Testing KarXT with KarX-EC for memory problems in Alzheimer's disease
Tests KarXT with KarX-EC against placebo in adults with mild to moderate Alzheimer's disease.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
Key facts
- Where
- 's-Hertogenbosch, Amsterdam, and Zwolle, NetherlandsSee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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 adults aged 60 to 85 with mild or moderate Alzheimer's disease dementia. They need a caregiver who stays in regular contact.
- Age
- 60 to 85 years
- Sex
- All sexes can join.
- Disease stage
- Alzheimer's disease at the mild (stage 4) or moderate (stage 5) dementia stage, with an MMSE score from 12 through 22 at screening.
- Earlier treatment
- People taking acetyl choline esterase inhibitors and/or memantine must have been on a stable dose for at least 12 weeks before screening. They must keep that dose during the study. People cannot join if they had KarXT before, or took disease-modifying anti-amyloid therapies for Alzheimer's within the past 6 months.
- Biomarker or test result
- Alzheimer's disease must be confirmed using the 2024 revised NIA-AA Workgroup criteria.
Main reasons for not taking part
- Any liver problem, urinary retention, active biliary disease, moderate-severe kidney impairment (eGFR below 50 mL/min), or unstable high blood pressure or fast heart rate
- Main psychiatric diagnosis such as major depression, schizoaffective disorder or bipolar disorder
- History of schizophrenia or other long-term psychosis
- Earlier KarXT use, or anti-amyloid therapy for Alzheimer's in the past 6 months
- Brain MRI at screening showing significant problems other than Alzheimer's
Read by machine on 9 November 2026.
Could this be for you?
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?
Source: NCT06976216, who can take part
Where in Netherlands
- Brain Research Center Den Bosch B.V.'s-Hertogenbosch, NetherlandsNot yet recruiting
- Brain Research Center Amsterdam B.V.Amsterdam, NetherlandsNot yet recruiting
- Brain Research Center Zwolle B.V.Zwolle, NetherlandsNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT06976216EU 2025-520746-30-00
- Record updated
- 27 October 2026
- Original description
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's DiseaseRead full original descriptionShow less
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 1)
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
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 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 reflect significant pathology other than AD or could affect safety or interfere with study procedures; Other protocol-defined Inclusion/Exclusion criteria apply.