Notice of Ordering Period Extension-Clinical Evaluation of Phenserine Tartrate Extended Controlled Release Tablet

The National Institute on Aging (NIA) intends to modify a single-award Indefinite Quantity Indefinite Delivery (IDIQ) contract to extend the ordering period by one year. The contract is for the clinical evaluation of Phenserine tartrate Extended Controlled Release Tablet (ECRT) formulation in early mild Alzheimer's disease and mild to moderate traumatic brain injury. The main objective of this contract is to provide a service to perform a phase 1/2 clinical trial evaluation of Phenserine tartrate ECRT in subjects with early mild Alzheimer's disease and in mild to moderate traumatic brain injury. The contract will involve a multiple ascending dose (MAD) study of Phenserine ECRT, and then the selection of the optimal dose of drug to carry forward into a longer-term analysis of early efficacy in AD and TBI subjects. • The contract will provide clinical services for the approved administration of the drug to two well-characterized patient populations. • The contract will obtain blood and other sample/measures from them under rigorously safe conditions for later evaluation of pharmacokinetic and pharmacodynamic measures associated with drug plasma concentrations, blood markers of drug action, tolerability, and brain/blood markers of efficacy. • The contract will involve a multiple ascending dose (MAD) study of Phenserine ECRT, and then the selection of the optimal dose of drug to carry forward into a longer-term analysis of early efficacy in AD and TBI subjects. • The contract will provide brain imaging, cognitive assessment, as well as blood and other samples to support evaluation of pharmacokinetic and pharmacodynamic measures.