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RecruitingPhase 3

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

Bristol-Myers Squibb · NCT06976216

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 60–85 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
586
US sites recruiting
24
Study start
July 14, 2025
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: KarXT; KarX-EC; Placebo

Conditions: Alzheimer's Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Healthy Brain Clinic

    Long Beach, CA 90804

    Site contact: Dung Trinh, Site 0173 · 562-606-5999

  • Anderson Clinical Research

    Redlands, CA 92374

    Site contact: Donald Anderson, Site 0008 · 909-792-9007

  • Mountain Neurological Research Center

    Basalt, CO 81621

    Site contact: Alison Allen, Site 0025 · 970-927-1141

  • Georgetown University Medical Center

    Washington D.C., DC 20007

    Site contact: Raymond Turner, Site 0024 · 202-687-7337

  • JEM Research Institute

    Atlantis, FL 33462

    Site contact: Linda Pao, Site 0154 · 561-968-2933

  • VIN-Julie Schwartzbard

    Aventura, FL 33180

    Site contact: Julie Schwartzbard, Site 0128 · 833-732-2484

  • Merritt Island Medical Research, LLC

    Merritt Island, FL 32952

    Site contact: Wasim Niazi, Site 0023 · 386-785-8009

  • Renstar Medical Research

    Ocala, FL 34470

    Site contact: Anette Nieves, Site 0055 · 352-629-5800

  • Alzheimer's Research and Treatment Center

    Stuart, FL 34996

    Site contact: Adam Falchook, Site 0263 · 561-209-2400

  • Charter Research - Lady Lake

    The Villages, FL 32162

    Site contact: Jeffrey Norton, Site 0184 · 352-775-1000

  • Center for Advanced Research & Education

    Gainesville, GA 30501

    Site contact: Angela Ritter, Site 0125 · 770-519-5254

  • Re:Cognition Health - Chicago

    Chicago, IL 60611

    Site contact: Antonio Iglesias, Site 0109 · 312-971-3318

  • Ascension Alexian Brothers

    Elk Grove Village, IL 60007

    Site contact: Concetta Forchetti, Site 0054 · 847-593-8553

  • Boston Center for Memory

    Newton, MA 02459

    Site contact: Paul Solomon, Site 0009 · 413-281-0577

  • HealthPartners Neuroscience Center

    Saint Paul, MN 55130

    Site contact: Marcel Hungs, Site 0110 · 111-111-1111

  • Advanced Memory Research Institute of New Jersey

    Toms River, NJ 08755

    Site contact: Arun Singh, Site 0123 · 732-341-9500

  • NYU Langone Health

    New York, NY 10016

    Site contact: Martin Sadowski, Site 0101 · 212-263-5708

  • SUNY Upstate Medical University

    Syracuse, NY 13210

    Site contact: Andrea Berg, Site 0202

  • Ohio State University

    Columbus, OH 43221

    Site contact: Douglas Scharre, Site 0073

  • NDx Clinical Research Inc.

    Dayton, OH 45459

    Site contact: Joel Vandersluis, Site 0026 · 305-456-7782

  • Summit Headlands

    Portland, OR 97210

    Site contact: Scott Losk, Site 0067 · 503-279-8252

  • Rhode Island Mood & Memory Research Institute

    East Providence, RI 02914

    Site contact: john stoukides, Site 0056 · 401-435-8950

  • Neurology Clinic, P.C.

    Cordova, TN 38018

    Site contact: Thomas Arnold, Site 0099 · 901-866-9252

  • Gadolin Research

    Beaumont, TX 77702

    Site contact: Joseph Oommen, Site 0018 · 409-331-6040

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.
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A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for… (NCT06976216) | Bored Studies