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Phase 3Recruiting

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease

Sponsored by Bristol-Myers Squibb

About this study

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Where this study is enrolling (23)

  • Anderson Clinical Research

    Redlands, California

    Call 909-792-9007

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  • Healthy Brain Clinic

    Long Beach, California

    Call 562-606-5999

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  • Mountain Neurological Research Center

    Basalt, Colorado

    Call 970-927-1141

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  • Georgetown University Medical Center

    Washington D.C., District of Columbia

    Call 202-687-7337

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  • Renstar Medical Research

    Ocala, Florida

    Call 352-629-5800

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Show all 23 locations

  • VIN-Julie Schwartzbard

    Aventura, Florida

    Call 833-732-2484

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  • Alzheimer's Research and Treatment Center

    Stuart, Florida

    Call 561-209-2400

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  • Charter Research - Lady Lake

    The Villages, Florida

    Call 352-775-1000

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  • Merritt Island Medical Research, LLC

    Merritt Island, Florida

    Call 386-785-8009

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  • JEM Research Institute

    Atlantis, Florida

    Call 561-968-2933

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  • Center for Advanced Research & Education

    Gainesville, Georgia

    Call 770-519-5254

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  • Ascension Alexian Brothers

    Elk Grove Village, Illinois

    Call 847-593-8553

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  • Re:Cognition Health - Chicago

    Chicago, Illinois

    Call 888-437-0813

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  • Boston Center for Memory

    Newton, Massachusetts

    Call 413-281-0577

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  • HealthPartners Neuroscience Center

    Saint Paul, Minnesota

    Call 111-111-1111

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  • Advanced Memory Research Institute of New Jersey

    Toms River, New Jersey

    Call 732-341-9500

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  • NYU Langone Health

    New York, New York

    Call 212-263-5708

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  • AMC Research, LLC

    Matthews, North Carolina

    Call 7043644000ext225

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  • NDx Clinical Research Inc.

    Dayton, Ohio

    Call 937-224-8200

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  • Summit Headlands

    Portland, Oregon

    Call 503-279-8252

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  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island

    Call 401-435-8950

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  • Neurology Clinic, P.C.

    Cordova, Tennessee

    Call 901-866-9252

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  • Gadolin Research

    Beaumont, Texas

    Call 409-331-6040

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Who can participate

Inclusion criteria

  • ✓Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach.
  • ✓Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening.
  • ✓Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities.
  • ✓Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.

Exclusion criteria

  • ✕Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment, urinary retention, active biliary disease, moderate-severe renal impairment (eGFR of \<50 mL/min), and unstable hypertension or tachycardia.
  • ✕Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.
  • ✕Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening.
  • ✕Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that reflect significant pathology other than AD or could affect safety or interfere with study procedures.
  • ✕Other protocol-defined Inclusion/Exclusion criteria apply.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.