A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1) (ADEPT-1)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease

This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease.

The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 410
• 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

• Bulgaria
  • Pleven, Bulgaria, 5800
    • Recruiting
    • Medical Center Medconsult Pleven OOD
    • Contact: Maria Aleksandrova, Site 4503; Phone Number: +35964910999
  • Vratsa, Bulgaria, 3000
    • Completed
    • Local Institution - 4504
  • Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1113
      • Recruiting
      • Medical Center Sveti Naum EOOD
      • Contact: Assen Karadaliev, Site 4501; Phone Number: +359888220704
    • Sofia, Sofia-Grad, Bulgaria, 1431
      • Completed
      • Local Institution - 4505
    • Sofia, Sofia-Grad, Bulgaria, 1510
      • Completed
      • Local Institution - 4502
• Croatia
  • City of Zagreb
    • Zagreb, City of Zagreb, Croatia, 10000
      • Recruiting
      • Polyclinic Neuron
      • Contact: Neven Henigsberg, Site 4102; Phone Number: +38514596866
    • Zagreb, City of Zagreb, Croatia, 10090
      • Recruiting
      • Psychiatric Clinic Sveti Ivan
      • Contact: Igor Filipcic, Site 4104; Phone Number: 38513430020
    • Zagreb, City of Zagreb, Croatia, 10000
      • Completed
      • Local Institution - 4103
    • Zagreb, City of Zagreb, Croatia, 10000
      • Active, not recruiting
      • Local Institution - 4105
    • Zagreb, City of Zagreb, Croatia, 10090
      • Active, not recruiting
      • Local Institution - 4101
• Czechia
  • Kutná Hora, Czechia, 284 01
    • Completed
    • Local Institution - 4001
  • Pilsen, Czechia, 301 00
    • Recruiting
    • A-SHINE s.r.o.
    • Contact: Lubos Janu, Site 4005; Phone Number: 420777242101
  • Prague, Czechia, 140 00
    • Completed
    • Local Institution - 4004
  • Rychnov nad Kněžnou, Czechia, 516 01
    • Recruiting
    • Vestra Clinics s.r.o.
    • Contact: Ladislav Pazdera, Site 4006; Phone Number: 420604236033
  • Praha, Hlavní Mesto
    • Prague, Praha, Hlavní Mesto, Czechia, 100 00
      • Recruiting
      • Clintrial s.r.o.
      • Contact: Zdenek Solle, Site 4002; Phone Number: +420222510607
  • South Moravian
    • Brno, South Moravian, Czechia, 628 00
      • Withdrawn
      • Local Institution - 4003
• France
  • Dijon, France, 21079
    • Active, not recruiting
    • Local Institution - 2502
  • Rouen, France, 76000
    • Completed
    • Local Institution - 2503
  • Marne
    • Reims, Marne, France, 51100
      • Active, not recruiting
      • Local Institution - 2501
• Germany
  • Baden-Wurttemberg
    • Böblingen, Baden-Wurttemberg, Germany, 71034
      • Completed
      • Local Institution - 2401
  • Bavaria
    • Bayreuth, Bavaria, Germany, 95445
      • Withdrawn
      • Local Institution - 2403
  • Saarland
    • Homburg, Saarland, Germany, 66424
      • Withdrawn
      • Local Institution - 2402
• Italy
  • Milan, Italy, 20121
    • Completed
    • Local Institution - 2304
  • Monza, Italy, 20900
    • Completed
    • Local Institution - 2305
  • Pisa, Italy, 56126
    • Completed
    • Local Institution - 2302
  • Roma, Italy, 00168
    • Active, not recruiting
    • Local Institution - 2303
  • Roma, Italy, 00189
    • Completed
    • Local Institution - 2309
  • Lazio
    • Rome, Lazio, Italy, 00179
      • Completed
      • Local Institution - 2301
  • Modena
    • Baggiovara, Modena, Italy, 41126
      • Recruiting
      • Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena
