Prevagen Review

Key Takeaways:

• Prevagen, one of several brain health supplements, contains the dietary ingredient apoaequorin, a jellyfish protein that has no relationship to age-related memory loss or brain function.
• Prevagen has a questionable track record and pushes false and misleading claims, preying on the fears of older consumers.
• Severe adverse events were left out of reporting to the FDA by the makers of Prevagen, prompting the filing of a lawsuit by the Federal Trade Commission (FTC).

Important note:

The content in this Prevagen review is not medical advice. No blog post or YouTube video should do this. Only your doctor knows you best – all of your medical problems, the medications you are taking, the monitoring they do with your blood work and labs, everything. I have done my best to give you my discerning view on this supplement based on verifiable facts gleaned from the internet and sound clinical research. I do not recommend you take this supplement, but if you choose to, please, for the sake of your health, talk to your doctor first.

Alright, now that I’ve said what I needed to, let’s get on with the Prevagen review…

Many older adults are concerned about the effects of aging on memory.

Specifically, there is anxiety and a real palpable fear among some middle-aged and older adults that they may develop cognitive impairment or Alzheimer’s disease.

The hope of staving off this decline, and maintaining a healthier brain and a sharper mind drives the highly profitable dietary supplement industry in the U.S.

Some examples are bacopa, vinpocetine, huperzine, etc. All of these have shown mixed, variable results.

The current scientific literature does not support the use of any of these supplements to assist in improving memory and learning.

Almost daily in my geriatric assessment clinic, my patients ask me about Prevagen, and whether it has convincing evidence that suggests it will help improve their memory.

When they do internet searches, they are presented with mixed information.

Some websites and posts suggest that the dietary supplement shows promising results and users experience significant cognitive benefits, while others list complaints associated with Prevagen.

This Prevagen review hopes to answer all of these questions and dive into some of the controversies surrounding this “memory” supplement.

So, does Prevagen lead to clearer thinking, help improve memory, and get you back to being “cognitively normal?” Let’s dive right in to find out…

Prevagen ingredients

Prevagen Regular Ingredient Label

 

Prevagen Extra Strength Ingredient Label

Prevagen Professional Strength Ingredient Label

The main ingredients in Prevagen are Vitamin D3 and a calcium-binding protein called apoaequorin, found in jellyfish

[Note: the apoaequorin found in Prevagen is synthetically produced in a lab, and this is what got the manufacturer in hot water with the Food and Drug Administration (FDA) because they were essentially marketing an unapproved new drug].

The strength of Vitamin D3 remains the same in all three formulations of Prevagen – 50 mcg (equivalent to 4000 units).

I am unsure why Vitamin D has been added to this supplement – there is no well-validated study that I know of that proves Vitamin D supplementation in healthy older adults improves cognition.

Apoaequorin, on the other hand, increases in strength accordingly based on the version of the product you are receiving.

Specifically, the Regular strength product contains 10 mg of Apoaequorin, the Extra Strength contains 20 mg, and the Professional Strength has 40 mg.

So, the logical question is, what is the relationship between apoaequorin and human brain function?

According to the brand, the general idea is that since the brain also contains calcium-binding proteins that play a crucial role in healthy brain function and other aspects of cognitive function, it stands to reason that taking apoaequorin may prevent damage to these brain cells and keep them healthy.

It then follows that consumers who take Prevagen may see a significant improvement in mild memory loss, purportedly, allowing consumers to lead a better life.

Maybe this might be so when this is done to cell cultures in dishes in the lab.

It is also important to note that the rat studies that showed positive results had researchers INJECT the apoaequorin directly into their brains!

We can safely say that no sane human would ask their doctor to inject this protein into their brain!

If injection into the brain is not an option, then the next logical step would be to take this protein orally.

However, this potential workaround presents one major and crucial problem: Apoaequorin, being a protein, would almost instantaneously be broken down and digested in the stomach into amino acids and peptides.

Hence, none of this protein would even make it out of the stomach intact to be transported to the brain, where it is supposed to have its positive effect.

The supplement manufacturer states that the active ingredient is broken down in the digestive tract in its much-hyped Madison Memory Trial!

