Metro International Biotech, LLC (MetroBiotech) is developing an NAD booster (MIB-626) for the treatment of patients with Alzheimer’s Disease (AD). MIB-626 is a proprietary formulation of the crystalline form of b-Nicotinamide Mononucleotide (NMN) that has immunomodulatory and anti- inflammatory properties, as well as an activator of stress protective pathways that can be downregulated in disease states in various human tissues. This project will include two randomized control clinical trials (RCTs) , wherein MIB-626 will be administered per os to patients with mild dementia. The objective of first RCT is to determine whether MIB-626, after daily oral administration for 90 days, penetrates the blood brain barrier. The concentration of the drug, as well as of key metabolites thereof, will be measured in the CSF using previously validated assays. This trial will also determine whether the drug dosing regimen elevates the abundance of 1) NAD in the brain using MRS and 2) in PBMC using a validated LC-MS/MS assay. If the primary outcome is met in the first trial, a second RCT trial will be planned and executed to determine whether MIB-626 dosed orally for 180 days improves CSF biomarkers of amyloid deposition, neuronal/axonal degeneration, synaptic function and neuroinflammation. The drug regimen will also be assessed for improvement of cognition and activities of daily living in the trial participants. In order to perform this second clinical trial, the safety of MIB-626 in chronic dosing will first be characterized in preclinical toxicology studies for up to 9 months in two species. If the efficacy, safety and bio availability in the CNS are demonstrated in the two RCTs, the MetroBiotech will proceed to fund larger and longer duration RCTs in AD patients that, if successful, will support a drug registration.