      • Contact: Giovanna Zamboni, Site 2306; Phone Number: +390593962201
  • Piedmont
    • Ponderano (Biella), Piedmont, Italy, 13875
      • Active, not recruiting
      • Local Institution - 2307
  • Tuscany
    • Florence, Tuscany, Italy, 50139
      • Completed
      • Local Institution - 2308
• Serbia
  • Belgrade, Serbia, 11000
    • Recruiting
    • Military Medical Academy
    • Contact: Aleksandar Eror, Site 4308; Phone Number: 381113609206
  • Belgrade, Serbia, 11000
    • Recruiting
    • Clinical Hospital Center Dragisa Misovic Dedinje
    • Contact: Vladimir Diligenski, Site 4306; Phone Number: +381637708765
  • Belgrade, Serbia, 11000
    • Completed
    • Local Institution - 4307
  • Kovin, Serbia, 26220
    • Completed
    • Local Institution - 4305
  • Kragujevac, Serbia, 34000
    • Recruiting
    • University Clinical Center Kragujevac
    • Contact: Vladimir Janjic, Site 4301; Phone Number: +38134370208
  • Novi Sad, Serbia, 21000
    • Recruiting
    • Clinical Centre of Vojvodina
    • Contact: Marija Semnic, Site 4309; Phone Number: 381184601111
  • Vršac, Serbia, 26300
    • Completed
    • Local Institution - 4311
  • Belgrade
    • Belgrade, Belgrade, Serbia, 11000
      • Recruiting
      • University Clinical Center of Serbia - Pasterova 2 - PPDS
      • Contact: Tanja Stojkovic, Site 4302; Phone Number: 381607545958
• Slovakia
  • Banská Bystrica, Slovakia, 974 04
    • Recruiting
    • MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.
    • Contact: Beata Dupejova, Site 4401; Phone Number: +421484124549
  • Dubnica nad Váhom, Slovakia, 018 41
    • Recruiting
    • KONZILIUM s.r.o
    • Contact: Magdalena Perichtova, Site 4402; Phone Number: +421424426231
  • Košice, Slovakia, 040 01
    • Recruiting
    • EPAMED s.r.o
    • Contact: Eva Palova, Site 4406; Phone Number: +421556402727
  • Vranov nad Topľou, Slovakia, 093 01
    • Recruiting
    • Crystal Comfort, s.r.o.
    • Contact: Dagmar Breznoscakova, Site 4403; Phone Number: +421574880251
  • Žilina, Slovakia, 012 07
    • Withdrawn
    • Local Institution - 4404
  • Košice Region
    • Košice, Košice Region, Slovakia, 041 90
      • Recruiting
      • Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43
      • Contact: Slavka Dubinska, Site 4405; Phone Number: +421903625643
• Spain
  • Barcelona, Spain, 8028
    • Completed
    • Local Institution - 2205
  • Madrid, Spain, 28006
    • Completed
    • Local Institution - 2207
  • Salamanca, Spain, 37007
    • Recruiting
    • Complejo Asistencial Universitario de Salamanca - H. Clinico
    • Contact: Angel Montejo Gonzalez, Site 2204; Phone Number: +34923126580
  • Seville, Spain, 41009
    • Recruiting
    • Hospital Victoria Eugenia
    • Contact: Felix Viñuela Fernandez, Site 2201; Phone Number: +34654566812
  • Valladolid, Spain, 47012
    • Recruiting
    • Hospital Universitario Rio Hortega
    • Contact: Juan Muñoz Sanchez, Site 2203; Phone Number: +34679279973
  • Zamora, Spain, 49021
    • Recruiting
    • Hospital Provincial de Zamora
    • Contact: Manuel Angel Franco Martin, Site 2202; Phone Number: 34980520200
  • Zaragoza, Spain, 50012
    • Recruiting
    • Hospital Viamed Montecanal
    • Contact: Antonio Oliveros-Cid, Site 2206; Phone Number: +34670492099
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZL
    • Withdrawn
    • Local Institution - 2105
  • Motherwell, United Kingdom, ML1 4UF
    • Withdrawn
    • Local Institution - 2104
  • Wiltshire
    • Swindon, Wiltshire, United Kingdom, SN3 6BW
