Age-Associated Memory Impairment Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled Study of Tricaprilin (AC-1202) Administered For Ninety Days In Subjects With Age-Associated Memory Impairment
The purpose of this study is to determine whether tricaprilin, a compound that increases energy availability in the brain, improves memory in older adults with "normal" loss of memory abilities since early adult life.
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).
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