reptides / piracetam

piracetam

Piracetam has a narrow, supported use for cortical myoclonus. The broad memory story is far weaker: tiny old healthy-person signals, fragile methods, and a 676-person one-year mild-cognitive-impairment trial that found no benefit.

Small-molecule racetam

  • Two small high-dose crossover studies support adult cortical myoclonus; one first selected apparent responders.
  • The 676-person N01001 trial found no cognitive benefit at 4.8 or 9.6 g/day after one year.
  • Healthy-person learning signals came from tiny 1970s studies; one intended crossover could not be used because of carryover.
  • Piracetam is cleared mainly unchanged in urine, and the UK label flags renal dosing, bleeding risk and abrupt withdrawal in myoclonus.
Use and identity Myoclonus trials Healthy cognition Challenge models MCI and dementia Stroke Surgical cognitive decline Language and dyslexia Chinese combination trial Mechanism and longevity Risks and withdrawal Product quality Other racetams

What is piracetam used for?

Piracetam is the parent racetam. The UK Nootropil label covers adult cortical myoclonus alongside other antimyoclonic medicines.

The labeled product is a 1,200 mg tablet, with supervised high daily doses for myoclonus. That indication does not establish a studying, IQ, mood or longevity benefit. The United States has no approved piracetam drug and has pursued unapproved-drug distribution.

Nootropil UK product information

Approved product information

ADVANZ Pharma. Nootropil 1200 mg SmPC. Updated July 1, 2025.

Adult cortical myoclonus is the stated indication. The record describes renal elimination, bleeding cautions, contraindications, and the risk of abrupt discontinuation.

Participants / model
Adults with cortical myoclonus
Study design
UK prescribing information

A UK indication does not establish a US approval or broad cognitive benefit.

Read the original source
PubChem: piracetam chemical identity

Government chemical identity database

National Library of Medicine. PubChem CID 4843.

C6H10N2O2; molecular weight 142.16 g/mol.

Participants / model
Chemical record
Follow-up
Living database
Study design
Curated structure record

Formula and molecular weight establish the recorded structure, not the contents of a retail product or an effective dose.

Read the original source
FDA: unapproved racetam distribution case

Official enforcement record

US FDA / US Department of Justice. Arizona company and CEO plead guilty to distribution of drugs not approved by FDA. 2023.

The case identifies piracetam, aniracetam, coluracetam, and phenylpiracetam among unapproved drugs marketed online.

Participants / model
United States distribution
Follow-up
2023
Study design
Official case record

This establishes the named US enforcement history, not every country’s status or a quantified rate of injury.

Read the original source

How strong is the cortical-myoclonus evidence?

Two small placebo-controlled crossover studies found less myoclonus and disability at high oral doses. The result supports the narrow indication, with serious design limits.

Brown enrolled 24 into an open run-in. One left after suspected pulmonary embolus, two failed to respond, and 21 entered and completed the blinded crossover. Total score improved from 66.3 on placebo to 52.4 on piracetam, a median 22.2% change (p=0.002); ten needed rescue on placebo and none on piracetam.

All 21 were thought to benefit during run-in, yet blinded outcomes classified six as nonresponders. Nineteen continued other drugs, there was no washout, and placebo periods were shorter because of rescue.

In Unverricht-Lundborg disease, 18 eligible participants showed better composite, motor and functional scores at 24 g/day. Handwriting and stimulus sensitivity were null. Each condition lasted two weeks without washout.

Effectiveness of piracetam in cortical myoclonus.

Primary human randomized study

Brown P et al. Movement Disorders. 1993. PMID 8419809. DOI 10.1002/mds.870080112.

Among 21 apparent run-in responders, total myoclonus score improved by a median 22.2%; 10 needed rescue during placebo and none during piracetam.

Participants / model
21 adults with cortical myoclonus who entered after an open run-in; 19 continued other antimyoclonic drugs
Follow-up
Planned 14-day periods without washout; placebo periods shortened by rescue
Study design
Double-blind placebo-controlled crossover after responder-enriched run-in
Funding
UCB funded the study; two authors reported consultancy relationships.

Twenty-four entered run-in: one left after suspected pulmonary embolus, two failed to respond, and 21 completed crossover. Six of those 21 were later controlled-phase nonresponders.

Read the original source
Piracetam in Unverricht to Lundborg progressive myoclonus epilepsy.

Primary human randomized study

Koskiniemi M et al. Journal of Neurology, Neurosurgery & Psychiatry. 1998. PMID 9527146.

At 24 g/day, piracetam improved the composite myoclonus, motor and functional-disability scores; lower doses also improved function.

Participants / model
20 people with Unverricht-Lundborg disease; 18 in the balanced efficacy analysis
Follow-up
Two weeks per condition without washout
Study design
Double-blind placebo-controlled dose crossover on stable background treatment
Funding
UCB funded the study; one author reported consultancy.

Small, short and background-medication-dependent; handwriting and stimulus sensitivity did not clearly improve.

Read the original source

Does piracetam improve memory in a rested healthy person?

The evidence is old, tiny and inconsistent. It contains verbal-learning signals, a failed crossover reconstruction and a direct acute study with EEG changes but null neuropsychological performance.

A 1976 abstract reports no difference after seven days and better verbal learning after 14 days of 4.8 g/day, but omits the sample size, arm sizes and effect magnitude.

