A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
- Conditions
- Psychosis Associated With Alzheimer's Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT06126224
- Lead Sponsor
- Karuna Therapeutics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 400
-
Is a male or female aged 55 to 90 years, inclusive, at Screening.
-
Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed.
-
Meets clinical criteria for Possible AD or Probable AD.
-
Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.
-
Have an identified study partner who should have daily contact (approximately 10 hours a week or more).
-
History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.
-
CGI-S scale with a score ≥ 4 at Screening and Baseline.
-
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:
- Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR
- Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items
-
MMSE score of 8 to 22, inclusive, at Screening.
Key
- Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia.
- History of major depressive episode with psychotic features during the 12 months prior to Screening.
- History of bipolar disorder, schizophrenia, or schizoaffective disorder.
- 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.
- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
- Prior exposure to KarXT.
- History of hypersensitivity to KarXT excipients or trospium chloride.
- Experienced any significant adverse events (AEs) due to trospium.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KarXT KarXT Xanomeline and Trospium Chloride Capsules Placebo Placebo Placebo Capsules
- Primary Outcome Measures
Name Time Method 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) Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.
- Secondary Outcome Measures
Name Time Method Change from Baseline to End of Treatment in the Cohen-Mansfield Agitation Inventory (CMAI) score Baseline and End of Treatment (up to 14 weeks) Cohen-Mansfield Agitation Inventory (CMAI) is a caregiver's rating 29-item questionnaire used to assess the frequency of manifestations of agitated behaviors in older adults. Each item is rated on a 7-point scale ranging from "1 = never" to "7 = several times per hour." Higher scores on this scale indicate worse outcomes.
Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) scale Baseline and End of Treatment (up to 14 weeks) Clinical Global Impressions-Severity (CGI-S) requires the assessor to consider aspects of the psychosis (hallucinations and delusions) prior to providing a global assessment of severity. Higher scores on this scale indicate worse outcomes.
Trial Locations
- Locations (119)
Local Institution - 7007
🇨🇳Hefei, Anhui, China
Local Institution - 7009
🇨🇳Guangzhou, Guangdong, 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 - 4802
🇬🇷Chaidari, Athens, Attiki, Greece
Local Institution - 4806
🇬🇷Marousi, Attiki, Greece
Local Institution - 4801
🇬🇷Heraklion, Greece
Local Institution - 7201
🇰🇷Seoul, Korea, Republic of
Local Institution - 1502
🇲🇽Saltillo Centro, Coahuila, Mexico
Local Institution - 1503
🇲🇽Monterrey, Nuevo LEON, Mexico
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 - 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 - 1126
🇺🇸Miami Gardens, Florida, United States
Local Institution - 1102
🇺🇸Miami Lakes, 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 - 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, Metropolitana, Chile
Local Institution - 6003
🇨🇱Antofagasta, Chile
Local Institution - 6001
🇨🇱Las Condes, Chile
Local Institution - 7004
🇨🇳Beijing, Beijing, China
Local Institution - 7005
🇨🇳Beijing, Beijing, China
Local Institution - 7015
🇨🇳Chongqing, Chongqing, China
Local Institution - 7008
🇨🇳Guangzhou, Guangdong, China
Local Institution - 7016
🇨🇳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, China
Local Institution - 7011
🇨🇳Shanghai, Shanghai, China
Local Institution - 7002
🇨🇳Chengdu, Sichuan, China
Local Institution - 7019
🇨🇳Tianjin, Tianjin, China
Local Institution - 7018
🇨🇳Wenzhou, Zhejiang, China
Local Institution - 4805
🇬🇷Athina, Attiki, Greece
Local Institution - 4803
🇬🇷Athina, Attiki, Greece
Local Institution - 4601
🇭🇺Pécs, Baranya, Hungary
Local Institution - 4602
🇭🇺Budapest, Hungary
Local Institution - 4603
🇭🇺Miskolc, Hungary
Local Institution - 7208
🇰🇷Buk-gu, Daegu Gwang'yeogsi, Korea, Republic of
Local Institution - 7207
🇰🇷Seongnam-si, Gyeonggido, Korea, Republic of
Local Institution - 7205
🇰🇷Incheon, Incheon Gwang'yeogsi, Korea, Republic of
Local Institution - 7202
🇰🇷Seongnam-si, Korea, Republic of
Local Institution - 7206
🇰🇷Seoul, Korea, Republic of
Local Institution - 7203
🇰🇷Seoul, Korea, Republic of
Local Institution - 1505
🇲🇽Monterrey, Nuevo LEON, Mexico
Local Institution - 1501
🇲🇽Culiacan, Sinaloa, Mexico
Local Institution - 1506
🇲🇽Mexico, Mexico
Local Institution - 6103
🇵🇪Pueblo Libre, Lima, Peru
Local Institution - 4206
🇵🇱Lublin, Lubelskie, Poland
Local Institution - 4207
🇵🇱Lodz, Lódzkie, Poland
Local Institution - 4208
🇵🇱Katowice, Slaskie, Poland
Local Institution - 4204
🇵🇱Bydgoszcz, Poland
Local Institution - 4205
🇵🇱Katowice, Poland
Local Institution - 4202
🇵🇱Lodz, Poland
Local Institution - 4201
🇵🇱Ścinawa, Poland
Local Institution - 4702
🇹🇷Atakum, Samsun, Turkey
Local Institution - 4701
🇹🇷Eskisehir, Turkey
Local Institution - 4704
🇹🇷Istanbul, Turkey
Local Institution - 4705
🇹🇷Izmir, Turkey
Local Institution - 4703
🇹🇷Izmir, Turkey