Even if all of the above were not true, here’s another kicker: the apoaequorin protein is too big to pass through the natural barrier that keeps blood separate from the brain, and will fall short of entering the brain anyway!

So apart from the company’s own questionable trial, there are no peer-reviewed publications from reputable medical journals that prove that Prevagen improves memory, despite their seeming carefully worded language to suggest that they adhere to the scientific method.

For these reasons, medical experts widely agree that there is no known role for apoaequorin in improving human memory.

Is Prevagen FDA Approved?

No, it is not. The FDA does not regulate Prevagen because it is a dietary supplement. It is not intended to diagnose, treat, cure, or prevent any disease.

Prevagen Side Effects and Legal Troubles 

FDA Warning Letter

The FDA issued a warning letter to the manufacturer of Prevagen on October 16, 2012, stating that the company’s product claims violated FDA regulations.

Specifically, the agency stated that the company made false and unsubstantiated health claims that Prevagen is “clinically proven” to improve memory and cognitive function.

Additionally, the apoaequorin in Prevagen is produced synthetically in their lab, although the protein is originally found in jellyfish.

Hence, by federal regulations, it must be marketed as a drug, not as a dietary supplement.

No approval has ever been sought by the manufacturer to market Prevagen as a drug, which is a violation of federal law.

Since this tangle with the FDA, the manufacturer has changed the product labeling to include the words, “contains a bioengineered food ingredient.”

I don’t really think that makes things any easier…imagine knowingly putting something that is “bioengineered” into your body!

Additionally, the FDA found serious issues with adverse event (An adverse event is any undesirable experience associated with the use of a medical product in a patient) reporting by the supplement manufacturer. This is opposite to their statement asserting that their product is safe.

Polypharmacy in older adults can lead to severe adverse events, including hospitalization and premature death.

If you want to learn about the 5th leading cause of death in older adults, go here to read my article.

In the 2012 Prevagen FDA warning letter, it was noted that the company failed to report serious adverse events to FDA.

These events included seizures, strokes, and worsening symptoms of multiple sclerosis.

Some of these adverse events resulted in hospitalization for some users.

Specifically, the FDA found records of more than 1000 adverse events and product complaints reported by individuals between May 2008 and December 1, 2011.

The following serious adverse events were identified:

Heart arrhythmias (heart rhythm issues), chest pain, vertigo, tremors, and syncope (fainting), in addition to the seizures, strokes, and worsening of multiple sclerosis already mentioned.

Other potential side effects noted were constipation, headache, nausea, edema, and hypertension (high blood pressure).

None of these adverse effects are clearly mentioned on the Prevagen website.

The brand only investigated or reported two of these adverse events to the FDA at the beginning of the inspection.

FTC Lawsuit and Class Action Lawsuit

Accordingly, the FTC and the New York State Attorney General filed a lawsuit against the manufacturer.

In addition to this litigation, a class action lawsuit was filed, and a settlement agreement was reached on November 18, 2020.

Here’s a news story on the lawsuit against Prevagen:

Does Prevagen Work?

No, Prevagen does NOT improve memory.

We know from our discussion above that the company states that improvements in memory were reported after study participants were administered the supplement.

What the website failed to mention transparently on that page is that this study was company-sponsored.

In the Medical and Pharmacy world, red flags go up whenever we see the results of a company-funded study being reported in a favorable light.

This is because there will always be an inherent bias in the reporting of these studies.

The company’s main goal would be to maximize profits from the sales of its product and minimize any information that could be viewed in a negative light.

The company-sponsored study seeks to prove to the reader that Prevagen works very well.

There are graphs that show increases in “memory tasks” from 5% to 10% to 20% over 90 days.

As Dr. Robert Shmerling, Senior Faculty Editor at Harvard Health Publishing Health states, these numbers prove nothing.

He mentions that there is no context for these numbers – what exactly are they referring to?

How many participants were included in the analysis?

Were there any other details?

What about a follow-up after 90 days?

In addition to the above concerns, Dr. Shmerling also notes that the published version of this study didn’t show any benefit to participants’ memory.

So, to reiterate…does Prevagen Help Improve Memory? The overwhelming evidence from multiple sources is clear: It does not.

