Regulating Supplements For Cognitive Health
The looseness around supplement advertising has to do with the Food & Drug Administration regulations surrounding the dietary supplement industry. Under the Dietary Supplement Health and Education Act of 1994 , its 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 arent regulated.
The regulatory requirement for a supplement is much lower , Sabbagh said. all have to pass the standard called generally recognized as safe, or GRAS. Theyre not required by law to show efficacy, and they are not allowed by law to make claims of therapeutic benefits. Theyre not allowed to treat specific diseases or conditions. They can, however, comment on treating symptoms or things like that. Its 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 Alzheimers.
And Prevagen in particular came under the radar when, in January 2017, the Federal Trade Commission and New York State Attorney General charged Quincy Bioscience with making false and unsubstantiated claims about their product.
The Tv Commercials And Advertisements About Supplements Seem So Real And Believable Why Should I Be Cautious
There are a number of people publishing testimony saying I’m so much sharper now that I’m taking this. That’s anecdotal. They’re prone to placebo response, which is a real response. If I give you an expensive pill and convince you it’s going to work, the odds are you will see it as working. I’m not saying they’re lying. They’re being honest. They feel like they’ve gotten better. The critical thing is to look at scientific studies. Remember, the Dietary Supplement Health and Education Act of 1994 exempted diet supplements and vitamins from supervision by the Food and Drug Administration . So, they are not controlled by the FDA the way prescription drugs are, and they don’t have to test these things. They don’t have to submit them to scientific study. The key is to look for the scientific evidence.
Find and book the expert care you need in seconds
Tags: ,,,
Cholinesterase Inhibitor And Glutamate Regulator Drug Combination
This combination of donepezil and Namenda is available under the brand-name prescription drug Namzaric.
Additional evidence suggests combining the two classes of drugs is more effective than using only one medication.
The researchers note that while it is superior to single drug therapy, it can complicate treatment plans for patients and their caregivers.
Don’t Miss: Does Stress Make Dementia Worse
The Fda Takes A Stand
Fortunately, the FDA does take note of false claims that go too far. On Feb. 11, 2019, Scott Gottlieb, the FDA commissioner, announced a plan to modernize regulation and oversight of dietary supplements. Key points include:
- notifying the public promptly if a dietary supplement is illegal or dangerous and should not be consumed
- ensuring flexible regulations to evaluate safety while encouraging development of new products
- creating a consortium of leading scientific minds from industry, academia, and government to improve safety evaluations of dietary supplements
- taking strong actions against makers of illegal products, including those making false claims or containing impurities or ingredients not listed on the label .
Is Prevagen Fda Approved
No, Prevagen is not approved by the Food and Drug Administration. The Food and Drug Administration does not regulate the supplement industry. Supplement companies know this its why theyre able to use questionable science to sell substandard products to unwitting consumers. So long as products like Prevagen do not claim to treat actual medical conditions or serious health problems, the FDA cannot regulate them.
You May Like: Is Alzheimer’s A Psychiatric Illness
Does It Pass My Mom Test
So, back to the original question: Does Prevagen Really Help Improve Memory or reduce cognitive decline? Would I give this supplement to my own mom?
Absolutely Not!
I believe that Prevagen provides no real benefit whatsoever to improving memory and learning.
From an efficacy standpoint, the company-sponsored study, as analyzed above, does not prove this to be so.
From a safety standpoint, it is a supplement, not regulated by the FDA.
More importantly, the companyâs lack of transparency about reporting adverse effects is deeply troubling.
Good News For Old Drugs
Another recent study shows drugs already recommended for AD, the cholinesterase inhibitors, slow cognitive decline and lower mortality for up to five years following diagnosis. The work is from the Karolinska Institute and published in Neurology.
Acetylcholine is a neurotransmitter that functions in memory, attention, and concentration. In AD, an enzyme breaks the neurotransmitter down too quickly inhibiting the enzyme keeps more of the needed molecule in brain synapses, facilitating neuron-to-neuron crosstalk. Three such drugs are galantamine, donepezil, and rivastigmine.
