‘Medical foods’ and supplements for brain health advance

As pharmaceutical companies struggle to devise new drugs to treat symptoms of dementia, a host of supplements and products called “medical foods” purporting to improve cognitive function are advancing toward the market.

Unlike drugs, medical foods and more common supplements aren’t allowed to claim they help cure illnesses. Medical foods are meant to be used under a doctor’s guidance to tackle a specific nutritional deficiency stemming from a disease, often in conjunction with pharmaceuticals to treat the particular ailment.

They aren’t regulated by the FDA and undergo much less stringent testing than drugs. Some manufacturers require patients to get a doctor’s prescription to use medical foods, but not always.

Accera says its Axona shakes might help keep healthy brain cells alive in people with Alzheimer’s disease by providing the brain with an alternative energy source.

Big food companies see opportunities in medical foods. Recently, Nestlé SA said it bought a stake in Accera, maker of milkshakes for Alzheimer’s disease patients. And at the Alzheimer’s Association conference in Vancouver, Canada, French food giant Group Danone SA said a study showed its investigational medical food, Souvenaid, could improve cognitive functioning.

Nevertheless, “medical foods is still an evolving area,” says William Thies, the association’s chief medical and scientific officer. “The Alzheimer’s Association is watching the area carefully so we can give people better advice.”

Danone rigorously tests new products and tries to adhere closely to the FDA’s definition of a medical food, says spokesman William Green. For instance, last week’s study on Souvenaid was the longest it has undertaken and involved 118 patients.

A combination of compounds naturally found in the diet, but not usually together, the Souvenaid shake was found in a six-month study to improve cognitive functioning in people with mild-to-moderate Alzheimer’s.

Earlier this month, results from a second six-month trial, which replicated the results of the first, were published in the Journal of Alzheimer’s Disease. Last week’s longer-term results showed the shake appeared safe and effective for use up to 48 weeks.

The Alzheimer’s Association says Danone has been “working hard” to demonstrate evidence for its product. “We’re interested in their science,” says DThies.

But such optional testing of a medical food is usually far less stringent than the regulatory hurdles drug makers face when trying to bring a new treatment to the market.

Pharmaceutical companies must not only show drugs are safe, but repeatedly—and at great expense—demonstrate that they work. The tough path to getting a drug to market was demonstrated Monday, as Pfizer Inc. said a highly anticipated potential treatment for Alzheimer’s failed to reach its goals in a Phase 3 study.

In order to speed their products to market, some companies skip the drug route and brand their products as medical foods or “nutraceuticals,” as the industry calls the huge category of over-the-counter nutritional supplements…..

The Wall Street Journal: Read the full article