Memory and Brain Supplements: What the Evidence and the FTC Say

Memory is the faculty people most fear losing, and the supplement aisle knows it. This page sets out what the published evidence and the public regulatory record actually say about products sold for memory, focus and “brain health”: the jellyfish-protein pill that became the subject of a seven-year federal case, the phospholipid that was studied at one dose and is often sold at another, the vitamin that injures sensory nerves when taken by the hundred milligrams, the stimulant blends that hide their amounts — and the one decision that matters more than any of them: never trading a prescribed dementia medicine for a bottle. Brand names appear here only as the courts and agencies have recorded them, with the primary documents linked so you can read them yourself.

Table of Contents

  1. 1. Why “Brain” Supplements Sell
  2. 2. Apoaequorin (Prevagen): The Public Record
  3. 3. The Pharmacology Objection
  4. 4. Phosphatidylserine: Ingredient vs. Dose
  5. 5. Vitamin B6 Megadoses
  6. 6. Stimulant-Style “Nootropic” Blends
  7. 7. The Risk That Dwarfs the Others
  8. 8. What Actually Has Evidence
  9. 9. How to Read “Clinically Proven”
  10. 10. The Honest Bottom Line
  11. Research Papers
  12. Connections
  13. Featured Videos

1. Why “Brain” Supplements Sell

In AARP’s 2019 national survey, 26% of American adults aged 50 and over said they take at least one supplement for brain health. Figures cited by AARP’s Global Council on Brain Health put global sales of brain-health supplements at about $3 billion in 2016, projected to reach $5.8 billion by 2023; neurologists writing in JAMA in 2019 described a “$3.2-billion industry promoting brain health” built on print, radio, television and internet advertising aimed squarely at people who are frightened of dementia.

The same Global Council — an expert panel convened by AARP — reviewed the evidence for that money and reached a plain conclusion: it “could not endorse any ingredient, product or supplement formulation designed for brain health”, because “scientific evidence does not support the use of any supplement to prevent, slow, reverse, or stop cognitive decline or dementia.”

How can a product be sold for a purpose no expert body endorses? Because US law lets a supplement carry a “structure/function” claim such as supports memory without any pre-market review, provided the label adds the sentence you have seen a thousand times: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” (21 CFR 101.93). Nobody checks the claim before the bottle reaches the shelf. What polices it afterwards is the Federal Trade Commission’s advertising law and, occasionally, a state attorney general — which is how the best-known memory supplement in America ended up in front of a jury.

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2. Apoaequorin (Prevagen): The Public Record

What it is. Prevagen’s active ingredient is apoaequorin, a calcium-binding protein originally isolated from a jellyfish — the protein that makes the animal glow — and manufactured for the supplement by genetically engineered E. coli. The company’s theory, as described in the government’s complaint, is that swallowed apoaequorin reaches the brain and replaces calcium-binding proteins lost with age.

The company’s study. The claims rested chiefly on the Madison Memory Study, a company-run, placebo-controlled trial of 218 community-dwelling adults aged 40–91 with self-reported memory concerns, who took 10 mg of apoaequorin or placebo daily for 90 days and were tested on a battery of computerized cognitive tasks. Company authors published it in 2016 in Advances in Mind-Body Medicine, reporting improved verbal learning and recall on two of the tasks.

The complaint. On 9 January 2017 the FTC and the New York Attorney General sued Quincy Bioscience Holding Company, Inc., Quincy Bioscience, LLC, Prevagen, Inc., Quincy Bioscience Manufacturing, LLC, and two executives in the US District Court for the Southern District of New York. The complaint alleges 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”; that the researchers then ran “more than 30 post hoc analyses” of subgroups; and that “the few positive findings on isolated tasks for small subgroups of the study population do not provide reliable evidence of a treatment effect.” It alleges US sales of $165 million from 2007 to mid-2015, at $24.29 to $69.95 per 30-tablet bottle depending on strength and seller.

The road to trial. The district court dismissed the case on 28 September 2017. On 21 February 2019 the Second Circuit vacated that dismissal and sent the case back; in July 2019 the district court declined to dismiss it again (the claims against the company’s CEO were dismissed with leave to amend). By trial the FTC was seeking an injunction, not money.

