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

NCT06585787 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: CN012-00562024-516363-92U1111-1310-4139
• Study Type: interventional
• Target: 406
• Locations: 25 countries
• Sites: 292

Brief 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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease; AD; ADEPT4; ADEPT-4; KarXT; Psychosis

Outcome Measures

Primary Outcomes (1)

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

  Up to Week 14

Secondary Outcomes (26)

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

  Up to Week 14

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

  Up to Week 14

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

  Up to Week 14

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

  Up to Week 14

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

  Up to Week 14

Study Arms (2)

KarXT

EXPERIMENTAL

Drug: KarXT

Placebo

EXPERIMENTAL

Drug: Placebo

Interventions

KarXT DRUG

Specified dose on specified days

Also known as: BMS-986510

KarXT

Placebo DRUG

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Karuna Therapeutics, Inc., a Bristol Myers Squibb company: lead

Study Sites (292)

Local Institution - 1227

Chandler, Arizona, 85224, United States

COMPLETED

Gilbert Neurology Partners - PLLC - Avacare

Gilbert, Arizona, 85297, United States

RECRUITING

Banner Alzheimer's Institute

Phoenix, Arizona, 85006-2528, United States

RECRUITING

Local Institution - 1220

Scottsdale, Arizona, 85260-6742, United States

COMPLETED

Advanced Research Center, Inc.