Wilsher’s planned 21-day crossover could not be interpreted because of carryover. The healthy first-period comparison was only six active versus eight placebo students. Trials-to-learn fell from 6.00 to 4.83 versus 6.87 to 6.12; the thesis does not establish a valid between-arm significance test for the quoted 8.6% gap. Forgetting, dichotic recall and information-absorption measures were null or unstable.

An 18-person normally aging crossover reported favorable perceptual-motor results without usable task effects or sequence data. In a later acute-dose study, every neuropsychological variable was null despite EEG changes.

Increase in the power of human memory in normal man through the use of drugs.

Primary human randomized study

Dimond SJ, Brouwers EM. Psychopharmacology. 1976. PMID 826948.

The abstract reports no verbal-learning difference after seven days and improvement after 14 days of 4.8 g/day.

Participants / model
Healthy volunteers; the primary abstract omits n, while a later thesis describes 16 participants
Follow-up
14 days
Study design
Double-blind study

The abstract gives no arm sizes, numeric effect, variance, attrition or adverse-event table.

Read the original source
Piracetam as an aid to learning in dyslexia. Preliminary report.

Primary human randomized study

Wilsher C et al. Psychopharmacology. 1979. PMID 116285.

The headline healthy-student and dyslexia learning results came from first-period comparisons after carryover made the intended crossover unusable.

Participants / model
16 adult men with former dyslexia and 14 healthy student volunteers
Follow-up
4.8 g/day for 21-day periods
Study design
Planned double-blind crossover, analyzed through first-period parallel groups for the learning claim

Healthy first-period groups were six active and eight placebo; the between-arm significance of the quoted percentage is not established in the thesis table.

Read the original source
A psychological investigation into the relationship between hemispheric specialisation and individual differences in normal and pathological language skills.

Primary author dissertation

Wilsher CR. Aston University doctoral thesis. 1980.

The thesis documents failed crossover interpretation, first-period arm sizes, outcome tables, UCB support and one nonadherence-associated perceptual complaint/withdrawal.

Participants / model
The same adult dyslexia and healthy-student trial reported in PMID 116285
Follow-up
21-day treatment periods
Study design
Author thesis with original methods and tables
Funding
UCB supplied coded samples and supported much of the work.

The trial’s full crossover could not be used because of carryover/perseveration; one participant doubled doses after missed days and left after a reversible visuospatial complaint.

Read the original source
Piracetam-induced improvement of mental performance. A controlled study on normally aging individuals.

Primary human randomized study

Mindus P et al. Acta Psychiatrica Scandinavica. 1976. PMID 785952.

The abstract says a majority of perceptual-motor tasks improved during 4.8 g/day treatment.

Participants / model
18 nondeteriorated adults, median age 56, range 47 to 73
Follow-up
Two four-week periods
Study design
Controlled two-period crossover

The review reports no task-level effect sizes, sequence, carryover, attrition, or adverse-event detail and could not extract usable first-period data.

Read the original source
Quantitative EEG and neuropsychological effects of piracetam and of the association piracetam-lecithin in healthy volunteers.

Primary human pharmacology study

Sannita WG et al. Neuropsychobiology. 1985. PMID 3835497.

Single 800 to 6,400 mg doses changed EEG measures while every tested neuropsychological variable was null.

Participants / model
Healthy volunteers; denominator absent from the indexed abstract
Follow-up
Single-dose sessions
Study design
Placebo-controlled acute dose study with piracetam and piracetam-plus-lecithin conditions

An EEG effect does not supply a cognitive benefit when the same study’s performance tests were null.

Read the original source

What about hypoxia and induced impairment?

Small studies suggest partial performance preservation under severe laboratory hypoxia. They do not test ordinary sleep loss, rested cognition or routine altitude use.

In a 12-person low-pressure crossover, errors improved while speed was null. Other hypoxia studies used nine or 18 participants and reported selected oculomotor, vigilance, EEG or psychometric effects under oxygen concentrations near 10%.

The cited controlled human studies did not test recovery from sleep deprivation or shift work with piracetam.

The effect of piracetam on volunteers in a low-pressure tank.

Primary human challenge study

Demay F, Bande J. Journal of International Medical Research. 1980. PMID 7358211.

Piracetam reduced errors under low-pressure hypoxia, while performance speed did not improve.

Participants / model
12 healthy volunteers during low-pressure/hypoxia exposure
Follow-up
Five days of dosing with acute hypoxia test
Study design
Double-blind placebo crossover challenge

Hypoxia is not sleep deprivation, rested cognition or ordinary altitude use.

Read the original source
Quantitative EEG and neuropsychological effects of piracetam and of the association piracetam-lecithin in healthy volunteers.

Primary human pharmacology study

Sannita WG et al. Neuropsychobiology. 1985. PMID 3835497.

Single 800 to 6,400 mg doses changed EEG measures while every tested neuropsychological variable was null.

Participants / model
Healthy volunteers; denominator absent from the indexed abstract
Follow-up
Single-dose sessions
Study design
Placebo-controlled acute dose study with piracetam and piracetam-plus-lecithin conditions

An EEG effect does not supply a cognitive benefit when the same study’s performance tests were null.

Read the original source

What happened in the largest memory trial?

N01001 randomized 676 people with mild cognitive impairment at 69 centers for 52 weeks. Neither 4.8 nor 9.6 g/day improved the primary cognitive composite.

