili, Site 1240, 617-636-5000

    Recruiting

  • Local Institution - 1123

    Tampa, Florida, 33614-2869

    Active, not recruiting

  • Guardian Angel Research

    Tampa, Florida, 33614

    Sadaf Bazargan, Site 1124, 813-300-3300

    Recruiting

  • Interventional Psychiatry of Tampa Bay

    Tampa, Florida, 33629-5837

    Jamie Fernandez, Site 1110, 813-251-1800

    Recruiting

  • Charter Research

    The Villages, Florida, 32162-2698

    Jeffrey Norton, Site 1256, 352-775-1000

    Recruiting

  • Advanced Memory Research Institute - CenExel - PPDS

    Toms River, New Jersey, 08755

    Arun Singh, Site 1202, 732-341-9500

    Recruiting

  • Local Institution - 1232

    Toms River, New Jersey, 08755

    Active, not recruiting

  • Conquest Research, LLC - Virginia - Vienna

    Vienna, Virginia, 22182

    Henry Tran, Site 1241, 703-717-7755

    Recruiting

  • Local Institution - 1233

    Wellington, Florida, 33414

    Withdrawn

  • Premiere Research Institute at Palm Beach Neurology, PA

    West Palm Beach, Florida, 33407-3209

    Paul Winner, Site 1216, 561-845-0500

    Recruiting

  • Five Towns Neurology, PC

    Woodmere, New York, 11598-1739

    David Steiner, Site 1025, 516-239-1800

    Recruiting

Other trials in United States

Japan26 sites, 16 recruiting

  • Local Institution - 7515

    Fukuoka, 815-0082

    Withdrawn

  • Local Institution - 7518

    Hachiōji, Tokyo, 193-0811

    Completed

  • Hatano Kousei Hospital

    Hadano, Kanagawa, 257-0003

    Yoshiro Sakai, Site 7505, +81-463-77-1108

    Recruiting

  • Hyogo Prefectural Harima-Himeji General Medical Center

    Himeji-Shi, Hyōgo, 672-8044

    Kenichi Shimada, Site 7526

    Recruiting

  • Funairi nou clinic

    Hiroshima, 730-0844

    Tomoko Murakami, Site 7516

    Recruiting

  • Local Institution - 7503

    Iizuka, Fukuoka, 820-0014

    Completed

  • Local Institution - 7510

    Kanzaki-Gun Yoshinogari-Cho, Saga-ken, 842-0192

    Withdrawn

  • Koukan Clinic

    Kawasaki-Shi, Kanagawa, 210-0852

    Yasuhiro Yoshii, Site 7507, 81443668900

    Recruiting

  • Southern TOHOKU Medical Clinic

    Kōriyama, Fukushima, 963-8052

    Chikako Kaneko, Site 7525, 812493454322

    Recruiting

  • Yuge Neuropsychiatric Hospital

    Kumamoto, 861-8002

    Masahiro Shono, Site 7524, 81-96-338-3838

    Recruiting

  • National Hospital Organization Utano National Hospital

    Kyoto, Kyoto, 616-8255

    Shinji Sudoh, Site 7511, 81-75-461-5121

    Recruiting

  • Asakayama General Hospital

    Sakai, Osaka, 590-0018

    Kazue Kamae, Site 7509, 0722294882

    Recruiting

  • Local Institution - 7522

    Sapporo, Hokkaido, 006-8555

    Completed

  • Sangenjaya Nakamura Mental Clinic

    Setagaya-Ku, Tokyo, 154-0004

    Satoshi Nakamura, Site 7521

    Recruiting

  • Kurumi Clinic

    Setagaya-Ku, Tokyo, 156-0041

    Chika Nishimura, Site 7519, 81333277462

    Recruiting

  • Tokyo Metropolitan Matsuzawa Hospital

    Setagaya-Ku, Tokyo, 156-0057

    Kenichi Oshima, Site 7528, 81333037211

    Recruiting

  • Local Institution - 7514

    Takamatsu, Kagawa-ken, 760-0065

    Completed

  • Shin-Abuyama Hospital

    Takatsuki, Osaka, 569-1041

    Kazushige Morimoto, Site 7501, 8.1726931881E10

