aniracetam
Aniracetam improved psychobehavioral measures in one 109-person Alzheimer trial, but the abstract did not report the treatment effect size. A 44-person crossover found no overall benefit in solvent-related cognitive illness. Small challenge studies tested recovery from induced impairment, not better-than-normal cognition or anxiety relief in healthy people.
Small-molecule racetam
- The six-month 109-person Alzheimer trial reported benefit but published no usable treatment magnitude.
- A 44-person double-blind crossover found no overall benefit across three months of aniracetam and three months of placebo.
- Healthy-volunteer studies induced scopolamine amnesia or hypoxia; they did not test better-than-normal cognition.
- The measured parent-drug half-life after a single 400 mg capsule was under one hour, but metabolites may contribute.
What is aniracetam, and which formulation was studied?
Aniracetam, also called Ro 13-5057, is a racetam studied as an oral pharmaceutical in cognitive disorders; it is chemically and clinically distinct from piracetam.
Human studies used different routes and contexts: 1,500 mg/day orally in dementia reports, 1 g/day in the solvent-exposure crossover, 1,500 mg orally during scopolamine challenge, and intravenous doses during hypoxia. Those results do not define one interchangeable consumer regimen.
PubChem: aniracetam chemical identity
Government chemical identity database
National Library of Medicine. PubChem CID 2196.
C12H13NO3; molecular weight 219.24 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 sourceAniracetam (Ro 13-5057) in the treatment of senile dementia of Alzheimer type (SDAT): results of a placebo controlled multicentre clinical study.
Primary human study
Senin U et al. European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology. 1991. PMID 1822317. DOI 10.1016/0924-977x(91)90004-e.
The aniracetam group improved on psychobehavioral measures relative to placebo after six months.
- Participants / model
- 109 older patients with mild-to-moderate probable Alzheimer-type dementia
- Follow-up
- 6 months
- Study design
- Double-blind randomized placebo-controlled multicenter study
The abstract gives significance statements but not detailed effect sizes, allocation counts, attrition, or a complete adverse-event table.
Read the original sourcePharmacokinetics and bioequivalence study of aniracetam after single-dose administration in healthy Chinese male volunteers.
Primary human pharmacokinetic study
Tian Y et al. Arzneimittelforschung. 2008. PMID 19025058.
After single 400 mg oral doses, parent aniracetam peaked at about 0.4 hours and had a measured plasma half-life about 0.47 to 0.49 hours.
- Participants / model
- 20 healthy Chinese men
- Follow-up
- Single-dose periods
- Study design
- Randomized two-period crossover bioequivalence study
The study measured formulation bioequivalence, not cognition or chronic safety; active metabolites may outlast parent drug.
Read the original sourceWhat does the controlled human evidence actually show?
The 109-person Alzheimer trial reported improvement versus placebo, but the abstract omits allocation counts, attrition, endpoint values and effect sizes. A separate 44-person, six-month crossover in chronic solvent-related cognitive illness found no overall benefit.
In the solvent study, only one of 19 neuropsychological measures favored aniracetam and one favored placebo. With 19 measures and opposite isolated findings, the study did not show a broad cognitive benefit.
These disease-specific results can differ without either showing enhancement in a healthy brain.
Aniracetam (Ro 13-5057) in the treatment of senile dementia of Alzheimer type (SDAT): results of a placebo controlled multicentre clinical study.
Primary human study
Senin U et al. European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology. 1991. PMID 1822317. DOI 10.1016/0924-977x(91)90004-e.
The aniracetam group improved on psychobehavioral measures relative to placebo after six months.
- Participants / model
- 109 older patients with mild-to-moderate probable Alzheimer-type dementia
- Follow-up
- 6 months
- Study design
- Double-blind randomized placebo-controlled multicenter study
The abstract gives significance statements but not detailed effect sizes, allocation counts, attrition, or a complete adverse-event table.
Read the original sourceAniracetam tested in chronic psychosyndrome after long-term exposure to organic solvents. A randomized, double-blind, placebo-controlled cross-over study with neuropsychological tests.