The adjusted difference versus placebo was −0.291 at 4.8 g/day (95% CI −0.787 to 0.206; p=0.251) and −0.298 at 9.6 g/day (−0.790 to 0.193; p=0.234). Completers numbered 171/225, 164/227 and 177/224.

A 162-person age-associated-memory-impairment study reported the strongest result at 4.8 g/day in lower-baseline participants, but all participants also entered a memory-training schedule. Only half had an unconfounded first six weeks, and usable arm data were not extractable.

The dementia review found heterogeneous global-impression signals with no reliable specific memory or MMSE benefit. Missing sponsor studies and untraceable reports raise publication-bias concerns.

Piracetam N01001 clinical study summary: mild cognitive impairment.

Primary sponsor clinical results summary

UCB. Clinical Study Summary N01001 / RXCE06E1660. Approved 7 September 2007.

Neither 4.8 nor 9.6 g/day improved the Cognitive Battery Composite Score versus placebo after 52 weeks.

Participants / model
676 randomized adults aged 50 to 89 with mild cognitive impairment at 69 centers
Follow-up
52 weeks after two-week placebo run-in
Study design
Randomized double-blind placebo-controlled parallel dose-ranging trial
Funding
Sponsor-authored results summary.

The disposition and permanent-drug-discontinuation tables use related but distinct adverse-event endpoints and denominators.

Read the original source
Efficacy and Safety of Piracetam Taken for 12 Months in Subjects Suffering From Mild Cognitive Impairment (MCI)

Primary trial registry

ClinicalTrials.gov NCT00567060 / UCB N01001.

The registry identifies the 52-week 4.8 and 9.6 g/day placebo-controlled MCI trial.

Participants / model
676 randomized adults with mild cognitive impairment
Follow-up
52 weeks
Study design
Randomized double-blind placebo-controlled study

Arm-level outcomes are reported in the sponsor results summary.

Read the original source
Drug therapy and memory training programs: a double-blind randomized trial of general practice patients with age-associated memory impairment.

Primary human randomized study

Israel L et al. International Psychogeriatrics. 1994. PMID 7865703.

The abstract reports the strongest result at 4.8 g/day in lower-baseline participants, but memory training confounded much of the schedule.

Participants / model
162 adults aged at least 55 with age-associated memory impairment; 135 completers
Follow-up
Three months
Study design
Randomized double-blind dose and memory-training study

Only half had an unconfounded first six weeks and the later review could not extract usable first-period arm data.

Read the original source
Piracetam for dementia or cognitive impairment.

Systematic review

Cochrane systematic review. Piracetam for dementia or cognitive impairment.

Heterogeneous global-impression signals did not translate into reliable specific cognitive-domain benefit; sponsor data not supplied to the reviewers limited the analysis.

Participants / model
People with dementia, cognitive impairment or age-associated memory complaints across 24 studies
Follow-up
Varied
Study design
Systematic review of randomized trials

Only four studies were poolable for global impression, with strong heterogeneity; specific memory and MMSE intervals included no effect.

Read the original source

Did piracetam improve recovery after acute stroke?

PASS, a 927-person randomized trial, found no overall recovery benefit. PASS II later enrolled 571 people and stopped for futility.

PASS week-four neurologic means were 57.7 and 57.6; week-12 Barthel means were 55.8 and 53.1. Mortality was 111/464 versus 89/463, relative risk 1.24 (95% CI 0.97 to 1.59). The difference was not conclusive, and overall efficacy was null.

A redefined under-seven-hour subgroup produced a favorable Barthel result, with a further moderate/severe subset. Those were exploratory. PASS II stopped after an interim analysis found less than a 20% chance of showing its target difference; the cited registry record does not report arm-level results.

Treatment of acute ischemic stroke with piracetam. Members of the Piracetam in Acute Stroke Study (PASS) Group.

Primary human randomized study

PASS Study Group. Stroke. 1997. PMID 9412612.

In 927 acute ischemic-stroke patients, piracetam did not improve the overall neurologic or functional outcomes; an earlier-treatment subgroup was post hoc.

Participants / model
927 patients treated within 12 hours of acute ischemic stroke
Follow-up
12-week regimen
Study design
Randomized double-blind placebo-controlled multicenter trial

Overall Orgogozo and Barthel outcomes were null. The under-seven-hour and severity subgroups were exploratory.

Read the original source
A Study to Evaluate the Efficacy and Safety of Piracetam on Aphasia After Acute Ischemic Cerebral Artery Stroke

Primary trial registry

ClinicalTrials.gov NCT01883011 / UCB N09642.

PASS II enrolled 571 and stopped after an interim futility analysis; no arm-level outcome results are posted.

Participants / model
571 people with acute ischemic middle-cerebral-artery stroke and aphasia
Follow-up
12-week regimen
Study design
Randomized double-blind placebo-controlled phase 4 study

Futility termination is program evidence, but the missing arm results prevent an exact treatment estimate.

Read the original source

Why do coronary-bypass trials look positive?

Several small trials found less early cognitive decline after coronary bypass. They tested protection from surgery and anesthesia, not performance above a healthy baseline.

In 64 men, a single 12 g IV dose produced a day-three cognitive z score of −0.46 versus −1.19 with placebo (p<0.001). In another 98-person regimen, the combined score favored piracetam per protocol (p=0.041) but only trended in intention-to-treat analysis (p=0.064).