    Recruiting

  • Tsutsujimental Hospital

    Tatebayashi, 374-0037

    Hajime Tabuchi, Site 7523, 81276802111

    Recruiting

  • Memory Clinic Toride

    Toride-shi, Ibaraki, 302-0004

    Youshun Boku, Site 7508, +297796166

    Recruiting

  • Local Institution - 7506

    Tsu, Mie-ken, 514-1101

    Completed

  • Local Institution - 7504

    Wako-Shi, Saitama, 351-0102

    Completed

  • Local Institution - 7520

    Yokohama, Kanagawa, 230-0074

    Completed

  • Yokohama City Minato Red Cross Hospital

    Yokohama, Kanagawa, 2310801

    Takuya Ohkubo, Site 7502, 0456286100

    Recruiting

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

    Keiko Ide, Site 7513, 81457872800

    Recruiting

  • Local Institution - 7512

    Yoshinogawa, Tokushima, 776-8585

    Completed

Other trials in Japan

China22 sites, 21 recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100025

    Dantao Peng, Site 7004, 8613910908579

    Recruiting

  • Beijing Anding Hospital Capital Medical University

    Beijing, Beijing Municipality, 100088

    Qinge Zhang, Site 7005, 8613811591959

    Recruiting

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

    Haibo Chen, Site 7025, 8613910000000

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, 410008

    Lu Shen, Site 7027, 073189753041

    Recruiting

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610000

    Weihong Kuang, Site 7002, +861898060171

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

    Yang Lv, Site 7015, +861361823653

    Recruiting

  • Local Institution - 7008

    Guangzhou, Guangdong, 0

    Withdrawn

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510120

    Jiehao Zhao, Site 7016, +861355619953

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qiantang Campus

    Hangzhou, Zhejiang, 310009

    Wei Chen, Site 7020, +86 138 0573 6335

    Recruiting

  • Zhejiang Hospital - Lingyin Campus

    Hangzhou, Zhejiang, 310013

    Xiaoli Liu, Site 7021, +865718798737

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

    Zhengluan Liao, Site 7006, 13958024692

    Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, 650032

    Jin Lu, Site 7022, 8613530000000

    Recruiting

  • The Second Affiliated Hospital of Nanjing Medical University - Main Campus

    Nanjing, Jiangsu, 210011

    Meijiang Feng, Site 7013, 8618951762651

    Recruiting

  • Nanjing Brain Hospital

    Nanjing, Jiangsu, 210029

    Weiwei Jiang, Site 7024, 13372003816

    Recruiting

  • The Affiliated Kangning Hospital of Ningbo University - Zhuangshi Campus

    Ningbo, Zhejiang, 315201

    Haihang Yu, Site 7030, +861360588018

    Recruiting

  • Shanghai Mental Health Center - PPDS

    Shanghai, Shanghai Municipality, 200030

    Xia Li, Site 7001, +861377427254

    Recruiting

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai Municipality, 200065

    Xijin Wang, Site 7028

    Recruiting

  • Local Institution - 7026

    Shanghai, Shanghai Municipality, 200233

    Site 7026

    Not yet recruiting

  • Shenzhen Kangning Hospital

    Shenzhen, Guangdong, 518118

    Yongjun Wang, Site 7003, 8613632587615

    Recruiting

  • Tianjin Anding Hospital(Tianjin mental Health Center)

