AzTrials
AzTrials

Psychosis Associated With Alzheimer's DiseasePhase 3NCT05511363

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

A Phase 3 study testing KarXT in people with Psychosis Associated With Alzheimer's Disease, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 129 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 55 to 90 years
What is being tested?
KarXT
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
410 participants
Where
129 sitesin 13 countries
Study dates
23 Aug 2022to 5 Oct 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • The subject's legally acceptable representative must provide informed consent; ii) The subject must provide assent or similar where permitted per local law/regulation and as approved by the IRB/IEC.
  • 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.
Show all 17Show fewer
  • 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, ≥ approximately 7 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:
  • 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:
  • 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.
  • Participant is willing and able to attend the study visit for the study duration, follow instructions, and comply with the protocol requirements
  • BMI must be within 16 to 40 kg/m2 and participants with a BMI of 16 to <18 kg/m2 must have a body weight ≥40 kg.
  • A female (as assigned at birth) is eligible to participate if she is not pregnant or breastfeeding. Individual of childbearing potential (IOCBP) 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.

Who cannot join

  • 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
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  • History of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, unstable thyroid function, or unexplained syncope
  • Any of the following:
  • 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:
  • History of bladder stones; ii) History of recurrent urinary tract infections; iii) For male participants:
  • Serum prostate specific antigen (PSA) > 10 ng/mL at Screening
  • An IPSS of 5 (almost always) on items 1, 3, 5, or 6
  • 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:
  • 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

