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

NCT06126224 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: CN012-0027KAR-0322023-504416-16
• Study Type: interventional
• Target: 500
• Locations: 14 countries
• Sites: 154

Brief 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.

Conditions

Psychosis Associated With Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score

  Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.

  Baseline and end of Treatment (up to 14 Weeks)

Secondary Outcomes (5)

• Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) scale

  Baseline and end of Treatment (up to 14 Weeks)

• Change From Baseline to end of Treatment in NPI-C Core score: Hallucinations, Delusions, Agitation, and Aggression Domains

  Baseline and end of Treatment (up to 14 Weeks)

• Change From Baseline to end of Treatment in NPI-C: Agitation score

  Baseline and end of Treatment (up to 14 Weeks)

• Change From Baseline to end of Treatment in NPI-C Core score: Caregiver Distress scale (Hallucinations, Delusions, Agitation, and Aggression domains)

  Baseline and end of Treatment (up to 14 Weeks)

• Responder Rate

  Baseline and end of Treatment (up to 14 Weeks)

Study Arms (2)

KarXT

EXPERIMENTAL

Xanomeline and Trospium Chloride Capsules

Drug: KarXT

Placebo

PLACEBO COMPARATOR

Placebo capsules

Drug: Placebo

Interventions

KarXT DRUG

KarXT 20/2 mg (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg (TDD 90/9 mg) KarXT 40/4 mg (TDD 120/12 mg) KarXT 50/5 mg (TDD 150/15 mg) KarXT 66.7/6.67 mg (TDD 200/20 mg)

KarXT

Placebo DRUG

Placebo capsules

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:

• Is a male or female aged 55 to 90 years, inclusive, at Screening.
• Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed.
• Meets clinical criteria for Possible AD or Probable AD.
• 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.
• Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.
• Have an identified study partner who should have daily contact (approximately 10 hours a week or more).
• History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.
• CGI-S scale with a score ≥ 4 at Screening and Baseline.
• 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:
• Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR
• Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items
• MMSE score of 8 to 22, inclusive, at Screening.

You may not qualify if:

• Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia.
• History of major depressive episode with psychotic features during the 12 months prior to Screening.
• History of bipolar disorder, schizophrenia, or schizoaffective disorder.
• 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.
• History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
• Prior exposure to KarXT.
• History of hypersensitivity to KarXT excipients or trospium chloride.
• Experienced any significant adverse events (AEs) due to trospium.
• 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.

Sponsors & Collaborators

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

Study Sites (154)