The verdict. After a two-week jury trial in early 2024 before Judge Louis L. Stanton, the jury decided New York’s claims and the judge decided the FTC’s. Eight advertising statements were at issue, from “Prevagen improves memory” to “Prevagen is clinically shown to provide other cognitive benefits.” In the court’s own words (Memorandum and Judgment, 18 November 2024): “The jury found that none of those statements was supported by competent and reliable scientific evidence, and two of them (about reduction of memory problems with aging) were materially misleading. Each of them has a tendency to deceive.” The court also recorded that “there was no evidence that Prevagen, or the challenged statements, had actually caused harm or economic injury” and that the jury “acquitted all but the two aging memory statements of being materially misleading.” The judgment ordered the defendants to “immediately remove all the above statements (and any others similar to them)” from every form of Prevagen promotion.

The injunction. On 6 December 2024 the court confirmed that the injunction against all eight statements “takes effect forthwith and applies nationally wherever Prevagen is marketed,” held that the company had violated the FTC Act, noted that it had “continued to use the Challenged Statements after trial,” and — citing “the evidence that the defendants intended no harm” — declined New York’s request for penalties and disgorgement. The FTC’s Bureau of Consumer Protection issued a statement on the ruling on 10 December 2024.

Where it stands. The company appealed and New York cross-appealed on monetary relief; the Second Circuit heard argument on 26 February 2026 (No. 25-12). As of this page’s last check on 5 September 2026 no appellate decision had been published. Check the FTC’s case page (linked under Regulatory Records) for the current status before relying on any summary, including this one.

What this record does and does not say: it says the memory claims were found to lack competent scientific support and that two were materially misleading; it does not say the product is unsafe, and the court found no evidence of physical harm. What a buyer is paying for is a protein whose memory claims its maker is, as of the December 2024 order, barred from making.

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3. The Pharmacology Objection: A Swallowed Protein Is Food

The scientific objection to the apoaequorin theory is the same one that applies to any protein sold to “replace” a protein in an organ: the digestive tract is built to destroy proteins. Stomach acid and pepsin, then pancreatic enzymes in the small intestine, cut swallowed protein into amino acids and short peptides, which are absorbed as generic building blocks. Eating collagen does not deliver collagen to your knees, and eating a jellyfish protein does not deliver that protein to your neurons.

The company’s own safety assessment, published in 2014 by employees with university co-authors, tested apoaequorin in simulated gastric fluid and reported that it “is easily digested by pepsin, a characteristic commonly exhibited by many non-allergenic dietary proteins” — a finding offered as reassurance about allergy, not as a claim about the brain. The government’s complaint drew the obvious inference: the defendants “do not have studies showing that orally-administered apoaequorin can cross the human blood brain barrier,” and “to the contrary, Defendants’ safety studies show that apoaequorin is rapidly digested in the stomach and broken down into amino acids and small peptides like any other dietary protein.” New York’s summary of the 2024 trial evidence describes internal documents and FDA submissions “admitting that Prevagen is quickly digested and unlikely to reach the brain.”

To be fair to the argument on the other side: the case was decided on whether the advertising had adequate scientific support, not on biochemistry, and the company maintains its product works. But a reader deciding whether to spend money can apply the test themselves. A 10 mg dose of any protein is a tiny fraction of the protein in an ordinary meal, and it meets the same enzymes. For the claim to be true, apoaequorin would have to survive digestion intact, be absorbed intact, cross the blood-brain barrier intact and take up residence inside neurons — none of which has been shown in humans.

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4. Phosphatidylserine: A Studied Ingredient Is Not a Studied Dose

Phosphatidylserine (PS) is a phospholipid found in every nerve-cell membrane, and unlike most brain-supplement ingredients it has a real, if thin, trial literature. The FDA acknowledged as much in 2003 — and said exactly how thin. It agreed not to object to the label claim “Consumption of phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly” only if it is immediately followed, in identical type, by: “Very limited and preliminary scientific research suggests that phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly. FDA concludes that there is little scientific evidence supporting this claim.” A qualified health claim with a built-in retraction is the most honest sentence on the shelf; notice how rarely you see the second half printed.

The dose the studies used. A 2015 review of 127 papers (one author employed by a supplement maker, so read it as an industry-friendly summary) describes the human trials as using 300 to 800 mg of PS per day, typically 100 mg three times daily. Three hundred milligrams a day is the floor at which anything was ever tested.