    Tianjin, Tianjin Municipality, 300222

    Daliang Sun, Site 7019, +8615122889423

    Recruiting

  • The Mental Health Center of Xi'an

    Xi'an, Shan1xi, 710061

    Wei Dang, Site 7029

    Recruiting

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001

    Ming Yu, Site 7023, 8613860000000

    Recruiting

Other trials in China

South Korea13 sites, 12 recruiting

  • Local Institution - 7214

    Ansan-si, Gyeonggido, 15355

    Completed

  • Hallym University Chuncheon Sacred Heart Hospital

    Gangwon-do, 200-704

    Do-Hoon Kim, Site 7218, 821041512959

    Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

    Manho Kim, Site 7206, +82-2-2072-2193

    Recruiting

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi, 06351

    Hong Jin Jeon, Site 7210, 82234103586

    Recruiting

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, Seoul Teugbyeolsi, 06591

    Dong Woo Kang, Site 7217, 82200000000

    Recruiting

  • Ewha Womans University Seoul Hospital

    Seoul, Seoul Teugbyeolsi, 07804

    Jee Hyang Jeong, Site 7213, +821090851927

    Recruiting

  • Ewha Womans University Mokdong Hospital

    Seoul, Seoul Teugbyeolsi, 7985

    Geon Ha Kim, Site 7215, 82226505298

    Recruiting

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

    Hanna Cho, Site 7219

    Recruiting

  • SMG - SNU Boramae Medical Center

    Seoul, 07071

    Jun-Young Lee, Site 7203, 8228702462

    Recruiting

  • Local Institution - 1-14KMN4SY

    Seoul, 143-729

    Site 1-14KMN4SY

    Not yet recruiting

  • Hanyang University Seoul Hospital

    Seoul, 4763

    Hee Jin Kim, Site 7211, +82222908374

    Recruiting

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Yeongdeungpo-gu, Seoul Teugbyeolsi, 07345

    Hyun-Kook Lim, Site 7212

    Recruiting

  • Yongin Severance Hospital, Yonsei University Health System

    Yongin-si, Gyeonggido, 16995

    Woo Jung Kim, Site 7216, +8218991004

    Recruiting

Other trials in South Korea

Poland10 sites, 5 recruiting

  • Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17

    Gdansk, Pomeranian Voivodeship, 80-214

    Adam Wlodarczyk, Site 4212, 48583493720

    Recruiting

  • Local Institution - 4207

    Iława, Warmian-Masurian Voivodeship, 14-200

    Withdrawn

  • Osrodek Badan Klinicznych BD Research Sp. z o.o. - Andersa 3

    Iława, Warmian-Masurian Voivodeship, 14-200

    Elzbieta Wagenknecht, Site 4215

    Recruiting

  • Local Institution - 4213

    Kielce, 25-411

    Withdrawn

  • Local Institution - 7527

    Lodz, 91-743

    Withdrawn

  • Pro Salus Sp. z o.o.sp. k

    Lodz, 91-743

    Lukasz Jasek, Site 4214

    Recruiting

  • Local Institution - 4206

    Lublin, 20-064

    Completed

  • Centrum Medyczne HCP Szpital im. Jana Pawla II

    Poznan, Greater Poland Voivodeship, 61-485

    Przemyslaw Osip, Site 4210, 48604116632

    Recruiting

  • RCMed Oddzial Sochaczew

    Sochaczew, 96-500

    Malgorzata Fengler-Czeczko, Site 4216, +480607705818

    Recruiting

  • Local Institution - 4211

    Wroclaw, 50-981

    Completed

Other trials in Poland

Argentina9 sites, 9 recruiting

  • Hospital Italiano de Buenos Aires

    Buenos Aires, 1199

    Maria Cecilia Fernandez, Site 5002, 5411500000x00

    Recruiting

  • Organización Médica de Investigación

    Buenos Aires, C1015ABO

    Daniel Politis, Site 5009, +541150319700

    Recruiting

  • Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI

    Buenos Aires, C1428AQK

    Pablo Bagnati, Site 5006, 542234000000

    Recruiting

  • CINME S.A. - Centro de Investigaciones Metabólicas - Viamonte 2213/2215

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1056

    Griselda Russo, Site 5004, 8888888888

    Recruiting

  • Centro Neurobiológico y de Estrés Traumático - CENydET S.R.L.

