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NCT06126224PHASE3Recruiting

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Start Date

8/28/2023

Completion Date

12/9/2026

Summary

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.

Eligibility Criteria

Age Range: 55 years to 90 years

Key Inclusion Criteria: 1. Is a male or female aged 55 to 90 years, inclusive, at Screening. 2. Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed. 3. Meets clinical criteria for Possible AD or Probable AD. 4. 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, e.g., major stroke, neoplasm, subdural hematoma. If not available, a non-contrast brain MRI or non-contrast head CT must be done during Screening. 5. Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening. 6. Have an identified study partner who should have daily contact (approximately 10 hours a week or more). 7. History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening. 8. CGI-S scale with a score ≥ 4 at Screening and Baseline. 9. AD subjects are required to have NPI-C: Hallucinations and Delusions (H+D) score of ≥ 6 AND meet at least 1 of the following criteria at Screening and Baseline: 1. Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR 2. Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items 10. MMSE score of 8 to 22, inclusive, at Screening. Key Exclusion Criteria: 1. Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia. 2. History of major depressive episode with psychotic features during the 12 months prior to Screening. 3. History of bipolar disorder, schizophrenia, or schizoaffective disorder. 4. Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular, or oncologic disease or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results. 5. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator. 6. Prior exposure to KarXT. 7. History of hypersensitivity to KarXT excipients or trospium chloride. 8. Experienced any significant adverse events (AEs) due to trospium. 9. Participation in another clinical study in which the subject received an experimental or investigational drug within 3 months before Screening or has participated in more than 2 clinical studies in the 12 months prior to Screening. 10. Other protocol-defined inclusion/exclusion criteria may apply.