The dose on the label. This is where “contains phosphatidylserine” parts company with “contains the phosphatidylserine that was studied.” Federal labelling rules (21 CFR 101.36(c)) let a manufacturer group ingredients into a proprietary blend and declare only the blend’s total weight, listing the ingredients inside it in descending order by weight with no individual amounts. A 400 mg “Memory Matrix” that lists PS last could, quite legally, contain a few milligrams of it. The reputation of the 300 mg trials is borrowed; the dose is not.

The label may not even be accurate. When Crawford and colleagues analysed 12 brain-health products chosen from 650 on the market, 8 of the 12 had at least one labelled ingredient that could not be detected, and 10 contained compounds not on the label at all. So the two questions to ask of any PS product are simple: how many milligrams of PS, stated separately, per day? And is it at least 300? If the answer is a blend total, the answer is no.

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5. Vitamin B6 Megadoses in “Brain” and “Energy” Formulas

Vitamin B6 is essential, cheap, water-soluble and therefore assumed harmless — which is why it turns up in “brain,” “energy,” “nerve support” and “stress” formulas at tens of milligrams, when an adult needs about 1.3 to 1.7 mg a day. It is one of the few vitamins with a well-documented nerve toxicity, and the documentation is forty years old.

The neuropathy record. In 1983 Schaumburg and colleagues reported in the New England Journal of Medicine seven adults with ataxia and “severe sensory-nervous-system dysfunction” after daily high-dose pyridoxine; their intakes, according to the Institute of Medicine’s account of the series, began at 50–100 mg a day and rose to 2–6 grams a day over months. Four were severely disabled. All improved after the vitamin was stopped. Muscle strength was spared: this is a disease of sensation and balance, which is exactly why it is missed.

The limits, and why they diverge. The US Tolerable Upper Intake Level, set in 1998, is 100 mg a day for adults — a no-effect level of 200 mg divided by an uncertainty factor of two. In 2023 the European Food Safety Authority re-examined the evidence, including pharmacovigilance reports and a case-control study, took 50 mg a day as its reference point, applied an uncertainty factor of four to reflect the “inverse relationship between dose and time to onset of symptoms,” and set the adult upper level at 12 mg a day. Both agencies agree that ordinary diets never approach the limit; the people who exceed it are, in EFSA’s words, “regular users of food supplements containing high doses of vitamin B6.”

Why a vitamin injures nerves. The 2021 review by Hadtstein and Vrolijk lays out the leading explanation: pyridoxine, the synthetic form in almost every supplement, is not itself active; it must be converted by the enzyme pyridoxal kinase, and at high concentrations pyridoxine inhibits that very enzyme. The result is a functional B6 deficiency inside sensory neurons — too much of the vitamin producing the effects of too little. The same review notes that modern nerve testing has detected damage at doses well below the gram-a-day cases of the 1980s.

The warning sign is numbness or tingling — in the feet first, then the hands, sometimes with burning pain or unsteadiness on the feet. Anyone with those symptoms should stop every product containing B6 and add up what they were taking: the energy shot, the B-complex, the multivitamin and the “nerve formula” each contribute, and a total above 12 mg a day is already above the European limit. Our Vitamin B6 Toxicity page covers symptoms, testing and recovery in detail.

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6. Stimulant-Style “Nootropic” Blends

A large share of what is sold as a “nootropic” or “focus” product is a stimulant stack: caffeine, often in an undeclared amount, plus L-tyrosine, hordenine and a rotating cast of plant extracts, usually inside a proprietary blend. The feeling of sharper focus is real and comes mostly from the caffeine; the risks come from the amounts you cannot see and the drugs you may already be taking.

Caffeine. The FDA cites 400 mg a day — “about two to three 12-fluid-ounce cups of coffee” — as an amount not generally associated with negative effects in healthy adults, and warns that pure and highly concentrated caffeine products “can have serious health consequences, including death.” A blend that lists “caffeine anhydrous” inside a 1,200 mg proprietary total tells you nothing about whether a serving holds 50 mg or 300 mg, and nothing about how it adds to your coffee.

Hordenine is an alkaloid from barley — the compound a 2017 study proposed as a contributor to beer’s mood-lifting effect after finding it activates dopamine D2 receptors in laboratory assays. That paper is now quoted on supplement labels as if it were a human trial; it is not. A 1989 pharmacology study found that hordenine is broken down by monoamine oxidase B but not by the MAO-A of the gut wall, so it is absorbed intact and, in animal tissue, boosted the effect of noradrenaline. That profile is the reason for two cautions: anyone taking an MAO inhibitor (a drug that blocks the enzyme that would clear it) and anyone on blood-pressure medication should treat hordenine-containing blends as off-limits, because its dose-response in people has never been studied.