Anaheim, California, 92805-5854, United States

RECRUITING

Inland Psychiatric Medical Group (IPMG)-Chino

Chino, California, 91710, United States

RECRUITING

Local Institution - 1230

Long Beach, California, 90805, United States

COMPLETED

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

Los Angeles, California, 90033-5313, United States

RECRUITING

Local Institution - 1219

Los Angeles, California, 90095, United States

WITHDRAWN

Local Institution - 1001

Orange, California, 92866, United States

COMPLETED

Local Institution - 1228

Orange, California, 92868-2847, United States

COMPLETED

Local Institution - 1043

Pasadena, California, 91106, United States

ACTIVE NOT RECRUITING

Local Institution - 1213

Rancho Cucamonga, California, 91730, United States

ACTIVE NOT RECRUITING

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

RECRUITING

Local Institution - 1225

Atlantis, Florida, 33462, United States

COMPLETED

Envision Trials LLC

Bonita Springs, Florida, 34134, United States

RECRUITING

Local Institution - 1138

Cutler Bay, Florida, 33189-1230, United States

ACTIVE NOT RECRUITING

Arrow Clinical Trials

Daytona Beach, Florida, 32117-5532, United States

RECRUITING

Local Institution - 1224

Deerfield Beach, Florida, 33442, United States

COMPLETED

Local Institution - 1164

Doral, Florida, 33122-1620, United States

ACTIVE NOT RECRUITING

Local Institution - 1264

Gulf Breeze, Florida, 32561, United States

NOT YET RECRUITING

Local Institution - 1120

Hialeah, Florida, 33012-4648, United States

ACTIVE NOT RECRUITING

Local Institution - 1237

Hialeah, Florida, 33013, United States

COMPLETED

Local Institution - 1229

Homestead, Florida, 33030, United States

ACTIVE NOT RECRUITING

Local Institution - 1040

Lady Lake, Florida, 32159, United States

COMPLETED

Local Institution - 1159

Miami, Florida, 33032, United States

ACTIVE NOT RECRUITING

Local Institution - 1021

Miami, Florida, 33122-1335, United States

ACTIVE NOT RECRUITING

Local Institution - 1125

Miami, Florida, 33135-1601, United States

ACTIVE NOT RECRUITING

Local Institution - 1236

Miami, Florida, 33135-2968, United States

ACTIVE NOT RECRUITING

Local Institution - 1115

Miami, Florida, 33135, United States

ACTIVE NOT RECRUITING

Local Institution - 1010

Miami, Florida, 33137, United States

COMPLETED

Local Institution - 1143

Miami, Florida, 33145-2455, United States

COMPLETED

Local Institution - 1113

Miami, Florida, 33155-6630, United States

ACTIVE NOT RECRUITING

Local Institution - 1129

Miami, Florida, 33165-3947, United States

ACTIVE NOT RECRUITING

Local Institution - 1150

Miami, Florida, 33165, United States

ACTIVE NOT RECRUITING

Local Institution - 1006

Miami, Florida, 33173-1474, United States

ACTIVE NOT RECRUITING

Local Institution - 1111

Miami, Florida, 33173, United States

ACTIVE NOT RECRUITING

Local Institution - 1158

Miami, Florida, 33175, United States

COMPLETED

Local Institution - 1235

Miami, Florida, 33176-1451, United States

COMPLETED

Local Institution - 1147

Miami, Florida, 33176-7947, United States

COMPLETED

Local Institution - 1234

Miami, Florida, 33176, United States

ACTIVE NOT RECRUITING

Local Institution - 1105

Miami, Florida, 33179-2537, United States

COMPLETED

Local Institution - 1157

Miami, Florida, 33184-1412, United States

ACTIVE NOT RECRUITING

Local Institution - 1126

Miami Gardens, Florida, 33056-4000, United States

ACTIVE NOT RECRUITING

Local Institution - 1209

Miami Lakes, Florida, 33014, United States

COMPLETED

Local Institution - 1118

Miami Lakes, Florida, 33016, United States

ACTIVE NOT RECRUITING

Aqualane Clinical Research

Naples, Florida, 34105, United States

RECRUITING

Sensible HealthCare, LLC

Ocoee, Florida, 34761-2964, United States

RECRUITING

Charter Research Orlando

Orlando, Florida, 32803, United States

RECRUITING

Nova Psychiatry

Orlando, Florida, 32803, United States

RECRUITING

Combined Research Orlando Phase I-IV LLC

Orlando, Florida, 32807-3555, United States

RECRUITING

Local Institution - 1204

Ormond Beach, Florida, 32174-3101, United States

ACTIVE NOT RECRUITING

Local Institution - 1205

Port Orange, Florida, 32127-5169, United States

ACTIVE NOT RECRUITING

Local Institution - 1133

Sweetwater, Florida, 33182, United States

COMPLETED

Local Institution - 1123

Tampa, Florida, 33614-2869, United States

ACTIVE NOT RECRUITING

Guardian Angel Research

Tampa, Florida, 33614, United States

RECRUITING

Interventional Psychiatry of Tampa Bay

Tampa, Florida, 33629-5837, United States

RECRUITING

Charter Research

The Villages, Florida, 32162-2698, United States

RECRUITING

Local Institution - 1233

Wellington, Florida, 33414, United States

WITHDRAWN

Premiere Research Institute at Palm Beach Neurology, PA

West Palm Beach, Florida, 33407-3209, United States

RECRUITING

Agile Clinical Research Trials, LLC

Atlanta, Georgia, 30328-5532, United States

RECRUITING

McLean Hospital

Belmont, Massachusetts, 02478-1064, United States

RECRUITING

Tufts Medical Center - 800 Washington St - PPDS

Boston, Massachusetts, 02111-1552, United States

RECRUITING

Boston Neuro Research Center

North Dartmouth, Massachusetts, 02747-2612, United States

RECRUITING

Local Institution - 1250

South Dartmouth, Massachusetts, 02747, United States

COMPLETED

Elixia Health - Springfield - Elixia - PPDS

Springfield, Massachusetts, 01103, United States

RECRUITING

Neurobehavioral Medicine Group (NBMG)