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1058AAJ

    Enrique Kuper, Site 5005, 541143000000

    Recruiting

  • Fundación para el Estudio y Tratamiento de Enfermedades mentales- FETEM

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1107

    Ricardo Corral, Site 5001, 5491144455572

    Recruiting

  • Centro Especializado en Neurociencias - CEN

    Córdoba, 5000

    Hernán Ruggeri, Site 5007, +543514512141

    Recruiting

  • Instituto Privado Kremer

    Córdoba, 5004

    Leonardo Kremer, Site 5003, 543515000000

    Recruiting

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, Santa Fe Province, S2000DEJ

    Javier Travella, Site 5008

    Recruiting

Other trials in Argentina

Italy8 sites, 1 recruiting

  • IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

    Brescia, Lombardy, 25125

    Stefania Orini, Site 2324

    Recruiting

  • Local Institution - 2323

    Milan, Lombardy, 20149

    Completed

  • Local Institution - 2307

    Ponderano (Biella), Piedmont, 13875

    Completed

  • Local Institution - 2309

    Roma, 00189

    Completed

  • Local Institution - 2322

    Rome, Lazio, 00161

    Completed

  • Local Institution - 2320

    Rome, Lazio, 00166

    Completed

  • Local Institution - 2321

    Rome, Roma, 00186

    Withdrawn

  • Local Institution - 2325

    Salerno, Campania, 84131

    Withdrawn

Other trials in Italy

Serbia8 sites, 6 recruiting

  • University Clinical Center of Serbia - Dr Subotica 6 - PPDS

    Belgrade, Belgrade, 11000

    Tanja Stojkovic, Site 4313, 381607545958

    Recruiting

  • Clinical Hospital Center Dragisa Misovic Dedinje

    Belgrade, 11000

    Vladimir Diligenski, Site 4306, 381637708765

    Recruiting

  • Military Medical Academy

    Belgrade, 11000

    Aleksandar Eror, Site 4308, 381113609206

    Recruiting

  • Military Medical Academy

    Belgrade, 11000

    Smiljana Kostic, Site 4314, +381112663470

    Recruiting

  • Local Institution - 4312

    Gornja Toponica, 705631

    Active, not recruiting

  • Local Institution - 4305

    Kovin, 26220

    Completed

  • University Clinical Center Kragujevac

    Kragujevac, 34000

    Vladimir Janjic, Site 4301, +38134370208

    Recruiting

  • Clinical Centre of Vojvodina

    Novi Sad, 21000

    Marija Semnic, Site 4309, 381184601111

    Recruiting

Other trials in Serbia

Spain8 sites, 7 recruiting

  • Local Institution - 2212

    Lleida, 25198

    Completed

  • Hospital Clinico San Carlos

    Madrid, 28040

    Jordi Matias Guiu, Site 2210

    Recruiting

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

    Pilar Sanchez Alonso, Site 2211

    Recruiting

  • Hospital Quironsalud Malaga

    Málaga, Málaga, 29004

    Jesus Romero Imbroda, Site 2213, 3495194000

    Recruiting

  • Hospital Universitario De Salamanca

    Salamanca, 37007

    Angel Montejo Gonzalez, Site 2204, +34923126580

    Recruiting

  • Hospital Victoria Eugenia

    Seville, 41009

    Felix Vinuela Fernandez, Site 2201, +34654566812

    Recruiting

  • Hospital Universitario Rio Hortega

    Valladolid, 47012

    Juan Muñoz Sanchez, Site 2203, +34679279973

    Recruiting

  • Hospital Viamed Montecanal

    Zaragoza, 50012

    Antonio Oliveros-Cid, Site 2206, +34670492099

    Recruiting

Other trials in Spain

Ukraine8 sites, 8 recruiting

  • Municipal NonProfit Enterprise Khmelnytskyi Regional Psychiatric Care Facility of the Khmelnytskyi Regional Council

