A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
NCT ID: NCT06126224
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2023-08-28
2025-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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KarXT
Xanomeline and Trospium Chloride Capsules
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)
Placebo
Placebo Capsules
Placebo
Placebo Capsules
Interventions
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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)
Placebo
Placebo Capsules
Eligibility Criteria
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Inclusion Criteria
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. Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.
5. Have an identified study partner who should have daily contact (approximately 10 hours a week or more).
6. History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.
7. CGI-S scale with a score ≥ 4 at Screening and Baseline.
8. 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
9. MMSE score of 8 to 22, inclusive, at Screening.
Exclusion Criteria
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.
55 Years
90 Years
ALL
No
Sponsors
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Karuna Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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)
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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KAR-032
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0027
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0027
Identifier Type: -
Identifier Source: org_study_id
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