In the longer regimen, anxiety improved more with placebo: −9.27 versus −6.37 points. These studies cannot support an anxiolytic claim.

Effect of piracetam on cognitive performance in patients undergoing bypass surgery.

Primary human randomized study

Uebelhack R et al. Pharmacopsychiatry. 2003. PMID 12806565.

A single 12 g IV dose reduced day-three cognitive decline after coronary bypass versus placebo.

Participants / model
64 men undergoing coronary artery bypass surgery
Follow-up
Single preoperative exposure with early follow-up
Study design
Randomized double-blind placebo-controlled perioperative trial

The outcome was less decline after surgery, not performance above baseline.

Read the original source
Piracetam prevents cognitive decline in coronary artery bypass: a randomized trial versus placebo.

Primary human randomized study

Szalma I et al. Annals of Thoracic Surgery. 2006. PMID 16996947.

A combined cognitive score favored piracetam per protocol but only trended in intention-to-treat analysis; anxiety improved more with placebo.

Participants / model
98 coronary-bypass patients, 50 piracetam and 48 placebo
Follow-up
IV perioperative treatment followed by oral treatment through six weeks
Study design
Randomized placebo-controlled perioperative trial

The surgical-injury setting and analysis disagreement prevent a healthy cognition or mood inference.

Read the original source

Does piracetam help language or dyslexia?

Post-stroke aphasia trials show a small short-term written-language signal, and dyslexia trials report selective reading or writing changes. Neither establishes general memory enhancement.

Across seven aphasia trials and 261 participants, overall severity was not significant: SMD 0.23 (95% CI −0.03 to 0.49). Written language was SMD 0.35 (0.04 to 0.66), and the signal weakened over time.

In 55 boys with dyslexia, reading speed and amount written improved, while perception, memory, language, reading accuracy, comprehension and writing accuracy were null. A larger 225-child study reported reading benefit but its abstract lacks the effect size and endpoint hierarchy.

Piracetam for Aphasia in Post-stroke Patients: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Systematic review and meta-analysis

Zhang J et al. CNS Drugs. 2016. PMID 27236454.

Across seven trials and 261 participants, overall aphasia severity was not significant; written language showed a small short-term signal.

Participants / model
Post-stroke patients with aphasia
Follow-up
Varied
Study design
Systematic review and meta-analysis of randomized trials

Overall severity SMD 0.23 (95% CI -0.03 to 0.49); written language SMD 0.35 (0.04 to 0.66).

Read the original source
Evaluation of the efficacy of piracetam in treating information processing, reading and writing disorders in dyslexic children.

Primary human randomized study

Tallal P et al. International Journal of Psychophysiology. 1986. PMID 3522509.

Reading speed and writing amount improved, while perception, memory, language, reading accuracy/comprehension and writing accuracy were null.

Participants / model
55 boys aged 8 to 13 with dyslexia
Follow-up
12 weeks
Study design
Double-blind placebo-controlled trial

Selective fluency changes in dyslexia do not establish healthy adult memory enhancement.

Read the original source
Piracetam as an aid to learning in dyslexia. Preliminary report.

Primary human randomized study

Wilsher C et al. Psychopharmacology. 1979. PMID 116285.

The headline healthy-student and dyslexia learning results came from first-period comparisons after carryover made the intended crossover unusable.

Participants / model
16 adult men with former dyslexia and 14 healthy student volunteers
Follow-up
4.8 g/day for 21-day periods
Study design
Planned double-blind crossover, analyzed through first-period parallel groups for the learning claim

Healthy first-period groups were six active and eight placebo; the between-arm significance of the quoted percentage is not established in the thesis table.

Read the original source

What did the Chinese memory trial find?

A two-month Chinese trial randomized 496 people with age-associated memory impairment to piracetam plus choline or placebo. The combination improved reported memory and reaction measures.

Among 218 per arm with memory testing, memory quotient rose 11.19 ± 12.13 points with the combination versus 5.55 ± 8.78 with placebo (p<0.01). Because both ingredients were given together, piracetam’s separate contribution is unknown. The cited abstract does not resolve exact ingredient content per capsule.

复方吡拉西坦治疗248例增龄相关记忆障碍 / Piracetam plus choline for age-associated memory impairment.

Primary human randomized study

Chinese Journal of Clinical Pharmacy report. Piracetam plus choline in age-associated memory impairment.

The piracetam-plus-choline combination improved reported memory and reaction measures over placebo; piracetam’s separate contribution cannot be identified.

Participants / model
496 people with age-associated memory impairment; 436 in memory testing and 60 in reaction testing
Follow-up
Two months
Study design
Randomized combination-versus-placebo trial

The abstract does not resolve exact ingredient content per capsule, allocation methods or complete safety tables.

Read the original source

Does mitochondrial or membrane research establish neuroprotection or longevity?

The UK label says the mechanism in cortical myoclonus remains unknown. Cell and short animal studies cannot establish human neuroprotection or longevity.

The cited human trials did not measure lifespan, mortality prevention, frailty, senescence or validated biological aging. Clinical dementia and MCI trials do not show disease modification.

Nootropil UK product information

Approved product information

ADVANZ Pharma. Nootropil 1200 mg SmPC. Updated July 1, 2025.

