RESOLVE Phase 4 Study of Zunveyl to Evaluate Safety, Tolerability, Neuropsychiatric Symptoms, and Caregiver Distress in Adults with Mild to Moderate Alzheimers Disease

What this Trial Is About

This research aims to evaluate the safety and tolerability of Zunveyl in adults aged 50 years and older who have mild to moderate Alzheimers disease. The study focuses on measuring neuropsychiatric symptoms and caregiver distress, providing important information about the effects of this treatment in a real-world clinical setting. It is a Phase 4, open-label study sponsored by Alpha Cognition, Inc, designed to assess routine clinical use over 12 weeks. Participants will take Zunveyl delayed release oral tablets starting at 5 mg twice daily for the first 4 weeks, then increasing to 10 mg twice daily for weeks 5 through 12. This single-group study involves no placebo or comparator arm. The treatment period spans 12 weeks, during which participants receive the medication and are monitored for safety and symptom changes. Throughout the study, participants and their caregivers will attend scheduled visits to assess adverse events, tolerability, neuropsychiatric symptoms using the Neuropsychiatric Inventory - 12 Domain NPI-12, and caregiver distress. Safety monitoring includes tracking serious adverse events, treatment interruptions, and dose reductions up to week 12, with global tolerability scores collected at multiple timepoints. The total participation lasts at least 17 weeks to include follow-up assessments after treatment completion.

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