About 5.8 million people in the U.S. have Alzheimer’s disease, and this number is expected to swell to 14 million by 2050. Numerous older adults are concerned about memory loss. Many Americans, including four out of five older adults, routinely use dietary supplements, such as vitamins, minerals, or herbs. The dietary supplement market is now an industry worth more than $40 billion, with more than 50,000 different products available to consumers.
Have you seen the commercial for Prevagen? The bottle promises it “improves memory” and “supports: healthy brain function, sharper mind, clearer thinking.” As a speaker on memory and brain health, I am often asked whether this supplement is effective. People search the Internet, but there is little to no objective peer-reviewed data on these supplements. Physicians also often lack guidance for educating their patients about supplements.
According to advertisements the main ingredient in Prevagen, apoaequorin, is a protein found in the Aequorea Victoria jellyfish. People are led to believe that taking apoaequorin may prevent the decline in memory and thinking skills that occurs normally with age and may improve memory, but there is no good scientific evidence to support its use for these or other conditions. Transporting a calcium binder such as apoaequorin to brain neurons in the human body has many challenges. After being ingested, it must first travel from the digestive tract into the blood, then through the blood without binding to calcium. And finally, it must cross the blood-brain barrier. But apoaequorin is a rapidly digested protein, and in the stomach, the digestive enzyme pepsin breaks down proteins. The result is that side effects from Prevagen, including interactions with drugs or other nutrients and other health risks, are rare. However, rapid digestion also inhibits apoaequorin from ever reaching the brain, which means it is not likely to stop memory loss or provide other brain health benefits.
In 2016, Quincy Bioscience published a self-funded report known as the Madison Memory Study, which claimed to provide evidence for the benefits of Prevagen. The study asserted that “Prevagen demonstrated the ability to improve aspects of cognitive function in older participants with either normal cognitive aging or very mild impairment.” However, the research cited to supposedly prove its efficacy was published in an obscure journal, was done by employees of the company, and used unreliable analysis methods. There have been no objective, peer-reviewed studies to confirm or replicate their results, according to Joanna Hellmuth, a neurologist at the University of California San Francisco (UCSF) Memory and Aging Center. This tends to be the case for other dietary supplements that claim to help brain health.
In January 2017, the Federal Trade Commission (FTC) and New York State Attorney General charged Quincy Bioscience with making false and unsubstantiated claims about their product. The complaint stated that the Madison Memory Study “failed to show a statistically significant improvement in the treatment group over the placebo group on any of the nine computerized cognitive tasks.” In the legal filings, Quincy Bioscience was accused of selectively reporting data and misleading the public by claiming that Prevagen is “clinically proven” to improve cognitive function, and yet still widely touting the Madison Memory Study in their advertising. In a January 2019 article published in JAMA, Hellmuth and two other doctors wrote: “No known dietary supplement prevents cognitive decline or dementia, yet supplements advertised as such are widely available and appear to gain legitimacy when sold by major U.S. retailers.”
In 2020, a separate class action lawsuit against the company was settled. The settlement benefits individuals who purchased one or more Prevagen products from Quincy Bioscience or an authorized retailer between Jan. 1, 2007 and July 21, 2020. According to the lawsuit, the marketing and advertising representations on these products deceived consumers into thinking that their brain health and memory loss would be helped by taking the supplements. Quincy Bioscience did not admit any wrongdoing but agreed to resolve the claims against them by providing cash refunds to eligible Class Members. People who qualify for the class should visit www.QuincyBioscienceSettlement.com for the forms to complete to join the suit.
Part of the problem with supplements is the loose guidelines for advertising. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), it is illegal for supplements to claim they prevent, treat or cure any diseases. Supplements are not required by law to show efficacy, but they are allowed to declare that they can help certain functions. Supplements may not be labelled with statements like, “clinically proven to prevent Alzheimer’s,” but are allowed to use statements like, “clinically proven to help memory.” The issue is that consumers may be misled by the wording in the advertising, or may be so frightened about the prospect of possibly developing memory problems that they take a supplement with the hope that it will help.
In February 2019, the FDA cracked down on a variety of supplement manufacturers that were illegally claiming to treat dementia and Alzheimer’s. Consumers are advised to be cautious when considering taking any supplements, and may wish to consult their physicians to be sure the supplements will not have adverse side effects or interact negatively with other medications they are taking.