L-tyrosine is the amino acid the body turns into dopamine and noradrenaline. A 2015 review of the human studies concluded that it can help cognitive performance in short, acutely stressful situations when those transmitters are temporarily depleted, but that its potential for treating clinical conditions “seems limited.” It is not a memory nutrient, and people on MAO inhibitors should ask a pharmacist before taking gram doses of a catecholamine precursor. See our Tyrosine page.

Unapproved drugs. The most serious finding in this category is that some “cognitive enhancement” supplements contain pharmaceuticals. Cohen and colleagues bought ten products whose labels named racetam-class drugs and found omberacetam and aniracetam, along with three drugs not declared at all — phenibut, vinpocetine and picamilon. A single serving could deliver up to 40.6 mg of omberacetam against a typical pharmacological dose of 10 mg; 9 of the 12 declared quantities were wrong; and one product could expose a user to four unapproved drugs at once. Any ingredient ending in -racetam is a drug, and phenibut is covered on our Sedatives, Phenibut and Kratom page.

If a focus product brings on a racing heart, chest pain, severe headache or agitation, treat it as a stimulant overdose: call 911 for chest pain or fainting, and Poison Control at 1-800-222-1222 for anything else, with the bottle in hand.

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7. The Risk That Dwarfs the Others: Replacing a Prescription With a Supplement

Nothing on this page — not the B6, not the stimulants — does as much damage as a quiet decision made in thousands of kitchens: a person with mild cognitive impairment or early dementia, or the family member managing their pills, stops donepezil, rivastigmine, galantamine or memantine in favour of a supplement that promises the same thing “naturally” and without side effects. It is worth being precise about what is being given up.

What the drugs do. The Cochrane review of cholinesterase inhibitors pooled 13 randomized, placebo-controlled trials and found that six to twelve months of treatment improved cognition by an average of 2.7 points on the 70-point ADAS-Cog scale (95% CI 2.3 to 3.0), with benefits also seen in clinicians’ global ratings, daily activities and behaviour — and the reviewer added, honestly, that “none of these treatment effects are large.” For memantine in moderate-to-severe Alzheimer’s, the 2019 Cochrane review found high-certainty evidence of a small benefit: about 3 points on the 100-point Severe Impairment Battery, a modest gain in daily function and behaviour, and slightly more dizziness (6.1% versus 3.9%); in mild disease it probably makes no difference.

What stopping costs. The DOMINO-AD trial randomized people with moderate-to-severe Alzheimer’s who were already on donepezil to continue or to stop. Those who continued scored 1.9 points higher on the Standardised Mini-Mental State Examination and 3.0 points better on a scale of daily-living abilities than those who stopped. Modest numbers — but they are the difference between managing at home a little longer and not, and they were lost by the people who stopped.

What no supplement has. No supplement has a Cochrane review of placebo-controlled trials in diagnosed dementia showing a benefit of any size. The Global Council on Brain Health could not endorse one. The best-known memory supplement’s own trial was run in people with self-reported memory concerns, not dementia, and a federal court found its claims unsupported. The most-studied herbal candidate, ginkgo, was tested at 120 mg twice daily in a large trial of older adults with normal cognition or mild impairment and did not reduce the incidence of dementia or Alzheimer’s disease. A supplement can be added alongside a prescription after a conversation with the prescriber; it cannot replace one. If you are the person who fills the pill organiser, that conversation is the most useful thing you can do this week.

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8. What Actually Has Evidence for an Ageing Brain

The honest answer to “what can I do for my memory?” is unglamorous, mostly free, and better supported than anything in a capsule. The Lancet Commission on dementia concluded in 2020 that 12 modifiable risk factors — less education, hearing loss, hypertension, smoking, obesity, depression, physical inactivity, diabetes, excess alcohol, traumatic brain injury, air pollution and social isolation — together account for about 40% of dementia cases. Its 2024 update added two more, high LDL cholesterol in midlife and untreated vision loss in later life, and raised the estimate to about 45%; hearing impairment and high LDL are the largest single contributors, at roughly 7% each.

