Axona was previously marketed as a medical food for the clinical dietary management of the impairment of metabolic processes associated with mild to moderate Alzheimer's disease.
Cericin,[1] the company that makes Axona, states that during digestion, caprylic triglyceride is broken down into ketones, which provide an alternative energy source for the brain.
[5] A medical food in the US is an official FDA product classification, and was originally defined by Congress as part of the Orphan Drug Amendments of 1988 as "a food which is formulated to be consumed or administered through a feeding tube under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.
[6] Alzheimer's disease is clinically characterized by a progressive decline in memory and language, and pathologically by accumulation of senile plaques and neurofibrillary tangles.
[4] Ketones act as an alternative energy source for brain cells that have an impaired ability to use glucose (sugar) as a result of Alzheimer's disease,[3] and the makers of Axona claim that this may have medical benefits.
[citation needed] Axona has been evaluated in Phase II clinical trials, paid for and conducted by Cerecin, only one of which was published in an open-access journal in 2009.