Friday, February 25, 2011

Medical Food for Alzheimer’s Patients - Axona

About Axona

Axona is a prescription medical food intended for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer's disease. The human brain relies almost exclusively on glucose as a source of energy. Research shows that, in Alzheimer's disease patients, there is a dramatic drop in the brain's ability to metabolize glucose.

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Axona addresses energy deficiencies in the brain by providing an alternative source of energy. In clinical trials, patients taking Axona experienced cognitive improvement in 45 days.

Axona has demonstrated safety and effectiveness in clinical trials. Axona is available by prescription only and its use must be supervised by a physician.

Axona Benefits

The results of clinical studies involving patients with mild to moderate Alzheimer's disease supported the positive role of Axona as a therapy that is compatible with drugs used to treat Alzheimer's disease.

Clinical studies demonstrated that Alzheimer's disease patients taking Axona:
  • Experienced cognitive improvement by day 45
  • Maintained cognitive benefits over the course of the study
  • Experienced few side effects
  • Could also take commonly prescribed Alzheimer's medications

Clinical Trial

Axona has been studied in clinical trials involving patients with mild to moderate Alzheimer's disease as well as healthy elderly volunteers. A study was conducted on 20 patients diagnosed with Alzheimer's disease or mild cognitive impairment. The results showed a positive response with improvement in paragraph recall (a primary measure of cognition).

Axona was evaluated in a double-blind, randomized, placebo-controlled study performed at multiple US clinical centers with 152 patients with mild to moderate Alzheimer's disease over a period of 90 days. Approximately 80% of those participating were receiving another type of Alzheimer's therapy. The results showed a significant improvement in cognitive function in certain patients taking Axona while a decline was demonstrated in the placebo group. The results also showed that cognitive benefits could be maintained over a period of time in the patients receiving Axona.

Axona Dozing

Axona is supplied as a powder, and is available in convenient individual packets of 40 grams per packet. It is recommended that patients take one packet of Axona once a day shortly after breakfast. The contents of each packet of Axona should be added to 4 to 8 ounces (118 to 236 milliliters) of water or other liquids, and shaken or blended until fully mixed.

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For those who are unable to tolerate a full dose of Axona, talk to your doctor about starting at a lower dose for a period of time. If you are able to tolerate half the dose (about 2 1/2 Tbsp) of Axona, you may be able to gradually increase to the full dose level (about 5 Tbsp).

In clinical trials, the current formulation of Axona was studied only when it was mixed with water. However, additional studies indicate that Axona is a highly stable product and may be mixed with other foods and liquids, such as:
  • Ice cream
  • Pudding
  • Meal replacement drinks
  • Oatmeal
  • Milk
  • Fruit juice
  • Chocolate syrup
In clinical studies, certain patients experienced improved results when they followed the dosing regimen exactly. Therefore, to take full advantage of your opportunity to achieve the best results, it is important to take Axona exactly as prescribed by your doctor.

About Medical Foods

Accera markets Axona as a medical food, available only by prescription.  Medical foods do not require the same U.S. Food and Drug Administration (FDA) review and approval as drugs.  Without the lengthy FDA review, if no data from placebo-controlled trials is published in peer-reviewed journals, it can be difficult to assess how effective a medical food is.

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.

Medical foods are subject to some FDA oversight and regulation, which can include monitoring manufacturing processes and quality assurance programs, and analyzing ingredients for safety.  The agency does not necessarily conduct inspections for all medical foods, though.  In addition, food ingredients must be “Generally Recognized as Safe” (GRAS) to be exempt from pre-market review and approval. 

Why did Accera choose to market Axona as a medical food rather than as an FDA-approved drug?  Probably, because developing a potential drug, conducting clinical trials and going through FDA review is a lengthy and expensive process, while marketing as medical food offers much faster access to the market.

Research Limitations

Limited studies, funded by the manufacturers of the product, confirmed that memory and cognition improved for people with mild to moderate Alzheimer's disease. However, more studies are needed to determine its safety and effectiveness.

Axona is marketed as a medical food. Medical foods are dietary supplements that help manage a disease or condition that causes nutritional deficiencies. The Alzheimer's Association, however, disputes the notion that Alzheimer's disease causes nutritional deficiencies and requires a medical food. Medical foods are given only under the supervision of a doctor. The Food and Drug Administration (FDA) doesn't approve medical foods, nor does it test medical foods for safety or effectiveness.

Until more is known, the Alzheimer's Association doesn't recommend the use of medical foods, including Axona, for the treatment of Alzheimer's disease.

Side Effects

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).

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