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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psychosis Associated With Alzheimer's Disease
• Intervention / Treatment: Drug: Placebo; Drug: KarXT

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Active, not recruiting
      • Local Institution - 2801
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Active, not recruiting
      • Local Institution - 2802
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • Active, not recruiting
      • Local Institution - 2803
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • Withdrawn
      • Local Institution - 1605
  • Ontario
    • Hamilton, Ontario, Canada, ON L8M 1W9
      • Withdrawn
      • Local Institution - 1603
    • Toronto, Ontario, Canada, M5B 1W8
      • Withdrawn
      • Local Institution - 1602
    • Whitby, Ontario, Canada, L1N 5S9
      • Withdrawn
      • Local Institution - 1604
  • Quebec
    • Montreal, Quebec, Canada, H4H 1R3
      • Withdrawn
      • Local Institution - 1606
    • Verdun, Quebec, Canada, H4H 1R3
      • Withdrawn
      • Local Institution - 1601
• Chile
  • Antofagasta, Chile, 1270244
    • Recruiting
    • Psicomed Estudios Medicos
    • Contact: Luis Barra, Site 6003; Phone Number: +56552240334
  • Las Condes, Chile, 7550000
    • Recruiting
    • Local Institution - 6001
    • Contact: Site 6001
  • Santiago Metropolitan
    • Providencia, Santiago Metropolitan, Chile, 7500000
      • Recruiting
      • BioMedica Research Group
      • Contact: Sergio Gloger Kojchen, Site 6002; Phone Number: +56226758700
• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Active, not recruiting
      • Local Institution - 7007
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100088
      • Active, not recruiting
      • Local Institution - 7005
    • Beijing, Beijing Municipality, China, 100025
      • Completed
      • Local Institution - 7004
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400016
      • Active, not recruiting
      • Local Institution - 7015
  • Guangdong
    • Guangzhou, Guangdong, China
      • Active, not recruiting
      • Local Institution - 7008
    • Guangzhou, Guangdong, China, 510120
      • Active, not recruiting
      • Local Institution - 7016
    • Guangzhou, Guangdong, China, 510260
      • Active, not recruiting
      • Local Institution - 7009
    • Shenzhen, Guangdong, China, 518118
      • Active, not recruiting
      • Local Institution - 7003
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Withdrawn
      • Local Institution - 7014
    • Nanjing, Jiangsu, China, 210011
      • Completed
      • Local Institution - 7013
  • Jiangxi
    • Nanchang, Jiangxi, China, 330008
      • Active, not recruiting
      • Local Institution - 7012
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Active, not recruiting
      • Local Institution - 7001
    • Shanghai, Shanghai Municipality, China, 200080
      • Active, not recruiting
      • Local Institution - 7011
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Active, not recruiting
      • Local Institution - 7002
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300222
      • Completed
      • Local Institution - 7019
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Active, not recruiting
      • Local Institution - 7017
    • Hangzhou, Zhejiang, China, 310013
      • Active, not recruiting
      • Local Institution - 7010
    • Hangzhou, Zhejiang, China, 310014
      • Active, not recruiting
      • Local Institution - 7006
    • Hangzhou, Zhejiang, China, 310016
      • Active, not recruiting
      • Local Institution - 7020
    • Wenzhou, Zhejiang, China, 325000
      • Active, not recruiting
      • Local Institution - 7018
• Greece
  • Heraklion, Greece, 71110
    • Active, not recruiting
    • Local Institution - 4801
  • Attica
    • Athens, Attica, Greece, 115 21
      • Active, not recruiting
      • Local Institution - 4805
    • Athens, Attica, Greece, 115 26
      • Active, not recruiting
      • Local Institution - 4803
    • Chaidari, Athens, Attica, Greece, 124 62
      • Active, not recruiting
      • Local Institution - 4802
    • Marousi, Attica, Greece, 151 23
      • Active, not recruiting
      • Local Institution - 4806
• Hungary
  • Budapest, Hungary, 1083
    • Active, not recruiting
    • Local Institution - 4602
  • Miskolc, Hungary, 3526
    • Active, not recruiting
    • Local Institution - 4603
  • Baranya
    • Pécs, Baranya, Hungary, 7633
      • Active, not recruiting
      • Local Institution - 4601
• Mexico
  • México, Mexico, 03100
    • Active, not recruiting
    • Local Institution - 1506
  • Coahuila
    • Saltillo Centro, Coahuila, Mexico, 25000
      • Active, not recruiting
