A Study of Zunveyl on Safety, Tolerability, Neuropsychiatric Symptoms, and Caregiver Distress in Alzheimer's Disease (RESOLVE)

The primary purpose of this study is to evaluate the safety and tolerability of Zunveyl® over 12 weeks of routine clinical use in adults with mild to moderate Alzheimer's disease.

Inclusion Criteria: 1. Male and female outpatients aged 50 years and greater at the time of informed consent. 2. Diagnosis of probable Alzheimer's disease in accordance with the 2024 National Institute on Aging-Alzheimer's Association (NIA-AA) criteria, supported by biomarker confirmation using the Fujirebio Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test. 3. Cognitive impairment consistent with mild-to-moderate Alzheimer's disease, confirmed at Screening by the Saint Louis University Mental Status (SLUMS) examination, with scores meeting the following criteria based on education level: 1. Less than high school education: SLUMS score 10 -18 2. High school education or higher: SLUMS score 10 - 20 4. The participant must be capable of providing informed consent; if not, a legally authorized representative (LAR)/caregiver may provide consent in compliance with federal and Institutional Review Board (IRB) regulations. 5. Participant currently receiving non-exclusionary chronic medications are eligible, provided doses have been stable for greater than or equal to \[\>=\] 4 weeks. 6. Any recent medication changes at baseline (less than 8 weeks) should be reviewed to confirm they are not expected to confound efficacy or safety assessments. 7. Availability of a reliable full-time caregiver or study partner who serves as a knowledgeable informant and: 1. Has at least 20 hours per week of direct contact with the participant; 2. Is capable of consistently completing tolerability assessments and the Neuropsychiatric Inventory (NPI) across study visits; 3. Can observe and accurately report tolerability, neuropsychiatric symptoms (including sleep), and caregiver distress; 4. Is available and willing to participate in all required study visits and assessments. 8. Participants must not have received disallowed concomitant medications within 2 weeks or 5 half-lives (whichever is longer) prior to baseline. 9. Compliance with washouts will be confirmed by medication history review. 10. The participant and caregiver must be willing and able to comply with all study procedures, including visits, assessments, and follow-up in an outpatient setting. Exclusion Criteria: 1. Dementia due to causes other than Alzheimer's disease, including but not limited to vascular dementia, frontotemporal dementia, or substance/medication-induced dementia, Parkinson's disease dementia and Lewy body dementia, Huntington's dementia, or any other types. 2. Negative biomarkers result on the Fujirebio Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test, indicating lack of biomarker support for a diagnosis of probable Alzheimer's disease according to the 2024 NIA-AA criteria. 3. Hospitalization in a psychiatric or mental health facility (For example \[e.g.\], psychiatric hospital, inpatient ward) at screening or within 3 months prior to screening. 4. Any concurrent or unstable medical condition that, in the investigator's judgment, could interfere with study conduct, confound interpretation of study data, or pose an undue risk to the participant's safety. Includes but is not limited to: 1. Malignancy within the past 2 years, except for adequately treated non-melanotic skin cancer, localized prostate cancer or cervical cancer in situ (other non-metastatic malignancies may be allowed with medical monitor approval). 2. Hematologic, endocrine, metabolic, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disorders that are unstable or progressive. 3. Cardiovascular examples: three documented episodes of blood pressure greater than (\>)185/100 millimeters of mercury (mmHg), unstable ischemic heart disease, dilated cardiomyopathy, unstable valvular disease, cardiac conduction abnormalities, or bradycardia (participants will be excluded if resting (awake) heart rate (HR) less than (\