Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KarXT KarX-EC for Cognitive Impairment in Mild to Moderate Alzheimers Disease MINDSET 2
Led by Bristol-Myers Squibb · Updated on 2026-06-08
586
Participants Needed
126
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the efficacy and safety of KarXT combined with KarX-EC for treating cognitive impairment in people with mild to moderate Alzheimers Disease. This phase 3, randomized, double-blind, placebo-controlled study aims to assess how well this combination works compared to placebo in improving cognitive function and overall condition in affected adults aged 60 to 85 years. Participants will receive either the active drugs KarXT plus KarX-EC or a placebo following a specified dosing schedule. The study lasts 24 weeks, during which participants will be randomly assigned to one of these two groups. The trial is designed to carefully monitor effects and side effects of the treatments under controlled conditions. Throughout the study, participants and their caregivers will attend regular visits where cognitive tests like the ADAS-Cog11 and CIBIC will be conducted to track changes from baseline. Additional assessments include daily living activities, neuropsychiatric symptoms, safety labs, vital signs, ECGs, and adverse event monitoring. Caregivers will help report on participant condition and medication adherence, supporting comprehensive evaluation of the treatments impact over the 24-week period.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a confirmed diagnosis of Alzheimer's disease at mild (stage 4) or moderate (stage 5) dementia stages based on NIA-AA criteria.
- Mini-Mental State Examination (MMSE) score between 12 and 22 at screening.
- Must have a caregiver with around 10 or more hours of contact per week willing to attend study visits and report on condition.
- If taking acetyl choline esterase inhibitors or memantine, dosage must be stable for at least 12 weeks before screening and maintained during the study.
- Age between 60 and 85 years.
You will not qualify if you...
- Significant or severe medical conditions that risk safety or study compliance, including any grade of liver impairment, urinary retention, active biliary disease, moderate to severe kidney impairment (eGFR <50 mL/min), unstable high blood pressure or fast heart rate.
- Primary psychiatric diagnoses like major depression, schizoaffective disorder, bipolar disorder, or severe psychiatric symptoms affecting assessments or study completion.
- History of schizophrenia or chronic psychosis.
- Previous exposure to KarXT or recent (within 6 months) treatment with disease-modifying anti-amyloid therapies for Alzheimer's Disease.
- Significant brain MRI abnormalities at screening that affect safety or study procedures.
- Other protocol-defined inclusion and exclusion criteria.
Research Team
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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First line of the email MUST contain NCT # and Site #.
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