A Double-Blind, Placebo-Controlled Study of Tricaprilin (AC-1202) Administered For Ninety Days In Subjects With Age-Associated Memory Impairment

One physiological hallmark of aging in mammals is a decreased uptake and metabolism of glucose within the brain. The impaired glucose metabolism in the brain may contribute or exacerbate the cognitive deficits observed during normal aging. Facilitation of memory in elderly individuals occurs when glucose levels are elevated by the administration of carbohydrate. However, such a treatment poses challenges since elevated blood glucose levels are difficult to maintain and must be within a relatively narrow window, as excessive hyperglycemia is associated with cognitive impairments. The purpose of this study is to explore whether increasing levels of other substrates for the brain improves cognitive functioning in normal aged individuals with memory disorders.

Study participants will be 120 men and women aged 50-85 who have been diagnosed as having Age-Associated Memory Impairment (AAMI). During the double-blind period of the protocol, 60 participants will receive tricaprilin and 60 participants will receive a matching placebo. Tricaprilin or the matching placebo will be administered once a day for ninety days by mixing powder in 8 ounces of a liquid. Each participant will be seen six (6) times: at Screening; Baseline; treatment days Days 30, 60, 90; and 14 days after the conclusion of treatment (Day 104).