      • Withdrawn
      • Local Institution - 2103
• United States
  • Alabama
    • Homewood, Alabama, United States, 35209-6809
      • Active, not recruiting
      • Local Institution - 1029
  • Arizona
    • Phoenix, Arizona, United States, 85012-2836
      • Completed
      • Local Institution - 1044
  • California
    • Encino, California, United States, 91436-2201
      • Completed
      • Local Institution - 1033
    • Irvine, California, United States, 92612-1246
      • Withdrawn
      • Local Institution - 1031
    • Orange, California, United States, 92866
      • Recruiting
      • ATP Clinical Research-302 W La Veta Ave
      • Contact: Gustavo Alva, Site 1001; Phone Number: 949-354-5353
    • Pasadena, California, United States, 91106
      • Completed
      • Local Institution - 1043
    • San Marcos, California, United States, 92069-3595
      • Completed
      • Local Institution - 1047
    • Walnut Creek, California, United States, 94596
      • Recruiting
      • Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS
      • Contact: Ira Glick, Site 1007; Phone Number: 925-298-5147
  • Colorado
    • Colorado Springs, Colorado, United States, 80907-5302
      • Completed
      • Local Institution - 1014
  • Connecticut
    • Stamford, Connecticut, United States, 06905-1206
      • Completed
      • Local Institution - 1013
  • Florida
    • Boca Raton, Florida, United States, 33487-2768
      • Completed
      • Local Institution - 1011
    • Bonita Springs, Florida, United States, 34134
      • Recruiting
      • Envision Trials LLC
      • Contact: Daniel Mandri, Site 1020; Phone Number: 305-819-2909
    • Bradenton, Florida, United States, 34209-4687
      • Completed
      • Local Institution - 1015
    • Clermont, Florida, United States, 34711-5933
      • Recruiting
      • K2 Medical Research - Winter Garden
      • Contact: Christopher Galloway, Site 1048; Phone Number: 321-500-5252
    • Daytona Beach, Florida, United States, 32117-5532
      • Recruiting
      • Arrow Clinical Trials
      • Contact: David Billmeier, Site 1023; Phone Number: 386-278-8000
    • Doral, Florida, United States, 33172-2638
      • Active, not recruiting
      • Local Institution - 1045
    • Hialeah, Florida, United States, 33012-5884
      • Withdrawn
      • Local Institution - 1024
    • Hialeah, Florida, United States, 33012-5826
      • Active, not recruiting
      • Local Institution - 1046
    • Hialeah, Florida, United States, 33012
      • Active, not recruiting
      • Local Institution - 1052
    • Homestead, Florida, United States, 33032
      • Active, not recruiting
      • Local Institution - 1049
    • Maitland, Florida, United States, 32751-5669
      • Recruiting
      • K2 Medical Research - Maitland
      • Contact: Brandon Lenox, Site 1039; Phone Number: 407-670-5833
    • Miami, Florida, United States, 33165-3947
      • Active, not recruiting
      • Local Institution - 1129
    • Miami, Florida, United States, 33173
      • Active, not recruiting
      • Local Institution - 1111
    • Miami, Florida, United States, 33186-5882
      • Active, not recruiting
      • Local Institution - 1042
    • Miami, Florida, United States, 33137
      • Completed
      • Local Institution - 1010
    • Miami, Florida, United States, 33155-4630
      • Active, not recruiting
      • Local Institution - 1009
    • Miami, Florida, United States, 33125-3724
      • Completed
      • Local Institution - 1005
    • Miami, Florida, United States, 33122-1335