Bloomfield Township, Michigan, 48302-1909, United States

RECRUITING

Precise Research Centers

Flowood, Mississippi, 39232, United States

RECRUITING

Tekton Research, LLC - Saint Louis Psychiatry - PPDS

St Louis, Missouri, 63128, United States

RECRUITING

Advanced Memory Research Institute - CenExel - PPDS

Toms River, New Jersey, 08755, United States

RECRUITING

Local Institution - 1232

Toms River, New Jersey, 08755, United States

ACTIVE NOT RECRUITING

Mid Hudson Medical Research PLLC

New Windsor, New York, 12553-7754, United States

RECRUITING

Local Institution - 1231

Syracuse, New York, 13203, United States

WITHDRAWN

SUNY Upstate Medical University

Syracuse, New York, 13210-2306, United States

RECRUITING

Five Towns Neurology, PC

Woodmere, New York, 11598-1739, United States

RECRUITING

Triad Clinical Trials - 515 College Rd

Greensboro, North Carolina, 27410-3311, United States

RECRUITING

AMC Research, LLC - Flourish - PPDS

Matthews, North Carolina, 28105-8336, United States

RECRUITING

Local Institution - 5005

Morehead City, North Carolina, 28557, United States

WITHDRAWN

West Clinical Research

Morehead City, North Carolina, 28557, United States

RECRUITING

Local Institution - 1252

Shelby, North Carolina, 28150-3803, United States

WITHDRAWN

Ohio State University

Columbus, Ohio, 43221, United States

RECRUITING

Local Institution - 1258

Dayton, Ohio, 45417-3445, United States

NOT YET RECRUITING

Insight Clinical Trials LLC - Independence

Independence, Ohio, 44131, United States

RECRUITING

The Rivus Wellness & Research Institute

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

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

Providence, Rhode Island, 02903, United States

RECRUITING

Vanderbilt Psychiatric Hospital

Nashville, Tennessee, 37212-3133, United States

RECRUITING

Local Institution - 1263

Austin, Texas, 78757-7566, United States

NOT YET RECRUITING

Local Institution - 1260

Dallas, Texas, 75231-6079, United States

NOT YET RECRUITING

Epic Medical Research LLC - DeSoto

DeSoto, Texas, 75115-2043, United States

RECRUITING

Advanced Neuro Research Center - El Paso

El Paso, Texas, 79912-1743, United States

RECRUITING

Local Institution - 1262

Fort Worth, Texas, 76104-4143, United States

NOT YET RECRUITING

Local Institution - 1261

Houston, Texas, 77030-1312, United States

NOT YET RECRUITING

University Hills Clinical Research - 102 Decker Ct

Irving, Texas, 75062-2898, United States

RECRUITING

Local Institution - 1238

Plano, Texas, 75093-8225, United States

COMPLETED

Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases

San Antonio, Texas, 78229-3901, United States

RECRUITING

Local Institution - 1134

Stafford, Texas, 77477-3929, United States

COMPLETED

Conquest Research, LLC - Virginia - Vienna

Vienna, Virginia, 22182, United States

RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, 98007-4879, United States

RECRUITING

Local Institution - 1254

Kirkland, Washington, 98034, United States

WITHDRAWN

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

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1056, Argentina

RECRUITING

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

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1058AAJ, Argentina

RECRUITING

Fundación para el Estudio y Tratamiento de Enfermedades mentales- FETEM

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1107, Argentina

RECRUITING

Instituto Médico de la Fundación Estudios Clínicos

Rosario, Santa Fe Province, S2000DEJ, Argentina

RECRUITING

Hospital Italiano de Buenos Aires

Buenos Aires, 1199, Argentina

RECRUITING

Organización Médica de Investigación

Buenos Aires, C1015ABO, Argentina

RECRUITING

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

Buenos Aires, C1428AQK, Argentina

RECRUITING

Centro Especializado en Neurociencias - CEN

Córdoba, 5000, Argentina

RECRUITING

Instituto Privado Kremer

Córdoba, 5004, Argentina

RECRUITING

Local Institution - 2806

Jette, Brussels Capital, 1090, Belgium

COMPLETED

Local Institution - 2803

Roeselare, West-Vlaanderen, 8800, Belgium

COMPLETED

Local Institution - 2804

Alken, 3570, Belgium

COMPLETED

Local Institution - 2807

Bruges, 8000, Belgium

WITHDRAWN

Local Institution - 2805

Kortrijk, 8500, Belgium

COMPLETED

L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME

Brasília, Federal District, 70200-730, Brazil

RECRUITING

CPQuali Pesquisa Clínica Sao Paulo

São Paulo, São Paulo, 01228-000, Brazil

RECRUITING

BR Trials - Pesquisa Clínica

São Paulo, São Paulo, 01236-030, Brazil

RECRUITING

Hospital Alemao Oswaldo Cruz (HAOC)