Adult cortical myoclonus is the stated indication. The record describes renal elimination, bleeding cautions, contraindications, and the risk of abrupt discontinuation.

Participants / model
Adults with cortical myoclonus
Study design
UK prescribing information

A UK indication does not establish a US approval or broad cognitive benefit.

Read the original source
Piracetam for dementia or cognitive impairment.

Systematic review

Cochrane systematic review. Piracetam for dementia or cognitive impairment.

Heterogeneous global-impression signals did not translate into reliable specific cognitive-domain benefit; sponsor data not supplied to the reviewers limited the analysis.

Participants / model
People with dementia, cognitive impairment or age-associated memory complaints across 24 studies
Follow-up
Varied
Study design
Systematic review of randomized trials

Only four studies were poolable for global impression, with strong heterogeneity; specific memory and MMSE intervals included no effect.

Read the original source

What changes the safety picture?

Kidney clearance, bleeding risk and withdrawal in myoclonus matter. Severe renal impairment, cerebral hemorrhage and Huntington’s chorea are contraindications in the UK label.

The label advises renal dose adjustment, caution with anticoagulants or antiplatelets, and gradual withdrawal to avoid myoclonus relapse or seizures. Common listed effects include nervousness, hyperkinesia and weight gain; reported effects also include somnolence, insomnia, agitation and hemorrhagic disorders.

N01001’s disposition table lists 26/225, 29/227 and 17/224 withdrawn due to adverse events in placebo, 4.8 g and 9.6 g arms. A separate safety analysis lists permanent drug discontinuation in 11.1%, 12.8% and 7.1% of 225/226/224. These are different endpoints and denominators.

In the tiny Wilsher study, one participant doubled doses after missed days and reported a reversible visuospatial-timing problem before withdrawal. Attribution is uncertain, but the study was not event-free.

Nootropil UK product information

Approved product information

ADVANZ Pharma. Nootropil 1200 mg SmPC. Updated July 1, 2025.

Adult cortical myoclonus is the stated indication. The record describes renal elimination, bleeding cautions, contraindications, and the risk of abrupt discontinuation.

Participants / model
Adults with cortical myoclonus
Study design
UK prescribing information

A UK indication does not establish a US approval or broad cognitive benefit.

Read the original source
Piracetam N01001 clinical study summary: mild cognitive impairment.

Primary sponsor clinical results summary

UCB. Clinical Study Summary N01001 / RXCE06E1660. Approved 7 September 2007.

Neither 4.8 nor 9.6 g/day improved the Cognitive Battery Composite Score versus placebo after 52 weeks.

Participants / model
676 randomized adults aged 50 to 89 with mild cognitive impairment at 69 centers
Follow-up
52 weeks after two-week placebo run-in
Study design
Randomized double-blind placebo-controlled parallel dose-ranging trial
Funding
Sponsor-authored results summary.

The disposition and permanent-drug-discontinuation tables use related but distinct adverse-event endpoints and denominators.

Read the original source
A psychological investigation into the relationship between hemispheric specialisation and individual differences in normal and pathological language skills.

Primary author dissertation

Wilsher CR. Aston University doctoral thesis. 1980.

The thesis documents failed crossover interpretation, first-period arm sizes, outcome tables, UCB support and one nonadherence-associated perceptual complaint/withdrawal.

Participants / model
The same adult dyslexia and healthy-student trial reported in PMID 116285
Follow-up
21-day treatment periods
Study design
Author thesis with original methods and tables
Funding
UCB supplied coded samples and supported much of the work.

The trial’s full crossover could not be used because of carryover/perseveration; one participant doubled doses after missed days and left after a reversible visuospatial complaint.

Read the original source

Can an online label be trusted?

A 2018 US market sample found large differences in presence, serving strength and label-directed daily exposure.

Eight of ten samples across four brands contained piracetam; one brand contained none. Measured content was 831 to 1,542 mg per serving, 85% to 118% of the label, and label directions could yield 831 to 11,283 mg/day.

A 2026 Chinese bioequivalence study used authenticated 800 mg tablets. Food delayed peak concentration and lowered the peak while total exposure and half-life stayed similar. That formulation study cannot validate US internet products or repeated use.

Presence of Piracetam in Cognitive Enhancement Dietary Supplements.

Primary product-analysis study

Cohen PA et al. JAMA Internal Medicine. 2020. PMID 31764936.

Eight of ten samples contained piracetam; measured serving content was 831 to 1,542 mg and label-directed exposure ranged 831 to 11,283 mg/day.

Participants / model
Two samples each from five US brands purchased in 2018
Follow-up
Single market snapshot
Study design
Cross-sectional laboratory product analysis

One brand contained no piracetam. The study does not estimate the current market or all products.

Read the original source
FDA: unapproved racetam distribution case

Official enforcement record

US FDA / US Department of Justice. Arizona company and CEO plead guilty to distribution of drugs not approved by FDA. 2023.

The case identifies piracetam, aniracetam, coluracetam, and phenylpiracetam among unapproved drugs marketed online.

Participants / model
United States distribution
Follow-up
2023
Study design
Official case record

This establishes the named US enforcement history, not every country’s status or a quantified rate of injury.

Read the original source
Pharmacokinetics and Bioequivalence Evaluation of Piracetam Tablet in Healthy Chinese Participants.

Primary human pharmacokinetic study

Yan H et al. Drugs in R&D. 2026. PMID 41851591.