Summary of the “Clinical Trial” by the Manufacturer: The Madison Memory Study

218 adults between the ages of 40 and 91 participated in this company-sponsored randomized, double-blinded, placebo-controlled “Madison Memory Study.”

The study investigators’ primary objective was to assess apoaequorin’s effectiveness in improving memory and cognitive function.

The secondary objective was to assess the supplement’s effect on sleep, energy, and quality of life.

Study participants were randomly assigned to one of two groups.

One group received 10mg of apoaequorin, and the other received a placebo (a similar-looking pill with harmless, inactive filler material).

Before starting the trial, participants completed the AD8 Dementia Screening Interview and took the computerized Cog State Research Battery.

These tests were repeated again on days 8, 30, and 90.

Then, during the trial, the study participants were tested on their delayed recall (memory) and executive functioning (more complex tasks such as planning, and problem-solving when presented with an unexpected immediate problem).

The tools used to measure these were the Groton Maze Learning, and Groton Maze recall tasks.

Using these tools, the study investigators reported improvements in these areas.

Another tool, the International Shopping Recall List, was used to measure verbal learning (the process of acquiring, retaining, and recalling verbal material) and delayed recall.

The investigators concluded that Prevagen supplementation improved cognitive function in individuals who were cognitively normal or mildly impaired.

The Madison Memory Trial’s use of the above screening tests introduces major concerns about the robustness and clinical applicability of its results.

It is not common practice to use the Groton and International Shopping Recall tests in clinical practice to screen patients for memory decline.

I have never seen these tools being used in all of my time in clinical practice.

From a real-world, clinically relevant standpoint, more well-known and proven screening tests such as the Trail Making Test Part A and B and Montreal Cognitive Assessment (MoCA) are used instead in medical practices across the country.

The Madison Memory Trial’s methods of measuring sleep and quality of life were even more troubling.

The assessments contained very serious errors.

Firstly, this part of the assessment contained very few participants.

As such, the study authors inappropriately applied the results of this analysis to the larger population (basically saying their results represented what would happen if the rest of the country took Prevagen – BIG overreach!). In statistical and biomedical research speak, this is called “External Validity.”

Secondly, there was also a high degree of possible investigator bias.

This is because the study was of an open-label design (In which both the health providers and the patients know the drug or treatment is given).

This type of study design is inherently ripe for investigator bias, which may skew the results based on the investigators’ personal bias or feelings about the study.

Finally, there was no standardization of the assessment questions.

As we can imagine, the answers from the study participants could have been “all over the place,” which would then have been difficult to measure and interpret.

Do Pharmacists Recommend Prevagen?

The Pharmacy Times states that 73% of pharmacists recommend Prevagen as the #1 memory support brand.

As a clinical pharmacist, I am extremely skeptical about this claim and question this seemingly high number of endorsements by pharmacists.

It just does not make sense to me, knowing what I know about the profession.

Pharmacists don’t just overwhelmingly endorse an unproven dietary supplement to this high degree.

Personally, I would never recommend this supplement to anyone.

NONE of my geriatrician colleagues will do so as well.

Then…what about the Pharmacy Times’ bold statement about this product being a top pharmacist-recommended memory support brand?

The following will hopefully shine some light on this strong endorsement and give us some perspective – survey participants were asked to select from a predetermined list of options.

In other words, they could not write in their choices freely, but rather, were forced to choose one product over others.

So, we can see how the lack of autonomous answer picks could have skewed the results to Prevagen.

In my opinion, this supplement has earned its place in popularity due to an extensive national advertising campaign, promotional emails, and tv spots.

Sophisticated and targeted advertising efforts by the manufacturer have also helped drive sales favorably for Prevagen.

The video below shows a Neurologist reviewing this supplement and I am happy to see that my views align with hers:

 

Prevagen Cost

As of June 30, 2023, the prices listed on Amazon are as follows:

• $65.21 (Prevagen Regular Strength capsules 10 mg/60 capsules).
• $90.43 (Prevagen Extra Strength capsules 20 mg/60 capsules).
• $214.38 (Prevagen Professional Strength capsules 40 mg/30 capsules, 3-pack).

