Introduction

Miracle drugs for diseases such as Alzheimer’s are heavily promoted in the news, in magazines and especially on the Internet. Several products claim to cure Alzheimer's and even prevent it from ever occurring.

Many of these products claim to be herbal or all natural. However, these claims do not mean the products are safe. In most cases there is not enough scientific evidence backing these products — neither proving their effectiveness nor disproving the existence of harmful side effects.

Products currently promoted as Alzheimer treatments include Ginkgo biloba, Hyuperzine A, Coenzyme Q10 and Phosphatidyl serine.

Ginkgo biloba

Ginkgo biloba is a plant extract containing several compounds that may have positive effects on cells within the brain and the body. Ginkgo biloba is thought to have both antioxidant and anti-inflammatory properties, to protect cell membranes, and to regulate neurotransmitter function. Ginkgo has been used for centuries in traditional Chinese medicine and currently is being used in Europe to alleviate cognitive symptoms associated with a number of neurological conditions.

In a study published in the Journal of the American Medical Association (October 22/29, 1997), Pierre L. Le Bars, M.D., Ph.D., of the New York Institute for Medical Research, and colleagues found ginkgo biloba to have a positive effect in individuals with Alzheimer’s disease.

This 52-week study initially involved 309 patients suffering from mild to moderately severe dementia, caused by either Alzheimer’s disease or multi-infarct dementia (MID, or vascular dementia). These patients were divided into two groups; participants in one group were administered 120 mg of ginkgo biloba extract each day, and participants in the second group received a placebo (sugar pill).

At the end of the study, data from only 202 of the participants were used to determine the efficacy of using ginkgo in the treatment of Alzheimer’s disease due to a significant dropout rate of participants during the course of the treatment. Participants were tested for improvement in cognition, daily living and social behavior, and overall impairment. Researchers found that modest improvements took place in cognition, activities of daily living (such as eating and dressing), and social behavior — but no measurable difference was noticed in overall impairment.

Results from this study show that ginkgo may help some individuals with Alzheimer’s disease slightly, but further research is needed in order to determine the exact mechanisms by which ginkgo works in the body. Also, results from this study are considered preliminary because of the low number of participants involved and methodological issues associated with the research.

Further study of ginkgo biloba is necessary to fully understand its potential therapeutic value in treating individuals with Alzheimer’s. Few side effects are associated with the use of ginkgo as a dietary supplement, although it is known to reduce the ability of blood to clot, potentially leading to more serious conditions, such as hemorrhaging. This possibility of hemorrhaging may increase if ginkgo biloba is taken in combination with other anticoagulants, such as aspirin.

The National Center for Complementary and Alternative Medicine of the U.S. National Institutes of Health has launched a large, multicenter study to determine if ginkgo biloba may help prevent Alzheimer's disease. Recruitment for this trial closed in 2002 and the trial will run for five years, so results will not be available until some time after 2007.

Huperzine A

Huperzine (HOOP-ur-zeen) is an herbal supplement derived from the club moss Huperzia serrata. It has been used for centuries in Chinese traditional medicine as a treatment for swelling, fever and blood disorders. Recent clinical trials in China have reportedly shown that huperzine also offers some benefit in Alzheimer’s disease.

Research suggests that huperzine A (HupA) functions as a cholinesterase inhibitor and that it may also have chemical properties that help protect nerve cells, but large-scale clinical trials are needed to confirm that huperzine is effective in treating Alzheimer’s disease. In spring 2004, the National Institute on Aging (NIA) launched the first U.S. trial of huperzine as a treatment for mild to moderate Alzheimer’s.

If trials document any benefit for huperzine, consumers will need access to a standardized formulation that offers consistent dosing and guaranteed purity.

Galantamine (Razadyne®, formerly Reminyl®), one of the FDA-approved cholinesterase inhibitors, was originally derived from the snowdrop Galanthus nivalis, although it is now made synthetically.

Pending results of large-scale trials, most experts recommend against use of huperzine A because there are cholinesterase inhibitors approved by the U.S. Food and Drug Administration (FDA) available. Under no circumstances should an individual who is already taking an FDA-approved cholinesterase inhibitor begin taking huperzine A in addition to the prescribed drug.

