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NCT06126224

PHASE3

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

Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

55 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2023-08-28

Completion Date

2026-12-09

Last Updated

2026-03-24

Healthy Volunteers

Conditions

Psychosis Associated With Alzheimer's Disease

Interventions

DRUG

KarXT

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)

DRUG

Placebo

Placebo capsules

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.

Locations (119)

Local Institution - 1116

Chandler, Arizona, United States

Local Institution - 1044

Phoenix, Arizona, United States

Local Institution - 1104

Anaheim, California, United States

Local Institution - 1119

Canoga Park, California, United States

Local Institution - 1151

Encino, California, United States

Local Institution - 1142

Lancaster, California, United States

Local Institution - 1117

Los Alamitos, California, United States

Local Institution - 1103

Sherman Oaks, California, United States

Local Institution - 1007

Walnut Creek, California, United States

Local Institution - 1156

Clermont, Florida, United States

Local Institution - 1138

Cutler Bay, Florida, United States

Local Institution - 1162

Delray Beach, Florida, United States

Local Institution - 1164

Doral, Florida, United States

Local Institution - 1165

Fort Myers, Florida, United States

Local Institution - 1155

Hialeah, Florida, United States

Local Institution - 1107

Hialeah, Florida, United States

Local Institution - 1120

Hialeah, Florida, United States

Local Institution - 1140

Hialeah, Florida, United States

Local Institution - 0150

Homestead, Florida, United States

Local Institution - 1145

Homestead, Florida, United States

Local Institution - 1127

Largo, Florida, United States

Local Institution - 1039

Maitland, Florida, United States

Local Institution - 1146

Maitland, Florida, United States

Local Institution - 1159

Miami, Florida, United States

Local Institution - 1118

Miami, Florida, United States

Local Institution - 1111

Miami, Florida, United States

Local Institution - 1108

Miami, Florida, United States

Local Institution - 1125

Miami, Florida, United States

Local Institution - 1115

Miami, Florida, United States

Local Institution - 1143

Miami, Florida, United States

Local Institution - 1113

Miami, Florida, United States

Local Institution - 1009

Miami, Florida, United States

Local Institution - 1129

Miami, Florida, United States

Local Institution - 1150

Miami, Florida, United States

Local Institution - 1109

Miami, Florida, United States

Local Institution - 1158

Miami, Florida, United States

Local Institution - 1147

Miami, Florida, United States

Local Institution - 1105

Miami, Florida, United States

Local Institution - 1157

Miami, Florida, United States

Local Institution - 1126

Miami Gardens, Florida, United States

Local Institution - 1102

Miami Lakes, Florida, United States

Local Institution - 1101

Okeechobee, Florida, United States

Local Institution - 1136

Orlando, Florida, United States

Local Institution - 1112

Orlando, Florida, United States

Local Institution - 1137

Port Orange, Florida, United States

Local Institution - 1133

Sweetwater, Florida, United States

Local Institution - 1041

Tampa, Florida, United States

Local Institution - 1124

Tampa, Florida, United States

Local Institution - 1123

Tampa, Florida, United States

Local Institution - 1110

Tampa, Florida, United States

Local Institution - 1131

Viera, Florida, United States

Local Institution - 1161

Decatur, Georgia, United States

Local Institution - 1148

Elgin, Illinois, United States

Local Institution - 1114

Marrero, Louisiana, United States

Local Institution - 1139

Rochester Hills, Michigan, United States

Local Institution - 1132

Flowood, Mississippi, United States

Local Institution - 1122

Dayton, Ohio, United States

Local Institution - 1106

Cypress, Texas, United States

Local Institution - 1163

Houston, Texas, United States

Local Institution - 1154

Katy, Texas, United States

Local Institution - 1134

Stafford, Texas, United States

Local Institution - 2801

Hasselt, Limburg, Belgium

Local Institution - 2802

Leuven, Vlaams Brabant, Belgium

Local Institution - 2803

Roeselare, West-Vlaanderen, Belgium

Local Institution - 6002

Providencia, Santiago Metropolitan, Chile

Local Institution - 6003

Antofagasta, Chile

Local Institution - 6001

Las Condes, Chile

Local Institution - 7007

Hefei, Anhui, China

Local Institution - 7004

Beijing, Beijing Municipality, China

Local Institution - 7005

Beijing, Beijing Municipality, China

Local Institution - 7015

Chongqing, Chongqing Municipality, China

Local Institution - 7008

Guangzhou, Guangdong, China

Local Institution - 7016

Guangzhou, Guangdong, China

Local Institution - 7009

Guangzhou, Guangdong, China

Local Institution - 7003

Shenzhen, Guangdong, China

Local Institution - 7013

Nanjing, Jiangsu, China

Local Institution - 7012

Nanchang, Jiangxi, China

Local Institution - 7001

Shanghai, Shanghai Municipality, China

Local Institution - 7011

Shanghai, Shanghai Municipality, China

Local Institution - 7002

Chengdu, Sichuan, China

Local Institution - 7019

Tianjin, Tianjin Municipality, China

Local Institution - 7017

Hangzhou, Zhejiang, China

Local Institution - 7010

Hangzhou, Zhejiang, China

Local Institution - 7006

Hangzhou, Zhejiang, China

Local Institution - 7020

Hangzhou, Zhejiang, China

Local Institution - 7018

Wenzhou, Zhejiang, China

Local Institution - 4805

Athens, Attica, Greece

Local Institution - 4803

Athens, Attica, Greece

Local Institution - 4802

Chaidari, Athens, Attica, Greece

Local Institution - 4806

Marousi, Attica, Greece

Local Institution - 4801

Heraklion, Greece

Local Institution - 4601

Pécs, Baranya, Hungary

Local Institution - 4602

Budapest, Hungary

Local Institution - 4603

Miskolc, Hungary

Local Institution - 1502

Saltillo Centro, Coahuila, Mexico

Local Institution - 1503

Monterrey, Nuevo León, Mexico

Local Institution - 1505

Monterrey, Nuevo León, Mexico

Local Institution - 1501

Culiacán, Sinaloa, Mexico

Local Institution - 1506

México, Mexico

Local Institution - 6103

Pueblo Libre, Lima region, Peru

Local Institution - 4206

Lublin, Lublin Voivodeship, Poland

Local Institution - 4207

Lodz, Lódzkie, Poland

Local Institution - 4208

Katowice, Silesian Voivodeship, Poland

Local Institution - 4204

Bydgoszcz, Poland

Local Institution - 4205

Katowice, Poland

Local Institution - 4202

Lodz, Poland

Local Institution - 4201

Ścinawa, Poland

Local Institution - 7208

Buk-gu, Daegu Gwang'yeogsi, South Korea

Local Institution - 7207

Seongnam-si, Gyeonggido, South Korea

Local Institution - 7205

Incheon, Incheon Gwang'yeogsi, South Korea

Local Institution - 7202

Seongnam-si, South Korea

Local Institution - 7206

Seoul, South Korea

Local Institution - 7203

Seoul, South Korea

Local Institution - 7201

Seoul, South Korea

Local Institution - 4702

Atakum, Samsun, Turkey (Türkiye)

Local Institution - 4701

Eskişehir, Turkey (Türkiye)

Local Institution - 4704

Istanbul, Turkey (Türkiye)

Local Institution - 4705

Izmir, Turkey (Türkiye)

Local Institution - 4703

Izmir, Turkey (Türkiye)

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (119)