São Paulo, São Paulo, 01327-001, Brazil

RECRUITING

Clinilive

São Paulo, São Paulo, 87013-250, Brazil

RECRUITING

Ruschel Medicina

Rio de Janeiro, 22270060, Brazil

RECRUITING

Instituto de Psiquiatria HC FMUSP

São Paulo, 05403-010, Brazil

RECRUITING

Local Institution - 4506

Sofia, Sofia-Grad, 1680, Bulgaria

COMPLETED

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

Plovdiv, 4001, Bulgaria

RECRUITING

University Multiprofile Hospital For Active Treatment Kanev AD

Rousse, 7002, Bulgaria

RECRUITING

Medical Center Medika 2005 - Branch Sofia

Sofia, 1164, Bulgaria

RECRUITING

Local Institution - 4510

Sofia, 1408, Bulgaria

WITHDRAWN

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100025, China

RECRUITING

Beijing Anding Hospital Capital Medical University

Beijing, Beijing Municipality, 100088, China

RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Local Institution - 7008

Guangzhou, Guangdong, 0, China

WITHDRAWN

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

Shenzhen Kangning Hospital

Shenzhen, Guangdong, 518118, China

RECRUITING

The Second Affiliated Hospital of Nanjing Medical University - Main Campus

Nanjing, Jiangsu, 210011, China

RECRUITING

Nanjing Brain Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212001, China

RECRUITING

Local Institution - 7029

Xi'an, Shan1xi, 710061, China

NOT YET RECRUITING

Shanghai Mental Health Center - PPDS

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, 200065, China

RECRUITING

Local Institution - 7026

Shanghai, Shanghai Municipality, 200233, China

NOT YET RECRUITING

West China Hospital Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Tianjin Anding Hospital(Tianjin mental Health Center)

Tianjin, Tianjin Municipality, 300222, China

RECRUITING

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

Hangzhou, Zhejiang, 310009, China

RECRUITING

Zhejiang Hospital - Lingyin Campus

Hangzhou, Zhejiang, 310013, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

The Affiliated Kangning Hospital of Ningbo University - Zhuangshi Campus

Ningbo, Zhejiang, 315201, China

RECRUITING

Xiangya Hospital Central South University

Changsha, 410008, China

RECRUITING

First Affiliated Hospital of Kunming Medical University

Kunming, 650032, China

RECRUITING

Local Institution - 4102

Zagreb, City of Zagreb, 10000, Croatia

COMPLETED

Local Institution - 4105

Zagreb, City of Zagreb, 10000, Croatia

COMPLETED

Local Institution - 4106

Zagreb, City of Zagreb, 10000, Croatia

WITHDRAWN

Local Institution - 4101

Zagreb, City of Zagreb, 10090, Croatia

COMPLETED

Local Institution - 4104

Zagreb, City of Zagreb, 10090, Croatia

COMPLETED

Local Institution - 2510

Nice, Alpes-Maritimes, 06100, France

COMPLETED

CHRU de Tours - Hôpital Bretonneau

Tours, Indre-et-Loire, 37044, France

RECRUITING

Local Institution - 2512

Toulouse, 31059 Cedex 9, France

WITHDRAWN

CHU de Toulouse- Gerontopole

Toulouse, 31059, France

RECRUITING

Local Institution - 2407

Böblingen, Baden-Wurttemberg, 71034, Germany

WITHDRAWN

Local Institution - 2402

Homburg, Saarland, 66424, Germany

COMPLETED

Local Institution - 2406

Berlin, 12163, Germany

WITHDRAWN

Local Institution - 2404

Erbach im Odenwald, 64711, Germany

COMPLETED

Local Institution - 2405

Frankfurt am Main, 60528, Germany

COMPLETED

Local Institution - 4803

Athens, Attica, 115 26, Greece

COMPLETED

Local Institution - 4802

Chaidari, Athens, Attica, 12462, Greece

COMPLETED

Local Institution - 4810

Kalyftaki-N. Kifissia, Attica, 145 64, Greece

COMPLETED

PAGNI-University General Hospital of Heraklion

Heraklion, Irakleio, 71500, Greece

RECRUITING

Local Institution - 4811

Thessaloniki, 546 36, Greece

COMPLETED

Psychotech Kft.