Hearing. In the ACHIEVE trial, 977 older adults (mean age 77) with untreated hearing loss were randomized to hearing aids and audiology support or to a health-education programme. Over three years, cognitive decline did not differ in the group as a whole — but in the prespecified analysis of the higher-risk cohort (older, more vascular risk factors, lower baseline scores) the hearing intervention significantly slowed decline. Read that as: correcting hearing may protect the people most at risk, and it certainly restores hearing. See Hearing Loss and Hearing Aids.

Blood pressure. SPRINT MIND followed 9,361 adults with hypertension treated to a systolic target below 120 mmHg or below 140. Intensive control cut the rate of mild cognitive impairment (14.6 versus 18.3 cases per 1,000 person-years; hazard ratio 0.81) and of impairment-or-dementia combined; the reduction in probable dementia alone (hazard ratio 0.83) did not reach significance in a trial that was stopped early. See Hypertension.

Exercise, diet and mental activity together. The Finnish FINGER trial gave 1,260 at-risk adults a two-year programme of diet, exercise, cognitive training and vascular-risk monitoring; the intervention group’s cognitive scores improved significantly more than the control group’s, and the commonest adverse event was sore muscles. See Exercise.

None of these is dramatic. All of them are real, replicated and safe, and every one costs less than a month of a memory supplement.

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9. How to Read a “Clinically Proven” Claim

The FTC’s standard for a health claim is “competent and reliable scientific evidence”: research “conducted and evaluated in an objective manner by experts” and “generally accepted in the profession to yield accurate and reliable results.” Its 2022 guidance says randomized, controlled human trials “are generally the type of substantiation that experts would require for health benefit claims,” that marketers “must have at least the level of support that they claim to have,” and that a post hoc analysis departing from the study’s protocol “doesn’t generally provide reliable evidence to substantiate a claim.” You can apply the same tests at the shelf:

  1. Who ran it and who paid? Look up the authors’ affiliations. A company-run study is not worthless, but it needs independent replication before it is “proof.”
  2. Was it published, where, and when? A trial whose results appear years later in a small journal — or only on the company’s website — has not been through the scrutiny the word “clinical” implies.
  3. Was it registered before it started? Trials such as SPRINT MIND and FINGER were registered on ClinicalTrials.gov with the primary outcome named in advance. Registration is what stops the goalposts moving.
  4. Did the whole group improve on the main outcome? If the headline number comes from a subgroup found after the fact, remember the FTC’s complaint alleging more than 30 post hoc analyses behind a single chart.
  5. How big is the effect, in units you understand? A prescription dementia drug moves the ADAS-Cog by 2.7 points out of 70. A supplement ad rarely gives a number at all; “improved” is not a size.
  6. Does the chart match the paper? At the 2024 trial, testimony concerned a bar graph “prominently displayed” in advertising that “selectively and misleadingly displayed certain data” from the study.
  7. Is the ingredient there at the studied dose? Section 4. A proprietary blend hides the answer.
  8. Read the small print literally. “This statement has not been evaluated by the Food and Drug Administration” means exactly that. And before buying any product sold for memory, search the FDA’s Health Fraud Product Database, linked below.

Note that “clinically shown” was the phrase at the centre of the Prevagen litigation: four of the eight enjoined statements begin with it.

