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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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

Key facts

Study ID

NCT06976216

Run by

Bristol-Myers Squibb

People needed

586

Starts

2025-07-14

Expected to finish

2029-02-23

Last updated by the study team

2026-06-26

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Rhode Island Mood & Memory Research Institute — East Providence, Rhode Island, United States (enrolling)
• Neurology Clinic, P.C. — Cordova, Tennessee, United States (enrolling)
• Healthy Brain Clinic — Long Beach, California, United States (enrolling)
• Anderson Clinical Research — Redlands, California, United States (enrolling)
• Mountain Neurological Research Center — Basalt, Colorado, United States (enrolling)
• Merritt Island Medical Research, LLC — Merritt Island, Florida, United States (enrolling)
• Renstar Medical Research — Ocala, Florida, United States (enrolling)
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Charter Research - Lady Lake — The Villages, Florida, United States (enrolling)
• JEM Research Institute — Atlantis, Florida, United States (enrolling)
• VIN-Julie Schwartzbard — Aventura, Florida, United States (enrolling)
• Re:Cognition Health - Chicago — Chicago, Illinois, United States (enrolling)
• Ascension Alexian Brothers — Elk Grove Village, Illinois, United States (enrolling)
• Boston Center for Memory — Newton, Massachusetts, United States (enrolling)
• HealthPartners Neuroscience Center — Saint Paul, Minnesota, United States (enrolling)
• Advanced Memory Research Institute of New Jersey — Toms River, New Jersey, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Alzheimer's Research and Treatment Center — Stuart, Florida, United States (enrolling)
• SUNY Upstate Medical University — Syracuse, New York, United States (enrolling)
• AMC Research, LLC — Matthews, North Carolina, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• NDx Clinical Research Inc. — Dayton, Ohio, United States (enrolling)
• Summit Headlands — Portland, Oregon, United States (enrolling)
• Center for Advanced Research & Education — Gainesville, Georgia, United States (enrolling)
• Gadolin Research — Beaumont, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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