Axona Medical Milkshake Questioned by Experts for Effectiveness

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Medical foods are FDA-regulated nutritional products intended for the management of a disease or condition. Unlike dietary supplements, medical foods must prove their claims through laboratory and clinical data and can only be administered under the supervision of a physician. One such medical food targeted to Alzheimer’s patients, called Axona, is drawing criticism from experts who call the milkshake “snake oil,” providing false hopes to patients and their caregivers.

Currently, according to the Alzheimer’s Association, there are five FDA-approved drugs to treat the symptoms of Alzheimer’s, but none provide any lasting protection from the gradual advance of the disease. This leads patients and families to search for alternative measures for a “glimmer of hope,” says neuroscience professor Dr. Paul Aisen, of the University of California, San Diego.

Axona was developed by Accera, a company that develops products that treat central nervous system disorders, including neurodegenerative diseases such as Alzheimer’s (AD) and Parkinson’s. The main premise behind the proprietary formulation of caprylic triglyceride is the biological fact that glucose is the primary source of energy for the brain. However, Alzheimer’s patients exhibit a decline in the ability to metabolize glucose which leads to brain damage resulting in impaired memory and cognition. Axona is an alternative fuel for the brain cells as the nutrients from the fatty acids are converted by the liver into ketone bodies which substitute for the inadequate glucose.

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Clinical trials suggest that Axona may help to improve cognition function in some patients with mild-to-moderate AD. In 2009, patients who drank one Axona milkshake per day had an improvement of 1.9 points on a 70-point cognitive testing scale, but the effect wasn’t long-lasting.

In a recent interview with ABC News, Dr. Sam Gandy, chair of Alzheimer’s disease research at Mount Sinai School of Medicine said it was “outrageous” that nothing could be done to stop exploiting unproven substances to vulnerable AD patients and their families. "Getting extra fuel to the brain would provide an energy boost that could potentially lead to modest improvements," he said. "But it is very short-lived and does nothing to stop or treat the disease. I would think a low-fat frozen yogurt would achieve the same thing."

Steven Ferris, director of the Aging and Dementia Research Center at New York University, and member of the scientific advisory board at Accera, says that while it is true that the benefits of Axona are not yet proven, he doesn’t believe the medical food is completely worthless. "I wouldn't characterize it as snake oil, simply because it does have a scientific basis and there is some data that suggests a potential benefit," he said. "If this were out there available in the supermarkets, I'd really be concerned. But we do have gatekeepers, the physicians. It really comes down to individual judgments by prescribers as to whether this is appropriate for their patients or not."

Axona milkshakes are intended to be administered orally once a day after a meal, preferably breakfast or lunch. They cost $70 to $90 for a 30-day supply and, despite requiring prescription, are typically not covered by insurance.

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