A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)

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

NCT06976203

Run by

Bristol-Myers Squibb

People needed

586

Starts

2025-07-21

Expected to finish

2029-02-23

Last updated by the study team

2026-07-17

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 could affect safety or interfere with study procedures.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

• Rainier Clinical Research Center — Renton, Washington, United States (enrolling)
• Inglewood Clinical — Los Angeles, California, United States (enrolling)
• Keystone Clinical Studies — Plymouth Meeting, Pennsylvania, United States (enrolling)
• Central Texas Neurology Consultants, PA — Round Rock, Texas, United States (enrolling)
• Research of the Rockies — Colorado Springs, Colorado, United States (enrolling)
• Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, United States (enrolling)
• Fullerton Neurology and Headache Center — Fullerton, California, United States (enrolling)
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (enrolling)
• Irvine Clinical Research — Irvine, California, United States (enrolling)
• Intercoastal Medical Group — Sarasota, Florida, United States (enrolling)
• USF Health Byrd Alzheimer's Institute — Tampa, Florida, United States (enrolling)
• Alzheimer's Research and Treatment Center — Wellington, Florida, United States (enrolling)
• Great Lakes Clinical Trials - Andersonville — Chicago, Illinois, United States (enrolling)
• Southern Illinois University School of Medicine — Springfield, Illinois, United States (enrolling)
• Josephson Wallack Munshower Neurology, PC — Indianapolis, Indiana, United States (enrolling)
• Stanford Neuroscience Health Center — Palo Alto, California, United States (enrolling)
• QUEST Research Institute — Farmington Hills, Michigan, United States (enrolling)
• Private Practice - Dr. Ronald Louis Schwartz — Hattiesburg, Mississippi, United States (enrolling)
• K2 MEDICAL Research THE VILLAGES — Lady Lake, Florida, United States (enrolling)
• The Cognitive and Research Center of New Jersey — Springfield, New Jersey, United States (enrolling)
• Advanced Clinical Institute — West Long Branch, New Jersey, United States (enrolling)
• Neurological Associates Albany — Albany, New York, United States (enrolling)
• Dent Neurosciences Research Center, Inc — Amherst, New York, United States (enrolling)
• University at Buffalo - UBMD Neurology — Buffalo, New York, United States (enrolling)
• Hospital Italiano de Buenos Aires — ABB, Buenos Aires F.D., Argentina (enrolling)

Full record on ClinicalTrials.gov

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