Local Institution - 1116

Chandler, Arizona, 85286, United States

ACTIVE NOT RECRUITING

Local Institution - 1044

Phoenix, Arizona, 85012-2836, United States

ACTIVE NOT RECRUITING

Local Institution - 1104

Anaheim, California, 92805-5854, United States

ACTIVE NOT RECRUITING

Local Institution - 1119

Canoga Park, California, 91303-1844, United States

ACTIVE NOT RECRUITING

Local Institution - 1151

Encino, California, 91316, United States

ACTIVE NOT RECRUITING

Local Institution - 1142

Lancaster, California, 93534-2839, United States

ACTIVE NOT RECRUITING

Local Institution - 1117

Los Alamitos, California, 90720-6506, United States

ACTIVE NOT RECRUITING

Local Institution - 1103

Sherman Oaks, California, 91403-2131, United States

ACTIVE NOT RECRUITING

Local Institution - 1007

Walnut Creek, California, 94596, United States

ACTIVE NOT RECRUITING

Local Institution - 1160

Apopka, Florida, 32703-5835, United States

WITHDRAWN

Local Institution - 1156

Clermont, Florida, 34711-5190, United States

ACTIVE NOT RECRUITING

Local Institution - 1138

Cutler Bay, Florida, 33189-1230, United States

ACTIVE NOT RECRUITING

Local Institution - 1162

Delray Beach, Florida, 33445-2581, United States

ACTIVE NOT RECRUITING

Local Institution - 1164

Doral, Florida, 33122-1620, United States

ACTIVE NOT RECRUITING

Local Institution - 1165

Fort Myers, Florida, 33912-4302, United States

ACTIVE NOT RECRUITING

Local Institution - 1155

Hialeah, Florida, 33012-3158, United States

ACTIVE NOT RECRUITING

Local Institution - 1107

Hialeah, Florida, 33012-3618, United States

ACTIVE NOT RECRUITING

Local Institution - 1120

Hialeah, Florida, 33012-4648, United States

ACTIVE NOT RECRUITING

Local Institution - 1140

Hialeah, Florida, 33016-1814, United States

ACTIVE NOT RECRUITING

Local Institution - 0150

Homestead, Florida, 33032-8187, United States

ACTIVE NOT RECRUITING

Local Institution - 1145

Homestead, Florida, 33032-8187, United States

ACTIVE NOT RECRUITING

Local Institution - 1127

Largo, Florida, 33777-1359, United States

ACTIVE NOT RECRUITING

Local Institution - 1039

Maitland, Florida, 32751-5669, United States

ACTIVE NOT RECRUITING

Local Institution - 1146

Maitland, Florida, 32751-6138, United States

ACTIVE NOT RECRUITING

Local Institution - 1159

Miami, Florida, 33032, United States

ACTIVE NOT RECRUITING

Local Institution - 1118

Miami, Florida, 33122-1721, United States

ACTIVE NOT RECRUITING

Local Institution - 1111

Miami, Florida, 33126-5683, United States

ACTIVE NOT RECRUITING

Local Institution - 1108

Miami, Florida, 33133-4231, United States

ACTIVE NOT RECRUITING

Local Institution - 1125

Miami, Florida, 33135-1601, United States

ACTIVE NOT RECRUITING

Local Institution - 1115

Miami, Florida, 33135, United States

ACTIVE NOT RECRUITING

Local Institution - 1143

Miami, Florida, 33145-2455, United States

ACTIVE NOT RECRUITING

Local Institution - 1113

Miami, Florida, 33155-6630, United States

ACTIVE NOT RECRUITING

Local Institution - 1009

Miami, Florida, 33155, 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 - 1109