      • Local Institution - 1502
  • Estado de Baja California
    • Zona Urbana Río Tijuana, Estado de Baja California, Mexico, 22010
      • Withdrawn
      • Local Institution - 1504
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45170
      • Withdrawn
      • Local Institution - 1507
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Active, not recruiting
      • Local Institution - 1503
    • Monterrey, Nuevo León, Mexico, 64620
      • Active, not recruiting
      • Local Institution - 1505
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80020
      • Active, not recruiting
      • Local Institution - 1501
• Peru
  • Callao, Peru, Callao 2
    • Withdrawn
    • Local Institution - 6101
  • Lima region
    • Miraflores, Lima region, Peru, 15046
      • Withdrawn
      • Local Institution - 6102
    • Pueblo Libre, Lima region, Peru, 15084
      • Active, not recruiting
      • Local Institution - 6103
• Poland
  • Bydgoszcz, Poland, 85-080
    • Active, not recruiting
    • Local Institution - 4204
  • Katowice, Poland, 40-282
    • Active, not recruiting
    • Local Institution - 4205
  • Lodz, Poland, 90-227
    • Active, not recruiting
    • Local Institution - 4202
  • Siemianowice Śląskie, Poland, 41-100
    • Withdrawn
    • Local Institution - 4209
  • Ścinawa, Poland, 59-330
    • Active, not recruiting
    • Local Institution - 4201
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-064
      • Active, not recruiting
      • Local Institution - 4206
  • Lódzkie
    • Lodz, Lódzkie, Poland, 90-349
      • Active, not recruiting
      • Local Institution - 4207
  • Pomeranian Voivodeship
    • Sopot, Pomeranian Voivodeship, Poland, 81-855
      • Withdrawn
      • Local Institution - 4203
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-156
      • Active, not recruiting
      • Local Institution - 4208
• South Korea
  • Busan, South Korea, 49201
    • Withdrawn
    • Local Institution - 7204
  • Seongnam-si, South Korea
    • Active, not recruiting
    • Local Institution - 7202
  • Seoul, South Korea, 07071
    • Active, not recruiting
    • Local Institution - 7203
  • Seoul, South Korea, 143-729
    • Active, not recruiting
    • Local Institution - 7201
  • Daegu Gwang'yeogsi
    • Buk-gu, Daegu Gwang'yeogsi, South Korea, 41404
      • Active, not recruiting
      • Local Institution - 7208
  • Gyeonggido
    • Seongnam-si, Gyeonggido, South Korea, 13496
      • Active, not recruiting
      • Local Institution - 7207
  • Incheon Gwang'yeogsi
    • Incheon, Incheon Gwang'yeogsi, South Korea, 21565
      • Active, not recruiting
      • Local Institution - 7205
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Completed
      • Local Institution - 7206
• Switzerland
  • Genève (fr)
    • Geneva, Genève (fr), Switzerland, CH-1205
      • Withdrawn
      • Local Institution - 2901
  • Vaud (fr)
    • Lausanne, Vaud (fr), Switzerland, 1011
      • Withdrawn
      • Local Institution - 2902
• Turkey (Türkiye)
  • Eskişehir, Turkey (Türkiye), 26040
    • Active, not recruiting
    • Local Institution - 4701
  • Istanbul, Turkey (Türkiye), 34093
    • Active, not recruiting
    • Local Institution - 4704
  • Izmir, Turkey (Türkiye), 35210
    • Active, not recruiting
    • Local Institution - 4705
  • Izmir, Turkey (Türkiye), 35575
    • Active, not recruiting
    • Local Institution - 4703
  • Samsun
    • Atakum, Samsun, Turkey (Türkiye), 55270
      • Active, not recruiting
      • Local Institution - 4702
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZL
    • Withdrawn
    • Local Institution - 2105
  • Chertsey, United Kingdom, KT16 9AU
    • Withdrawn
    • Local Institution - 2109
  • Edinburgh, United Kingdom, EH4 2XU
    • Withdrawn
    • Local Institution - 2112
  • Leeds, United Kingdom, LS7 3JX
    • Withdrawn
    • Local Institution - 2106
  • Motherwell, United Kingdom, ML1 4UF
    • Withdrawn
    • Local Institution - 2104
  • Preston, United Kingdom, PR2 9HT
    • Withdrawn
    • Local Institution - 2111
  • Sheffield, SouthYorkshire, United Kingdom, s5 7JT
    • Withdrawn
    • Local Institution - 2107
  • Greater London
    • Ilford, Greater London, United Kingdom, IG1 4HP
      • Withdrawn
      • Local Institution - 2110
  • Greater Manchester
    • Swinton, Greater Manchester, United Kingdom, M27 8FF
      • Withdrawn
      • Local Institution - 2108
  • Surrey
    • London, Surrey, United Kingdom, SE5 8AZ
      • Withdrawn
      • Local Institution - 2101
• United States
  • Arizona
    • Chandler, Arizona, United States, 85286
      • Active, not recruiting
      • Local Institution - 1116
    • Phoenix, Arizona, United States, 85012-2836
      • Active, not recruiting
