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Purpose

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 and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

Condition

Eligibility

Eligible Ages
Between 55 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Is aged 55 to 90 years, inclusive, at Screening 2. 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. 1. The subject's legally acceptable representative or caregiver/study partner, if local regulations allow, must provide informed consent 2. The subject must provide informed assent 3. Meets clinical criteria for possible or probable Alzheimer's Disease 4. 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. 5. Living at the same home or residential assisted-living facility for a minimum of six weeks before Screening 6. Capable of self-locomotion (alone or with the aid of an assistive device) and have an identified or proxy caregiver (spends approximately 10 hours/week with the subject) that is willing to: 1. Attend all visits and report on subject's status 2. Oversee subject compliance with medication and study procedures 3. Participate in the study assessments and provide informed consent to participate in the study 7. History of psychotic symptoms (meeting International Psychogeriatric Association [IPA] criteria) for at least 2 months prior to Screening. 8. 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. 9. Subjects are required to meet at least one of the following criteria at Screening and Baseline: 1. Moderate to severe delusions, defined as Neuropsychiatric Inventory-Clinician (NPI-C): Delusions domain score of ≥2 on two of the eight items OR 2. Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on two of the seven items. 10. Mini-Mental State Examination (MMSE) score of 8 to 22, inclusive, at Screening 11. 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. 12. 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 13. BMI must be within 18 to 40 kg/m2 inclusive 14. 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. Sperm donation is not allowed for 30 days after the final dose of the IMP or matching placebo.

Exclusion Criteria

  1. Psychotic symptoms that are primarily attributable to a condition other than the Alzheimer's Disease causing dementia 2. History of major depressive episode with psychotic features during the 12 months prior to Screening 3. History of a diagnosis 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. Significant or severe renal impairment based on a screening cutoff for Estimated Glomerular Filtration Rate (eGFR) of <60 mL/min/1.73 m2 6. History of ischemic stroke within 12 months prior to Screening or any evidence of hemorrhagic stroke 7. History of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, unstable thyroid function, or unexplained syncope 8. Any of the following: 1. New York Heart Association Class 2 congestive heart failure 2. Grade 2 or greater angina pectoris 3. Sustained ventricular tachycardia 4. Ventricular fibrillation 5. Torsade de pointes 6. Implantable cardiac defibrillator 9. Myocardial infarction within the 6 months prior to Screening 10. Personal or family history of symptoms of long QT syndrome as evaluated by the investigator 11. Human immunodeficiency virus, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections as indicated by medical history or liver function tests results 12. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the investigator 13. For males only, any one of the following: 1. History of bladder stones 2. History of recurrent urinary tract infections 3. Serum prostate specific antigen (PSA) > 10 ng/mL at Screening 4. An International Prostate Symptom Score (IPSS) of 5 (almost always) on items 1, 3, 5, or 6 5. A sum of scores on IPSS items 1, 3, 5, and 6 of ≥9 14. History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months 15. Risk of suicidal behavior during the study as determined by clinical assessment and/ or C-SSRS 16. Clinically significant abnormal finding on the physical examination, electrocardiogram, or clinical laboratory results at Screening 17. 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 18. Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (e.g., lamotrigine, divalproex), lithium, tricyclic antidepressants (e.g., imipramine, desipramine), or any other psychoactive medications except for as-needed anxiolytics (e.g., lorazepam, chloral hydrate) 1. 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 2. Mirtazapine or trazodone may be used as a hypnotic 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. 19. 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 20. 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 21. Unable to taper and discontinue a concomitant medication that would preclude participation in the study 22. Prior exposure to KarXT 23. Experienced any significant adverse events due to trospium, including a known hypersensitivity to trospium 24. 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Tilda Alabama - PPDS
Homewood, Alabama 35209-6809
Contact:
Mark Ricketts, Site 1029
888-888-8888

IMA Clinical Research - Phoenix - PPDS
Phoenix, Arizona 85012-2836
Contact:
Danielle Goldfarb(Cabral), Site 1044
623-832-5328

ATP Clinical Research
Costa Mesa, California 92626
Contact:
Gustavo Alva, Site 1001
714-277-4472

Asclepes Research
Encino, California 91436-2201
Contact:
Jonathan Eskenazi, Site 1033
626-250-2070

Sunwise Clinical Research, LLC - IVY - PPDS
Lafayette, California 94549
Contact:
Ira Glick, Site 1007
925-298-5147

SC3 Research - Pasadena - 960 E. Green St
Pasadena, California 91106
Contact:
M. Lorraine Purino, Site 1043
626-250-2070

The Neuron Clinic
San Marcos, California 92069-3595
Contact:
Jose Soria Lopez, Site 1047
619-425-3840

Colorado Springs Neurological Associates
Colorado Springs, Colorado 80907-5302
Contact:
Julia Brinley, Site 1014
719-473-3272

Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut 06905-1206
Contact:
Peter McAllister, Site 1013
203-914-1900

South Florida Neurology Associates
Boca Raton, Florida 33487-2768
Contact:
Marc Feinberg, Site 1011
561-939-0333

Envision Trials LLC
Bonita Springs, Florida 34134-4154
Contact:
Daniel Mandri, Site 1020
305-819-2909

