A Single Site, Randomized, Double-blind, Placebo Controlled Trial of NIC5-15 in Subjects With Alzheimer's Disease

Inclusion Criteria: * NINCDS/ADRDA criteria for probable AD * MMSE between 12-27 * Treatment with a cholinesterase inhibitor or an NMDA (N-methyl-D-asparate) antagonist with stable dose for at least 12 weeks * Home monitoring available for supervision of medications * Caregiver available to accompany patient to all visits and willing to participate in study as informant * Fluent in English or Spanish * Medical stability for this study as confirmed by review of records, internist's physical exam, neurological exam, and laboratory tests * Stable doses of non-excluded medication * No evidence of hepatic insufficiency * Able to swallow oral medications * Ability to participate in the informed consent process Exclusion Criteria: * History of Diabetes Mellitus (OGTT criteria) requiring treatment with an excluded antidiabetic medication (see below) or history of hypoglycemia * Active hepatic or renal disease * Cardiac disease including history of congestive heart failure or current treatment for CHF; history of recent myocardial infarction * Use of another investigational drug within the past two months * History of clinically significant stroke * History of seizure or head trauma with disturbance of consciousness within the past two years * Major mental illness including psychotic disorders, bipolar disorder, or major depressive episode within the past two years Medication Exclusion * Current use of oral hypoglycemic agents including sulfonylureas and meglintinides * Current or …