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

Launched by BRISTOL-MYERS SQUIBB · May 9, 2025

Keywords

ClinConnect Summary

The MINDSET 2 clinical trial is a research study designed to test a new treatment called KarXT combined with KarX-EC for people with cognitive impairment due to Alzheimer's disease. This study aims to find out if this treatment can help improve thinking and memory skills in individuals diagnosed with mild to moderate Alzheimer's. The trial is not yet recruiting participants, but it will involve adults aged 21 to 45 years, and both men and women are welcome to participate.

To be eligible for the study, participants must have a confirmed diagnosis of Alzheimer's disease at a mild or moderate stage and have a specific score on a memory test called the Mini-Mental State Examination (MMSE). They also need to have a caregiver who can attend study visits and help with medication management. It's important to note that potential participants should not have serious health issues or certain psychiatric conditions that could affect their safety or the study results. During the trial, participants will be closely monitored for their safety and the effectiveness of the treatment. If you or a loved one is interested in learning more about this study, please keep an eye out for recruitment updates.

Gender

ALL

Eligibility 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.
• • 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.