RecruitingRecruiting
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
NCT06126224 · Karuna Therapeutics, Inc., a Bristol Myers Squibb company
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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
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.
Study design
Enrollment target: 500 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2023-08-28
Estimated completion: 2026-12-09
Last updated: 2026-06-02
Interventions
Drug: KarXTDrug: Placebo
Primary outcomes
- • Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score (Baseline and end of Treatment (up to 14 Weeks))
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (154)
Local Institution - 1116Active Not Recruiting
Chandler, Arizona, United States
Local Institution - 1044Active Not Recruiting
Phoenix, Arizona, United States
Local Institution - 1104Active Not Recruiting
Anaheim, California, United States
Local Institution - 1119Active Not Recruiting
Canoga Park, California, United States
Local Institution - 1151Active Not Recruiting
Encino, California, United States
Local Institution - 1142Active Not Recruiting
Lancaster, California, United States
Local Institution - 1117Active Not Recruiting
Los Alamitos, California, United States
Local Institution - 1103Active Not Recruiting
Sherman Oaks, California, United States
Local Institution - 1007Active Not Recruiting
Walnut Creek, California, United States
Local Institution - 1160Withdrawn
Apopka, Florida, United States
Local Institution - 1156Active Not Recruiting
Clermont, Florida, United States
Local Institution - 1138Active Not Recruiting
Cutler Bay, Florida, United States
Local Institution - 1162Active Not Recruiting
Delray Beach, Florida, United States
Local Institution - 1164Active Not Recruiting
Doral, Florida, United States
Local Institution - 1165Active Not Recruiting
Fort Myers, Florida, United States
Local Institution - 1155Active Not Recruiting
Hialeah, Florida, United States
Local Institution - 1107Active Not Recruiting
Hialeah, Florida, United States
Local Institution - 1120Active Not Recruiting
Hialeah, Florida, United States
Local Institution - 1140Active Not Recruiting
Hialeah, Florida, United States
Local Institution - 0150Active Not Recruiting
Homestead, Florida, United States
Local Institution - 1145Active Not Recruiting
Homestead, Florida, United States
Local Institution - 1127Active Not Recruiting
Largo, Florida, United States
Local Institution - 1039Active Not Recruiting
Maitland, Florida, United States
Local Institution - 1146Active Not Recruiting
Maitland, Florida, United States
Local Institution - 1159Active Not Recruiting
Miami, Florida, United States
Local Institution - 1118Active Not Recruiting
Miami, Florida, United States
Local Institution - 1111Active Not Recruiting
Miami, Florida, United States
Local Institution - 1108Active Not Recruiting
Miami, Florida, United States
Local Institution - 1125Active Not Recruiting
Miami, Florida, United States
Local Institution - 1115Active Not Recruiting
Miami, Florida, United States
Local Institution - 1143Active Not Recruiting
Miami, Florida, United States
Local Institution - 1113Active Not Recruiting
Miami, Florida, United States
Local Institution - 1009Active Not Recruiting
Miami, Florida, United States
Local Institution - 1129Active Not Recruiting
Miami, Florida, United States
Local Institution - 1150Active Not Recruiting
Miami, Florida, United States
Local Institution - 1109Active Not Recruiting
Miami, Florida, United States
Local Institution - 1158Active Not Recruiting
Miami, Florida, United States
Local Institution - 1147Active Not Recruiting
Miami, Florida, United States
Local Institution - 1105Active Not Recruiting
Miami, Florida, United States
Local Institution - 1157Active Not Recruiting
Miami, Florida, United States
Local Institution - 1126Active Not Recruiting
Miami Gardens, Florida, United States
Local Institution - 1102Active Not Recruiting