Pécs, Baranya, 7633, Hungary

RECRUITING

Local Institution - 4610

Szeged, Csongrád megye, 6720, Hungary

WITHDRAWN

Clinexpert Gyöngyös Kft.

Gyöngyös, Heves County, 3200, Hungary

RECRUITING

Semmelweis Egyetem Pszichiátriai és Pszichoterápiás Klinika

Budapest, 1083, Hungary

RECRUITING

Eszak-budai Szent Janos Centrumkorhaz

Budapest, 1123, Hungary

RECRUITING

Local Institution - 1-13SNAZL0

Aurangabad, Maharashtra, 431005, India

NOT YET RECRUITING

Central Institute of Behavioural Sciences

Nagpur, Maharashtra, 440010, India

RECRUITING

Postgraduate Institute of Medical Education & Research (PGIMER)

Chandigarh, Punjab, 160012, India

RECRUITING

Jawaharlal Nehru Medical College, Ajmer

Ajmer, Rajasthan, 305001, India

RECRUITING

Asha Hospital - Hyderabad

Hyderabad, 500034, India

RECRUITING

Institute of Neurosciences Kolkata

Kolkata, 700017, India

RECRUITING

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

Varanasi, 211 005, India

RECRUITING

Local Institution - 3101

Jerusalem, Jerusalem, 90000, Israel

COMPLETED

Local Institution - 3103

Ashkelon, Tel Aviv, 7830604, Israel

COMPLETED

Local Institution - 3102

Petah Tikva, 49100, Israel

COMPLETED

Local Institution - 3104

Ramat Gan, 5265601, Israel

COMPLETED

Local Institution - 2325

Salerno, Campania, 84131, Italy

WITHDRAWN

Local Institution - 2322

Rome, Lazio, 00161, Italy

COMPLETED

Local Institution - 2320

Rome, Lazio, 00166, Italy

COMPLETED

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

Brescia, Lombardy, 25125, Italy

RECRUITING

Local Institution - 2323

Milan, Lombardy, 20149, Italy

COMPLETED

Local Institution - 2307

Ponderano (Biella), Piedmont, 13875, Italy

COMPLETED

Local Institution - 2321

Rome, Roma, 00186, Italy

WITHDRAWN

Local Institution - 2309

Roma, 00189, Italy

COMPLETED

Local Institution - 7503

Iizuka, Fukuoka, 820-0014, Japan

COMPLETED

Southern TOHOKU Medical Clinic

Kōriyama, Fukushima, 963-8052, Japan

RECRUITING

Local Institution - 7522

Sapporo, Hokkaido, 006-8555, Japan

COMPLETED

Hyogo Prefectural Harima-Himeji General Medical Center

Himeji-Shi, Hyōgo, 672-8044, Japan

RECRUITING

Memory Clinic Toride

Toride-shi, Ibaraki, 302-0004, Japan

RECRUITING

Local Institution - 7514

Takamatsu, Kagawa-ken, 760-0065, Japan

COMPLETED

Hatano Kousei Hospital

Hadano, Kanagawa, 257-0003, Japan

RECRUITING

Koukan Clinic

Kawasaki-Shi, Kanagawa, 210-0852, Japan

RECRUITING

Local Institution - 7520

Yokohama, Kanagawa, 230-0074, Japan

COMPLETED

Yokohama City Minato Red Cross Hospital

Yokohama, Kanagawa, 2310801, Japan

RECRUITING

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

RECRUITING

National Hospital Organization Utano National Hospital

Kyoto, Kyoto, 616-8255, Japan

RECRUITING

Local Institution - 7506

Tsu, Mie-ken, 514-1101, Japan

COMPLETED

Asakayama General Hospital

Sakai, Osaka, 590-0018, Japan

RECRUITING

Shin-Abuyama Hospital

Takatsuki, Osaka, 569-1041, Japan

RECRUITING

Local Institution - 7510

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

WITHDRAWN

Local Institution - 7504

Wako-Shi, Saitama, 351-0102, Japan

COMPLETED

Local Institution - 7512

Yoshinogawa, Tokushima, 776-8585, Japan

COMPLETED

Local Institution - 7518

Hachiōji, Tokyo, 193-0811, Japan

COMPLETED

Sangenjaya Nakamura Mental Clinic

Setagaya-Ku, Tokyo, 154-0004, Japan

RECRUITING

Kurumi Clinic

Setagaya-Ku, Tokyo, 156-0041, Japan

RECRUITING

Tokyo Metropolitan Matsuzawa Hospital

Setagaya-Ku, Tokyo, 156-0057, Japan

RECRUITING

Local Institution - 7515

Fukuoka, 815-0082, Japan

WITHDRAWN

Funairi nou clinic

Hiroshima, 730-0844, Japan

RECRUITING

Yuge Neuropsychiatric Hospital

Kumamoto, 861-8002, Japan

RECRUITING

Tsutsujimental Hospital

Tatebayashi, 374-0037, Japan

RECRUITING

Centrum Medyczne HCP Szpital im. Jana Pawla II

Poznan, Greater Poland Voivodeship, 61-485, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17

