KarXT plus KarX-EC for cognitive impairment in Alzheimer's disease (MINDSET 2)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

MINDSET 2 is a Phase 3, randomized interventional study comparing the combination of KarXT plus KarX-EC to placebo for cognitive impairment in Alzheimer's disease. Participants must have mild to moderate AD confirmed by the 2024 NIA‑AA criteria and an MMSE score between 12 and 22, and each participant needs a caregiver who can attend visits and report on the participant. The study will monitor cognitive outcomes and safety while participants receive the study drugs or placebo. Sites for enrollment are located in Southern California and the sponsor is Bristol-Myers Squibb.

Why it matters

Who can join: the full rules

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

Where it's running

• Fullerton Neurology and Headache Center
  Fullerton, California, United States Recruiting
• Irvine Clinical Research
  Irvine, California, United States Recruiting
• Inglewood Clinical
  Los Angeles, California, United States Recruiting
• Stanford Neuroscience Health Center
  Palo Alto, California, United States Recruiting
• Research of the Rockies
  Colorado Springs, Colorado, United States Recruiting
• Neuropsychiatric Research Center of Southwest Florida
  Fort Myers, Florida, United States Recruiting

+78 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.