    Khmelnytskyi, 32120

    Viktoriia Kachynska, Site 8003, 380672624158

    Recruiting

  • Municipal non-profit enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital

    Lviv, Lviv Oblast, 79053

    Yuriy Filts, Site 8007, 380676702827

    Recruiting

  • Iqmed Llc

    Lviv, 79035

    Andriy Tsona, Site 8006, 38000000000

    Recruiting

  • MNE Cherkasy Regional Psychiatric Hospital of Cherkasy RC

    Smila, 20708

    Iryna Kosenkova, Site 8004, 380473321979

    Recruiting

  • MNE Ternopil Regional Clinical Psychoneurological Hospital of TRC

    Ternopil, 46027

    Olena Venger, Site 8008, +380677565556

    Recruiting

  • Neyromed LLC - Uzhhorod

    Uzhhorod, 88000

    Oleksandr Romaniv, Site 8005, 380509997971

    Recruiting

  • MI Vinnytsia Regional Psychoneurological Hospital n.a. acad. O.I. Yushchenko

    Vinnytsia, Vinnytsia Oblast, 21005

    Oksana Serebrennikova, Site 8002, +380679605672

    Recruiting

  • Local Institution - 8001

    Vinnytsia, Vinnytsia Oblast, Ukraine

    Site 8001

    Not yet recruiting

Other trials in Ukraine

Brazil7 sites, 7 recruiting

  • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

    Brasília, Federal District, 70200-730

    Eduardo Vasconcellos, Site 6201, 55-6199983-1080

    Recruiting

  • Ruschel Medicina

    Rio de Janeiro, 22270060

    Sandra Ruschel, Site 6204, 5521999822072

    Recruiting

  • CPQuali Pesquisa Clínica Sao Paulo

    São Paulo, São Paulo, 01228-000

    Leonel Takada, Site 6202, 558888888888

    Recruiting

  • BR Trials - Pesquisa Clínica

    São Paulo, São Paulo, 01236-030

    Acioly Lacerda, Site 6206, +551938639438

    Recruiting

  • Hospital Alemao Oswaldo Cruz (HAOC)

    São Paulo, São Paulo, 01327-001

    Diogo Santos, Site 6207

    Recruiting

  • Clinilive

    São Paulo, São Paulo, 87013-250

    Antonio Carlos Da Silva, Site 6203

    Recruiting

  • Instituto de Psiquiatria HC FMUSP

    São Paulo, 05403-010

    Tania Correa de Toledo Ferraz, Site 6205

    Recruiting

Other trials in Brazil

India7 sites, 7 recruiting

  • Jawaharlal Nehru Medical College, Ajmer

    Ajmer, Rajasthan, 305001

    Parth Singh Meena, Site 7406, 8118877284

    Recruiting

  • Local Institution - 1-13SNAZL0

    Aurangabad, Maharashtra, 431005

    Site 1-13SNAZL0

    Not yet recruiting

  • Postgraduate Institute of Medical Education & Research (PGIMER)

    Chandigarh, Punjab, 160012

    Aseem Mehra, Site 7405, +8264690790

    Recruiting

  • Asha Hospital - Hyderabad

    Hyderabad, 500034

    Chandrasekhar Kammammettu, Site 7403, 888888888

    Recruiting

  • Institute of Neurosciences Kolkata

    Kolkata, 700017

    Hrishikesh Kumar, Site 7404, 91987464544

    Recruiting

  • Central Institute of Behavioural Sciences

    Nagpur, Maharashtra, 440010

    Shailesh Pangaonkar, Site 7401, +917122548966

    Recruiting

  • Deva Institute of Healthcare & Research (DIHR) Pvt Ltd (Deva Institute of Healthcare)

    Varanasi, 211 005

    Venu Gopal Jhanwar, Site 7402, 8662444999

    Recruiting

Other trials in India

Romania7 sites, 6 recruiting

  • Local Institution - 4907

    Bucharest, 11241

    Site 4907

    Not yet recruiting

  • Prof Dr Alexandru Obregia Clinical Psychiatric Hospital- Centrul de Sanatate Mintala