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10. The Honest Bottom Line

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Research Papers

  1. Hellmuth J, Rabinovici GD, Miller BL. The Rise of Pseudomedicine for Dementia and Brain Health. JAMA. 2019;321(6):543-544. doi:10.1001/jama.2018.21560 — neurologists describe a “$3.2-billion industry” marketing unproven brain-health products to people frightened of dementia.
  2. Mehegan L, et al. 2019 AARP Brain Health and Dietary Supplements Survey. AARP Research. 2019. doi:10.26419/res.00318.001 — 26% of US adults aged 50+ take at least one supplement for brain health.
  3. Moran DL, Underwood MY, Gabourie TA, Lerner KC. Effects of a Supplement Containing Apoaequorin on Verbal Learning in Older Adults in the Community. Adv Mind Body Med. 2016;30(1):4-11. PMID 26878676 — the company-authored Madison Memory Study: 218 adults, 10 mg apoaequorin vs placebo for 90 days; the trial at the centre of the FTC case.
  4. Moran DL, Tetteh AO, Goodman RE, Underwood MY. Safety assessment of the calcium-binding protein, apoaequorin, expressed by Escherichia coli. Regul Toxicol Pharmacol. 2014;69(2):243-249. doi:10.1016/j.yrtph.2014.04.004 — the company’s own safety study: apoaequorin “is easily digested by pepsin.”
  5. Glade MJ, Smith K. Phosphatidylserine and the human brain. Nutrition. 2015;31(6):781-786. doi:10.1016/j.nut.2014.10.014 — narrative review of 127 papers; the human studies used 300–800 mg/day.
  6. Crawford C, et al. A Public Health Issue: Dietary Supplements Promoted for Brain Health and Cognitive Performance. J Altern Complement Med. 2020;26(4):265-272. doi:10.1089/acm.2019.0447 — of 12 brain-health products analysed, 8 lacked a labelled ingredient and 10 contained undeclared compounds.
  7. Schaumburg H, Kaplan J, Windebank A, Vick N, Rasmus S, Pleasure D, Brown MJ. Sensory Neuropathy from Pyridoxine Abuse. N Engl J Med. 1983;309(8):445-448. doi:10.1056/NEJM198308253090801 — seven adults with ataxia and severe sensory neuropathy from high-dose B6; all improved after withdrawal.
  8. Hadtstein F, Vrolijk M. Vitamin B-6-Induced Neuropathy: Exploring the Mechanisms of Pyridoxine Toxicity. Adv Nutr. 2021;12(5):1911-1929. doi:10.1093/advances/nmab033 — pyridoxine inhibits pyridoxal kinase, starving sensory neurons of active B6; damage detected at lower doses than once assumed.
  9. EFSA Panel on Nutrition, Novel Foods and Food Allergens (Turck D, et al.). Scientific opinion on the tolerable upper intake level for vitamin B6. EFSA J. 2023;21(5):e08006. doi:10.2903/j.efsa.2023.8006 — adult UL set at 12 mg/day from a 50 mg/day reference point and an uncertainty factor of 4.
  10. Sommer T, Hübner H, El Kerdawy A, Gmeiner P, Pischetsrieder M, Clark T. Identification of the Beer Component Hordenine as Food-Derived Dopamine D2 Receptor Agonist by Virtual Screening a 3D Compound Database. Sci Rep. 2017;7:44201. doi:10.1038/srep44201 — hordenine activates D2 receptors in laboratory assays; a beer-chemistry paper, not a human trial.
  11. Barwell CJ, et al. Deamination of hordenine by monoamine oxidase and its action on vasa deferentia of the rat. J Pharm Pharmacol. 1989;41(6):421-423. doi:10.1111/j.2042-7158.1989.tb06492.x — hordenine is a selective MAO-B substrate, escapes gut MAO-A, and potentiated noradrenaline in animal tissue: the basis of the MAOI and blood-pressure cautions.
  12. Jongkees BJ, Hommel B, Kühn S, Colzato LS. Effect of tyrosine supplementation on clinical and healthy populations under stress or cognitive demands—A review. J Psychiatr Res. 2015;70:50-57. doi:10.1016/j.jpsychires.2015.08.014 — tyrosine helps only in short-term stress when catecholamines are depleted; clinical potential “seems limited.”
  13. Cohen PA, Avula B, Wang YH, Zakharevich I, Khan I. Five Unapproved Drugs Found in Cognitive Enhancement Supplements. Neurol Clin Pract. 2021;11(3):e303-e307. doi:10.1212/CPJ.0000000000000960 — omberacetam, aniracetam, phenibut, vinpocetine and picamilon in ten products; 9 of 12 declared quantities inaccurate.
  14. Birks J. Cholinesterase inhibitors for Alzheimer’s disease. Cochrane Database Syst Rev. 2006;(1):CD005593. doi:10.1002/14651858.CD005593 — 13 RCTs; cognition improved by 2.7 ADAS-Cog points at 6–12 months; “none of these treatment effects are large.”
  15. McShane R, Westby MJ, Roberts E, Minakaran N, Schneider L, Farrimond LE, Maayan N, Ware J, Debarros J. Memantine for dementia. Cochrane Database Syst Rev. 2019;3(3):CD003154. doi:10.1002/14651858.CD003154.pub6 — small but high-certainty benefit in moderate-to-severe Alzheimer’s; probably none in mild disease.
  16. Howard R, et al. Donepezil and Memantine for Moderate-to-Severe Alzheimer’s Disease. N Engl J Med. 2012;366(10):893-903. doi:10.1056/NEJMoa1106668 — DOMINO-AD: continuing donepezil preserved 1.9 SMMSE points and 3.0 BADLS points versus stopping it.
  17. DeKosky ST, et al. Ginkgo biloba for Prevention of Dementia: A Randomized Controlled Trial. JAMA. 2008;300(19):2253-2262. doi:10.1001/jama.2008.683 — 120 mg twice daily did not reduce the incidence of dementia or Alzheimer’s disease.
  18. Livingston G, Huntley J, Liu KY, Costafreda SG, et al. Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission. Lancet. 2024;404(10452):572-628. doi:10.1016/S0140-6736(24)01296-0 — 14 modifiable risk factors linked to about 45% of dementia cases; updates the 2020 report’s 12 factors and 40% (doi:10.1016/S0140-6736(20)30367-6).
  19. Lin FR, Pike JR, Albert MS, et al. Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial. Lancet. 2023;402(10404):786-797. doi:10.1016/S0140-6736(23)01406-X — no overall difference at 3 years; significant slowing of decline in the higher-risk cohort.
  20. Williamson JD, Pajewski NM, Auchus AP, et al.; SPRINT MIND Investigators. Effect of Intensive vs Standard Blood Pressure Control on Probable Dementia: A Randomized Clinical Trial. JAMA. 2019;321(6):553-561. doi:10.1001/jama.2018.21442 — intensive control reduced mild cognitive impairment (HR 0.81); probable dementia HR 0.83, not significant.
  21. Ngandu T, et al. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015;385(9984):2255-2263. doi:10.1016/S0140-6736(15)60461-5 — 1,260 at-risk adults; a small but significant cognitive benefit from the combined programme.