Miami Lakes, Florida, United States
Local Institution - 1136Active Not Recruiting
Orlando, Florida, United States
Local Institution - 1112Active Not Recruiting
Orlando, Florida, United States
Local Institution - 1137Active Not Recruiting
Port Orange, Florida, United States
Health Synergy Clinical Research,LLC - StuartRecruiting
Stuart, Florida, United States
Local Institution - 1133Active Not Recruiting
Sweetwater, Florida, United States
Local Institution - 1041Active Not Recruiting
Tampa, Florida, United States
Local Institution - 1124Active Not Recruiting
Tampa, Florida, United States
Local Institution - 1123Completed
Tampa, Florida, United States
Local Institution - 1110Active Not Recruiting
Tampa, Florida, United States
Local Institution - 1040Withdrawn
The Villages, Florida, United States
Local Institution - 1131Recruiting
Viera, Florida, United States
Local Institution - 1152Withdrawn
Augusta, Georgia, United States
Local Institution - 1141Withdrawn
Columbus, Georgia, United States
Local Institution - 1161Active Not Recruiting
Decatur, Georgia, United States
Local Institution - 1148Active Not Recruiting
Elgin, Illinois, United States
Local Institution - 1114Active Not Recruiting
Marrero, Louisiana, United States
Local Institution - 1139Active Not Recruiting
Rochester Hills, Michigan, United States
Local Institution - 1132Active Not Recruiting
Flowood, Mississippi, United States
Local Institution - 1144Withdrawn
Las Vegas, Nevada, United States
Local Institution - 1153Withdrawn
New Hyde Park, New York, United States
Local Institution - 1135Withdrawn
Port Jefferson Station, New York, United States
Local Institution - 1122Active Not Recruiting
Dayton, Ohio, United States
Local Institution - 1149Withdrawn
Malvern, Pennsylvania, United States
Local Institution - 1106Recruiting
Cypress, Texas, United States
Local Institution - 1163Active Not Recruiting
Houston, Texas, United States
Local Institution - 1154Active Not Recruiting
Katy, Texas, United States
Local Institution - 1121Withdrawn
Red Oak, Texas, United States
Local Institution - 1134Active Not Recruiting
Stafford, Texas, United States
Local Institution - 2801Active Not Recruiting
Hasselt, Limburg, Belgium
Local Institution - 2802Active Not Recruiting
Leuven, Vlaams Brabant, Belgium
Local Institution - 2803Active Not Recruiting
Roeselare, West-Vlaanderen, Belgium
Local Institution - 1605Withdrawn
Calgary, Alberta, Canada
Local Institution - 1603Withdrawn
Hamilton, Ontario, Canada
Local Institution - 1602Withdrawn
Toronto, Ontario, Canada
Local Institution - 1604Withdrawn
Whitby, Ontario, Canada
Local Institution - 1606Withdrawn
Montreal, Quebec, Canada
Local Institution - 1601Withdrawn
Verdun, Quebec, Canada
Biomedica Research GroupRecruiting
Providencia, Santiago Metropolitan, Chile
Psicomed Estudios MedicosRecruiting
Antofagasta, Chile
Local Institution - 6001Recruiting
Las Condes, Chile
Local Institution - 7007Active Not Recruiting
Hefei, Anhui, China
Local Institution - 7004Completed
Beijing, Beijing Municipality, China
Local Institution - 7005Active Not Recruiting
Beijing, Beijing Municipality, China
Local Institution - 7015Active Not Recruiting
Chongqing, Chongqing Municipality, China
Local Institution - 7008Active Not Recruiting
Guangzhou, Guangdong, China
Local Institution - 7016Active Not Recruiting
Guangzhou, Guangdong, China
Local Institution - 7009Active Not Recruiting
Guangzhou, Guangdong, China
Local Institution - 7003Active Not Recruiting
Shenzhen, Guangdong, China
Local Institution - 7014Withdrawn
Nanjing, Jiangsu, China
Local Institution - 7013Completed
Nanjing, Jiangsu, China
Local Institution - 7012Active Not Recruiting
Nanchang, Jiangxi, China
Local Institution - 7001Active Not Recruiting
Shanghai, Shanghai Municipality, China
Local Institution - 7011Active Not Recruiting
Shanghai, Shanghai Municipality, China
Local Institution - 7002Active Not Recruiting
Chengdu, Sichuan, China
Local Institution - 7019Completed
Tianjin, Tianjin Municipality, China