    Bucharest, 40874

    Mihaela-Cleopatra Rosca, Site 4906, +40745588989

    Recruiting

  • Cai Ferate Clinical Hospital Constanta

    Constanța, 90123

    Ana-Maria Ionescu, Site 4902, 4024151078x3

    Recruiting

  • Institutul Privat de Cercetări Melchisedec pentru Boli Autoimune, Ereditare și Rare -I.P.C.M

    Craiova, 200157

    George Badescu, Site 4903, +40762088099

    Recruiting

  • Local Institution - 4905

    Iași, 700282

    Withdrawn

  • CMI Dr. Buhas Ramocea Elena Daniela - Cabinet Medical de Psihiarie

    Oradea, Bihor County, 410027

    Elena Daniela Buhas Ramocea, Site 4904, 0040747056934

    Recruiting

  • S.C. Carpe Diem SRL

    Sibiu, 550281

    Cosmina Muntean, Site 4901, 4026944141x5

    Recruiting

Other trials in Romania

Portugal6 sites, 1 recruiting

  • Local Institution - 2701

    Guimarães, Braga District, 4835-044

    Completed

  • Local Institution - 2704

    Lisbon, Lisbon District, 1349-019

    Completed

  • ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS

    Lisbon, 1649-035

    Ana Verdelho, Site 2705, 3512178050x50

    Recruiting

  • Local Institution - 2706

    Lisbon, 1998-018

    Withdrawn

  • Local Institution - 2703

    Matosinhos Municipality, Porto District, 4454-509

    Completed

  • Local Institution - 2702

    Torres Vedras, Lisbon District, 2560-280

    Completed

Other trials in Portugal

Slovakia6 sites, 3 recruiting

  • MUDr. Beata Dupejova - Neurologicka Ambulancia s.r.o

    Banská Bystrica, 974 04

    Beata Dupejova, Site 4401, +421484124549

    Recruiting

  • KONZILIUM s.r.o

    Dubnica nad Váhom, 018 41

    Magdalena Perichtova, Site 4402, +421424426231

    Recruiting

  • Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43

    Košice, Košice Region, 041 90

    Slavka Dubinska, Site 4405, +421903625643

    Recruiting

  • Local Institution - 4406

    Košice, 040 01

    Completed

  • Local Institution - 4407

    Pezinok, 902 18

    Completed

  • Local Institution - 4403

    Vranov nad Topľou, 093 01

    Completed

Other trials in Slovakia

Turkey (Türkiye)6 sites, 3 recruiting

  • Hacettepe University Medical Faculty

    Ankara, 06230

    Gul Yalcin Cakmakli, Site 4706

    Recruiting

  • Local Institution - 4702

    Atakum, Samsun, 55270

    Completed

  • Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi

    Eskişehir, 26040

    Fatma Nazli Durmaz Celik, Site 4701, +905069093663

    Recruiting

  • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

    Istanbul, 34093

    Hasmet Ayhan Hanagasi, Site 4704, +905322728519

    Recruiting

  • Local Institution - 4705

    Izmir, 35340

    Completed

  • Local Institution - 4703

    Izmir, 35370

    Completed

Other trials in Turkey (Türkiye)

