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Looking for participantsPhase3

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

Sponsor: Bristol-Myers Squibb

NCT ID: NCT06976203

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
KarXT (drug), KarX-EC (drug), Placebo (other)
How long the study runs
Study runs about 43 months (dates as stated)
About the drug or intervention
KarXT — drug: Specified dose on specified days · KarX-EC — drug: Specified dose on specified days · Placebo — other: Specified dose on specified days
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
60 Years to 85 Years
Who
All
Number of participants
586
Started
2025-07-21
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for alzheimer's disease
  • • Phase3 - 586 participants
  • • The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Who can take part?

  • • Ages 60 Years to 85 Years
  • • Diagnosed with alzheimer's disease

Where?

  • • Manchester - NIHR Manchester Clinical Research Facility
  • • London - The Maudsley Hospital
  • • Edinburgh - Western General Hospital
  • • Oxford - Warneford Hospital
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Alzheimer's Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 60 Years - 85 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

Treatment history

Treatments you must have had:

  • ✓ been on a stable dosage for at least 12 weeks

What the study is looking for

  • ✓Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the...

Who cannot take part

  • ✗Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening...
  • ✗Other protocol-defined Inclusion/Exclusion criteria apply.
See the 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 could affect safety or interfere with study procedures. * Other protocol-defined Inclusion/Exclusion criteria apply.

Where Is This Study? (8 UK sites)

NIHR Manchester Clinical Research Facility

Manchester M13 9WL, United Kingdom

Recruiting
Site contact (verified)
Ross Dunne, Site 0097+447407715609

The Maudsley Hospital

London SE5 8AZ, United Kingdom

Recruiting
Site contact (verified)
Dag Aarsland, Site 01160800 731 2864

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)
Catherine Pennington, Site 01030131 537 3388

Warneford Hospital

Oxford OX3 7JX, United Kingdom

Recruiting
Site contact (verified)
Qi Pei, Site 001001865 902698

Re:Cognition Health - Birmingham

Birmingham B16 8LT, United Kingdom

Recruiting
Site contact (verified)
Terence McLoughlin, Site 000500447896241251

Leeds and York Partnership NHS Foundation Trust

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
George Crowther, Site 011107703288239

NeuroClin Glasgow

Motherwell ML1 4UF, United Kingdom

Recruiting
Site contact (verified)
Jennifer Lynch, Site 0126+44 141 948 0206

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield S10 2JF, United Kingdom

Recruiting
Site contact (verified)
Dan Blackburn, Site 011801142159101

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-10