      • Active, not recruiting
      • Local Institution - 1021
    • Miami, Florida, United States, 33135
      • Active, not recruiting
      • Local Institution - 1115
    • Miami, Florida, United States, 33166
      • Active, not recruiting
      • Local Institution - 1053
    • Miami, Florida, United States, 33173-1474
      • Active, not recruiting
      • Local Institution - 1006
    • Miami, Florida, United States, 33186-4643
      • Active, not recruiting
      • Local Institution - 1054
    • Miami, Florida, United States, 33145-2455
      • Completed
      • Local Institution - 1143
    • Miami Lakes, Florida, United States, 33014-5602
      • Active, not recruiting
      • Local Institution - 1032
    • Miami Springs, Florida, United States, 33166-5260
      • Active, not recruiting
      • Local Institution - 1026
    • Ocala, Florida, United States, 34470-6657
      • Withdrawn
      • Local Institution - 1027
    • Pensacola, Florida, United States, 32504-8608
      • Completed
      • Local Institution - 1012
    • St. Petersburg, Florida, United States, 33713-8844
      • Active, not recruiting
      • Local Institution - 1008
    • Tampa, Florida, United States, 33606
      • Recruiting
      • University Of South Florida
      • Contact: Mark Kindy, Site 1050; Phone Number: 813-972-2000
    • Tampa, Florida, United States, 33607-4629
      • Completed
      • Local Institution - 1041
    • The Villages, Florida, United States, 32159-8986
      • Withdrawn
      • Local Institution - 1040
  • Illinois
    • Chicago, Illinois, United States, 60623
      • Completed
      • Local Institution - 1037
  • New York
    • Manhasset, New York, United States, 11030-3816
      • Active, not recruiting
      • Local Institution - 1018
    • New York, New York, United States, 10016
      • Withdrawn
      • Local Institution - 1030
    • New York, New York, United States, 10032
      • Completed
      • Local Institution - 1017
    • New York, New York, United States, 10032-3720
      • Completed
      • Local Institution - 1051
    • Staten Island, New York, United States, 10314-1607
      • Active, not recruiting
      • Local Institution - 1002
    • Stony Brook, New York, United States, 11794-0001
      • Completed
      • Local Institution - 1034
    • Woodmere, New York, United States, 11598-1739
      • Recruiting
      • Five Towns Neurology, PC
      • Contact: David Steiner, Site 1025; Phone Number: 516-239-1800
  • Ohio
    • Canton, Ohio, United States, 44718
      • Withdrawn
      • Local Institution - 1003
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104-5007
      • Withdrawn
      • Local Institution - 1028
    • Oklahoma City, Oklahoma, United States, 73112
      • Completed
      • Local Institution - 1016
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Completed
      • Local Institution - 1019
  • South Carolina
    • Charleston, South Carolina, United States, 29425-8900
      • Completed
      • Local Institution - 1035
  • Tennessee
    • Franklin, Tennessee, United States, 37067-5922
      • Completed
      • Local Institution - 1038
  • Texas
    • Flower Mound, Texas, United States, 75028-2011
      • Completed
      • Local Institution - 1022
    • Frisco, Texas, United States, 75034-6262
      • Completed
      • Local Institution - 1036
    • Houston, Texas, United States, 77074-2085
      • Recruiting
      • Clinical Trial Network - 7080 Southwest Fwy
      • Contact: Djamchid Lotfi, Site 1004; Phone Number: 713-484-6947