K2 Medical Research - Winter Garden
Clermont, Florida 34711-5933
Contact:
Christopher Galloway, Site 1048
321-500-5252

Arrow Clinical Trials
Daytona Beach, Florida 32117-5532
Contact:
David Billmeier, Site 1023
386-304-7070

Betancourt Research Services
Doral, Florida 33172-2638
Contact:
Jose Guerra-Valencia, Site 1045
786-741-2887

United Research Institute
Hialeah, Florida 33012-5826
Contact:
Leonard Cohen, Site 1046
305-488-0976

Coral Clinic Research
Homestead, Florida 33032
Contact:
Nelson Gonzalez, Site 1049
786-715-2200

K2 Medical Research - Maitland
Maitland, Florida 32751-5669
Contact:
Brandon Lenox, Site 1039
407-670-5833

San Marcus Research Clinic Inc
Miami Lakes, Florida 33014-5602
Contact:
Nancy Navarro Gonzalez, Site 1032
305-424-7420

Ocean Blue Medical Research Center Inc
Miami Springs, Florida 33166-5260
Contact:
Antonio Terrelonge, Site 1026
305-885-8983

South Florida Research Phase I - IV
Miami Springs, Florida 33166-7225
Contact:
Silvia Silva-Duluc, Site 1053
305-669-6166

Premier Clinical Research Institute - Miami - ClinEdge - PPDS
Miami, Florida 33122-1335
Contact:
Emelina Arocha, Site 1021
305-445-5994

Global Medical Institutes, LLC - Miami - ClinEdge - PPDS
Miami, Florida 33125-3724
Contact:
Leonardo Alonso, Site 1005
305-547-2011

Miami Jewish Health Systems
Miami, Florida 33137
Contact:
Marc Agronin, Site 1010
305-762-1426

MedOne Clinical Research LLC
Miami, Florida 33145-2455
Contact:
Thierry Jacquemin, Site 1143
305-359-7666

Allied Biomedical Research Institute
Miami, Florida 33155-4630
Contact:
Michael Pfeffer, Site 1009
305-643-8400

Future Care Solution LLC
Miami, Florida 33165-3947
Contact:
Pilar Trueba, Site 1129
305-888-0410

Coral Research Clinic & Coral Diagnostic Center
Miami, Florida 33186-4643
Contact:
Jorge Paoli Bruno, Site 1054
000-000-0000

ONHEALTH Research Center
Miami, Florida 33186-5882
Contact:
Maria Rodil, Site 1042
786-808-0832

Las Mercedes Clinical Research West Kendall
Miami, Florida 33196
Contact:
Frank Alvarez, Site 1052
786-577-5977

Emerald Coast Center for Neurological Disorders
Pensacola, Florida 32504-8608
Contact:
David Bear, Site 1012
850-438-1136

Suncoast Neuroscience Associates Inc
Saint Petersburg, Florida 33713-8844
Contact:
Alberto Vasquez, Site 1008
727-824-7135

K2 Medical Research - Tampa
Tampa, Florida 33607-4629
Contact:
Kelley Yokum, Site 1041
813-800-5252

Research Network America - Chicago - 3845 W 26th St
Chicago, Illinois 60623
Contact:
Ralph Menezes, Site 1037
713-484-6947

The Feinstein Institutes for Medical Research - BRANY - PPDS
Manhasset, New York 11030-3816
Contact:
Jeremy Koppel, Site 1018
516-562-2905

Columbia University Medical Center (CUMC)
New York, New York 10032-3720
Contact:
Davangere Devanand, Site 1051
646-774-8658

Columbia University Medical Center
New York, New York 10032
Contact:
Davangere Devanand, Site 1017
212-305-2515

Richmond Behavioral Associates
Staten Island, New York 10314-1607
Contact:
Waqar Siddiqui, Site 1002
678-942-5986

Stony Brook University Medical Center
Stony Brook, New York 11794-0001
Contact:
Nikhil Palekar, Site 1034
631-954-2323

Five Towns Neurology, PC
Woodmere, New York 11598-1739
Contact:
David Steiner, Site 1025
516-239-1800

Lehigh Center for Clinical Research - 401 N 17th St
Allentown, Pennsylvania 18104-5049
Contact:
Paul Gross, Site 1019
610-820-0342

Medical University of South Carolina (MUSC) - PPDS
Charleston, South Carolina 29425-8900
Contact:
Jacobo Mintzer, Site 1035
803-792-7183

KCA Neurology, PLLC
Franklin, Tennessee 37067-5922
Contact:
Gretchen Campbell, Site 1038
615-550-1800

North Pointe Psychiatry - Flower Mound
Flower Mound, Texas 75028-2011
Contact:
Asad Islam, Site 1022
469-444-2244

Beautiful Minds
Frisco, Texas 75034-6262
Contact:
Humera Chowdhary, Site 1036
214-229-9102

Clinical Trial Network - 7080 Southwest Fwy
Houston, Texas 77074-2085
Contact:
Nelson Berrios, Site 1004

More Details

NCT ID
NCT05511363
Status
Recruiting
Sponsor
Karuna Therapeutics

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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