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RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT06126224

Registry updated: 2026-10-16
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Description

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.

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)
  • Placebo (Drug)
    Placebo capsules

Eligibility criteria

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.

Conditions

Psychosis Associated With Alzheimer's Disease

Locations

  • 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 - 1160 — Apopka, Florida, 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 - 1136 — Orlando, Florida, United States
  • Local Institution - 1112 — Orlando, Florida, United States
  • Local Institution - 1137 — Port Orange, Florida, United States
  • Health Synergy Clinical Research,LLC - Stuart — Stuart, 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 - 1040 — The Villages, Florida, United States
  • Local Institution - 1131 — Viera, Florida, United States
  • Local Institution - 1152 — Augusta, Georgia, United States
  • Local Institution - 1141 — Columbus, Georgia, 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 - 1144 — Las Vegas, Nevada, United States
  • Local Institution - 1153 — New Hyde Park, New York, United States
  • Local Institution - 1135 — Port Jefferson Station, New York, United States
  • Local Institution - 1122 — Dayton, Ohio, United States
  • Local Institution - 1149 — Malvern, Pennsylvania, 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 - 1121 — Red Oak, 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 - 1605 — Calgary, Alberta, Canada
  • Local Institution - 1603 — Hamilton, Ontario, Canada
  • Local Institution - 1602 — Toronto, Ontario, Canada
  • Local Institution - 1604 — Whitby, Ontario, Canada
  • Local Institution - 1606 — Montreal, Quebec, Canada
  • Local Institution - 1601 — Verdun, Quebec, Canada
  • Local Institution - 6005 — Las Condes, Santiago Metropolitan, Chile
  • Biomedica Research Group — Providencia, Santiago Metropolitan, Chile
  • Psicomed Estudios Medicos — Antofagasta, Chile
  • Local Institution - 6001 — Las Condes, Chile
  • Local Institution - 7007 — Hefei, Anhui, China
  • Local Institution - 7004 — Beijing, Beijing Municipality, China
  • Local Institution - 7045 — 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 - 7014 — Nanjing, Jiangsu, China
  • Local Institution - 7013 — Nanjing, Jiangsu, China
  • Local Institution - 7012 — Nanchang, Jiangxi, China
  • Local Institution - 7001 — Shanghai, Shanghai Municipality, China
  • Shanghai General Hospital - North Campus — Shanghai, Shanghai Municipality, China
  • Local Institution - 7002 — Chengdu, Sichuan, China
  • Local Institution - 7043 — Zigong, Sichuan, China
  • Local Institution - 7019 — Tianjin, Tianjin Municipality, China
  • Local Institution - 7017 — Hangzhou, Zhejiang, China
  • Local Institution - 7020 — Hangzhou, Zhejiang, China
  • Local Institution - 7010 — Hangzhou, Zhejiang, China
  • Local Institution - 7006 — 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 - 1504 — Zona Urbana Río Tijuana, Estado de Baja California, Mexico
  • Local Institution - 1507 — Zapopan, Jalisco, 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 - 6102 — Miraflores, Lima region, Peru
  • Local Institution - 6103 — Pueblo Libre, Lima region, Peru
  • Local Institution - 6101 — Callao, Peru
  • Local Institution - 4206 — Lublin, Lublin Voivodeship, Poland
  • Local Institution - 4207 — Lodz, Lódzkie, Poland
  • Local Institution - 4203 — Sopot, Pomeranian Voivodeship, 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 - 4209 — Siemianowice Śląskie, 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 - 7206 — Seoul, Seoul Teugbyeolsi, South Korea
  • Local Institution - 7204 — Busan, South Korea
  • Local Institution - 7202 — Seongnam-si, South Korea
  • Local Institution - 7203 — Seoul, South Korea
  • Local Institution - 7201 — Seoul, South Korea
  • Local Institution - 2901 — Geneva, Genève (fr), Switzerland
  • Local Institution - 2902 — Lausanne, Vaud (fr), Switzerland
  • 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)
  • Local Institution - 2110 — Ilford, Greater London, United Kingdom
  • Local Institution - 2108 — Swinton, Greater Manchester, United Kingdom
  • Local Institution - 2101 — London, Surrey, United Kingdom
  • Local Institution - 2105 — Aberdeen, United Kingdom
  • Local Institution - 2109 — Chertsey, United Kingdom
  • Local Institution - 2112 — Edinburgh, United Kingdom
  • Local Institution - 2106 — Leeds, United Kingdom
  • Local Institution - 2104 — Motherwell, United Kingdom
  • Local Institution - 2111 — Preston, United Kingdom
  • Local Institution - 2107 — Sheffield, SouthYorkshire, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record