Belgium5 sites

  • Local Institution - 2804

    Alken, 3570

    Completed

  • Local Institution - 2807

    Bruges, 8000

    Withdrawn

  • Local Institution - 2806

    Jette, Brussels Capital, 1090

    Completed

  • Local Institution - 2805

    Kortrijk, 8500

    Completed

  • Local Institution - 2803

    Roeselare, West-Vlaanderen, 8800

    Completed

Other trials in Belgium

Bulgaria5 sites, 3 recruiting

  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-66 Peshtersko Shosse blvd

    Plovdiv, 4001

    Penka Atanasova, Site 4508

    Recruiting

  • University Multiprofile Hospital For Active Treatment Kanev AD

    Rousse, 7002

    Neli Petrova, Site 4507, 359888793906

    Recruiting

  • Local Institution - 4506

    Sofia, Sofia-Grad, 1680

    Completed

  • Medical Center Medika 2005 - Branch Sofia

    Sofia, 1164

    Plamen Tsvetanov, Site 4509

    Recruiting

  • Local Institution - 4510

    Sofia, 1408

    Withdrawn

Other trials in Bulgaria

Croatia5 sites

  • Local Institution - 4102

    Zagreb, City of Zagreb, 10000

    Completed

  • Local Institution - 4105

    Zagreb, City of Zagreb, 10000

    Completed

  • Local Institution - 4106

    Zagreb, City of Zagreb, 10000

    Withdrawn

  • Local Institution - 4101

    Zagreb, City of Zagreb, 10090

    Completed

  • Local Institution - 4104

    Zagreb, City of Zagreb, 10090

    Completed

Other trials in Croatia

Germany5 sites

  • Local Institution - 2406

    Berlin, 12163

    Withdrawn

  • Local Institution - 2407

    Böblingen, Baden-Wurttemberg, 71034

    Withdrawn

  • Local Institution - 2404

    Erbach im Odenwald, 64711

    Completed

  • Local Institution - 2405

    Frankfurt am Main, 60528

    Completed

  • Local Institution - 2402

    Homburg, Saarland, 66424

    Completed

Other trials in Germany

Greece5 sites, 1 recruiting

  • Local Institution - 4803

    Athens, Attica, 115 26

    Completed

  • Local Institution - 4802

    Chaidari, Athens, Attica, 12462

    Completed

  • PAGNI-University General Hospital of Heraklion

    Heraklion, Irakleio, 71500

    Ioannis Zaganas, Site 4801, +302810394643

    Recruiting

  • Local Institution - 4810

    Kalyftaki-N. Kifissia, Attica, 145 64

    Completed

  • Local Institution - 4811

    Thessaloniki, 546 36

    Completed

Other trials in Greece

Hungary5 sites, 4 recruiting

  • Semmelweis Egyetem Pszichiátriai és Pszichoterápiás Klinika

    Budapest, 1083

    János Réthelyi, Site 4602, +3612100336

    Recruiting

  • Eszak-budai Szent Janos Centrumkorhaz

    Budapest, 1123

    Tamás Kurimay, Site 4612, +3614584537

    Recruiting

  • Clinexpert Gyöngyös Kft.

    Gyöngyös, Heves County, 3200

    Tibor Kelemen, Site 4611, 3637312491

    Recruiting

  • Psychotech Kft.

    Pécs, Baranya, 7633

    Viktor Voros, Site 4601, +36203236939

    Recruiting

  • Local Institution - 4610

    Szeged, Csongrád megye, 6720

    Withdrawn

Other trials in Hungary

Puerto Rico5 sites, 1 recruiting

  • Local Institution - 1303

    Bayamón, 00961-6910

    Completed

  • Local Institution - 1301

    Bayamón, 961

    Completed

  • Instituto De Neurologia Dra. Ivonne Fraga,Psc

    San Juan, 00918-4502

    Ivonne De L Fraga Berrios, Site 1302, 7874035534

    Recruiting

  • Local Institution - 1304

    San Juan, 00926-3160

    Active, not recruiting

  • Local Institution - 1305

    San Juan, 00935

    Withdrawn

Other trials in Puerto Rico

France4 sites, 2 recruiting

  • Local Institution - 2510

    Nice, Alpes-Maritimes, 06100

    Completed

  • Local Institution - 2512

    Toulouse, 31059 Cedex 9

    Withdrawn

  • CHU de Toulouse- Gerontopole

    Toulouse, 31059

    Maria Eugenia Soto-Martin, Site 2513

    Recruiting

  • CHRU de Tours - Hôpital Bretonneau

    Tours, Indre-et-Loire, 37044

    Thomas Desmidt, Site 2511, 0234378952

    Recruiting

Other trials in France

Israel4 sites

  • Local Institution - 3103

    Ashkelon, Tel Aviv, 7830604

    Completed

  • Local Institution - 3101

    Jerusalem, Jerusalem, 90000

    Completed

  • Local Institution - 3102

    Petah Tikva, 49100

    Completed

  • Local Institution - 3104

    Ramat Gan, 5265601

    Completed

Other trials in Israel

About this study

Official title: 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.