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Is aged 55 to 90 years, inclusive, at Screening

• Can understand the nature of the study and protocol requirements and provide a signed informed consent form before any study assessments are performed. If the subject is deemed not competent to provide consent, the following requirements for consent must be met.

  i) The subject's legally acceptable representative must provide informed consent; ii) The subject must provide informed consent.

• Meets clinical criteria for possible or probable Alzheimer's Disease
• Has 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. If not available, a non-contrast brain MRI or non-contrast head CT must be done during screening.
• Living at the same location for a minimum of 4 weeks before Screening, with the intention of living at the same location throughout the study.

• Capable of self-locomotion (alone or with the aid of an assistive device) and have an identified caregiver or study partner who, in the investigator's judgment, has frequent and sufficient contact with the participant (ie, ≥10 hours per week) on a regular basis to reliably provide accurate information regarding the participant's cognitive, behavioral, and functional status, and is willing to:

  i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures; iii) Participate in the study assessments and provide informed consent to participate in the study.

• History of psychotic symptoms (meeting International Psychogeriatric Association [IPA] criteria) for at least 2 months prior to Screening.
• Clinical Global Impressions-Severity (CGI-S) scale with a score ≥4 (moderate) at Screening and Baseline. CGI-S requires the assessor to consider aspects of the psychosis prior to providing a global assessment of severity. These aspects include hallucinations and delusions.

• Subjects are required to meet at least one of the following criteria at Screening and Baseline:

  i) Moderate to severe delusions, defined as Neuropsychiatric Inventory-Clinician (NPI-C): Delusions domain score of ≥2 on two of the eight items OR; ii) Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on two of the seven items.

• Mini-Mental State Examination (MMSE) score of 6 to 24, inclusive, at Screening
• If the subject is taking a cholinesterase inhibitor and/or memantine, they must have been on a stable dose for 6 weeks prior to Screening and be willing to maintain a stable dose for the duration of the study.
• Subject is willing and able to visit the clinic in an outpatient setting for the study duration, follow instructions, and comply with the protocol requirements
• BMI must be within 16 to 40 kg/m2 inclusive
• Female subjects must not be pregnant or breastfeeding. Women of childbearing potential (WOCBP), or men whose sexual partners are WOCBP, must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last dose of IMP or matching placebo.

Exclusion Criteria:

• Psychotic symptoms that are primarily attributable to a condition other than the Alzheimer's Disease causing dementia
• History of major depressive episode with psychotic features during the 12 months prior to Screening
• History of a diagnosis 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
• Significant or severe renal impairment based on a screening cutoff for Estimated Glomerular Filtration Rate (eGFR) of <50 mL/min
• History of ischemic stroke within 12 months prior to Screening or any evidence of hemorrhagic stroke
• History of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, unstable thyroid function, or unexplained syncope

• Any of the following:

  i) New York Heart Association Class 2 congestive heart failure; ii) Grade 2 or greater angina pectoris; iii) Sustained ventricular tachycardia; iv) Ventricular fibrillation; v) Torsade de pointes; vi) Implantable cardiac defibrillator.

• Myocardial infarction within the 6 months prior to Screening
• Personal or family history of symptoms of long QT syndrome as evaluated by the investigator
• Human immunodeficiency virus, cirrhosis, biliary duct abnormalities, active biliary disease, hepatobiliary carcinoma, and/or active hepatic viral infections as indicated by medical history or liver function tests results
• History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the investigator

• Participants with any of the following:

  i) History of bladder stones; ii) History of recurrent urinary tract infections; iii) For male participants:

  1. Serum prostate specific antigen (PSA) > 10 ng/mL at Screening
  2. An IPSS of 5 (almost always) on items 1, 3, 5, or 6
  3. A sum of scores on IPSS items 1, 3, 5, and 6 of ≥9
• History of obstructive gastrointestinal disorder, gastric retention, irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months
• Risk of suicidal behavior during the study as determined by clinical assessment and/ or C-SSRS
• Clinically significant abnormal finding on the physical examination, electrocardiogram, or clinical laboratory results at Screening
• Urine toxicology screen is positive substances other than cannabis or benzodiazepines (both cannabis and short-or medium-acting benzodiazepines are allowed in limited quantities during the study) unless approval has been given by the Medical Monitor

• Currently receiving monoamine oxidase inhibitors, anticonvulsants (e.g., lamotrigine, divalproex), mood stabilizers (eg, lithium) tricyclic antidepressants (e.g., imipramine, desipramine), or any other psychoactive medications except for as-needed anxiolytics (e.g., lorazepam) and unable to complete the washout:

  i) Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening may be permitted; ii) Mirtazapine or trazodone may be used if started at least 8 weeks prior to Screening. If needed, an extension (up to two weeks) of the Screening Period may be allowed with approval of the Sponsor/Medical Monitor.