Gdansk, Pomeranian Voivodeship, 80-214, Poland

RECRUITING

Local Institution - 4207

Iława, Warmian-Masurian Voivodeship, 14-200, Poland

WITHDRAWN

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

Iława, Warmian-Masurian Voivodeship, 14-200, Poland

RECRUITING

Local Institution - 4213

Kielce, 25-411, Poland

WITHDRAWN

Local Institution - 7527

Lodz, 91-743, Poland

WITHDRAWN

Pro Salus Sp. z o.o.sp. k

Lodz, 91-743, Poland

RECRUITING

Local Institution - 4206

Lublin, 20-064, Poland

COMPLETED

Local Institution - 4216

Sochaczew, 96-500, Poland

NOT YET RECRUITING

Local Institution - 4211

Wroclaw, 50-981, Poland

COMPLETED

Local Institution - 2701

Guimarães, Braga District, 4835-044, Portugal

COMPLETED

Local Institution - 2704

Lisbon, Lisbon District, 1349-019, Portugal

COMPLETED

Local Institution - 2702

Torres Vedras, Lisbon District, 2560-280, Portugal

COMPLETED

Local Institution - 2703

Matosinhos Municipality, Porto District, 4454-509, Portugal

COMPLETED

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

Lisbon, 1649-035, Portugal

RECRUITING

Local Institution - 2706

Lisbon, 1998-018, Portugal

WITHDRAWN

Local Institution - 1303

Bayamón, 00961-6910, Puerto Rico

COMPLETED

Local Institution - 1301

Bayamón, 961, Puerto Rico

COMPLETED

Instituto De Neurologia Dra. Ivonne Fraga,Psc

San Juan, 00918-4502, Puerto Rico

RECRUITING

Local Institution - 1304

San Juan, 00926-3160, Puerto Rico

ACTIVE NOT RECRUITING

Local Institution - 1305

San Juan, 00935, Puerto Rico

WITHDRAWN

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

Oradea, Bihor County, 410027, Romania

RECRUITING

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

Bucharest, 40874, Romania

RECRUITING

Cai Ferate Clinical Hospital Constanta

Constanța, 90123, Romania

RECRUITING

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

Craiova, 200157, Romania

RECRUITING

Local Institution - 4905

Iași, 700282, Romania

WITHDRAWN

S.C. Carpe Diem SRL

Sibiu, 550281, Romania

RECRUITING

University Clinical Center of Serbia - Dr Subotica 6 - PPDS

Belgrade, Belgrade, 11000, Serbia

RECRUITING

Clinical Hospital Center Dragisa Misovic Dedinje

Belgrade, 11000, Serbia

RECRUITING

Military Medical Academy

Belgrade, 11000, Serbia

RECRUITING

Military Medical Academy

Belgrade, 11000, Serbia

RECRUITING

Local Institution - 4312

Gornja Toponica, 705631, Serbia

ACTIVE NOT RECRUITING

Local Institution - 4305

Kovin, 26220, Serbia

COMPLETED

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

Clinical Centre of Vojvodina

Novi Sad, 21000, Serbia

RECRUITING

Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43

Košice, Košice Region, 041 90, Slovakia

RECRUITING

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

Banská Bystrica, 974 04, Slovakia

RECRUITING

KONZILIUM s.r.o

Dubnica nad Váhom, 018 41, Slovakia

RECRUITING

Local Institution - 4406

Košice, 040 01, Slovakia

COMPLETED

Local Institution - 4407

Pezinok, 902 18, Slovakia

COMPLETED

Local Institution - 4403

Vranov nad Topľou, 093 01, Slovakia

COMPLETED

Local Institution - 7214

Ansan-si, Gyeonggido, 15355, South Korea