Studies so far have followed too few patients for too little time to demonstrate efficacy, but the Swedish investigation compared 11,652 patients treated with the drugs to 5,826 untreated patients, for five years from diagnosis. The drugs were associated with slower cognitive decline and 27% lower mortality.
You May Like: Does Meredith Have Alzheimerâs
Read Also: Was Ist Der Unterschied Zwischen Demenz Und Alzheimer
What Is Memantine And How Does It Work
Memantine is a prescription drug used to treat moderate to severe confusion related to Alzheimerâs disease. It does not cure Alzheimerâs disease, but it may improve memory, awareness, and the ability to perform daily functions. This medication works by blocking the action of a certain natural substancein the brain that is believed to be linked to symptoms of Alzheimerâs disease.
- Memantine is available under the following different brand names: Namenda XR, and Namenda.
But Thats Not What The Companys Own Study Showed
According to the Federal Trade Commission , which charged Quincy Bioscience with false and deceptive advertising last January, the company study found that Prevagen was no more effective than a placebo at improving any of the nine cognitive skills, including memory, that the company measured.
So how can the company claim otherwise?
Because Quincy Bioscience went back and sliced and diced the results, performing more than 30 additional analyses of the data, and came up with three results that were statistically significant .
Its these three positive results that Quincy Bioscience touts as evidence that Prevagen is a breakthrough for helping with mild memory problems associated with aging.
Don’t Miss: What Are The Stages Of Frontotemporal Dementia
Are Vitamin B6 And B12 Supplements Helpful
Common B vitamins, which were identified early on as possibly having something to do with memory, are popular. Its understandable why people think B12 has something to do with memory because we advise doctors to check a B12 level on anyone with dementia. It turns out studies have failed to show that there’s ever been a case of someone with dementia caused by low B12. We advise doctors to check it because people who have dementia frequently don’t eat right, and frequently become deficient in B12, which has all kinds of other problems like anemia and spinal cord problems. That can be easily fixed.
We tell doctors to look for it not because the B12 causes memory problems, but because it’s something common in people who have memory problems. Studies have failed to show that supplementing B vitamins actually does any good. It doesn’t help memory in the short run and it doesn’t decrease the risk of dementia in the long run.
Increase Omega 3 Fats
Deficiencies in essential fats are common in people with autism. Research by Dr Gordon Bell at Stirling University has shown that some autistic individuals have an enzymatic defect that removes essential fats from brain cell membranes more quickly than it should10. This means that autistic individuals are likely to need a higher intake of essential fats. It has been found that supplementing EPA, which can slow the activity of the defective enzyme, has clinically improved behaviour, mood, imagination, spontaneous speech, sleep patterns and focus in autistic individuals. There have since been clinical trials testing omega-3 supplementation, which have found that when individuals with autism were given omega-3 supplements, improvements in symptoms such as hyperactivity, social ability, concentration, irritability and aggression were reported 11,12.
Read Also: Do Blood Tests Show Dementia
Mind The Gap Between Graphics And Reality
As “proof” of power, a bar graph shows a rise from 5% to 10% to 20% over 90 days in “recall tasks.” But theres no way to know what these numbers refer to, how many people were studied, or other important details. And no information is provided about effects on memory after 90 days. The fine print under the graph says that the supplement “improved recall tasks in subjects” without explaining what this means. While a company-sponsored study reported improvements in memory after people took apoaequorin, the demonstrated minimal improvement 30157-2/fulltext” rel=”nofollow”> here).
The US Federal Trade Commission wasnt convinced of the supplements benefits. It charged the supplement maker with false advertising back in 2012. In the legal filings, the company was accused of selectively reporting data and misleading the public though claims that Prevagen is “clinically proven” to improve cognitive function. The lawsuit has not yet been decided.
