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Purpose

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

Condition

Eligibility

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

Inclusion Criteria

  • A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay. ii) If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval. B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following: - Amyloid PET. - Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay. - Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1). - Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) 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 agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1). - AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2). - CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (Visit 2).

Exclusion Criteria

  • Medical Conditions: i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia. ii) History of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator. iv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR. - Prior/Concomitant Therapy: i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam). A. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted. B. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1). C. Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1). - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KarXT + KarX-EC
  • Drug: Xanomeline/Trospium Chloride Capsule
    Specified dose on specified days
    Other names:
    • KarXT
    • BMS-986510
  • Drug: Xanomeline Enteric Capsule
    Specified dose on specified days
    Other names:
    • KarX-EC
    • BMS-986519
Placebo Comparator
Placebo
  • Drug: Placebo
    Specified dose on specified days

Recruiting Locations

Imaging Endpoints
Scottsdale, Arizona 85258
Contact:
Nida Laurin, Site 1619
480-290-1547

Advanced Research Center (ARC) - Anaheim
Anaheim, California 92805
Contact:
Steven Macina, Site 1657
714-999-6688

The Neurology Group
Pomona, California 91767
Contact:
Sadiq Altamimi, Site 1662

Sunwise Clinical Research
Walnut Creek, California 94596
Contact:
Ira Glick, Site 1651
925-298-5147

Hope Research Network - Miami
Miami, Florida 33166
Contact:
Jorge Jorge, Site 1609
786-681-4959

Combined Research Orlando (CRO)
Orlando, Florida 32807
Contact:
Eric Carbonell, Site 1635
407-440-4493

Progressive Medical Research
Port Orange, Florida 32127
Contact:
Alexander White, Site 1612
386-304-7070

CBH Health
Gaithersburg, Maryland 20877
Contact:
Elia Acevedo Diaz, Site 1636
301-251-4702

Boston Center for Memory
Newton, Massachusetts 02459
Contact:
Paul Solomon, Site 1638
413-281-0577

Mayflower Clinical Research
South Dartmouth, Massachusetts 02747
Contact:
Mushtaque Chachar, Site 1642
508-925-7403

Elixia MA
Springfield, Massachusetts 01103
Contact:
Brittany Perreault, Site 1660

NeuroBehavioral Medicine Group
Bloomfield Hills, Michigan 48302
Contact:
Richard Jackson, Site 1665
412-916-2425

Oakland Medical Research
Troy, Michigan 48085
Contact:
Jay Sandberg, Site 1620
248-687-7412

Redbird Research
Las Vegas, Nevada 89119
Contact:
Jelena Kunovac, Site 1649
760-758-2222

Global Medical Institutes LLC; Princeton Medical Institute
Princeton, New Jersey 08540
Contact:
Matthew Adasofunjo, Site 1664

Mid Hudson Medical Research
New Windsor, New York 12553
Contact:
Sashi Makam, Site 1656
845-674-9398

Five Towns Neurology PC -Woodmere - 923 Broadway
Woodmere, New York 11598-1739
Contact:
David Steiner, Site 1658
516-239-1800

Central States Research
Tulsa, Oklahoma 74136
Contact:
Sarah Land, Site 1640
918-645-5400

Advanced Neurology Epilepsy and Sleep Center
El Paso, Texas 79912
Contact:
Aamr Herekar, Site 1643
505-903-1715

Wasatch Clinical Research, LLC
Salt Lake City, Utah 84107
Contact:
Albert Jarvi, Site 1641
801-288-0607

The Memory Clinic
Bennington, Vermont 05201-9810
Contact:
Lisa Catapano-Friedman, Site 1646
413-281-0575

Kingfisher Cooperative
Spokane, Washington 99201
Contact:
David Greeley, Site 1654
509-458-7720

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

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.