      • Local Institution - 1044
  • California
    • Anaheim, California, United States, 92805-5854
      • Active, not recruiting
      • Local Institution - 1104
    • Canoga Park, California, United States, 91303-1844
      • Active, not recruiting
      • Local Institution - 1119
    • Encino, California, United States, 91316
      • Active, not recruiting
      • Local Institution - 1151
    • Lancaster, California, United States, 93534-2839
      • Active, not recruiting
      • Local Institution - 1142
    • Los Alamitos, California, United States, 90720-6506
      • Active, not recruiting
      • Local Institution - 1117
    • Sherman Oaks, California, United States, 91403-2131
      • Active, not recruiting
      • Local Institution - 1103
    • Walnut Creek, California, United States, 94596
      • Active, not recruiting
      • Local Institution - 1007
  • Florida
    • Apopka, Florida, United States, 32703-5835
      • Withdrawn
      • Local Institution - 1160
    • Clermont, Florida, United States, 34711-5190
      • Active, not recruiting
      • Local Institution - 1156
    • Cutler Bay, Florida, United States, 33189-1230
      • Active, not recruiting
      • Local Institution - 1138
    • Delray Beach, Florida, United States, 33445-2581
      • Active, not recruiting
      • Local Institution - 1162
    • Doral, Florida, United States, 33122-1620
      • Active, not recruiting
      • Local Institution - 1164
    • Fort Myers, Florida, United States, 33912-4302
      • Active, not recruiting
      • Local Institution - 1165
    • Hialeah, Florida, United States, 33012-3158
      • Active, not recruiting
      • Local Institution - 1155
    • Hialeah, Florida, United States, 33012-3618
      • Active, not recruiting
      • Local Institution - 1107
    • Hialeah, Florida, United States, 33012-4648
      • Active, not recruiting
      • Local Institution - 1120
    • Hialeah, Florida, United States, 33016-1814
      • Active, not recruiting
      • Local Institution - 1140
    • Homestead, Florida, United States, 33032-8187
      • Active, not recruiting
      • Local Institution - 0150
    • Homestead, Florida, United States, 33032-8187
      • Active, not recruiting
      • Local Institution - 1145
    • Largo, Florida, United States, 33777-1359
      • Active, not recruiting
      • Local Institution - 1127
    • Maitland, Florida, United States, 32751-5669
      • Active, not recruiting
      • Local Institution - 1039
    • Maitland, Florida, United States, 32751-6138
      • Active, not recruiting
      • Local Institution - 1146
    • Miami, Florida, United States, 33145-2455
      • Active, not recruiting
      • Local Institution - 1143
    • Miami, Florida, United States, 33165-3947
      • Active, not recruiting
      • Local Institution - 1129
    • Miami, Florida, United States, 33135
      • Active, not recruiting
      • Local Institution - 1115
    • Miami, Florida, United States, 33032
      • Active, not recruiting
      • Local Institution - 1159
    • Miami, Florida, United States, 33122-1721
      • Active, not recruiting
      • Local Institution - 1118
    • Miami, Florida, United States, 33126-5683
      • Active, not recruiting
      • Local Institution - 1111
    • Miami, Florida, United States, 33133-4231
      • Active, not recruiting
      • Local Institution - 1108
    • Miami, Florida, United States, 33135-1601
      • Active, not recruiting
      • Local Institution - 1125
    • Miami, Florida, United States, 33155-6630
      • Active, not recruiting
      • Local Institution - 1113
    • Miami, Florida, United States, 33155
      • Active, not recruiting
      • Local Institution - 1009
    • Miami, Florida, United States, 33165
      • Active, not recruiting
      • Local Institution - 1150
    • Miami, Florida, United States, 33174-2950
      • Active, not recruiting
      • Local Institution - 1109
    • Miami, Florida, United States, 33175
      • Active, not recruiting
      • Local Institution - 1158
    • Miami, Florida, United States, 33176-7947
      • Active, not recruiting
      • Local Institution - 1147
    • Miami, Florida, United States, 33179-2537
      • Active, not recruiting
      • Local Institution - 1105
    • Miami, Florida, United States, 33184-1412
      • Active, not recruiting
      • Local Institution - 1157
    • Miami Gardens, Florida, United States, 33056-4000
      • Active, not recruiting
      • Local Institution - 1126
    • Miami Lakes, Florida, United States, 33014-6435
      • Active, not recruiting
      • Local Institution - 1102
    • Orlando, Florida, United States, 32806-1041
      • Active, not recruiting
      • Local Institution - 1136
    • Orlando, Florida, United States, 32807-3555
