Neuroinflammation has been shown to play a major role in many neurodegenerative diseases, including Alzheimer’s disease.  Microglia are the resident immune cells in the brain and under normal conditions, play an important role in promoting the clearance of amyloid and protecting the brain from damage.  When tissue homeostasis is disturbed, microglia are activated and promote a pro-inflammatory response to protect the brain against insult.  However, when this response continues chronically, such as in neurodegenerative conditions, the microglia are predominantly detrimental because they induce neuroinflammation in the brain and impair synaptic function and memory.  NeuroTherapia is developing a novel small molecule, NTRX-07, that binds selectively to activated microglia and restores their physiological activity, thereby inhibiting neuroinflammation, promoting amyloid clearance and restoring synaptic plasticity, cognition and memory in rodent models of AD.  The Company has recently completed a Phase 1 single ascending dose safety study in healthy volunteers with no side effects observed at the predicted therapeutic dose.  The current proposed clinical studies will extend the clinical development to multiple (7 days, twice a day) dosing of NTRX-07 in both healthy and AD subjects to ensure the safety of the product following repeat dosing.  In addition, the effect of food on drug exposure will be studied.  Once the safety studies are completed, a 28-day study in AD subjects will be carried out to assess not only the safety of repeat dosing, but also to provide an indication of the ability of NTRX-07 to reduce neuroinflammation by analyzing appropriate biomarkers pre- and post-treatment.  When completed, these studies will allow NeuroTherapia to begin a large Phase 2 clinical trial to demonstrate that inhibition of neuroinflammation will be beneficial in treating AD.