Safety and Effects of NTRX-07 in People Aged 65-80 With Mild Cognitive Impairment or Mild to Moderate Alzheimers Disease A Randomized, Double-Masked, Placebo-Controlled Phase 2 Study

What this Trial Is About

Researchers are evaluating the safety and effects of a new drug called NTRX-07 in people aged 65 to 80 with mild cognitive impairment or mild to moderate Alzheimers disease. This phase 2, randomized, double-masked, placebo-controlled study aims to understand how the drug interacts with the body over a 28-day treatment period, focusing mainly on safety and tolerability. The study is important as it explores new options to manage symptoms and potentially slow Alzheimers progression. Participants will be randomly assigned to one of two groups one receiving NTRX-07 orally as two 45 mg tablets once daily, and the other receiving matching placebo tablets daily for 28 days. Before treatment, there is a screening period of up to 45 days to confirm eligibility, including physical exams, cognitive assessments, MRI brain scans, and blood tests. After the treatment period, participants have a follow-up visit 7 days later for final safety checks. During the study, participants will have regular evaluations including safety monitoring of vital signs, physical exams, lab tests, ECGs, and cognitive testing using tools like ADAS-cog and MMSE. Blood and cerebrospinal fluid samples will be collected to measure drug levels and biomarkers related to Alzheimers disease. Brain activity will be assessed with EEG, and MRI scans will evaluate brain structure changes. The total involvement for each participant lasts about 7 to 10 weeks, including screening, treatment, and follow-up.

A Study of NTRX-07 in Participants With Alzheimer's Disease