Single 800 mg test/reference tablets were bioequivalent; food delayed Tmax and lowered Cmax while AUC and half-life changed little.

Participants / model
Two cohorts of 28 healthy Chinese participants
Follow-up
Single-dose periods with seven-day washout
Study design
Randomized open-label two-period crossover under fasting or fed conditions

All reported events were grade 1 and judged unrelated; this does not establish efficacy or repeated-use safety.

Read the original source

Can another racetam inherit piracetam’s evidence?

The myoclonus trials tested piracetam. Aniracetam, oxiracetam, L-oxiracetam, and phenylpiracetam are different compounds with different routes, populations, and outcomes.

Shared family names and metabolites do not establish interchangeable efficacy, dose or safety.

Effectiveness of piracetam in cortical myoclonus.

Primary human randomized study

Brown P et al. Movement Disorders. 1993. PMID 8419809. DOI 10.1002/mds.870080112.

Among 21 apparent run-in responders, total myoclonus score improved by a median 22.2%; 10 needed rescue during placebo and none during piracetam.

Participants / model
21 adults with cortical myoclonus who entered after an open run-in; 19 continued other antimyoclonic drugs
Follow-up
Planned 14-day periods without washout; placebo periods shortened by rescue
Study design
Double-blind placebo-controlled crossover after responder-enriched run-in
Funding
UCB funded the study; two authors reported consultancy relationships.

Twenty-four entered run-in: one left after suspected pulmonary embolus, two failed to respond, and 21 completed crossover. Six of those 21 were later controlled-phase nonresponders.

Read the original source
PubChem: piracetam chemical identity

Government chemical identity database

National Library of Medicine. PubChem CID 4843.

C6H10N2O2; molecular weight 142.16 g/mol.

Participants / model
Chemical record
Follow-up
Living database
Study design
Curated structure record

Formula and molecular weight establish the recorded structure, not the contents of a retail product or an effective dose.

Read the original source

Studies and sources

Nootropil UK product information

Approved product information

ADVANZ Pharma. Nootropil 1200 mg SmPC. Updated July 1, 2025.

Adult cortical myoclonus is the stated indication. The record describes renal elimination, bleeding cautions, contraindications, and the risk of abrupt discontinuation.

Participants / model
Adults with cortical myoclonus
Study design
UK prescribing information

A UK indication does not establish a US approval or broad cognitive benefit.

Read the original source
Effectiveness of piracetam in cortical myoclonus.

Primary human randomized study

Brown P et al. Movement Disorders. 1993. PMID 8419809. DOI 10.1002/mds.870080112.

Among 21 apparent run-in responders, total myoclonus score improved by a median 22.2%; 10 needed rescue during placebo and none during piracetam.

Participants / model
21 adults with cortical myoclonus who entered after an open run-in; 19 continued other antimyoclonic drugs
Follow-up
Planned 14-day periods without washout; placebo periods shortened by rescue
Study design
Double-blind placebo-controlled crossover after responder-enriched run-in
Funding
UCB funded the study; two authors reported consultancy relationships.

Twenty-four entered run-in: one left after suspected pulmonary embolus, two failed to respond, and 21 completed crossover. Six of those 21 were later controlled-phase nonresponders.

Read the original source
FDA: unapproved racetam distribution case

Official enforcement record

US FDA / US Department of Justice. Arizona company and CEO plead guilty to distribution of drugs not approved by FDA. 2023.

The case identifies piracetam, aniracetam, coluracetam, and phenylpiracetam among unapproved drugs marketed online.

Participants / model
United States distribution
Follow-up
2023
Study design
Official case record

This establishes the named US enforcement history, not every country’s status or a quantified rate of injury.

Read the original source
PubChem: piracetam chemical identity

Government chemical identity database

National Library of Medicine. PubChem CID 4843.

C6H10N2O2; molecular weight 142.16 g/mol.

Participants / model
Chemical record
Follow-up
Living database
Study design
Curated structure record

Formula and molecular weight establish the recorded structure, not the contents of a retail product or an effective dose.

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复方吡拉西坦治疗248例增龄相关记忆障碍 / Piracetam plus choline for age-associated memory impairment.

Primary human randomized study

Chinese Journal of Clinical Pharmacy report. Piracetam plus choline in age-associated memory impairment.

The piracetam-plus-choline combination improved reported memory and reaction measures over placebo; piracetam’s separate contribution cannot be identified.

Participants / model
496 people with age-associated memory impairment; 436 in memory testing and 60 in reaction testing
Follow-up
Two months
Study design
Randomized combination-versus-placebo trial

The abstract does not resolve exact ingredient content per capsule, allocation methods or complete safety tables.

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Treatment of acute ischemic stroke with piracetam. Members of the Piracetam in Acute Stroke Study (PASS) Group.

Primary human randomized study

PASS Study Group. Stroke. 1997. PMID 9412612.

In 927 acute ischemic-stroke patients, piracetam did not improve the overall neurologic or functional outcomes; an earlier-treatment subgroup was post hoc.

Participants / model
927 patients treated within 12 hours of acute ischemic stroke
Follow-up
12-week regimen
Study design
Randomized double-blind placebo-controlled multicenter trial

Overall Orgogozo and Barthel outcomes were null. The under-seven-hour and severity subgroups were exploratory.