Trial locations and contacts

129 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

129 sites in 13 countries

United States59 sites, 9 recruiting

  • Local Institution - 1019

    Allentown, Pennsylvania, 18103

    Completed

  • Local Institution - 1011

    Boca Raton, Florida, 33487-2768

    Completed

  • Local Institution - 1020

    Bonita Springs, Florida, 34134

    Completed

  • Local Institution - 1015

    Bradenton, Florida, 34209-4687

    Completed

  • Local Institution - 1003

    Canton, Ohio, 44718

    Withdrawn

  • Local Institution - 1035

    Charleston, South Carolina, 29425-8900

    Completed

  • Local Institution - 1037

    Chicago, Illinois, 60623

    Completed

  • K2 Medical Research - Winter Garden

    Clermont, Florida, 34711-5933

    Christopher Galloway, Site 1048, 321-500-5252

    Recruiting

  • Local Institution - 1014

    Colorado Springs, Colorado, 80907-5302

    Completed

  • Arrow Clinical Trials

    Daytona Beach, Florida, 32117-5532

    David Billmeier, Site 1023, 386-278-8000

    Recruiting

  • Local Institution - 1045

    Doral, Florida, 33172-2638

    Active, not recruiting

  • Local Institution - 1033

    Encino, California, 91436-2201

    Completed

  • Local Institution - 1022

    Flower Mound, Texas, 75028-2011

    Completed

  • Local Institution - 1038

    Franklin, Tennessee, 37067-5922

    Completed

  • Local Institution - 1036

    Frisco, Texas, 75034-6262

    Completed

  • Local Institution - 1046

    Hialeah, Florida, 33012-5826

    Active, not recruiting

  • Local Institution - 1024

    Hialeah, Florida, 33012-5884

    Withdrawn

  • Local Institution - 1052

    Hialeah, Florida, 33012

    Active, not recruiting

  • Local Institution - 1049

    Homestead, Florida, 33032

    Active, not recruiting

  • Local Institution - 1029

    Homewood, Alabama, 35209-6809

    Active, not recruiting

  • Clinical Trial Network - 7080 Southwest Fwy

    Houston, Texas, 77074-2085

    Djamchid Lotfi, Site 1004, 713-484-6947

    Recruiting

  • Local Institution - 1031

    Irvine, California, 92612-1246

    Withdrawn

  • K2 Medical Research - Maitland

    Maitland, Florida, 32751-5669

    Brandon Lenox, Site 1039, 407-670-5833

    Recruiting

  • Local Institution - 1018

    Manhasset, New York, 11030-3816

    Active, not recruiting

  • Local Institution - 1021

    Miami, Florida, 33122-1335

    Active, not recruiting

  • Local Institution - 1005

    Miami, Florida, 33125-3724

    Completed

  • Local Institution - 1115

    Miami, Florida, 33135

    Active, not recruiting

  • Local Institution - 1010

    Miami, Florida, 33137

    Completed

  • Local Institution - 1143

    Miami, Florida, 33145-2455

    Completed

  • Local Institution - 1009

    Miami, Florida, 33155-4630

    Active, not recruiting

  • Local Institution - 1129

    Miami, Florida, 33165-3947

    Active, not recruiting

  • Local Institution - 1053

    Miami, Florida, 33166

    Active, not recruiting

  • Local Institution - 1006

    Miami, Florida, 33173-1474

    Active, not recruiting

  • Local Institution - 1111

    Miami, Florida, 33173

    Active, not recruiting

  • Local Institution - 1054

    Miami, Florida, 33186-4643

    Active, not recruiting

  • Local Institution - 1042

    Miami, Florida, 33186-5882

    Active, not recruiting

  • Local Institution - 1032

    Miami Lakes, Florida, 33014-5602

    Active, not recruiting

  • Local Institution - 1026

    Miami Springs, Florida, 33166-5260

    Active, not recruiting

  • Local Institution - 1-14IL3BJP

    New York, New York, 10003-1759

    Site 1-14IL3BJP

    Not yet recruiting

  • Local Institution - 1030

    New York, New York, 10016

    Withdrawn

  • Local Institution - 1051

    New York, New York, 10032-3720

    Completed

  • Local Institution - 1017

    New York, New York, 10032

    Completed

  • Local Institution - 1027

    Ocala, Florida, 34470-6657

    Withdrawn

  • Local Institution - 1028

    Oklahoma City, Oklahoma, 73104-5007

    Withdrawn

  • Local Institution - 1016

    Oklahoma City, Oklahoma, 73112

    Completed

  • ATP Clinical Research-302 W La Veta Ave

    Orange, California, 92866

    Gustavo Alva, Site 1001, 949-354-5353

    Recruiting

  • Local Institution - 1043

    Pasadena, California, 91106

    Completed

  • Local Institution - 1012

    Pensacola, Florida, 32504-8608

    Completed

  • Local Institution - 1044

    Phoenix, Arizona, 85012-2836

    Completed