Omega-3 fatty acids

Omega-3s are a type of polyunsaturated fatty acid (PUFA). Research has linked certain types of omega-3s to a reduced risk of heart disease and stroke.

The U.S. Food and Drug Administration (FDA) permits supplements and foods to display labels with “a qualified health claim” for two omega-3s called docosahexaneoic acid (DHA) and eicosapentaenoic acid (EPA). The labels may state, “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease,” and then list the amount of DHA or EPA in the product. The FDA recommends taking no more than a combined total of 3 grams of DHA or EPA a day, with no more than 2 grams from supplements.

Research has also linked high intake of omega-3s to a possible reduction in risk of dementia or cognitive decline. The chief omega-3 in the brain is DHA, which is found in the fatty membranes that surround nerve cells, especially at the microscopic junctions where cells connect to one another.

A Jan. 25, 2006, literature review by the Cochrane Collaboration found that published research does not currently include any clinical trials large enough to recommend omega-3 supplements to prevent cognitive decline or dementia. But the reviewers found enough laboratory and epidemiological studies to conclude this should be a priority area for further research.

According to the review, results of at least two larger clinical trials are expected in 2008. The Cochrane Collaboration is an independent, nonprofit organization that makes objective assessments of available evidence on a variety of issues in treatment and health care.

Theories about why omega-3s might influence dementia risk include their benefit for the heart and blood vessels; anti-inflammatory effects; and support and protection of nerve cell membranes. There is also preliminary evidence that omega-3s may also be of some benefit in depression and bipolar disorder (manic depression).

A report in the April 2006 Nature described the first direct evidence for how omega-3s might have a helpful effect on nerve cells (neurons). Working with laboratory cell cultures, the researchers found that omega-3s stimulate growth of the branches that connect one cell to another. Rich branching creates a dense “neuron forest,” which provides the basis of the brain’s capacity to process, store and retrieve information.

See also the 2004 FDA press release announcing extension of the qualified health claim for omega-3s and coronary heart disease from supplements to foods.

Coenzyme Q10

Coenzyme Q10, or ubiquinone, is an antioxidant that occurs naturally in the body and is needed for normal cell reactions to occur. This compound has not been studied for its effectiveness in treating Alzheimer’s.

A synthetic version of this compound, called idebenone, was tested for Alzheimer’s disease but did not show favorable results. Little is known about what dosage of coenzyme Q10 is considered safe, and there could be harmful effects if too much is taken.

Phosphatidylserine

Phosphatidylserine (pronounced FOS-fuh-TIE-dil-sair-een) is a kind of lipid, or fat, that is the primary component of cell membranes of neurons. In Alzheimer’s disease and similar disorders, neurons degenerate for reasons that are not yet understood. The strategy behind the possible treatment with phosphatidylserine is to shore up the cell membrane and possibly protect cells from degenerating.

The first clinical trials with phosphatidylserine were conducted with a form derived from the brain cells of cows. Some of these trials had promising results. However, most trials were with small samples of participants.

This line of investigation came to an end in the 1990s over concerns about mad cow disease. There have been some animals studies since then to see whether phosphatidylserine derived from soy may be a potential treatment. A report was published in 2000 about a clinical trial with 18 participants with age-associated memory impairment who were treated with phosphatidylserine. The authors concluded that the results were encouraging but that there would need to be large carefully controlled trials to determine if this could be a viable treatment.

Coral calcium

“Coral” calcium supplements have been heavily marketed as a cure for Alzheimer’s disease, cancer and other serious illnesses. Coral calcium is a form of calcium carbonate claimed to be derived from the shells of formerly living organisms that once made up coral reefs.

In June 2003, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) filed a formal complaint against the promoters and distributors of coral calcium. The agencies state that they are aware of no competent and reliable scientific evidence supporting the exaggerated health claims and that such unsupported claims are unlawful.

“Coral” calcium differs from ordinary calcium supplements only in that it contains traces of some additional minerals incorporated into the shells by the metabolic processes of the animals that formed them. It offers no extraordinary health benefits. Most experts recommend that individuals who need to take a calcium supplement for bone health take a purified preparation marketed by a reputable manufacturer.