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Piracetam in Unverricht to Lundborg progressive myoclonus epilepsy.

Primary human randomized study

Koskiniemi M et al. Journal of Neurology, Neurosurgery & Psychiatry. 1998. PMID 9527146.

At 24 g/day, piracetam improved the composite myoclonus, motor and functional-disability scores; lower doses also improved function.

Participants / model
20 people with Unverricht-Lundborg disease; 18 in the balanced efficacy analysis
Follow-up
Two weeks per condition without washout
Study design
Double-blind placebo-controlled dose crossover on stable background treatment
Funding
UCB funded the study; one author reported consultancy.

Small, short and background-medication-dependent; handwriting and stimulus sensitivity did not clearly improve.

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Increase in the power of human memory in normal man through the use of drugs.

Primary human randomized study

Dimond SJ, Brouwers EM. Psychopharmacology. 1976. PMID 826948.

The abstract reports no verbal-learning difference after seven days and improvement after 14 days of 4.8 g/day.

Participants / model
Healthy volunteers; the primary abstract omits n, while a later thesis describes 16 participants
Follow-up
14 days
Study design
Double-blind study

The abstract gives no arm sizes, numeric effect, variance, attrition or adverse-event table.

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Piracetam as an aid to learning in dyslexia. Preliminary report.

Primary human randomized study

Wilsher C et al. Psychopharmacology. 1979. PMID 116285.

The headline healthy-student and dyslexia learning results came from first-period comparisons after carryover made the intended crossover unusable.

Participants / model
16 adult men with former dyslexia and 14 healthy student volunteers
Follow-up
4.8 g/day for 21-day periods
Study design
Planned double-blind crossover, analyzed through first-period parallel groups for the learning claim

Healthy first-period groups were six active and eight placebo; the between-arm significance of the quoted percentage is not established in the thesis table.

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A psychological investigation into the relationship between hemispheric specialisation and individual differences in normal and pathological language skills.

Primary author dissertation

Wilsher CR. Aston University doctoral thesis. 1980.

The thesis documents failed crossover interpretation, first-period arm sizes, outcome tables, UCB support and one nonadherence-associated perceptual complaint/withdrawal.

Participants / model
The same adult dyslexia and healthy-student trial reported in PMID 116285
Follow-up
21-day treatment periods
Study design
Author thesis with original methods and tables
Funding
UCB supplied coded samples and supported much of the work.

The trial’s full crossover could not be used because of carryover/perseveration; one participant doubled doses after missed days and left after a reversible visuospatial complaint.

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Piracetam-induced improvement of mental performance. A controlled study on normally aging individuals.

Primary human randomized study

Mindus P et al. Acta Psychiatrica Scandinavica. 1976. PMID 785952.

The abstract says a majority of perceptual-motor tasks improved during 4.8 g/day treatment.

Participants / model
18 nondeteriorated adults, median age 56, range 47 to 73
Follow-up
Two four-week periods
Study design
Controlled two-period crossover

The review reports no task-level effect sizes, sequence, carryover, attrition, or adverse-event detail and could not extract usable first-period data.

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Quantitative EEG and neuropsychological effects of piracetam and of the association piracetam-lecithin in healthy volunteers.

Primary human pharmacology study

Sannita WG et al. Neuropsychobiology. 1985. PMID 3835497.

Single 800 to 6,400 mg doses changed EEG measures while every tested neuropsychological variable was null.

Participants / model
Healthy volunteers; denominator absent from the indexed abstract
Follow-up
Single-dose sessions
Study design
Placebo-controlled acute dose study with piracetam and piracetam-plus-lecithin conditions

An EEG effect does not supply a cognitive benefit when the same study’s performance tests were null.

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The effect of piracetam on volunteers in a low-pressure tank.

Primary human challenge study

Demay F, Bande J. Journal of International Medical Research. 1980. PMID 7358211.

Piracetam reduced errors under low-pressure hypoxia, while performance speed did not improve.

Participants / model
12 healthy volunteers during low-pressure/hypoxia exposure
Follow-up
Five days of dosing with acute hypoxia test
Study design
Double-blind placebo crossover challenge

Hypoxia is not sleep deprivation, rested cognition or ordinary altitude use.

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Piracetam N01001 clinical study summary: mild cognitive impairment.

Primary sponsor clinical results summary

UCB. Clinical Study Summary N01001 / RXCE06E1660. Approved 7 September 2007.

Neither 4.8 nor 9.6 g/day improved the Cognitive Battery Composite Score versus placebo after 52 weeks.

Participants / model
676 randomized adults aged 50 to 89 with mild cognitive impairment at 69 centers
Follow-up
52 weeks after two-week placebo run-in
Study design
Randomized double-blind placebo-controlled parallel dose-ranging trial
Funding
Sponsor-authored results summary.

The disposition and permanent-drug-discontinuation tables use related but distinct adverse-event endpoints and denominators.

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Efficacy and Safety of Piracetam Taken for 12 Months in Subjects Suffering From Mild Cognitive Impairment (MCI)

Primary trial registry

ClinicalTrials.gov NCT00567060 / UCB N01001.

The registry identifies the 52-week 4.8 and 9.6 g/day placebo-controlled MCI trial.

Participants / model
676 randomized adults with mild cognitive impairment
Follow-up
52 weeks
Study design
Randomized double-blind placebo-controlled study

Arm-level outcomes are reported in the sponsor results summary.