  • Local Institution - 1047

    San Marcos, California, 92069-3595

    Completed

  • Local Institution - 1008

    St. Petersburg, Florida, 33713-8844

    Active, not recruiting

  • Local Institution - 1013

    Stamford, Connecticut, 06905-1206

    Completed

  • Local Institution - 1002

    Staten Island, New York, 10314-1607

    Active, not recruiting

  • Local Institution - 1034

    Stony Brook, New York, 11794-0001

    Completed

  • University of South Florida

    Tampa, Florida, 33606

    Mark Kindy, Site 1050, 813-972-2000

    Recruiting

  • Local Institution - 1041

    Tampa, Florida, 33607-4629

    Completed

  • Local Institution - 1040

    The Villages, Florida, 32159-8986

    Withdrawn

  • Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS

    Walnut Creek, California, 94596

    Ira Glick, Site 1007, 925-298-5147

    Recruiting

  • Five Towns Neurology, PC

    Woodmere, New York, 11598-1739

    David Steiner, Site 1025, 516-239-1800

    Recruiting

Other trials in United States

Serbia11 sites, 8 recruiting

  • University Clinical Center of Serbia - Pasterova 2 - PPDS

    Belgrade, Belgrade, 11000

    Tanja Stojkovic, Site 4302, 381607545958

    Recruiting

  • Clinical Hospital Center Dragisa Misovic Dedinje

    Belgrade, 11000

    Vladimir Diligenski, Site 4306, +381637708765

    Recruiting

  • Local Institution - 4307

    Belgrade, 11000

    Completed

  • Military Medical Academy

    Belgrade, 11000

    Ranko Raicevic, Site 4304, 381113609206

    Recruiting

  • Military Medical Academy

    Belgrade, 11000

    Aleksandar Eror, Site 4308, 381113609206

    Recruiting

  • Local Institution - 4305

    Kovin, 26220

    Completed

  • University Clinical Center Kragujevac

    Kragujevac, 34000

    Mirjana Jovanovic, Site 4310, +381698776622

    Recruiting

  • University Clinical Center Kragujevac

    Kragujevac, 34000

    Dragana Ignjatovic Ristic, Site 4303, +38163685994

    Recruiting

  • University Clinical Center Kragujevac

    Kragujevac, 34000

    Vladimir Janjic, Site 4301, +38134370208

    Recruiting

  • Clinical Centre of Vojvodina

    Novi Sad, 21000

    Marija Semnic, Site 4309, 381184601111

    Recruiting

  • Local Institution - 4311

    Vršac, 26300

    Completed

Other trials in Serbia

Italy10 sites, 3 recruiting

  • Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena

    Baggiovara, Modena, 41126

    Giovanna Zamboni, Site 2306, +390593962201

    Recruiting

  • Local Institution - 2308

    Florence, Tuscany, 50139

    Completed

  • Local Institution - 2304

    Milan, 20121

    Completed

  • Local Institution - 2305

    Monza, 20900

    Completed

  • Local Institution - 2302

    Pisa, 56126

    Completed

  • Local Institution - 2307

    Ponderano (Biella), Piedmont, 13875

    Active, not recruiting

  • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

    Roma, 00168

    Camillo Marra, Site 2303, +390630154333

    Recruiting

  • Local Institution - 2309

    Roma, 00189

    Completed

  • Local Institution - 2301

    Rome, Lazio, 00179

    Completed

  • Local Institution - 1-14ILFYZQ

    Salerno, Campania, 84131

    Site 1-14ILFYZQ

    Not yet recruiting

Other trials in Italy

Bulgaria7 sites, 4 recruiting

  • Local Institution - 4506

    Cherven Bryag, 5980

    Site 4506

    Not yet recruiting

  • Medical Center Medconsult Pleven OOD

    Pleven, 5800

    Maria Aleksandrova, Site 4503, +35964910999

    Recruiting

  • Local Institution - 4505

    Sofia, Sofia-Grad, 1431

    Completed

  • Local Institution - 4502

    Sofia, Sofia-Grad, 1510

    Completed

  • Medical Center Sveti Naum EOOD

    Sofia, 1113

    Assen Karadaliev, Site 4501, +359888220704

    Recruiting

  • Local Institution - 1-14IBHZ4D

    Stara Zagora, 6003

    Site 1-14IBHZ4D

    Not yet recruiting

  • Local Institution - 4504

    Vratsa, 3000

    Completed

Other trials in Bulgaria

Czechia7 sites, 4 recruiting

  • Local Institution - 4003

    Brno, South Moravian, 628 00

    Withdrawn

  • Local Institution - 4001

    Kutná Hora, 284 01

    Completed

  • A-SHINE s.r.o.

    Pilsen, 301 00

    Lubos Janu, Site 4005, 420777242101

    Recruiting

  • CLINTRIAL s.r.o.

    Prague, Praha, Hlavní Mesto, 100 00

    Zdenek Solle, Site 4002, +420222510607

    Recruiting

  • Local Institution - 1-14IL3BFV

    Prague, 109 00

    Site 1-14IL3BFV

    Not yet recruiting

  • Local Institution - 4004

    Prague, 140 00

    Completed

  • Vestra Clinics s.r.o.

