They are an ever-growing field of medications and supplements known as Nootropics (cognitive enhancers and smart drugs) that continue to be marketed to seniors in this country. Nootropics is a compound word that gained traction by those peddling natural "brain" medications as far back as 1972 by combining two Greek words ‘nous’ which means mind, and ‘tropos’ which means to bend or turn. For this blog, we will focus on over-the-counter Nootropics or supplements that target older adults and those experiencing mild cognitive impairment (MCI).
"We are all looking for a way to battle Alzheimer's disease and other dementias," said certified elder law Attorney RJ Connelly III. "Unfortunately, the nootropics industry thrives due to the increasing prevalence of Alzheimer's disease and its lack of effective treatments. The companies that market these products prey on older American's fear of dementia and charge, in some cases, the same as a week's worth of groceries for a bottle of a supplement that has no clinical proof that it works."
The Memory Booster Craze
We’ve all seen them in stores and heard them advertised on television, promising increased cognitive abilities, and the ability to boost memory. The ads all tout the same thing, that their product “keeps your mind sharp and memory strong with an ingredient that’s clinically proven to improve memory and recall in healthy adults. It’s powered by the #1 clinically studied ingredient for memory among leading brain health supplements.”
Pay attention to the last sentence in this claim – “powered by the #1 clinically studied ingredient for memory among leading brain health supplements.” Notice it doesn’t say the #1 “proven” supplement, it says #1 clinically "studied" ingredient. Read it fast and it looks impressive. And then comes this disclaimer at the bottom of each advertisement, "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease and results may vary. Testimonial results are not typical. Customers may have received a gift certificate after submitting their testimonial."
Now put those statements into context and maybe, just maybe, that bottle of instant cognition is not as good as the ad makes it sound. But with the greying of America and an ongoing focus on Alzheimer's and other types of dementia, why would those selling these supplements waste time with the truth when there is real cash to be made? So, are these OTC nootropics effective and are older adults really buying into this craze? The answer is yes.
"But with the graying of America and an ongoing focus on Alzheimer's and other forms of dementia, why would those selling these supplements waste time on the truth when there is real cash to be made."
According to a 2019 survey conducted by the American Association of Retired Persons (AARP), nearly one in four adults over the age of fifty are taking brain supplements for health reasons making them a multi-billion-dollar industry that continues to grow at a rapid pace, with a quarter of our seniors spending hundreds if not thousands of dollars annually to ward off cognitive decline as they age. There are several dangers in this, most importantly, putting off a visit to the doctor when such symptoms present in favor of these modern-day snake oil products when medical treatment, at an early stage of cognitive decline, could offer some help.
According to multiple medical journals, a review of studies to date has found no good evidence that such products can prevent or even delay the onset of memory lapses, MCI, or dementia in older adults.
Some of the most widely touted supplements or ingredients contained in these supplements have been studied for their effectiveness. These include fish oils (omega-3 fatty acids), B vitamins such as folate, B6 and B12, Ginkgo Biloba extract, made from the leaves of the gingko tree, ginseng and more. And what were the findings?
For Gingko Biloba, a study of nearly 3000 adults, as cited in Lancet Neurology, who presented with memory complaints were given a dose of Ginkgo Biloba twice a day for five years. The findings? Those who took this extract had no fewer cases of Alzheimer's than those who took the placebo (a pill with no active or study ingredients).
What about the fish oil? There have been some studies that found that diets high in Omega-3 fatty acids may lower the risk of developing dementia, but a review of those studies found that thousands of older adults who took Omega-3 fatty acid supplements had no fewer dementia diagnoses or better scores on tests of short-term memory than those who took a placebo.
B vitamins also offered little in the way of protection. A 2015 review of studies found that supplementation with B6, B12, and/or folic acid failed to slow or reduce the risk of cognitive decline in healthy older adults and did not improve brain function in those with cognitive decline or dementia.
Some of these supplements that sneak in under the FDA regulations, have been shown to contain unlisted and unapproved pharmaceuticals that were not even listed on the label. Dr. Pieter Cohen, an associate professor at the Harvard School of Medicine, stated, "we don’t know how these drugs will affect human health, in some cases, there is a mixture of drugs combined in the same product that have never been tested together.”