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Drug therapy and memory training programs: a double-blind randomized trial of general practice patients with age-associated memory impairment.

Primary human randomized study

Israel L et al. International Psychogeriatrics. 1994. PMID 7865703.

The abstract reports the strongest result at 4.8 g/day in lower-baseline participants, but memory training confounded much of the schedule.

Participants / model
162 adults aged at least 55 with age-associated memory impairment; 135 completers
Follow-up
Three months
Study design
Randomized double-blind dose and memory-training study

Only half had an unconfounded first six weeks and the later review could not extract usable first-period arm data.

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Piracetam for dementia or cognitive impairment.

Systematic review

Cochrane systematic review. Piracetam for dementia or cognitive impairment.

Heterogeneous global-impression signals did not translate into reliable specific cognitive-domain benefit; sponsor data not supplied to the reviewers limited the analysis.

Participants / model
People with dementia, cognitive impairment or age-associated memory complaints across 24 studies
Follow-up
Varied
Study design
Systematic review of randomized trials

Only four studies were poolable for global impression, with strong heterogeneity; specific memory and MMSE intervals included no effect.

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A Study to Evaluate the Efficacy and Safety of Piracetam on Aphasia After Acute Ischemic Cerebral Artery Stroke

Primary trial registry

ClinicalTrials.gov NCT01883011 / UCB N09642.

PASS II enrolled 571 and stopped after an interim futility analysis; no arm-level outcome results are posted.

Participants / model
571 people with acute ischemic middle-cerebral-artery stroke and aphasia
Follow-up
12-week regimen
Study design
Randomized double-blind placebo-controlled phase 4 study

Futility termination is program evidence, but the missing arm results prevent an exact treatment estimate.

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Effect of piracetam on cognitive performance in patients undergoing bypass surgery.

Primary human randomized study

Uebelhack R et al. Pharmacopsychiatry. 2003. PMID 12806565.

A single 12 g IV dose reduced day-three cognitive decline after coronary bypass versus placebo.

Participants / model
64 men undergoing coronary artery bypass surgery
Follow-up
Single preoperative exposure with early follow-up
Study design
Randomized double-blind placebo-controlled perioperative trial

The outcome was less decline after surgery, not performance above baseline.

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Piracetam prevents cognitive decline in coronary artery bypass: a randomized trial versus placebo.

Primary human randomized study

Szalma I et al. Annals of Thoracic Surgery. 2006. PMID 16996947.

A combined cognitive score favored piracetam per protocol but only trended in intention-to-treat analysis; anxiety improved more with placebo.

Participants / model
98 coronary-bypass patients, 50 piracetam and 48 placebo
Follow-up
IV perioperative treatment followed by oral treatment through six weeks
Study design
Randomized placebo-controlled perioperative trial

The surgical-injury setting and analysis disagreement prevent a healthy cognition or mood inference.

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Piracetam for Aphasia in Post-stroke Patients: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Systematic review and meta-analysis

Zhang J et al. CNS Drugs. 2016. PMID 27236454.

Across seven trials and 261 participants, overall aphasia severity was not significant; written language showed a small short-term signal.

Participants / model
Post-stroke patients with aphasia
Follow-up
Varied
Study design
Systematic review and meta-analysis of randomized trials

Overall severity SMD 0.23 (95% CI -0.03 to 0.49); written language SMD 0.35 (0.04 to 0.66).

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Evaluation of the efficacy of piracetam in treating information processing, reading and writing disorders in dyslexic children.

Primary human randomized study

Tallal P et al. International Journal of Psychophysiology. 1986. PMID 3522509.

Reading speed and writing amount improved, while perception, memory, language, reading accuracy/comprehension and writing accuracy were null.

Participants / model
55 boys aged 8 to 13 with dyslexia
Follow-up
12 weeks
Study design
Double-blind placebo-controlled trial

Selective fluency changes in dyslexia do not establish healthy adult memory enhancement.

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Presence of Piracetam in Cognitive Enhancement Dietary Supplements.

Primary product-analysis study

Cohen PA et al. JAMA Internal Medicine. 2020. PMID 31764936.

Eight of ten samples contained piracetam; measured serving content was 831 to 1,542 mg and label-directed exposure ranged 831 to 11,283 mg/day.

Participants / model
Two samples each from five US brands purchased in 2018
Follow-up
Single market snapshot
Study design
Cross-sectional laboratory product analysis

One brand contained no piracetam. The study does not estimate the current market or all products.

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Pharmacokinetics and Bioequivalence Evaluation of Piracetam Tablet in Healthy Chinese Participants.

Primary human pharmacokinetic study

Yan H et al. Drugs in R&D. 2026. PMID 41851591.

Single 800 mg test/reference tablets were bioequivalent; food delayed Tmax and lowered Cmax while AUC and half-life changed little.

Participants / model
Two cohorts of 28 healthy Chinese participants
Follow-up
Single-dose periods with seven-day washout
Study design
Randomized open-label two-period crossover under fasting or fed conditions

All reported events were grade 1 and judged unrelated; this does not establish efficacy or repeated-use safety.

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Why is piracetam in A tier?

A applies to adult cortical myoclonus under the UK prescription label. Healthy cognition has weak, inconsistent evidence, while sleep-loss performance, anxiety treatment, strength and longevity lack adequate positive human evidence.

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