    Rychnov nad Kněžnou, 516 01

    Ladislav Pazdera, Site 4006, 420604236033

    Recruiting

Other trials in Czechia

Spain7 sites, 5 recruiting

  • Local Institution - 2205

    Barcelona, 8028

    Completed

  • Local Institution - 2207

    Madrid, 28006

    Completed

  • Complejo Asistencial Universitario de Salamanca - H. Clinico

    Salamanca, 37007

    Angel Montejo Gonzalez, Site 2204, +34923126580

    Recruiting

  • Hospital Victoria Eugenia

    Seville, 41009

    Felix Vinuela Fernandez, Site 2201, +34654566812

    Recruiting

  • Hospital Universitario Rio Hortega

    Valladolid, 47012

    Juan Muñoz Sanchez, Site 2203, +34679279973

    Recruiting

  • Hospital Provincial de Zamora

    Zamora, 49021

    Manuel Angel Franco Martin, Site 2202, 34980520200

    Recruiting

  • Hospital Viamed Montecanal

    Zaragoza, 50012

    Antonio Oliveros-Cid, Site 2206, +34670492099

    Recruiting

Other trials in Spain

Croatia6 sites, 3 recruiting

  • Local Institution - 1-14JRHMIY

    Zagreb, City of Zagreb, 10000

    Site 1-14JRHMIY

    Not yet recruiting

  • Local Institution - 4103

    Zagreb, City of Zagreb, 10000

    Completed

  • Local Institution - 4105

    Zagreb, City of Zagreb, 10000

    Active, not recruiting

  • Polyclinic Neuron

    Zagreb, City of Zagreb, 10000

    Neven Henigsberg, Site 4102, +38514596866

    Recruiting

  • Local Institution - 4101

    Zagreb, City of Zagreb, 10090

    Active, not recruiting

  • Psychiatric Clinic Sveti Ivan

    Zagreb, City of Zagreb, 10090

    Igor Filipcic, Site 4104, 38513430020

    Recruiting

Other trials in Croatia

Slovakia6 sites, 5 recruiting

  • MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.

    Banská Bystrica, 974 04

    Beata Dupejova, Site 4401, +421484124549

    Recruiting

  • KONZILIUM s.r.o

    Dubnica nad Váhom, 018 41

    Magdalena Perichtova, Site 4402, +421424426231

    Recruiting

  • Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43

    Košice, Košice Region, 041 90

    Slavka Dubinska, Site 4405, +421903625643

    Recruiting

  • EPAMED s.r.o

    Košice, 040 01

    Eva Palova, Site 4406, +421556402727

    Recruiting

  • Crystal Comfort, s.r.o.

