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Clinical trial · NCT06126224

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

RecruitingPhase 3

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

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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.

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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (154)

  • Local Institution - 1116, Chandler, Arizona · Active, not recruiting
  • Local Institution - 1044, Phoenix, Arizona · Active, not recruiting
  • Local Institution - 1104, Anaheim, California · Active, not recruiting
  • Local Institution - 1119, Canoga Park, California · Active, not recruiting
  • Local Institution - 1151, Encino, California · Active, not recruiting
  • Local Institution - 1142, Lancaster, California · Active, not recruiting
  • Local Institution - 1117, Los Alamitos, California · Active, not recruiting
  • Local Institution - 1103, Sherman Oaks, California · Active, not recruiting
  • Local Institution - 1007, Walnut Creek, California · Active, not recruiting
  • Local Institution - 1160, Apopka, Florida · Withdrawn
  • Local Institution - 1156, Clermont, Florida · Active, not recruiting
  • Local Institution - 1138, Cutler Bay, Florida · Active, not recruiting
  • Local Institution - 1162, Delray Beach, Florida · Active, not recruiting
  • Local Institution - 1164, Doral, Florida · Active, not recruiting
  • Local Institution - 1165, Fort Myers, Florida · Active, not recruiting
  • Local Institution - 1155, Hialeah, Florida · Active, not recruiting
  • Local Institution - 1107, Hialeah, Florida · Active, not recruiting
  • Local Institution - 1120, Hialeah, Florida · Active, not recruiting
  • Local Institution - 1140, Hialeah, Florida · Active, not recruiting
  • Local Institution - 0150, Homestead, Florida · Active, not recruiting
  • Local Institution - 1145, Homestead, Florida · Active, not recruiting
  • Local Institution - 1127, Largo, Florida · Active, not recruiting
  • Local Institution - 1039, Maitland, Florida · Active, not recruiting
  • Local Institution - 1146, Maitland, Florida · Active, not recruiting
  • Local Institution - 1159, Miami, Florida · Active, not recruiting
  • Local Institution - 1118, Miami, Florida · Active, not recruiting
  • Local Institution - 1111, Miami, Florida · Active, not recruiting
  • Local Institution - 1108, Miami, Florida · Active, not recruiting
  • Local Institution - 1125, Miami, Florida · Active, not recruiting
  • Local Institution - 1115, Miami, Florida · Active, not recruiting
  • Local Institution - 1143, Miami, Florida · Active, not recruiting
  • Local Institution - 1113, Miami, Florida · Active, not recruiting
  • Local Institution - 1009, Miami, Florida · Active, not recruiting
  • Local Institution - 1129, Miami, Florida · Active, not recruiting
  • Local Institution - 1150, Miami, Florida · Active, not recruiting
  • Local Institution - 1109, Miami, Florida · Active, not recruiting
  • Local Institution - 1158, Miami, Florida · Active, not recruiting
  • Local Institution - 1147, Miami, Florida · Active, not recruiting
  • Local Institution - 1105, Miami, Florida · Active, not recruiting
  • Local Institution - 1157, Miami, Florida · Active, not recruiting
  • Local Institution - 1126, Miami Gardens, Florida · Completed
  • Local Institution - 1102, Miami Lakes, Florida · Completed
  • Local Institution - 1136, Orlando, Florida · Active, not recruiting
  • Local Institution - 1112, Orlando, Florida · Active, not recruiting
  • Local Institution - 1137, Port Orange, Florida · Active, not recruiting
  • Health Synergy Clinical Research,LLC - Stuart, Stuart, Florida · Recruiting
  • Local Institution - 1133, Sweetwater, Florida · Active, not recruiting