What Quincy Bioscience Did Is Called A Post Hoc Analysis
This is an after-the-fact, unplanned exploration of the data to see if anything else of interest happened in the trial. Some might call it a fishing expedition. Scientists do this all the time, but with a big caveat: post hoc results are considered tentative, not conclusive. Before theyre accepted as valid outcomes, they need to be confirmed by additional studies.
Thats because random events happen all the time in scientific studies. Some of them may seem statistically significant, but theyre flukes and not the result of cause-and-effect. And the more post hoc analyses you do , the more likely youll encounter these chance results.
Scientists guard against accepting them as real by setting a high bar for statistical significance and by not accepting post hoc findings until theyve been tested again.
But if Quincy Bioscience tested Prevagen again, it hasnt said so.
Recommended Reading: Is Dementia Short Term Memory Loss
Thioflavin T Fluorometry Studies
The effects of different memory-support dietary supplements/products and cats claw extracts to disaggregate/reduce pre-formed A 142 fibrils and tau protein tangles, was determined using a previously described method of quantitative Thioflavin T fluorometry,,. Using this sensitive quantitative assay, any decreases or increases in fluorescence correlated with an increase or decrease in the amount of A fibrils or tau protein tangles present, allowing one to determine the extent of potential inhibitors and reducers of A amyloid fibrils and/or tau protein tangles,.
For the studies involving A fibrils, 22 µM of A 140 or A 142 was incubated in 96-well assay plates at 37 °C for 13 days either alone or in the presence of increasing amounts of memory-support dietary supplement products and/or cats claw bark powder extracts . The A:test compound ratios studied were usually 34 increasing concentrations at 1:0.001, 1:0.01, 1:0.1 and 1:1 ratios on a weight-to-weight basis. No real solubility issues of dietary supplement products were observed due to the high dilutions used from stock solutions.
Where Does The Blue Light From Apoaequorin Come From
Overview Information Apoaequorin is a protein that comes from a specific type of jellyfish that glows. When apoaequorin is exposed to calcium, the protein and calcium bind and a blue light is produced. Apoaequorin is a protein that was originally discovered in the jellyfish species Aequorea victoria.
You May Like: Can Dementia Be Seen On A Brain Scan
What Are The Side Effects Of Prevagen
There are a few mild side effects that may occur as a result of using the product. For example, apoaequorin may lead to symptoms like headaches, nausea, or dizziness. Less commonly, anxiety and difficulty sleeping .
Vitamin D only has side effects if you take too much. These may include headache, dry mouth, loss of appetite, nausea, vomiting, fatigue, weakness, sleepiness, or a metallic taste .
Is There A Lawsuit Against Prevagen
Yes, there is a lawsuit against Prevagen. Quincy Bioscience has been sued multiple times over allegations of false advertising for Prevagen, including by the US government. After hearing about the lawsuits against Prevagen, Prevagen users say they felt like their worst nightmareof losing their memorieshad been exploited by Quincy.
Also Check: Can Kidney Failure Cause Dementia
Fda Curbs Unfounded Memory Supplement Claims
- By Robert H. Shmerling, MD, Senior Faculty Editor, Harvard Health Publishing
I must have seen the commercial for Prevagen 50 times. Perhaps youve seen it, too: âYou might take something for your heart your joints your digestion. So why wouldnt you take something for the most important part of you your brain? With an ingredient originally found in jellyfish! Healthier brain, better life!â
Like many heavily-advertised supplements, this one makes many claims. The bottle promises it âimproves memoryâ and âsupports: healthy brain function, sharper mind, clearer thinking.â Never mind that the main ingredient in jellyfish has no known role in human memory, or that many experts believe supplements like this would most likely be digested in the stomach and never wind up anywhere near the brain. Oh, and the commercial doesnt mention any risks of treatment or cost .
But does this supplement actually do what it says? If it doesnt, how can the manufacturer make these claims? And if apoaequorin is so great, why arent jellyfish smarter, as a colleague of mine wonders?