    Vranov nad Topľou, 093 01

    Dagmar Breznoscakova, Site 4403, +421574880251

    Recruiting

  • Local Institution - 4404

    Žilina, 012 07

    Withdrawn

Other trials in Slovakia

France4 sites, 2 recruiting

  • Local Institution - 2502

    Dijon, 21079

    Active, not recruiting

  • CHU de Reims Hôpital Robert Debré

    Reims, Marne, 51100

    Jean Luc Novella, Site 2501, +33326784410

    Recruiting

  • Local Institution - 2503

    Rouen, 76000

    Completed

  • Local Institution - 1-14ILFZ33

    Villeurbanne, Rhône, 69100

    Site 1-14ILFZ33

    Not yet recruiting

Other trials in France

Germany3 sites

  • Local Institution - 2403

    Bayreuth, Bavaria, 95445

    Withdrawn

  • Local Institution - 2401

    Böblingen, Baden-Wurttemberg, 71034

    Completed

  • Local Institution - 2402

    Homburg, Saarland, 66424

    Withdrawn

Other trials in Germany

India3 sites, 3 recruiting

  • Local Institution - 1-14IL3BK3

    Ahmedabad, Gujarat, 380061

    Site 1-14IL3BK3

    Not yet recruiting

  • Local Institution - 1-14IW4MT8

    Hyderabad, 500034

    Site 1-14IW4MT8

    Not yet recruiting

  • Local Institution - 1-14IW4MUN

    New Delhi, National Capital Territory of Delhi, 110029

    Site 1-14IW4MUN

    Not yet recruiting

Other trials in India

South Korea3 sites, 3 recruiting

  • Local Institution - 1-14IVVWPL

    Junggu, Incheon Gwang'yeogsi, 22332

    Site 1-14IVVWPL

    Not yet recruiting

  • Local Institution - 1-14IG4A3I

    Pusan, Busan Gwangyeogsi, 49241

    Site 1-14IG4A3I

    Not yet recruiting

  • Local Institution - 1-14IG4A1R

    Seoul, Seoul Teugbyeolsi, 05505

    Site 1-14IG4A1R

    Not yet recruiting

Other trials in South Korea

United Kingdom3 sites

  • Local Institution - 2105

    Aberdeen, AB25 2ZL

    Withdrawn

  • Local Institution - 2104

    Motherwell, ML1 4UF

    Withdrawn

  • Local Institution - 2103

    Swindon, Wiltshire, SN3 6BW

    Withdrawn

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
KarXT, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KarXTDrug

    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

  • PlaceboDrug

    Placebo Capsules

Study groups in NCT05511363
Study groupRoleWhat they receive
KarXTExperimentalXanomeline and Trospium Chloride Capsules
Receives: Drug: KarXT
PlaceboPlacebo comparatorPlacebo Capsules
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from randomization to relapse

    Measured: Week 38

Secondary outcomes (19)

  1. Time from randomization to first occurrence of treatment discontinuation for any reason or relapse

    Measured: Week 38

  2. Change in NPI-C: H+D Caregiver Observed Frequency x Severity Score (NPI-C: H+D CObs)

    Measured: Up to approximately Week 38

  3. Change in Neuropsychiatric Inventory-Clinician rating scale (NPI-C) Core score Caregiver Distress scale

    NPI-C Core score includes assessment for hallucinations, delusions, agitation, and aggression domains.

    Measured: Up to approximately Week 38

  4. Number of participants with Adverse Events (AEs)

    Measured: Up to approximately Week 42

  5. Number of participants with Treatment Emergent Adverse Events (TEAEs)

    Measured: Up to approximately Week 42

  6. Number of participants with Serious Adverse Events (SAEs)

    Measured: Up to approximately Week 42

  7. Number of participants with TEAEs leading to study withdrawal

    Measured: Up to approximately Week 42

  8. 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.

    Measured: Up to approximately Week 42

  9. Number of participants with Adverse Events of Special Interest (AESIs)

    AESIs include symptomatic orthostasis, syncope, urinary adverse events, and elevated liver enzymes.

    Measured: Up to approximately Week 42

  10. Barnes Akathisia Rating Scale (BARS)

    Measured: Up to approximately Week 38

  11. Abnormal Involuntary Movement Scale (AIMS)

    Measured: Up to approximately Week 38

  12. Body weight

    Measured: Up to approximately Week 38

  13. BMI

    Measured: Up to approximately Week 38

  14. Number of participants with clinically significant orthostatic vital signs

    Measured: Up to approximately Week 38

  15. Number of participants with clinically significant laboratory evaluations

    Laboratory evaluations include hematology, clinical chemistry, coagulation, prolactin levels, and urinalysis

    Measured: Up to approximately Week 38

  16. Number of participants with clinically significant 12-lead electrocardiogram (12-lead ECG)

    Measured: Up to approximately Week 38

  17. Number of participants with suicidal ideation as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Measured: Up to approximately Week 38

  18. Assessment of cognition as measured by Mini-Mental State Examination (MMSE)

    Measured: Up to approximately Week 38

  19. International Prostate Symptom Score (IPSS) (males only)

    Measured: Up to approximately Week 38

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2022
  2. Study start23 Aug 2022
  3. Primary completion5 Oct 2026 (estimated)
  4. Study completion5 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
410 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05511363
Sponsor's protocol ID
CN012-0026
Other IDs
CN012-0026, KAR-031, 2024-511740-11
Status last verified
Aug 2026
First submitted
19 Aug 2022
Last updated
17 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KarXT in people with Psychosis Associated With Alzheimer's Disease, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 129 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Serbia, Italy, Bulgaria, Czechia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from randomization to relapse (time frame: Week 38). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05511363.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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