COMPLETED

Yongin Severance Hospital, Yonsei University Health System

Yongin-si, Gyeonggido, 16995, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 03080, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul Teugbyeolsi, 06351, South Korea

RECRUITING

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

Seoul, Seoul Teugbyeolsi, 06591, South Korea

RECRUITING

Ewha Womans University Seoul Hospital

Seoul, Seoul Teugbyeolsi, 07804, South Korea

RECRUITING

Ewha Womans University Mokdong Hospital

Seoul, Seoul Teugbyeolsi, 7985, South Korea

RECRUITING

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

Yeongdeungpo-gu, Seoul Teugbyeolsi, 07345, South Korea

RECRUITING

Hallym University Chuncheon Sacred Heart Hospital

Gangwon-do, 200-704, South Korea

RECRUITING

Gangnam Severance Hospital, Yonsei University Health System

Seoul, 06273, South Korea

RECRUITING

SMG - SNU Boramae Medical Center

Seoul, 07071, South Korea

RECRUITING

Local Institution - 1-14KMN4SY

Seoul, 143-729, South Korea

NOT YET RECRUITING

Hanyang University Seoul Hospital

Seoul, 4763, South Korea

RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital Quironsalud Malaga

Málaga, Málaga, 29004, Spain

RECRUITING

Local Institution - 2212

Lleida, 25198, Spain

COMPLETED

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario De Salamanca

Salamanca, 37007, Spain

RECRUITING

Hospital Victoria Eugenia

Seville, 41009, Spain

RECRUITING

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

RECRUITING

Hospital Viamed Montecanal

Zaragoza, 50012, Spain

RECRUITING

Local Institution - 4702

Atakum, Samsun, 55270, Turkey (Türkiye)

COMPLETED

Hacettepe University Medical Faculty

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi

Eskişehir, 26040, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Local Institution - 4705

Izmir, 35340, Turkey (Türkiye)

COMPLETED

Local Institution - 4703

Izmir, 35370, Turkey (Türkiye)

COMPLETED

Local Institution - 8007

Lviv, Lviv Oblast, 79053, Ukraine

NOT YET RECRUITING

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

Vinnytsia, Vinnytsia Oblast, 21005, Ukraine

RECRUITING

Local Institution - 8001

Vinnytsia, Vinnytsia Oblast, Ukraine, Ukraine

NOT YET RECRUITING

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

Khmelnytskyi, 32120, Ukraine

RECRUITING

Local Institution - 8006

Lviv, 79035, Ukraine

NOT YET RECRUITING

MNE Cherkasy Regional Psychiatric Hospital of Cherkasy RC

Smila, 20708, Ukraine

RECRUITING

MNE Ternopil Regional Clinical Psychoneurological Hospital of TRC

Ternopil, 46027, Ukraine

RECRUITING

Neyromed LLC - Uzhhorod

Uzhhorod, 88000, Ukraine

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Alzheimer Disease; Psychotic Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 19, 2024
• Study Start: September 26, 2024
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): December 22, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

DE (5); PT (6); CR (5); KR (13); IT (8); HU (5); BU (5); UA (8); GR (5); BE (5); TU (6); AR (9); PR (5); ES (8); IL (4); RO (6); SE (8); IN (7); SL (6); BR (7); CN (22); FR (4); PL (10); US (99); JP (26)