  • Local Institution - 1041, Tampa, Florida · Active, not recruiting
  • Local Institution - 1124, Tampa, Florida · Active, not recruiting
  • Local Institution - 1123, Tampa, Florida · Completed
  • Local Institution - 1110, Tampa, Florida · Active, not recruiting
  • Local Institution - 1040, The Villages, Florida · Withdrawn
  • Local Institution - 1131, Viera, Florida · Recruiting
  • Local Institution - 1152, Augusta, Georgia · Withdrawn
  • Local Institution - 1141, Columbus, Georgia · Withdrawn
  • Local Institution - 1161, Decatur, Georgia · Active, not recruiting
  • Local Institution - 1148, Elgin, Illinois · Active, not recruiting
  • Local Institution - 1114, Marrero, Louisiana · Active, not recruiting
  • Local Institution - 1139, Rochester Hills, Michigan · Active, not recruiting
  • Local Institution - 1132, Flowood, Mississippi · Active, not recruiting
  • Local Institution - 1144, Las Vegas, Nevada · Withdrawn
  • Local Institution - 1153, New Hyde Park, New York · Withdrawn
  • Local Institution - 1135, Port Jefferson Station, New York · Withdrawn
  • Local Institution - 1122, Dayton, Ohio · Active, not recruiting
  • Local Institution - 1149, Malvern, Pennsylvania · Withdrawn
  • Local Institution - 1106, Cypress, Texas · Recruiting
  • Local Institution - 1163, Houston, Texas · Active, not recruiting
  • Local Institution - 1154, Katy, Texas · Active, not recruiting
  • Local Institution - 1121, Red Oak, Texas · Withdrawn
  • Local Institution - 1134, Stafford, Texas · Active, not recruiting
  • Local Institution - 2801, Hasselt, Limburg · Active, not recruiting
  • Local Institution - 2802, Leuven, Vlaams Brabant · Active, not recruiting
  • Local Institution - 2803, Roeselare, West-Vlaanderen · Active, not recruiting
  • Local Institution - 1605, Calgary, Alberta · Withdrawn
  • Local Institution - 1603, Hamilton, Ontario · Withdrawn
  • Local Institution - 1602, Toronto, Ontario · Withdrawn
  • Local Institution - 1604, Whitby, Ontario · Withdrawn
  • Local Institution - 1606, Montreal, Quebec · Withdrawn
  • Local Institution - 1601, Verdun, Quebec · Withdrawn
  • Biomedica Research Group, Providencia, Santiago Metropolitan · Recruiting
  • Psicomed Estudios Medicos, Antofagasta, Chile · Recruiting
  • Local Institution - 6001, Las Condes, Chile · Recruiting
  • Local Institution - 7007, Hefei, Anhui · Active, not recruiting
  • Local Institution - 7004, Beijing, Beijing Municipality · Completed
  • Local Institution - 7005, Beijing, Beijing Municipality · Active, not recruiting
  • Local Institution - 7015, Chongqing, Chongqing Municipality · Active, not recruiting
  • Local Institution - 7008, Guangzhou, Guangdong · Completed
  • Local Institution - 7016, Guangzhou, Guangdong · Active, not recruiting
  • Local Institution - 7009, Guangzhou, Guangdong · Active, not recruiting
  • Local Institution - 7003, Shenzhen, Guangdong · Active, not recruiting
  • Local Institution - 7014, Nanjing, Jiangsu · Withdrawn
  • Local Institution - 7013, Nanjing, Jiangsu · Completed
  • Local Institution - 7012, Nanchang, Jiangxi · Active, not recruiting
  • Local Institution - 7001, Shanghai, Shanghai Municipality · Completed
  • Shanghai General Hospital - North Campus, Shanghai, Shanghai Municipality · Recruiting
  • Local Institution - 7002, Chengdu, Sichuan · Active, not recruiting
  • Local Institution - 7019, Tianjin, Tianjin Municipality · Completed
  • Local Institution - 7017, Hangzhou, Zhejiang · Active, not recruiting
  • Local Institution - 7020, Hangzhou, Zhejiang · Completed
  • Local Institution - 7010, Hangzhou, Zhejiang · Active, not recruiting
  • Local Institution - 7006, Hangzhou, Zhejiang · Completed
  • Local Institution - 7018, Wenzhou, Zhejiang · Active, not recruiting