Miami, Florida, 33174-2950, United States

ACTIVE NOT RECRUITING

Local Institution - 1158

Miami, Florida, 33175, United States

ACTIVE NOT RECRUITING

Local Institution - 1147

Miami, Florida, 33176-7947, United States

ACTIVE NOT RECRUITING

Local Institution - 1105

Miami, Florida, 33179-2537, United States

ACTIVE NOT RECRUITING

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 - 1102

Miami Lakes, Florida, 33014-6435, United States

ACTIVE NOT RECRUITING

Local Institution - 1136

Orlando, Florida, 32806-1041, United States

ACTIVE NOT RECRUITING

Local Institution - 1112

Orlando, Florida, 32807-3555, United States

ACTIVE NOT RECRUITING

Local Institution - 1137

Port Orange, Florida, 32127-2914, United States

ACTIVE NOT RECRUITING

Health Synergy Clinical Research,LLC - Stuart

Stuart, Florida, 34994, United States

RECRUITING

Local Institution - 1133

Sweetwater, Florida, 33182, United States

ACTIVE NOT RECRUITING

Local Institution - 1041

Tampa, Florida, 33607-4629, United States

ACTIVE NOT RECRUITING

Local Institution - 1124

Tampa, Florida, 33614-2700, United States

ACTIVE NOT RECRUITING

Local Institution - 1123

Tampa, Florida, 33614-2846, United States

COMPLETED

Local Institution - 1110

Tampa, Florida, 33629-5837, United States

ACTIVE NOT RECRUITING

Local Institution - 1040

The Villages, Florida, 32159-8986, United States

WITHDRAWN

Local Institution - 1131

Viera, Florida, 32940, United States

RECRUITING

Local Institution - 1152

Augusta, Georgia, 30912-0020, United States

WITHDRAWN

Local Institution - 1141

Columbus, Georgia, 31909-1693, United States

WITHDRAWN

Local Institution - 1161

Decatur, Georgia, 30030, United States

ACTIVE NOT RECRUITING

Local Institution - 1148

Elgin, Illinois, 60123-9215, United States

ACTIVE NOT RECRUITING

Local Institution - 1114

Marrero, Louisiana, 70072-3083, United States

ACTIVE NOT RECRUITING

Local Institution - 1139

Rochester Hills, Michigan, 48307-2760, United States

ACTIVE NOT RECRUITING

Local Institution - 1132

Flowood, Mississippi, 39232, United States

ACTIVE NOT RECRUITING

Local Institution - 1144

Las Vegas, Nevada, 89106-4145, United States

WITHDRAWN

Local Institution - 1153

New Hyde Park, New York, 11042-2062, United States

WITHDRAWN

Local Institution - 1135

Port Jefferson Station, New York, 11776-3386, United States

WITHDRAWN

Local Institution - 1122

Dayton, Ohio, 45459-4248, United States

ACTIVE NOT RECRUITING

Local Institution - 1149

Malvern, Pennsylvania, 19355-3267, United States

WITHDRAWN

Local Institution - 1106

Cypress, Texas, 77429-6070, United States

RECRUITING

Local Institution - 1163

Houston, Texas, 77074-2085, United States

ACTIVE NOT RECRUITING

Local Institution - 1154

Katy, Texas, 77450-1759, United States

ACTIVE NOT RECRUITING

Local Institution - 1121

Red Oak, Texas, 75154, United States

WITHDRAWN

Local Institution - 1134

Stafford, Texas, 77477-3929, United States

ACTIVE NOT RECRUITING

Local Institution - 2801

Hasselt, Limburg, 3500, Belgium

ACTIVE NOT RECRUITING

Local Institution - 2802

Leuven, Vlaams Brabant, 3000, Belgium

ACTIVE NOT RECRUITING

Local Institution - 2803

Roeselare, West-Vlaanderen, 8800, Belgium

ACTIVE NOT RECRUITING

Local Institution - 1605

Calgary, Alberta, T2N 1N4, Canada

WITHDRAWN

Local Institution - 1603

Hamilton, Ontario, ON L8M 1W9, Canada

WITHDRAWN

Local Institution - 1602

Toronto, Ontario, M5B 1W8, Canada

WITHDRAWN

Local Institution - 1604

Whitby, Ontario, L1N 5S9, Canada

WITHDRAWN

Local Institution - 1606

Montreal, Quebec, H4H 1R3, Canada

WITHDRAWN

Local Institution - 1601

Verdun, Quebec, H4H 1R3, Canada

WITHDRAWN

Local Institution - 6002

Providencia, Santiago Metropolitan, 7500000, Chile

RECRUITING

Local Institution - 6003

Antofagasta, 127-0244, Chile

RECRUITING

Local Institution - 6001

Las Condes, 7550000, Chile

RECRUITING

Local Institution - 7007

Hefei, Anhui, 230022, China

ACTIVE NOT RECRUITING

Local Institution - 7004

Beijing, Beijing Municipality, 100025, China

ACTIVE NOT RECRUITING

Local Institution - 7005

Beijing, Beijing Municipality, 100088, China

ACTIVE NOT RECRUITING

Local Institution - 7015

Chongqing, Chongqing Municipality, 400016, China

ACTIVE NOT RECRUITING

Local Institution - 7008

Guangzhou, Guangdong, 0, China

ACTIVE NOT RECRUITING

Local Institution - 7016

Guangzhou, Guangdong, 510120, China

ACTIVE NOT RECRUITING

Local Institution - 7009

Guangzhou, Guangdong, 510260, China

ACTIVE NOT RECRUITING

Local Institution - 7003

Shenzhen, Guangdong, 518118, China

ACTIVE NOT RECRUITING

Local Institution - 7014

Nanjing, Jiangsu, 210009, China

WITHDRAWN

Local Institution - 7013

Nanjing, Jiangsu, 210011, China

ACTIVE NOT RECRUITING

Local Institution - 7012

Nanchang, Jiangxi, 330008, China

ACTIVE NOT RECRUITING

Local Institution - 7001

Shanghai, Shanghai Municipality, 200030, China

ACTIVE NOT RECRUITING

Local Institution - 7011

Shanghai, Shanghai Municipality, 200080, China

ACTIVE NOT RECRUITING

Local Institution - 7002

Chengdu, Sichuan, 610000, China

ACTIVE NOT RECRUITING

Local Institution - 7019

Tianjin, Tianjin Municipality, 300222, China

ACTIVE NOT RECRUITING

