Alzheimer’s disease is the most common form of dementia, affecting 5.2 million people in the United States alone. This progressive and invariably fatal disease is the sixth leading cause of death in the U.S.
Quite apart from mortality statistics and the suffering of people with the disease, it can have devastating emotional, financial, and physical effects on family, friends, and caregivers. The U.S. Family Caregiver Alliance estimates that up to 80% of Alzheimer’s disease caregivers provide care unpaid seven days a week.
Central to the issue is the fact that Alzheimer’s is a disease with no cure, and no truly effective treatments. Currently available pharmaceuticals cannot cure and cannot halt or even delay the progression of the disease. For patients, family, and caregivers, the focus is typically on improving quality of life.
Medical Food Products – a New Class of Treatment
Enter Accera, a privately-owned biotechnology with a focus on developing novel treatments for disorders of the central nervous system. In 2009, the company plans to launch a new product called Axona, a first-in-class medical food product designed to help manage early, mild-to-moderate Alzheimer’s symptoms.
The FDA defines such products differently from drugs and nutritional supplements: a medical food product can be a prescription product (but does not have to be), and any claims made as to the efficacy of a medical food product must be supported by clinical and laboratory data (just as with a pharmaceutical drug). In addition, medical food ingredients must be designated “Generally Recognized as Safe” by the FDA (this is the highest standard of safety which can be given to a food).
How does it Work?
One of the key features of Alzheimer’s disease is a marked drop in glucose uptake and metabolism in certain areas of the brain – and this reduced metabolism actually begins some ten to twenty years before symptoms of Alzheimer’s disease start to appear.
Axona targets this metabolic deficiency by supplying the brain with molecules called ketone bodies, which provide an alternative source of fuel. Brain cells can gain up to 60% of the metabolic energy they need from ketone bodies, and according to Accera’s clinical trials, the Axona food product may help reduce the effects of Alzheimer’s by supplying this alternative food source.
In randomized, controlled clinical trials, Axona has been shown to improve cognitive function and memory in people who have been diagnosed with mild-to-moderate Alzheimer’s disease. The new product will be marketed not as a stand-alone treatment, but as an addition to currently available and approved pharmaceuticals – it will require a prescription, and physician supervision, for people who use it.
Henderson ST. Ketone bodies as a therapeutic for Alzheimer’s disease. Neurotherapeutics. 2008 Jul;5 (3):470-80.