You May Like: What Is The Difference Between Dementia And Senility
Alzheimer’s Disease Biospecimen Resource
The use of human biospecimens plays a key role in accelerating scientific discoveries in neurological research by providing scientists with a direct experimental model system to advance understanding of pathogenesis and treatment of neurological disease, including Alzheimers disease and related dementias . Access to the appropriate human biospecimen can be challenging for some investigators. To address thus gap, NDRIs Human Tissue and Organs for Research Resource Program was recently awarded an administrative supplemental grant from the National Institute on Aging to support Alzheimers Disease and AD-related dementia studies that require whole brain and other tissues for their experimental analysis.
The ADBR program can tailor acquisition of both whole brain and other tissue samples to meet the specific needs of each research project. The ADBR can provide tissue types for a wide range of experimental needs. This includes:
- Fixed tissue, frozen tissue, or fresh tissue shipped on ice in culture media with antibiotics
- CNS and PNS structures whole brain, brain tissue samples, spinal cord, dorsal root ganglia, peripheral nerves
- Tissues from any body system
- Samples from both AD/ADRD and non-diseased, control donors are available
Don’t Miss: How To Persuade Someone With Dementia
What Other Information Should I Know
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Help And Advice For Carers
If you care for someone with dementia, you may find it helpful to read more about:
Carer’s breaks and respite care this can allow you to take breaks from caring
Benefits for carers such as allowances and tax credits that may be available
Page last reviewed: 05 March 2020 Next review due: 05 March 2023
Recommended Reading: Can Cbd Help With Dementia
Do Pharmacists Really Recommend Prevagen
According to Prevagen, 73% of pharmacists who recommend memory support products, recommend Prevagen. This is of course not true at all pharmacists do not really recommend Prevagen. Quincy Bioscience obviously polled specific pharmacists to get this figure, if they reall asked any pharmacists at all. Pharmacists do not recommend supplements, especially supplements like Prevagen that lack scientific backing!
Be Sure To Take Your Vitamins And Memory
If youre serious about the prevention of Alzheimers and improving memory loss, you should definitely take a high potency multiple vitamin and mineral capsule. Be sure the vitamin formula you choose contains folic acid and vitamin C. Folic acid reduces homocysteine levelshigh homocysteine levels put you at risk for both heart disease and memory loss. Vitamin C has been shown to reduce your risk of Alzheimers disease by 20% when taken with vitamin E. To take advantage of its fullest benefits, you should take a dose of 2,000 mg of vitamin C per day.
When you create a balanced diet that puts your overall wellbeing at the forefront, youre not only doing good for your body, but youre also supporting and enhancing your memory as well.
Consider including the following memory-specific nutrients in your daily vitamin plan:
Discover our latest research update in the Summer 2014 White Paper.
Also Check: Can You Die From Alcohol Dementia
The Facts Behind 5 Supplements
Collagen.Collagen, is one of the most abundant proteins in the body and helps form our skin, bones, muscles, tendons and ligaments. As we age, we naturally start reducing its production. Some studies show that taking collagen supplements can reduce signs of aging, increase bone density and improve joint, back and knee pain. But many of these studies are small and funded by the companies behind such products, increasing the opportunity for bias. Certain products also have flaws that reduce the likelihood of their efficacy: Topical creams, for example, are unlikely to make it into the deeper level of the skin where collagen is produced.
Magnesium.Though low levels of magnesium have been associated with various sleep disorders, the evidence for the benefits of taking it for better sleep in supplemental form is thin. In fact, most people already have sufficient levels of the mineral, which helps support immune health, blood sugar regulation, and nerve and muscle function. Magnesium is easy to get in foods including nuts, greens, seeds, beans, yogurt and fish.
Vitamin B6.This essential nutrient is involved in a number of chemical reactions that are important for the proper functioning of the immune and nervous systems. As with the other essential vitamins, the body cannot produce B6 on its own, so you can only get it from foods or supplements. Most healthy adults get more than enough vitamin B6 from their diets alone, so B6 supplements are generally not needed.