RESOLVE: A Phase 4, Open-label Study to Assess the Effect of Zunveyl on Safety and Tolerability, Neuropsychiatric Symptoms, and Caregiver Distress in Adults With Mild to Moderate Alzheimer's Disease
Alpha Cognition, Inc
Summary
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.
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
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:…
Interventions
- DrugZunveyl®
Zunveyl® delayed release oral tablets.
Location
- Tekton Research Saint Louis PsychiatrySt Louis, Missouri