• If, in the opinion of the Investigator and/or Sponsor/Medical Monitor, subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the Investigator and/or Sponsor/ Medical Monitor, may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements
• Positive test for coronavirus (COVID-19) within 2 weeks before or at Screening; antigen or PCR local testing can be done at the discretion of the Investigator
• Unable to taper and discontinue a concomitant medication that would preclude participation in the study
• Prior exposure to KarXT
• Experienced any significant adverse events due to trospium, including a known hypersensitivity 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 past year
• Other protocol-defined Inclusion/Exclusion criteria apply

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KarXT; Xanomeline and Trospium Chloride Capsules	Drug: KarXT; KarXT 20 mg/2 mg TID KarXT 30 mg/3 mg TID KarXT 40 mg/4 mg TID KarXT 50 mg/5 mg TID KarXT 66.7/6.67 mg TID
Placebo Comparator: Placebo; Placebo Capsules	Drug: Placebo; Placebo Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time from randomization to relapse during the 38-week study	Week 38

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from randomization to first occurrence of treatment discontinuation for any reason or relapse during the 38-week study		Week 38
Change in Neuropsychiatric Inventory-Clinician rating scale (NPI-C) Core Caregiver Distress score	NPI-C score includes assessment for hallucinations, delusions, agitation, and aggression domains.	Up to approximately Week 38
Number of participants with Adverse Events (AEs)		Up to approximately Week 42
Number of participants with Treatment Emergent Adverse Events (TEAEs)		Up to approximately Week 42
Number of participants with Serious Adverse Events (SAEs)		Up to approximately Week 42
Number of participants with TEAEs leading to study withdrawal		Up to approximately Week 42
Number of participants with AEs including procholinergic and anticholinergic symptoms	Procholinergic symptoms include nausea, vomiting, and diarrhea and anticholinergic symptoms include dry mouth, constipation, urinary retention and blurred vision.	Up to approximately Week 42
Number of participants with Adverse Events of Special Interest (AESIs)	AESIs include symptomatic orthostasis, syncope, urinary adverse events, and elevated liver enzymes requiring drug-induced liver injury (DILI) monitoring.	Up to approximately Week 42
Barnes Akathisia Rating Scale (BARS)		Up to approximately Week 38
Abnormal Involuntary Movement Scale (AIMS)		Up to approximately Week 38
Body weight		Up to approximately Week 38
BMI		Up to approximately Week 38
Number of participants with clinically significant orthostatic vital signs		Up to approximately Week 38
Number of participants with clinically significant laboratory evaluations	Laboratory evaluations include hematology, clinical chemistry, coagulation, prolactin levels, urinalysis, and drug screen	Up to approximately Week 38
Number of participants with clinically significant 12-lead electrocardiogram (12-lead ECG)		Up to approximately Week 38
Number of participants with suicidal ideation as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS)		Up to approximately Week 38
Assessment of cognition as measured by Mini-Mental State Examination (MMSE)		Up to approximately Week 38
International Prostate Symptom Score (IPSS) (males only)		Up to approximately Week 38

Collaborators and Investigators

• Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
• Collaborators: 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 23, 2022
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): October 5, 2026

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 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; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: CN012-0026 (Other Identifier: Bristol-Myers Squibb Protocol ID); KAR-031 (Other Identifier: Karuna Pharmaceuticals Protocol ID); 2024-511740-11 (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