      • Active, not recruiting
      • Local Institution - 1112
    • Port Orange, Florida, United States, 32127-2914
      • Active, not recruiting
      • Local Institution - 1137
    • Stuart, Florida, United States, 34994
      • Recruiting
      • Health Synergy Clinical Research,LLC - Stuart
      • Contact: Mohammad Nisar, Site 1101; Phone Number: 786-831-7303
    • Sweetwater, Florida, United States, 33182
      • Active, not recruiting
      • Local Institution - 1133
    • Tampa, Florida, United States, 33607-4629
      • Active, not recruiting
      • Local Institution - 1041
    • Tampa, Florida, United States, 33614-2700
      • Active, not recruiting
      • Local Institution - 1124
    • Tampa, Florida, United States, 33629-5837
      • Active, not recruiting
      • Local Institution - 1110
    • Tampa, Florida, United States, 33614-2869
      • Completed
      • Local Institution - 1123
    • The Villages, Florida, United States, 32159-8986
      • Withdrawn
      • Local Institution - 1040
    • Viera, Florida, United States, 32940
      • Recruiting
      • Local Institution - 1131
      • Contact: Site 1131
  • Georgia
    • Augusta, Georgia, United States, 30912-0020
      • Withdrawn
      • Local Institution - 1152
    • Columbus, Georgia, United States, 31909-1693
      • Withdrawn
      • Local Institution - 1141
    • Decatur, Georgia, United States, 30030
      • Active, not recruiting
      • Local Institution - 1161
  • Illinois
    • Elgin, Illinois, United States, 60123-9215
      • Active, not recruiting
      • Local Institution - 1148
  • Louisiana
    • Marrero, Louisiana, United States, 70072-3083
      • Active, not recruiting
      • Local Institution - 1114
  • Michigan
    • Rochester Hills, Michigan, United States, 48307-2760
      • Active, not recruiting
      • Local Institution - 1139
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Active, not recruiting
      • Local Institution - 1132
  • Nevada
    • Las Vegas, Nevada, United States, 89106-4145
      • Withdrawn
      • Local Institution - 1144
  • New York
    • New Hyde Park, New York, United States, 11042-2062
      • Withdrawn
      • Local Institution - 1153
    • Port Jefferson Station, New York, United States, 11776-3386
      • Withdrawn
      • Local Institution - 1135
  • Ohio
    • Dayton, Ohio, United States, 45459-4248
      • Active, not recruiting
      • Local Institution - 1122
  • Pennsylvania
    • Malvern, Pennsylvania, United States, 19355-3267
      • Withdrawn
      • Local Institution - 1149
  • Texas
    • Cypress, Texas, United States, 77429-6070
      • Recruiting
      • Local Institution - 1106
      • Contact: Site 1106
    • Houston, Texas, United States, 77074-2085
      • Active, not recruiting
      • Local Institution - 1163
    • Katy, Texas, United States, 77450-1759
      • Active, not recruiting
      • Local Institution - 1154
    • Red Oak, Texas, United States, 75154
      • Withdrawn
      • Local Institution - 1121
    • Stafford, Texas, United States, 77477-3929
      • Active, not recruiting
      • Local Institution - 1134

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo capsules	Drug: Placebo; Placebo capsules
Experimental: KarXT; Xanomeline and Trospium Chloride Capsules	Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score	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.	Baseline and end of Treatment (up to 14 Weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) scale	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.	Baseline and end of Treatment (up to 14 Weeks)
Change From Baseline to end of Treatment in NPI-C Core score: Hallucinations, Delusions, Agitation, and Aggression Domains		Baseline and end of Treatment (up to 14 Weeks)
Change From Baseline to end of Treatment in NPI-C: Agitation score		Baseline and end of Treatment (up to 14 Weeks)
Change From Baseline to end of Treatment in NPI-C Core score: Caregiver Distress scale (Hallucinations, Delusions, Agitation, and Aggression domains)		Baseline and end of Treatment (up to 14 Weeks)
Responder Rate	Responder rate is defined as NPI-C: H+D score ≥ 40% improvement	Baseline and end of Treatment (up to 14 Weeks)

Collaborators and Investigators

• Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Estimated): December 9, 2026
• Study Completion (Estimated): December 9, 2026

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Psychotic Disorders; Alzheimer Disease; Mental Disorders
• Other Study ID Numbers: CN012-0027 (Other Identifier: Bristol-Myers Squibb Protocol ID); KAR-032 (Other Identifier: Karuna Pharmaceuticals Protocol ID); 2023-504416-16 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No