Axona, A Medical Food for Alzheimer's Disease
Axona is a prescription medical food designed to address certain nutritional and metabolic needs associated with Alzheimer’s disease. According to the manufacturer, Accera, the goal of Axona therapy is to optimize a person’s cognitive function.
Medical foods were defined in 1988 by Congress as a special category of products that are designed for dietary management of a condition or disease that has specific nutritional requirements that have been verified by medical evaluation. Producers of medical foods are required to show that their products meet the specific nutritional needs of a particular condition using testing that includes clinical trials. Because they are not classified as drugs, they do not need the official approval of the Food and Drug Administration (FDA), as prescription medications do.
In people with Alzheimer’s disease, there is a substantial decline in the brain’s ability to metabolize glucose, which contributes to the course of the disease. Axona was designed to address this need: once it is ingested, it forms the ketone body B-hydroxybutyrate, which provides the brain cells with an alternative to glucose. The medical food is available in single-serving packages that patients are supposed to mix with water and drink once daily.
In 2007, Accera presented the results of a phase 2 double-blind, randomized, multicenter, placebo-controlled trial in which they tested 152 patients with probable mild to moderate Alzheimer’s disease. The study showed that patients who took Axona (which was called Ketasyn at that time) had significant improvement in the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-cog) after taking the food for 45 days.
The ADAS-cog measures factors such as memory, attention, language, and other cognitive abilities. In this study, improvement continued through day 90, although it was not significant at that point except in a small number of patients.
Side effects included diarrhea, heartburn, and flatulence. Axona contains milk and soy products. The company notes that it should be used with caution in people who are hypersensitive to palm or coconut oil, those at risk for ketoacidosis, or those with a history of metabolic syndrome, gastrointestinal inflammation, and/or renal problems. There were no significant interactions noted with commonly used Alzheimer’s drugs, including donepezil (Aricept) or memantine (Namenda).
Axona, which has been on the market for less than one year, is available only by prescription, so people with Alzheimer’s disease and their families who are interested in this medical food must talk to their doctors. The Alzheimer’s Association does not agree that Alzheimer’s causes nutritional deficiencies and so does not agree it requires a medical food.
Constantini LC et al. BMC Neurosci 2008 Dec 3; 9 Suppl 2:S16.
Henderson ST. Neurotherapeutics 2008 Jul; 5(3): 470-80.