Abstract
TAME is designed on the premise that geroscience-based therapeutics will affect multiple disease outcomes. Extensive biological data show that metformin targets the biology of aging, and epidemiologic and some clinical trial data show that it prevents multiple age-related diseases. TAME will randomize 3,000 older persons (65–79 yrs) without diabetes to metformin (1500 mg/day) or placebo for 4 years. TAME’s primary endpoint is the incidence of any one of several age-related chronic diseases (myocardial infarction, congestive heart failure, stroke, most cancers, MCI/Dementia and death). The trial will have 90% power to detect a 22.5% reduction in the primary endpoint. Other outcomes focus on physical and cognitive function and common geriatric syndromes and conditions. The primary outcome was shaped by FDA input related to the development of aging relevant indications to spur new drug development. A biologic specimen repository will support studies to understand which biomarkers / mechanisms underlie metformin’s benefits.