Local Institution - 7017Active Not Recruiting
Hangzhou, Zhejiang, China
Local Institution - 7010Active Not Recruiting
Hangzhou, Zhejiang, China
Local Institution - 7006Active Not Recruiting
Hangzhou, Zhejiang, China
Local Institution - 7020Active Not Recruiting
Hangzhou, Zhejiang, China
Local Institution - 7018Active Not Recruiting
Wenzhou, Zhejiang, China
Local Institution - 4805Active Not Recruiting
Athens, Attica, Greece
Local Institution - 4803Active Not Recruiting
Athens, Attica, Greece
Local Institution - 4802Active Not Recruiting
Chaidari, Athens, Attica, Greece
Local Institution - 4806Active Not Recruiting
Marousi, Attica, Greece
Local Institution - 4801Active Not Recruiting
Heraklion, Greece
Local Institution - 4601Active Not Recruiting
Pécs, Baranya, Hungary
Local Institution - 4602Active Not Recruiting
Budapest, Hungary
Local Institution - 4603Active Not Recruiting
Miskolc, Hungary
Local Institution - 1502Active Not Recruiting
Saltillo Centro, Coahuila, Mexico
Local Institution - 1504Withdrawn
Zona Urbana Río Tijuana, Estado de Baja California, Mexico
Local Institution - 1507Withdrawn
Zapopan, Jalisco, Mexico
Local Institution - 1503Active Not Recruiting
Monterrey, Nuevo León, Mexico
Local Institution - 1505Active Not Recruiting
Monterrey, Nuevo León, Mexico
Local Institution - 1501Active Not Recruiting
Culiacán, Sinaloa, Mexico
Local Institution - 1506Active Not Recruiting
México, Mexico
Local Institution - 6102Withdrawn
Miraflores, Lima region, Peru
Local Institution - 6103Active Not Recruiting
Pueblo Libre, Lima region, Peru
Local Institution - 6101Withdrawn
Callao, Peru
Local Institution - 4206Active Not Recruiting
Lublin, Lublin Voivodeship, Poland
Local Institution - 4207Active Not Recruiting
Lodz, Lódzkie, Poland
Local Institution - 4203Withdrawn
Sopot, Pomeranian Voivodeship, Poland
Local Institution - 4208Active Not Recruiting
Katowice, Silesian Voivodeship, Poland
Local Institution - 4204Active Not Recruiting
Bydgoszcz, Poland
Local Institution - 4205Active Not Recruiting
Katowice, Poland
Local Institution - 4202Active Not Recruiting
Lodz, Poland
Local Institution - 4209Withdrawn
Siemianowice Śląskie, Poland
Local Institution - 4201Active Not Recruiting
Ścinawa, Poland
Local Institution - 7208Active Not Recruiting
Buk-gu, Daegu Gwang'yeogsi, South Korea
Local Institution - 7207Active Not Recruiting
Seongnam-si, Gyeonggido, South Korea
Local Institution - 7205Active Not Recruiting
Incheon, Incheon Gwang'yeogsi, South Korea
Local Institution - 7206Completed
Seoul, Seoul Teugbyeolsi, South Korea
Local Institution - 7204Withdrawn
Busan, South Korea
Local Institution - 7202Active Not Recruiting
Seongnam-si, South Korea
Local Institution - 7203Active Not Recruiting
Seoul, South Korea
Local Institution - 7201Active Not Recruiting
Seoul, South Korea
Local Institution - 2901Withdrawn
Geneva, Genève (fr), Switzerland
Local Institution - 2902Withdrawn
Lausanne, Vaud (fr), Switzerland
Local Institution - 4702Active Not Recruiting
Atakum, Samsun, Turkey (Türkiye)
Local Institution - 4701Active Not Recruiting
Eskişehir, Turkey (Türkiye)
Local Institution - 4704Active Not Recruiting
Istanbul, Turkey (Türkiye)
Local Institution - 4705Active Not Recruiting
Izmir, Turkey (Türkiye)
Local Institution - 4703Active Not Recruiting
Izmir, Turkey (Türkiye)
Local Institution - 2110Withdrawn
Ilford, Greater London, United Kingdom
Local Institution - 2108Withdrawn
Swinton, Greater Manchester, United Kingdom
Local Institution - 2101Withdrawn
London, Surrey, United Kingdom
Local Institution - 2105Withdrawn
Aberdeen, United Kingdom
Local Institution - 2109Withdrawn
Chertsey, United Kingdom
Local Institution - 2112Withdrawn
Edinburgh, United Kingdom
Local Institution - 2106Withdrawn
Leeds, United Kingdom
Local Institution - 2104Withdrawn
Motherwell, United Kingdom
Local Institution - 2111Withdrawn
Preston, United Kingdom
Local Institution - 2107Withdrawn
Sheffield, SouthYorkshire, United Kingdom