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.
Male and female outpatients aged 50 years and greater at the time of informed consent.
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.
Less than high school education: SLUMS score 10 -18
High school education or higher: SLUMS score 10 - 20
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.
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.
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.
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).
Single group
Zunveyl®
DrugZunveyl® delayed release oral tablets.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of Participants who Discontinued due to AEs
Number of Participants with Treatment Interruptions or Dose Reductions
Global Tolerability Score
Functional Assessment of Chronic Illness Therapy (FACIT) General Physical Well-Being domain Item 5 (GP5) will be used to assess the patient-reported impact of treatment toxicity that uses a single item "I am bothered by side effects of treatment" on a 5-point scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). Higher scores indicate greater bother from treatment side effects and worse treatment toxicity.
Change from Baseline in Neuropsychiatric Symptoms as Measured by Neuropsychiatric Inventory - 12 Domain (NPI-12) Total Score up to Week 12
The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. NPI: Total score ranges from 0 to 144, with higher scores indicating worse neuropsychiatric symptoms. Each domain is scored as frequency × severity (0-12 per domain). Assesses 12 domains including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and night-time behavior disorders, and appetite/eating abnormalities.
Change from Baseline in Total Caregiver Distress Score up to Week 12
The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. NPI: Total score ranges from 0 to 144, with higher scores indicating worse neuropsychiatric symptoms. Each domain is scored as frequency × severity (0-12 per domain). Assesses 12 domains including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and night-time behavior disorders, and appetite/eating abnormalities.
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