Not only did these supplements contain unapproved drugs, but some of those that made the ingredient list were found to be almost three times the amount listed. “The thing about every compound, regardless of where it comes from, is that too much can kill you,” Cohen stated. “Even caffeine, one of the safest compounds, can kill you if the dose is high enough.”
Using a mass spectrometer, a machine that identifies the ingredients in a compound, Cohen and his team found some troubling results. One of those unlisted pharmaceuticals, picamilon, is a drug that is approved in other countries to block seizures, another, phenibut, is approved in Russia and is also an antiseizure medication. and, said Cohen, is known to be addictive.
Then came a recent study of a large number of so-called nootropic supplements for the actual amounts of B vitamins, omega-3 fatty acids, vitamin D, caffeine, coenzyme Q10, and Ginkgo Biloba that were contained in the product. What came about in the study, however, was a finding that some of the products contained a drug called piracetam which is not permitted in to be in supplements in the United States due to harmful side effects.
"Piracetam is approved for prescription use in Europe [for dementia], however, it has been associated with adverse psychological and physiological effects including depression, anxiety, insomnia, and weight gain."
Piracetam is approved for prescription use in Europe, where the typical daily dose for someone with dementia is 2,400 to 4,800 milligrams (mg), however, it has been associated with adverse psychological and physiological effects including depression, anxiety, insomnia, and weight gain. Because they require a prescription, such side effects can be monitored and managed by providers, but when included in unregulated OTC supplements without any medical oversight, problems occur.
Side Effects and Interactions
There are a lot of unknowns for these supplements, particularly when they’re being used at potentially higher doses than have been studied and, as we wrote earlier, without the supervision of a physician.
Large doses of some vitamins, minerals and even some herbs can cause side effects, such as nausea, diarrhea, constipation, fainting, headaches, seizures, heart attack, or stroke, and even lead to liver or kidney damage. Products that contain melatonin can offer their own dangers as it is not recommended for those with dementia due to the “risk of increased falls or other adverse events.”
Perhaps, the most important concern when it comes to senior health is to be aware that the use of some dietary supplements that are contained in nootropics may also have harmful interactions with prescription medications that could prevent them from working as they should. Here are some examples:
BLACK COHOSH - Black cohosh has been shown to reduce the effectiveness of such drugs like amiodarone, fexofenadine (Allegra), glyburide, and many statin medications.
CURCUMIN - A single study showed that curcumin could cause decreased levels of many antidepressant and antipsychotic medications and has also been shown to increase sulfasalazine (Azulfidine) levels.
GARLIC - Garlic extract has been shown in human studies to decrease concentrations of colchicine, digoxin, doxorubicin (Adriamycin), quinidine, rosuvastatin (Crestor), tacrolimus (Prograf), and verapamil should not be combined with other garlic supplements.
GINKGO - Ginkgo is known to inhibit platelet aggregation, which could theoretically increase bleeding risk, especially in combination with antiplatelet or anticoagulant drugs such as warfarin.
GOLDENSEAL- Goldenseal has been shown to inhibit two major metabolic enzymes which are responsible for the metabolism of more than one-half of currently used pharmaceutical agents (Goldenseal has been a favorite of those abusing certain drugs to "pass" a urine test, although the effectiveness is in doubt).
GREEN TEA EXTRACT - Green tea extract has been investigated for the ability to increase simvastatin (Zocor) concentrations and inhibit the transport of many medications, including statins, fluoroquinolones, some beta-blockers, and antiretrovirals.
KAVA KAVA - Kava Kava has been shown to inhibit the metabolizing of many nonsteroidal anti-inflammatory drugs, angiotensin receptor blockers, glipizide (Glucotrol), glyburide, rosiglitazone (Avandia), valproic acid (Depakene), warfarin, proton pump inhibitors, phenytoin (Dilantin), and clopidogrel (Plavix). Caution should also be exercised in patients using central nervous system depressants, such as benzodiazepines or alcohol, because of the increased risk of drowsiness and motor reflex depression.
