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

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 definedby the National Institute on Aging and Alzheimer's Association (NIA-AA) coreclinical criteria. The diagnosis of AD pathology must be confirmed through the 2024revised NIA-AA Workgroup criteria using a stepwise diagnostic approach.

• Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12through 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 caregivermust also be responsible for reporting on the participant's condition, overseeingmedication compliance, and consenting to their involvement in both their own and theparticipant's study-related activities.

• Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, musthave been on a stable dosage for at least 12 weeks prior to screening, and agree tomaintain 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 majordepression, schizoaffective disorder, or bipolar disorder, and those with severepsychiatric 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, aswell as those who have previously been exposed to KarXT or are currently undergoingtreatment with disease-modifying anti-amyloid therapies for AD within the past 6months prior to screening.

• Participants must not have significant pathological findings on brain magneticresonance imaging (MRI) at screening that could affect safety or interfere withstudy procedures.

• Other protocol-defined Inclusion/Exclusion criteria apply.