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A Study of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease

This study is looking into whether two drugs, KarXT and KarX-EC, can help with thinking and memory problems (cognitive impairment) in people with Alzheimer's disease, and if they are safe. You might be able to join if you are between 60 and 85 years old and have been diagnosed with mild or moderate Alzheimer's disease. The study will measure changes in your cognitive abilities using tools like the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) and the Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+) after 24 weeks. The study aims to enroll 586 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 586 participants. It will compare KarXT + KarX-EC to a placebo (an inactive substance).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at week 24, suggesting follow-up for at least that duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06976203

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

Recruiting
PHASE3Ages 60–85InterventionalTreatment
Bristol-Myers Squibb
~586 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:KarXTKarX-ECPlacebo

At a glance

Recruiting sites
103 of 126 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11)
Measured over At week 24
+1 more outcome measured

Conditions

Alzheimer's Disease

Explore related trials

Alzheimer's Disease

Where it's being run

126 sites across 79 states
Florida7
California5
France5
New York4
Argentina4
Germany4
Portugal4
United Kingdom4

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11)At week 24
  • Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+)At week 24