NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
RecruitingPhase 3
Sponsor: Bristol-Myers Squibb
Conditions: Alzheimer's Disease
Interventions: KarXT, KarX-EC, Placebo
Countries: United States, Argentina, Australia, Brazil, Finland, France, Germany, Greece
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Eligibility overview
Sex: ALL
Age: 60 Years to 85 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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, 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.
Locations (126)
- Fullerton, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- Colorado Springs, Colorado, United States
- Fort Myers, Florida, United States
- Hallandale, Florida, United States
- Jacksonville, Florida, United States
- Lady Lake, Florida, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Wellington, Florida, United States
- Chicago, Illinois, United States
- Springfield, Illinois, United States
- Indianapolis, Indiana, United States
- Watertown, Massachusetts, United States
- Farmington Hills, Michigan, United States
- Hattiesburg, Mississippi, United States
- Ridgewood, New Jersey, United States
- Springfield, New Jersey, United States
- West Long Branch, New Jersey, United States
- Albany, New York, United States
- Amherst, New York, United States
- Buffalo, New York, United States
- Lake Success, New York, United States
- Plymouth Meeting, Pennsylvania, United States
- Dallas, Texas, United States
- Round Rock, Texas, United States
- Renton, Washington, United States
- + 96 more on CT.gov