Local Institution - 7017

Hangzhou, Zhejiang, 310003, China

ACTIVE NOT RECRUITING

Local Institution - 7010

Hangzhou, Zhejiang, 310013, China

ACTIVE NOT RECRUITING

Local Institution - 7006

Hangzhou, Zhejiang, 310014, China

ACTIVE NOT RECRUITING

Local Institution - 7020

Hangzhou, Zhejiang, 310016, China

ACTIVE NOT RECRUITING

Local Institution - 7018

Wenzhou, Zhejiang, 325000, China

ACTIVE NOT RECRUITING

Local Institution - 4805

Athens, Attica, 115 21, Greece

ACTIVE NOT RECRUITING

Local Institution - 4803

Athens, Attica, 115 26, Greece

ACTIVE NOT RECRUITING

Local Institution - 4802

Chaidari, Athens, Attica, 124 62, Greece

ACTIVE NOT RECRUITING

Local Institution - 4806

Marousi, Attica, 151 23, Greece

ACTIVE NOT RECRUITING

Local Institution - 4801

Heraklion, 71110, Greece

ACTIVE NOT RECRUITING

Local Institution - 4601

Pécs, Baranya, 7633, Hungary

ACTIVE NOT RECRUITING

Local Institution - 4602

Budapest, 1083, Hungary

ACTIVE NOT RECRUITING

Local Institution - 4603

Miskolc, 3526, Hungary

ACTIVE NOT RECRUITING

Local Institution - 1502

Saltillo Centro, Coahuila, 25000, Mexico

ACTIVE NOT RECRUITING

Local Institution - 1504

Zona Urbana Río Tijuana, Estado de Baja California, 22010, Mexico

WITHDRAWN

Local Institution - 1507

Zapopan, Jalisco, 45170, Mexico

WITHDRAWN

Local Institution - 1503

Monterrey, Nuevo León, 64460, Mexico

ACTIVE NOT RECRUITING

Local Institution - 1505

Monterrey, Nuevo León, 64620, Mexico

ACTIVE NOT RECRUITING

Local Institution - 1501

Culiacán, Sinaloa, 80020, Mexico

ACTIVE NOT RECRUITING

Local Institution - 1506

México, 03100, Mexico

ACTIVE NOT RECRUITING

Local Institution - 6102

Miraflores, Lima region, 15046, Peru

WITHDRAWN

Local Institution - 6103

Pueblo Libre, Lima region, 15084, Peru

ACTIVE NOT RECRUITING

Local Institution - 6101

Callao, Callao 2, Peru

WITHDRAWN

Local Institution - 4206

Lublin, Lublin Voivodeship, 20-064, Poland

ACTIVE NOT RECRUITING

Local Institution - 4207

Lodz, Lódzkie, 90-349, Poland

ACTIVE NOT RECRUITING

Local Institution - 4203

Sopot, Pomeranian Voivodeship, 81-855, Poland

WITHDRAWN

Local Institution - 4208

Katowice, Silesian Voivodeship, 40-156, Poland

ACTIVE NOT RECRUITING

Local Institution - 4204

Bydgoszcz, 85-080, Poland

ACTIVE NOT RECRUITING

Local Institution - 4205

Katowice, 40-282, Poland

ACTIVE NOT RECRUITING

Local Institution - 4202

Lodz, 90-227, Poland

ACTIVE NOT RECRUITING

Local Institution - 4209

Siemianowice Śląskie, 41-100, Poland

WITHDRAWN

Local Institution - 4201

Ścinawa, 59-330, Poland

ACTIVE NOT RECRUITING

Local Institution - 7208

Buk-gu, Daegu Gwang'yeogsi, 41404, South Korea

ACTIVE NOT RECRUITING

Local Institution - 7207

Seongnam-si, Gyeonggido, 13496, South Korea

ACTIVE NOT RECRUITING

Local Institution - 7205

Incheon, Incheon Gwang'yeogsi, 21565, South Korea

ACTIVE NOT RECRUITING

Local Institution - 7204

Busan, 49201, South Korea

WITHDRAWN

Local Institution - 7202

Seongnam-si, 0, South Korea

ACTIVE NOT RECRUITING

Local Institution - 7206

Seoul, 03080, South Korea

ACTIVE NOT RECRUITING

Local Institution - 7203

Seoul, 07071, South Korea

ACTIVE NOT RECRUITING

Local Institution - 7201

Seoul, 143-729, South Korea

ACTIVE NOT RECRUITING

Local Institution - 2901

Geneva, Genève (fr), CH-1205, Switzerland

WITHDRAWN

Local Institution - 2902

Lausanne, Vaud (fr), 1011, Switzerland

WITHDRAWN

Local Institution - 4702

Atakum, Samsun, 55270, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Local Institution - 4701

Eskişehir, 26040, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Local Institution - 4704

Istanbul, 34093, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Local Institution - 4705

Izmir, 35210, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Local Institution - 4703

Izmir, 35575, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Local Institution - 2110

Ilford, Greater London, IG1 4HP, United Kingdom

WITHDRAWN

Local Institution - 2108

Swinton, Greater Manchester, M27 8FF, United Kingdom

WITHDRAWN

Local Institution - 2101

London, Surrey, SE5 8AZ, United Kingdom

WITHDRAWN

Local Institution - 2105

Aberdeen, AB25 2ZL, United Kingdom

WITHDRAWN

Local Institution - 2109

Chertsey, KT16 9AU, United Kingdom

WITHDRAWN

Local Institution - 2112

Edinburgh, EH4 2XU, United Kingdom

WITHDRAWN

Local Institution - 2106

Leeds, LS7 3JX, United Kingdom

WITHDRAWN

Local Institution - 2104

Motherwell, ML1 4UF, United Kingdom

WITHDRAWN

Local Institution - 2111

Preston, PR2 9HT, United Kingdom

WITHDRAWN

Local Institution - 2107

Sheffield, SouthYorkshire, s5 7JT, United Kingdom

WITHDRAWN

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

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: November 3, 2023
• First Posted: November 13, 2023
• Study Start: August 28, 2023
• Primary Completion (Estimated): December 9, 2026
• Study Completion (Estimated): December 9, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

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

Locations

CA (6); GB (10); CH (2); PE (3); HU (3); GR (5); BE (3); CN (20); KR (8); ME (7); TU (5); CL (3); PL (9); US (70)