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Taking people in GreecePhase 3

Tests KarXT with KarX-EC for memory and thinking problems in Alzheimer's disease

Tests KarXT with KarX-EC against a placebo in people with mild to moderate Alzheimer's.

Key facts

Who runs it
Bristol-Myers Squibb
Where
Athens, Maroussi, Patras, and Thessaloniki, GreeceSee the 4 sitesAlso in 16 other countries, 119 sites
Trial code
Registry title
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
Status
Recruiting
Phase
Phase 3
People taking part
586 people, planned
Started
21 Jul 2025
Expected to end
23 Feb 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • KarXT
  • KarX-EC
  • Placebo
Record updated
8 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 60 to 85 with mild or moderate Alzheimer's disease who have a caregiver. It tests KarXT + KarX-EC against placebo for memory and thinking problems.

Age
60 Years to 85 Years
Sex
All
Disease stage
Alzheimer's disease at the mild (stage 4) or moderate (stage 5) dementia stage, confirmed with the 2024 revised NIA-AA criteria. Mini-Mental State Examination (MMSE) score of 12 through 22 at screening.
Earlier treatment
People taking acetyl choline esterase inhibitors (AChEIs) and/or memantine must have been on a stable dose for at least 12 weeks before screening and keep that dose during the study. People who had KarXT before, or who took disease-modifying anti-amyloid therapies for Alzheimer's in the past 6 months, cannot join.
Biomarker or test result
Alzheimer's disease changes must be confirmed using the 2024 revised NIA-AA criteria. The record gives no further detail.

Main reasons for not taking part

  • Any grade of liver problems, urinary retention, active bile disease, or moderate to severe kidney problems (eGFR below 50 mL/min)
  • Unstable high blood pressure or fast heart rate
  • Major depression, schizoaffective disorder or bipolar disorder, or severe psychiatric symptoms
  • Past schizophrenia or other long-term psychosis
  • Significant findings on the brain MRI at screening

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 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 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 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 60 and 85 years old?

Where in Greece

Also in 16 other countries, 119 sites

  • University General Hospital AttikonAthens, GreeceTaking people
  • Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.Maroussi, GreeceTaking people
  • General University Hospital Of PatrasPatras, GreeceTaking people
  • University General Hospital of Thessaloniki - AHEPAThessaloniki, GreeceTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • KarXT + KarX-ECExisting treatment, for comparison

    Treatment: KarXT and KarX-EC

  • PlaceboPlacebo, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated With Mild to Moderate Alzheimer's Disease (MINDSET 2)
Plain-language title
Tests KarXT with KarX-EC for memory and thinking problems in Alzheimer's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06976203, who can take part
Record updated
8 October 2026