  • Local Institution - 4805, Athens, Attica · Active, not recruiting
  • Local Institution - 4803, Athens, Attica · Active, not recruiting
  • Local Institution - 4802, Chaidari, Athens, Attica · Active, not recruiting
  • Local Institution - 4806, Marousi, Attica · Active, not recruiting
  • Local Institution - 4801, Heraklion, Greece · Active, not recruiting
  • Local Institution - 4601, Pécs, Baranya · Active, not recruiting
  • Local Institution - 4602, Budapest, Hungary · Active, not recruiting
  • Local Institution - 4603, Miskolc, Hungary · Active, not recruiting
  • Local Institution - 1502, Saltillo Centro, Coahuila · Active, not recruiting
  • Local Institution - 1504, Zona Urbana Río Tijuana, Estado de Baja California · Withdrawn
  • Local Institution - 1507, Zapopan, Jalisco · Withdrawn
  • Local Institution - 1503, Monterrey, Nuevo León · Active, not recruiting
  • Local Institution - 1505, Monterrey, Nuevo León · Active, not recruiting
  • Local Institution - 1501, Culiacán, Sinaloa · Active, not recruiting
  • Local Institution - 1506, México, Mexico · Active, not recruiting
  • Local Institution - 6102, Miraflores, Lima region · Withdrawn
  • Local Institution - 6103, Pueblo Libre, Lima region · Active, not recruiting
  • Local Institution - 6101, Callao, Peru · Withdrawn
  • Local Institution - 4206, Lublin, Lublin Voivodeship · Active, not recruiting
  • Local Institution - 4207, Lodz, Lódzkie · Active, not recruiting
  • Local Institution - 4203, Sopot, Pomeranian Voivodeship · Withdrawn
  • Local Institution - 4208, Katowice, Silesian Voivodeship · Completed
  • Local Institution - 4204, Bydgoszcz, Poland · Active, not recruiting
  • Local Institution - 4205, Katowice, Poland · Active, not recruiting
  • Local Institution - 4202, Lodz, Poland · Active, not recruiting
  • Local Institution - 4209, Siemianowice Śląskie, Poland · Withdrawn
  • Local Institution - 4201, Ścinawa, Poland · Active, not recruiting
  • Local Institution - 7208, Buk-gu, Daegu Gwang'yeogsi · Active, not recruiting
  • Local Institution - 7207, Seongnam-si, Gyeonggido · Active, not recruiting
  • Local Institution - 7205, Incheon, Incheon Gwang'yeogsi · Active, not recruiting
  • Local Institution - 7206, Seoul, Seoul Teugbyeolsi · Completed
  • Local Institution - 7204, Busan, South Korea · Withdrawn
  • Local Institution - 7202, Seongnam-si, South Korea · Active, not recruiting
  • Local Institution - 7203, Seoul, South Korea · Active, not recruiting
  • Local Institution - 7201, Seoul, South Korea · Active, not recruiting
  • Local Institution - 2901, Geneva, Genève (fr) · Withdrawn
  • Local Institution - 2902, Lausanne, Vaud (fr) · Withdrawn
  • Local Institution - 4702, Atakum, Samsun · Active, not recruiting
  • Local Institution - 4701, Eskişehir, Turkey (Türkiye) · Active, not recruiting
  • Local Institution - 4704, Istanbul, Turkey (Türkiye) · Active, not recruiting
  • Local Institution - 4705, Izmir, Turkey (Türkiye) · Active, not recruiting
  • Local Institution - 4703, Izmir, Turkey (Türkiye) · Active, not recruiting
  • Local Institution - 2110, Ilford, Greater London · Withdrawn
  • Local Institution - 2108, Swinton, Greater Manchester · Withdrawn
  • Local Institution - 2101, London, Surrey · Withdrawn
  • Local Institution - 2105, Aberdeen, United Kingdom · Withdrawn
  • Local Institution - 2109, Chertsey, United Kingdom · Withdrawn
  • Local Institution - 2112, Edinburgh, United Kingdom · Withdrawn
  • Local Institution - 2106, Leeds, United Kingdom · Withdrawn
  • Local Institution - 2104, Motherwell, United Kingdom · Withdrawn
  • Local Institution - 2111, Preston, United Kingdom · Withdrawn
  • Local Institution - 2107, Sheffield, SouthYorkshire, United Kingdom · Withdrawn

Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2026-09-04.