Dosing is one capsule of Prevagen to be taken once daily with or without food.

If we translate this to annual costs, the dollar amount comes to $391 – $858!

To many people, this is a lot of money that they don’t have.

Additionally, I have seen that the manufacturer keeps increasing the price over time.

I will have to keep coming back to this article every 2-3 months to update the pricing!

In my opinion, your money could be better used to pay for prescription medications, healthcare, food, and other vital daily expenses.

My alternative nootropic supplement recommendations

Hopefully, you have gained enough information from this Prevagen review to ascertain that this supplement should be avoided.

Instead, I recommend the following evidence-based supplements instead of Neuriva and Prevagen for short-term memory support and cognitive function: Mind Lab Pro, Panax Ginseng, Gingko Biloba, and MCT Oil.

Important note: Gingko and Ginseng may interact with certain prescription medications.

Always check with your doctor or pharmacist first to ensure it is safe to take the recommended supplements.

Full transparency: The products I recommend below are affiliate links. I may earn a small commission at no additional cost to you, should you decide to purchase from links on this page. Thank you for supporting my website so I can continue posting more useful content.

I recommend Mind Lab Pro, one of the world’s best-selling nootropic supplements.

It has 11 research-backed ingredients that target 6 brain pathways to improve cognition, short-term memory, neuroplasticity, and processing speed, among others.

It is the only full-stack nootropic available on the market.

Read my detailed Mind Lab Pro review where I cover everything you need to know about this amazing supplement.

MCT Oil

Another evidence-based ingredient I recommend is MCT oil.

I am especially proud to partner with Bubs Naturals, a supplement company created in honor of fallen Navy Seal Glen “Bub” Doherty, who gave his life defending his brothers in Benghazi, Libya on September 12, 2012.

The fine people at Bubs Naturals sell MCT oil, which has been shown to maintain or improve memory and cognitive function in over 80% of Alzheimer’s dementia patients after nine months of consistent use, according to this clinical study.

You can place your order on their official website by clicking this link. Scroll down halfway, and you will see the section on their MCT oil powder product to learn more.

Gingko Biloba

Gingko Biloba has likely been studied the most in clinical trials among the nootropics.

In this 2015 systematic review and meta-analysis published in the Journal of Alzheimer’s Disease, the authors concluded that Gingo Biloba extract favorably improved scores for cognition in patients with cognitive impairment and dementia.

Gingko Biloba has also been found to be effective for healthy brain function in younger, healthy adults.

A medical review published in the Journal of Psychopharmacology concluded that young adults saw improvement in their cognitive function and attention when they took the herb.

Herbal Roots Supplements is a supplement company I recommend highly.

Their products are derived from the whole herb and don’t contain any unnecessary fillers, additives, sugar, or binders.

If you would like to try out their Ginkgo Biloba, you can order from their official website at the link here.

Panax Ginseng

Panax Ginseng has been found to possibly decrease Alzheimer’s-related neuropathology and increase acetylcholine neurotransmitter expression in the brain, according to this medical review.

Herbal Roots supplements also carry Panax Ginseng.

If you’d like to order, you can click this link to be brought to the secure product page on its website.

Neuriva vs Prevagen

You have probably heard about Neuriva as well, another nootropic supplement.

I have written extensively about it in my Neuriva review article.

I encourage you to read it fully, as it contains important information about the manufacturer and their questionable practices and conduct.

The Neuriva brand settled an $8 million class action lawsuit in 2021 for falsely claiming that their product was “backed by science” and “clinically proven” to enhance brain performance without actually providing scientific or clinical proof to back up their claims.

Final Points from this Prevagen review

• Prevagen does NOT help with memory improvement.
• Prevagen has a questionable track record and pushes false and misleading claims.
• The maker of Prevagen left out severe adverse events in its reporting to the FDA.
• The apoaequorin used in your Prevagen has no relationship to memory or brain function.
• It is EXPENSIVE!!!
• It fails my “Mom” Test – I would never give it to my own Mother.

I hope you found this article helpful! Please be on the lookout for many more fact-based and well-researched posts related to geriatric pharmacy.