TAMPA — Dr. Amanda Smith is a specialist in treating Alzheimer's disease, so she's accustomed to desperate families grasping at hope as they watch their loved ones disappear into dementia.
But her annoyance is clear when she recalls one woman who came into the office recently, holding a newspaper clipping touting a product's power to "reverse memory loss by up to 10 to 15 years."
"Did you see this article?' the woman asked, clearly excited.
What she held in her hand was an advertisement for Procera AVH, one of many over-the-counter pills claiming to boost brain power. Containing various herbs, extracts and nutrients (though the labeling usually is not precise), these products are finding their target in a rapidly aging population. They represent a growing share of the $25.2 billion-a-year nutritional supplement industry.
"Clear away 'brain fog,' " claim the makers of Procera AVH, which sells for about $1 a pill, plus shipping and handling. "Guaranteed to support your memory in as little as two weeks or your money back!" boasts another popular product, Focus Factor, which costs slightly less.
"It makes me angry," said Smith, medical director of the Byrd Alzheimer's Institute at the University of South Florida. "I come to work every day legitimately trying to find a cure for Alzheimer's. These people give people false hope."
But is it all false hope? Do the products provide any benefits?
Many doctors say the supplements lack scientific evidence to prove they work, and as nutritional supplements, they are not regulated by the federal government as are medications. The ads tout clinical trials, but these are at best small, short-term tests published in journals that are not well-known or respected — hardly comparable with accepted medical standards.
Some brain supplements do contain ingredients that have been studied extensively and are used widely for memory disorders. The moss extract huperzine A, found in Procera AVH, has similar properties to the Alzheimer's drug Aricept, and is the most common treatment for Alzheimer's in China, Smith said.
But with vague labeling and little regulation, there's no way to know how much of these ingredients are in any supplement, or how high their quality is.
All of which leaves doctors like Smith at a loss when patients and family members ask about brain boosters advertised in the newspaper or on the TV or Internet — sometimes offering a free introductory bottle (plus shipping and handling).
"I'm not going to say it might not help," Smith said of the supplements. "I don't want to pan these companies across the board."
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People who have been diagnosed with dementia or Alzheimer's disease are usually prescribed medications that have been approved by the Food and Drug Administration to treat their condition.
But many healthy, middle-aged people who suddenly can't find the car keys or recall a client's name, are looking for ways to counteract declining memory or lapses in focus and concentration. And some younger people are seeking an extra mental edge at school or work.
Some are turning to neuroenhancements, prescription medications such as Ritalin (normally used to treat attention deficit hyperactivity disorder) or Provigil (used for excessive sleepiness) that many say also enhance memory and cognitive skills. Some doctors are prescribing such drugs off-label, but many people are buying them on the Internet or from friends.
But more are buying brain supplements, which – unlike neuroenhancers – require no prescription and are more widely available. Brain supplement sales topped $410 million in 2008, a 7 percent increase from the year before, according to the Nutrition Business Journal, which tracks industry trends.
Though there are more than 50 brain supplements on the market, many contain the same ingredients, such as plant extracts ginkgo biloba (which has been discredited for any ability to improve memory) and huperzine A, or various vitamins and minerals.
Joshua Reynolds, a developer of Procera AVH whose photo appears in the ad, said he studied many extracts and nutrients before choosing huperzine A, an extract of the Chinese club moss plant; vinpocetine, an extract of the periwinkle flower; and acetyl-l-carnitine, a substance naturally found in the body. He said those three help oxygenate brain cells, restore diminished neurotransmitter levels and protect against environmental toxins that can damage the brain. He would not, however, say exactly how much of each ingredient is in his product.
But what the product's marketing lacks in specifics, it makes up in creativity. "The memory pill ingredient …'lights up aging brains like a Christmas tree!' " reads the Procera AVH ad, which appears in newspapers nationwide, including the St. Petersburg Times.
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Unlike drugs, the Food and Drug Administration isn't required to approve supplements for safety and effectiveness before they reach the consumer. The only thing manufacturers are required to report to the FDA is any new ingredients their products contain.
Nor do supplements have to reveal how much of the advertised ingredients they contain, a vital piece of information, says Dr. Glenn Whelan, a doctor of pharmacy at USF.
"Even if (a product) has benefit, it may get lost in the bath water because they didn't use the right dose," he said.
Huperzine A is a good example. Smith said USF was involved in a government study that found the moss extract had positive effects on memory, but only in daily doses of 400 micrograms. Procera AVH labeling doesn't specify how much huperzine A is in the product, only that it's part of a proprietary blend. Reynolds said in an interview that a daily dose of two to three pills contains between 75 and 200 micrograms of huperzine A.
The ad says Procera AVH was proven effective in a double-blind, placebo-controlled study by the Brain Sciences Institute at Swinburne University of Technology in Australia and published in JANA.
Note, however, that's not the same as JAMA, the well-respected Journal of the American Medical Association. JANA is the Journal of the American Nutraceutical Association.
Reynolds said Procera AVH would soon be the subject of a larger study conducted by the Brain Sciences Institute.
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Whelan said extracts such as huperzine A have only recently begun to be studied in clinical trials. And though small studies praised the healing effects of ginkgo biloba, one of the first large-scale trials — published in JAMA — found it does not delay or prevent memory decline.
Like many supplements, however, it is not harmless. Ginkgo is not recommended for people on blood thinners, as it can increase bleeding. And huperzine A can cause a variety of side effects, including raising blood pressure. It is not recommended for people with epilepsy, ulcers and lung conditions like asthma.
Without more definitive studies, Whelan worries that people who take brain supplements may be doing themselves more harm than good — either in side effects, or by not getting proper care.
"As people self-prescribe, diagnose and treat, they may be delaying an actual diagnosis of dementia or Alzheimer's," he said.
Richard Martin can be reached at firstname.lastname@example.org or (727) 893-8330. For more health news, visit tampabay.com/health.