Dietary supplements make up a ubiquitous, $40 billion industry. Some of the 50,000 different types of supplements out there claim to improve your mood, energy, vitamin levels and overall health. And some supplements, like Prevagen, bank on the population of people living with dementia or Alzheimer’s.
Some 5.8 million people in the U.S. have Alzheimer’s, a number that is expected to swell to 14 million by 2050. At a time when the population affected by these diseases is growing, some supplement manufacturers claim they can protect people against memory loss, and even delay dementia and Alzheimer’s.
Prevagen is one of the most popular supplements and says it can help protect against mild memory loss, boost brain function and improve thinking. But is there any truth to these claims? We spoke with experts to find out.
What Is Prevagen?
Dr. Marwan Sabbagh is Medical Director at the Cleveland Clinic Lou Ruvo Center for Brain Health. He says that countless numbers of patients buy supplements like Prevagen, and often come to him asking if these products can help them with memory loss.
“As a clinician, I get asked about supplements a lot — it’s one of the most common things I’m asked about,” Sabbagh said. “There’s a huge gap of knowledge. Patients are going to the Internet, and there is no objective peer-reviewed data on these supplements. And what the physician side is lacking is guidance to the lay audience about supplements.”
Prevagen is a dietary supplement manufactured by Quincy Bioscience, a biotechnology company based in Madison, Wisconsin. On its website, the company says it focuses on “the discovery, development and commercialization of novel technologies to support cognitive function and other normal health challenges associated with aging.”
A bottle of Prevagen can cost from $24.29 to nearly $70, depending on the type (Prevagen Regular Strength, Prevagen Extra Strength, Prevagen Professional) and where you buy it. It’s sold online, at health stores and even pharmacies like Duane Reade, CVS and Walgreens.
Efficacy of Prevagen and Alzheimer’s Supplements
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 relied heavily on the purported cognitive benefits of apoaequorin, an ingredient in Prevagen and a protein found in jellyfish.
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, there have been no objective, peer-reviewed studies to confirm or replicate these results, says Joanna Hellmuth, a neurologist at the University of California San Francisco (UCSF) Memory and Aging Center. And this tends to be the case for other dietary supplements that claim to help brain health.
“Supplement manufacturers are legally allowed to make misleading claims that may not have the greatest degree of scientific integrity. This is not something an academic researcher would stake her career on,” Hellmuth said in an interview with Being Patient.
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.”
Regulating Supplements for Cognitive Health
The looseness around supplement advertising has to do with the Food & Drug Administration (FDA) regulations surrounding the dietary supplement industry. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), it’s illegal for supplements to claim they prevent, treat or cure any diseases. Supplements are allowed, however, to declare that they can help certain functions. For example, claims like “clinically proven to help memory” are legal and aren’t regulated.
“The regulatory requirement for a supplement is much lower [than a prescription drug],” Sabbagh said. “[Supplements] all have to pass the standard called generally recognized as safe, or GRAS. They’re not required by law to show efficacy, and they are not allowed by law to make claims of therapeutic benefits. They’re not allowed to treat specific diseases or conditions. They can, however, comment on treating symptoms or things like that. It’s a very grey area.”
Recently, however, the FDA pledged to bolster regulation of dietary supplements. In February 2019, the FDA also cracked down on a variety of supplement manufacturers that were illegally claiming to treat dementia and Alzheimer’s.
And Prevagen in particular came under the radar when, 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. (Read the latest on that lawsuit and settlement here.)
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.” Still, the complaint reads, Quincy Bioscience “widely touted the Madison Memory Study in their advertising.”
When asked for comment, a spokesperson for Quincy Bioscience stated: “Prevagen is regulated as a dietary supplement and therefore we cannot comment on any potential benefits related to disease. Prevagen is intended for people that are experiencing mild memory loss related to aging. Beyond that we have no further comment.”
Even though manufacturers of these supplements like Quincy Bioscience don’t always claim that their products can stop or prevent diseases, the information they do provide can be confusing to patients, Hellmuth says.
“Supplements are allowed to say, ‘This is clinically proven to help memory,’ and not allowed to say, ‘clinically proven to prevent Alzheimer’s,’” Hellmuth said. “But the average consumer may not be able to tell the difference.”
She says that she’s trying to stop the confusion out there by educating her own patients about how misleading supplement advertising can be.
“We have to spend a lot of time educating patients about these issues,” Hellmuth said. “We try to have an honest scientific conversation about what data there are on efficacy.”
Patients diagnosed with dementia or Alzheimer’s, or people whose loved ones are diagnosed, are often desperate for answers and solutions. Hellmuth says this may play a role in why many people purchase supplements that may give them a glimmer of hope, even if there’s no evidence behind them.
“People are scared and willing to spend money, and want to alleviate their fears,” Hellmuth said. “A lot of people ask, ‘Could it hurt?’ The counter-argument is that it’s not medically, financially or ethically benign if people are being misled about the scientific data.”
What she tries to tell patients instead, is that certain lifestyle changes do have research supporting their benefits for cognitive health.
“There is some evidence that lifestyle interventions can put people at lower risk for developing cognitive issues,” Hellmuth said. “Exercise has been shown to lower rates of developing dementia. I recommend that my patients exercise two and a half hours a week based on the American Heart Association recommendations. We also know that controlling risk factors for cerebrovascular disease — like blood pressure, cholesterol and not smoking — that those can reduce your risk as well.”
Sabbagh echoes Hellmuth’s advice about lifestyle changes. And when it comes to supplements, he will simply tell patients that he believes they are safe, but that the data about their efficacy is unproven.
“Physicians are evidence-based, and until these [products] are studied objectively, it’s hard to make recommendations around them,” Sabbagh said.
He also hopes that someday, the supplement industry will be more rigorously regulated.
“Being unregulated, [manufacturers] are really kind of bending the rules of acceptability,” Sabbagh said. “I think you would see that a more structural regulatory pathway would cause a lot of supplement companies to go out of business. But I think this is an area, for the sake of public safety, that should be regulated more.”