Being tested
KarXT, Placebo
Keywords
Alzheimer's Disease, AD, ADEPT4, ADEPT-4, KarXT, Psychosis
Medical subject headings
Alzheimer Disease, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KarXTDrug

    Also called BMS-986510

    Specified dose on specified days

  • PlaceboDrug

    Specified dose on specified days

Study groups in NCT06585787
Study groupRoleWhat they receive
KarXTExperimentalNot described
Receives: Drug: KarXT
PlaceboExperimentalNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score

    Measured: Up to Week 14

Secondary outcomes (26)

  1. Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale

    Measured: Up to Week 14

  2. Change from baseline in Neuropsychiatric Inventory-Clinician (NPI-C) Core score: Hallucination Domain

    Measured: Up to Week 14

  3. Change from baseline in NPI-C Core score: Delusion Domain

    Measured: Up to Week 14

  4. Change from baseline in NPI-C Core score: Agitation Domain

    Measured: Up to Week 14

  5. Change from baseline in NPI-C Core score: Aggression Domain

    Measured: Up to Week 14

  6. Change from baseline in NPI-C Agitation score

    Measured: Up to Week 14

  7. Change from baseline in NPI-C Core score: Caregiver Distress Scale

    Measured: Up to Week 14

  8. Number of participants with a ≥ 40% improvement from Baseline in NPI-C: H+D score

    Measured: Up to Week 14

  9. Number of participants with Adverse Events (AEs)

    Measured: Up to Week 14

  10. Number of participants with Treatment-Emergent Adverse Events (TEAEs)

    Measured: Up to Week 14

  11. Number of participants with Serious Adverse Events (SAEs)

    Measured: Up to Week 14

  12. Number of participants with TEAEs leading to study withdrawal

    Measured: Up to Week 14

  13. Number of participants with procholinergic symptoms

    Measured: Up to Week 14

  14. Number of participants with anticholinergic symptoms

    Measured: Up to Week 14

  15. Number of participants with AEs of Special Interest (AESIs)

    Measured: Up to Week 14

  16. Barnes Akathisia Rating Scale (BARS) Score

    Measured: Up to Week 14

  17. Abnormal Involuntary Movement Scale (AIMS) Score

    Measured: Up to Week 14

  18. Body Weight

    Measured: Up to Week 14

  19. Body Mass Index (BMI)

    Measured: Up to Week 14

  20. Number of participants with vital sign abnormalities

    Measured: Up to Week 14

  21. Number of participants with clinical laboratory abnormalities

    Measured: Up to Week 14

  22. Number of participants with 12-lead electrocardiogram (ECG) abnormalities

    Measured: Up to Week 14

  23. Cognition as assessed by the Mini-Mental State Examination (MMSE)

    Measured: Up to Week 14

  24. International Prostate Symptom Score (IPSS)

    Measured: Up to Week 14

  25. Number of participants with suicidal ideation and behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

    Measured: Up to Week 14

  26. Cognition as assessed by the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13)

    Measured: Up to Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start26 Sep 2024
  3. Primary completion24 Nov 2026 (estimated)
  4. Study completion22 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
406 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06585787
Sponsor's protocol ID
CN012-0056
Other IDs
2024-516363-92, U1111-1310-4139
Status last verified
Sep 2026
First submitted
30 Aug 2024
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KarXT in people with Alzheimer Disease, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 296 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 296 sites in United States, Japan, China, South Korea, Poland and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score (time frame: Up to Week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06585787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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Clinical Trial NCT06585787 | AzTrials