Interventions

DRUG

KarXT

DRUG

Placebo

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Conditions

Psychosis Associated With Alzheimer's Disease

Locations

Local Institution - 1116

Chandler, Arizona 85286

United States

Local Institution - 1044

Phoenix, Arizona 85012-2836

United States

Local Institution - 1104

Anaheim, California 92805-5854

United States

Local Institution - 1119

Canoga Park, California 91303-1844

United States

Local Institution - 1151

Encino, California 91316

United States

Local Institution - 1142

Lancaster, California 93534-2839

United States

Local Institution - 1117

Los Alamitos, California 90720-6506

United States

Local Institution - 1103

Sherman Oaks, California 91403-2131

United States

Local Institution - 1007

Walnut Creek, California 94596

United States

Local Institution - 1160

Apopka, Florida 32703-5835

United States

Local Institution - 1156

Clermont, Florida 34711-5190

United States

Local Institution - 1138

Cutler Bay, Florida 33189-1230

United States

Local Institution - 1162

Delray Beach, Florida 33445-2581

United States

Local Institution - 1164

Doral, Florida 33122-1620

United States

Local Institution - 1165

Fort Myers, Florida 33912-4302

United States

Local Institution - 1155

Hialeah, Florida 33012-3158

United States

Local Institution - 1107

Hialeah, Florida 33012-3618

United States

Local Institution - 1120

Hialeah, Florida 33012-4648

United States

Local Institution - 1140

Hialeah, Florida 33016-1814

United States

Local Institution - 0150

Homestead, Florida 33032-8187

United States

Local Institution - 1145

Homestead, Florida 33032-8187

United States

Local Institution - 1127

Largo, Florida 33777-1359

United States

Local Institution - 1039

Maitland, Florida 32751-5669

United States

Local Institution - 1146

Maitland, Florida 32751-6138

United States

Local Institution - 1159

Miami, Florida 33032

United States

Local Institution - 1118

Miami, Florida 33122-1721

United States

Local Institution - 1111

Miami, Florida 33126-5683

United States

Local Institution - 1108

Miami, Florida 33133-4231

United States

Local Institution - 1125

Miami, Florida 33135-1601

United States

Local Institution - 1115

Miami, Florida 33135

United States

Local Institution - 1143

Miami, Florida 33145-2455

United States

Local Institution - 1113

Miami, Florida 33155-6630

United States

Local Institution - 1009

Miami, Florida 33155

United States

Local Institution - 1129

Miami, Florida 33165-3947

United States

Local Institution - 1150

Miami, Florida 33165

United States

Local Institution - 1109

Miami, Florida 33174-2950

United States

Local Institution - 1158

Miami, Florida 33175

United States

Local Institution - 1147

Miami, Florida 33176-7947

United States

Local Institution - 1105

Miami, Florida 33179-2537

United States

Local Institution - 1157

Miami, Florida 33184-1412

United States

Local Institution - 1126

Miami Gardens, Florida 33056-4000

United States

Local Institution - 1102

Miami Lakes, Florida 33014-6435

United States

Local Institution - 1136

Orlando, Florida 32806-1041

United States

Local Institution - 1112

Orlando, Florida 32807-3555

United States

Local Institution - 1137

Port Orange, Florida 32127-2914

United States

Health Synergy Clinical Research,LLC - Stuart

Stuart, Florida 34994

United States

Local Institution - 1133

Sweetwater, Florida 33182

United States

Local Institution - 1041

Tampa, Florida 33607-4629

United States

Local Institution - 1124

Tampa, Florida 33614-2700

United States

Local Institution - 1123

Tampa, Florida 33614-2869

United States

Local Institution - 1110

Tampa, Florida 33629-5837

United States

Local Institution - 1040

The Villages, Florida 32159-8986

United States

Local Institution - 1131

Viera, Florida 32940

United States

Local Institution - 1152

Augusta, Georgia 30912-0020

United States

Local Institution - 1141

Columbus, Georgia 31909-1693

United States

Local Institution - 1161

Decatur, Georgia 30030

United States

Local Institution - 1148

Elgin, Illinois 60123-9215

United States

Local Institution - 1114

Marrero, Louisiana 70072-3083

United States

Local Institution - 1139

Rochester Hills, Michigan 48307-2760

United States

Local Institution - 1132

Flowood, Mississippi 39232

United States

Local Institution - 1144

Las Vegas, Nevada 89106-4145

United States

Local Institution - 1153

New Hyde Park, New York 11042-2062

United States

Local Institution - 1135

Port Jefferson Station, New York 11776-3386

United States

Local Institution - 1122

Dayton, Ohio 45459-4248

United States

Local Institution - 1149

Malvern, Pennsylvania 19355-3267

United States

Local Institution - 1106

Cypress, Texas 77429-6070

United States

Local Institution - 1163

Houston, Texas 77074-2085

United States

Local Institution - 1154

Katy, Texas 77450-1759

United States

Local Institution - 1121

Red Oak, Texas 75154

United States

Local Institution - 1134

Stafford, Texas 77477-3929

United States

Local Institution - 2801

Hasselt, Limburg 3500

Belgium

Local Institution - 2802

