Phase 2a Study to Evaluate Safety, Tolerability, and Cognitive Effects of NSC001 in Adults Aged 50 to 85 with Mild to Moderate Alzheimers Disease

What this Trial Is About

This research aims to evaluate the safety and tolerability of NSC001, an experimental drug, in people aged 50 to 85 years with mild to moderate Alzheimers disease. NSC001 is designed to target specific brain receptors to potentially improve cognitive and behavioral functions. The study is a randomized, double-blind, placebo-controlled trial conducted across multiple centers to explore both safety and effects on cognition and behavior. Participants will be randomly assigned to one of three groups receiving 40 mg of NSC001 daily, 40 mg of NSC001 daily combined with 20 mg of Trospium, or a placebo with or without 20 mg of Trospium. Treatment and monitoring will occur over 16 weeks, with assessments of drug levels in the blood at specific times. The study includes careful safety monitoring and evaluation of cognitive function throughout the trial. During the study, participants and their caregivers will attend scheduled visits for physical, cognitive, and behavioral assessments. Brain imaging such as MRI or CT scans will be reviewed if available, and tests to confirm Alzheimers diagnosis will be done. Researchers will track medication adherence, collect blood samples, and monitor safety and tolerability. The primary outcomes focus on safety at the start and end of treatment, while secondary measures analyze how the drug behaves in the body over time.

A Study to Assess Safety and Tolerability and to Explore Efficacy of NSC001 in Mild to Moderate Alzheimer's Disease