ST. JOHN'S WORT - St. John's Wort has been shown in multiple human studies to reduce concentrations of cyclosporine (Sandimmune), tacrolimus, warfarin, protease inhibitors, irinotecan (Camptosar), theophylline, digoxin, venlafaxine, and oral contraceptives.
GINSENG - Caution advised about concomitant use with phenelzine (Nardil), warfarin (Coumadin), oral hypoglycemics, insulin, or caffeine, and about use in patients with hypertension or bleeding.
As for the Food and Drug Administration (FDA), they do not treat supplements like prescription medication and therefore manufacturers are not held to the rigorous clinical trials that are required to prove the claims they make. Many supplements are not tested for accuracy of the ingredients that are stated on the bottle nor do they have the need to prove through legitimate scientific methods that their products work period.
The Prevagen Story
One of the most advertised nootropic has been Prevagen, which is still being widely advertised today. The makers of this supplement claim that they use an additive from jellyfish that they claim has been shown to be a "known memory booster". This led the United States Federal Trade Commission (FTC) and the New York Attorney General to file suit against Quincy Bioscience, a Wisconsin based company, for false advertising.
At that time, the FTC issued the following statement, "The Federal Trade Commission and New York State Attorney General have charged the marketers of the dietary supplement Prevagen with making false and unsubstantiated claims that the product improves memory, provides cognitive benefits, and is clinically shown to work. The extensive national advertising campaign for Prevagen, including TV spots on national broadcast and cable networks such as CNN, Fox News, and NBC, featured charts depicting rapid and dramatic improvement in memory for users of the product."
The FTC gave Quincy Bioscience a chance to prove that their product worked, but they were unable to do so. The company accused the FTC of "overreach in an attempt to close down small business." Quincy Bioscience has also resorted to some research double-speak to keep their product on the market. Despite all these issues, the company continues to market Prevagen and reap millions of dollars in profits from uneducated and gullible consumers.
In 2019 on Connelly Law's Southcoast Seniors Radio Show, which appeared on Providence's WPRV, our guest was Dr. John Stoukides, a renowned Alzheimer’s disease researcher and the Director of Geriatrics at Roger Williams Medical Center in Providence, RI and the medical director and lead researcher at Rhode Island Mood & Memory Research Institute. When he was asked about these products, he was quite clear, “Save your money,” he said. Instead, Dr. Stoukides stated that older individuals would do better by “adopting healthier lifestyles, including exercise and eating a more nutritious diet”.
A Healthier Lifestyle
While we continue to look to the researchers who are doing the real work of finding ways to combat an aging brain and conditions like Alzheimer's disease, there are things we can do that have a real impact on our cognitive health. Let's look at them.
Diet - Nutrition is one of the best ways to protect your brain. A diet rich in produce with healthy oils from olive oil, nuts and seeds and fatty cold-water fish. Dark leafy greens, as well as orange and red fruits and other vegetables.
Watch your Alcohol Use - Excessive alcohol can increase the risk of cognitive decline.
Exercise - Regular exercise has been strongly associated with the prevention of cognitive problems. It is recommended that we get about three hours of exercise weekly. This includes weight bearing and aerobic work.
Sleep. Being sleep-deprived is linked to cognitive decline, so get your rest.
Being with others - Easy to say after the COVID issues and we will find out what this isolation did to American of all ages very soon, but for now, try to spend time with others and limit isolation.
Don't Let Your Health Go - Chronic health problems like Type 2 diabetes and high blood pressure can increase the chances of cognitive decline and dementia. To lower your risk, work with your doctor to manage any illnesses.
"Here's the bottom line, to date, scientific evidence does not support the use of any supplement to prevent, slow, reverse, or stop cognitive decline or dementia or other related neurological diseases," said Attorney Connelly. "Many of these unproven and costly 'remedies' pass quickly through the kidneys and into the toilet, prompting many medical providers in other parts of the globe to say, 'Americans have the most expensive urine in the world', save your money and buy vegetables or a gym membership."