Leuven, Vlaams Brabant 3000

Belgium

Local Institution - 2803

Roeselare, West-Vlaanderen 8800

Belgium

Local Institution - 1605

Calgary, Alberta T2N 1N4

Canada

Local Institution - 1603

Hamilton, Ontario ON L8M 1W9

Canada

Local Institution - 1602

Toronto, Ontario M5B 1W8

Canada

Local Institution - 1604

Whitby, Ontario L1N 5S9

Canada

Local Institution - 1606

Montreal, Quebec H4H 1R3

Canada

Local Institution - 1601

Verdun, Quebec H4H 1R3

Canada

Biomedica Research Group

Providencia, Santiago Metropolitan 7500000

Chile

Psicomed Estudios Medicos

Antofagasta, 1270244

Chile

Local Institution - 6001

Las Condes, 7550000

Chile

Local Institution - 7007

Hefei, Anhui 230022

China

Local Institution - 7004

Beijing, Beijing Municipality 100025

China

Local Institution - 7005

Beijing, Beijing Municipality 100088

China

Local Institution - 7015

Chongqing, Chongqing Municipality 400016

China

Local Institution - 7008

Guangzhou, Guangdong 0

China

Local Institution - 7016

Guangzhou, Guangdong 510120

China

Local Institution - 7009

Guangzhou, Guangdong 510260

China

Local Institution - 7003

Shenzhen, Guangdong 518118

China

Local Institution - 7014

Nanjing, Jiangsu 210009

China

Local Institution - 7013

Nanjing, Jiangsu 210011

China

Local Institution - 7012

Nanchang, Jiangxi 330008

China

Local Institution - 7001

Shanghai, Shanghai Municipality 200030

China

Shanghai General Hospital - North Campus

Shanghai, Shanghai Municipality 200080

China

Local Institution - 7002

Chengdu, Sichuan 610000

China

Local Institution - 7019

Tianjin, Tianjin Municipality 300222

China

Local Institution - 7017

Hangzhou, Zhejiang 310003

China

Local Institution - 7020

Hangzhou, Zhejiang 310009

China

Local Institution - 7010

Hangzhou, Zhejiang 310013

China

Local Institution - 7006

Hangzhou, Zhejiang 310014

China

Local Institution - 7018

Wenzhou, Zhejiang 325000

China

Local Institution - 4805

Athens, Attica 115 21

Greece

Local Institution - 4803

Athens, Attica 115 26

Greece

Local Institution - 4802

Chaidari, Athens, Attica 124 62

Greece

Local Institution - 4806

Marousi, Attica 151 23

Greece

Local Institution - 4801

Heraklion, 71110

Greece

Local Institution - 4601

Pécs, Baranya 7633

Hungary

Local Institution - 4602

Budapest, 1083

Hungary

Local Institution - 4603

Miskolc, 3526

Hungary

Local Institution - 1502

Saltillo Centro, Coahuila 25000

Mexico

Local Institution - 1504

Zona Urbana Río Tijuana, Estado de Baja California 22010

Mexico

Local Institution - 1507

Zapopan, Jalisco 45170

Mexico

Local Institution - 1503

Monterrey, Nuevo León 64460

Mexico

Local Institution - 1505

Monterrey, Nuevo León 64620

Mexico

Local Institution - 1501

Culiacán, Sinaloa 80020

Mexico

Local Institution - 1506

México, 03100

Mexico

Local Institution - 6102

Miraflores, Lima region 15046

Peru

Local Institution - 6103

Pueblo Libre, Lima region 15084

Peru

Local Institution - 6101

Callao, Callao 2

Peru

Local Institution - 4206

Lublin, Lublin Voivodeship 20-064

Poland

Local Institution - 4207

Lodz, Lódzkie 90-349

Poland

Local Institution - 4203

Sopot, Pomeranian Voivodeship 81-855

Poland

Local Institution - 4208

Katowice, Silesian Voivodeship 40-156

Poland

Local Institution - 4204

Bydgoszcz, 85-080

Poland

Local Institution - 4205

Katowice, 40-282

Poland

Local Institution - 4202

Lodz, 90-227

Poland

Local Institution - 4209

Siemianowice Śląskie, 41-100

Poland

Local Institution - 4201

Ścinawa, 59-330

Poland

Local Institution - 7208

Buk-gu, Daegu Gwang'yeogsi 41404

South Korea

Local Institution - 7207

Seongnam-si, Gyeonggido 13496

South Korea

Local Institution - 7205

Incheon, Incheon Gwang'yeogsi 21565

South Korea

Local Institution - 7206

Seoul, Seoul Teugbyeolsi 03080

South Korea

Local Institution - 7204

Busan, 49201

South Korea

Local Institution - 7202

Seongnam-si, 0

South Korea

Local Institution - 7203

Seoul, 07071

South Korea

Local Institution - 7201

Seoul, 143-729

South Korea

Local Institution - 2901

Geneva, Genève (fr) CH-1205

Switzerland

Local Institution - 2902

Lausanne, Vaud (fr) 1011

Switzerland

Local Institution - 4702

Atakum, Samsun 55270

Turkey (Türkiye)

Local Institution - 4701

Eskişehir, 26040

Turkey (Türkiye)

Local Institution - 4704

Istanbul, 34093

Turkey (Türkiye)

Local Institution - 4705

Izmir, 35210

Turkey (Türkiye)

Local Institution - 4703

Izmir, 35575

Turkey (Türkiye)

Local Institution - 2110

Ilford, Greater London IG1 4HP

United Kingdom

Local Institution - 2108

Swinton, Greater Manchester M27 8FF

United Kingdom

Local Institution - 2101

London, Surrey SE5 8AZ

United Kingdom

Local Institution - 2105

Aberdeen, AB25 2ZL

United Kingdom

Local Institution - 2109

Chertsey, KT16 9AU

United Kingdom

Local Institution - 2112

Edinburgh, EH4 2XU

United Kingdom

Local Institution - 2106

Leeds, LS7 3JX

United Kingdom

Local Institution - 2104

Motherwell, ML1 4UF

United Kingdom

Local Institution - 2111

Preston, PR2 9HT

United Kingdom

Local Institution - 2107

Sheffield, SouthYorkshire, s5 7JT

United Kingdom