Regulatory Records

  1. FTC. FTC, New York State Charge the Marketers of Prevagen With Making Deceptive Memory, Cognitive Improvement Claims. Press release, 9 January 2017. ftc.gov
  2. FTC and People of the State of New York v. Quincy Bioscience Holding Company, Inc., et al., No. 17 Civ. 124 (S.D.N.Y.). Complaint for Permanent Injunction and Other Equitable Relief, filed 9 January 2017 (paragraphs 20 and 28–31 quoted above). ftc.gov (PDF)
  3. US Court of Appeals for the Second Circuit. Summary Order vacating the dismissal and remanding, 21 February 2019. ftc.gov (PDF)
  4. US District Court, S.D.N.Y. (Stanton, J.). Memorandum and Judgment, 18 November 2024 (Dkt. 513) — the eight challenged statements and the jury’s findings. ftc.gov (PDF)
  5. US District Court, S.D.N.Y. (Stanton, J.). Order, 6 December 2024 — nationwide injunction confirmed; penalties and disgorgement denied. ftc.gov (PDF)
  6. FTC. Statement on FTC’s Win in Lawsuit Against the Makers of Dietary Supplement Prevagen, 10 December 2024. ftc.gov
  7. FTC. Quincy Bioscience Holding Company, Inc. — case page with the full docket timeline; check here for the status of the Second Circuit appeal (argued 26 February 2026). ftc.gov
  8. New York Attorney General. Attorney General James Wins Trial Against Quincy Bioscience for Deceptive and Fraudulent Advertising of “Memory Improvement” Supplement Prevagen. Press release, 8 May 2024. ag.ny.gov
  9. FDA. Qualified Health Claims: Letters of Enforcement Discretion — Phosphatidylserine and Cognitive Dysfunction and Dementia, 13 May 2003. fda.gov (index); archived letter text (the original FDA page has been retired; this is the agency’s own archive copy).
  10. FTC. Health Products Compliance Guidance, December 2022 — the “competent and reliable scientific evidence” standard. ftc.gov
  11. 21 CFR 101.36(c) — proprietary blends: total weight declared, individual amounts not required. ecfr.gov. 21 CFR 101.93(c) — the mandatory “not been evaluated by the FDA” disclaimer. ecfr.gov
  12. Institute of Medicine. Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline (1998), chapter 7, Vitamin B6 — UL of 100 mg/day for adults. ncbi.nlm.nih.gov (NCBI Bookshelf)
  13. FDA. Spilling the Beans: How Much Caffeine Is Too Much? Consumer update. fda.gov
  14. FDA. Health Fraud Product Database — search any product before buying. fda.gov
  15. AARP Global Council on Brain Health. The Real Deal on Brain Health Supplements (2019) — the “could not endorse any ingredient, product or supplement formulation” conclusion and the market figures cited above. aarp.org

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