Primary human randomized study
Somnier FE et al. Psychopharmacology. 1990. PMID 2188276.
Across three months each of aniracetam and placebo, clinicians and participants found no overall benefit; one of 19 neuropsychological measures favored aniracetam and one favored placebo.
- Participants / model
- 44 adults with chronic cognitive and behavioral illness after long-term organic-solvent exposure
- Follow-up
- Three months per treatment
- Study design
- Randomized double-blind placebo-controlled crossover
The indexed abstract supplies the overall null result but not a complete numerical outcome or adverse-event table.
Read the original sourceDid it improve cognition in healthy volunteers?
The cited studies do not include an oral placebo comparison in healthy, rested, unchallenged people. The positive volunteer experiments first induced impairment.
In 26 healthy volunteers, 1,500 mg oral aniracetam attenuated scopolamine-related memory and information-processing deficits. In ten men, intravenous aniracetam attenuated changes during acute hypoxia. These are rescue models, not evidence of above-baseline learning, focus or altitude adaptation.
The use of a scopolamine model to study the potential nootropic effects of aniracetam and piracetam in healthy volunteers.
Primary human challenge study
Wesnes K et al. Journal of Psychopharmacology. 1990. PMID 22281851.
Oral aniracetam 1,500 mg attenuated scopolamine-induced memory and information-processing deficits; the study did not test enhancement without scopolamine.
- Participants / model
- 26 healthy volunteers after experimentally induced scopolamine impairment
- Follow-up
- Acute sessions
- Study design
- Double-blind counterbalanced seven-session Latin-square challenge
Healthy enrollment does not make this a healthy-rested enhancement result because every relevant session induced impairment.
Read the original sourceThe hypoxia model in human psychopharmacology: neurophysiological and psychometric studies with aniracetam i.v.
Primary human challenge study
Saletu B et al. Human Neurobiology. 1984. PMID 6434496.
Intravenous aniracetam attenuated selected EEG, psychomotor and memory changes during acute hypoxia.
- Participants / model
- Ten healthy men breathing 11.2% oxygen in laboratory sessions
- Follow-up
- Acute sessions
- Study design
- Double-blind weekly Latin-square challenge
The abstract does not give endpoint-level effect sizes; IV hypoxia rescue does not establish oral rested-person benefit.
Read the original sourceDoes AMPA-receptor activity prove a nootropic effect?
Aniracetam changes AMPA-type glutamate signaling in neural preparations. This confirms receptor activity, but does not show a cognitive benefit in people.
Two experiments in naïve mice found no learning or anxiolytic benefit under dosing schedules intended to capture exposure. Injured-animal rescue remains plausible, but it should stay attached to the impairment model.
Modulation of excitatory synaptic transmission by drugs that reduce desensitization at AMPA/kainate receptors.
Preclinical primary study
Vyklicky L, Patneau DK, Mayer ML. Modulation of excitatory synaptic transmission by drugs that reduce desensitization at AMPA/kainate receptors. Neuron. 1991. DOI 10.1016/0896-6273(91)90342-w.
Aniracetam slowed excitatory-current decay and increased evoked currents in rat hippocampal neurons.
- Participants / model
- Rat hippocampal neurons
- Follow-up
- Acute experiments
- Study design
- Controlled neuropharmacology experiments
Animal pharmacology does not establish a human cognitive benefit.
Read the original sourceAniracetam does not alter cognitive and affective behavior in adult C57BL/6J mice.
Preclinical primary study
Elston TW et al. PLoS One. 2014.
Repeated oral aniracetam did not improve spatial, associative, motor or object-recognition learning and did not show an anxiolytic effect in naïve mice.
- Participants / model
- Adult naïve C57BL/6J mice
- Follow-up
- Repeated acute testing schedule
- Study design
- Controlled behavioral experiments
A mouse null does not prove human ineffectiveness, but it directly fails to support enhancement in an unimpaired model.
Read the original sourceDid the 276-person dementia cohort confirm the old trial?
No. It was open and not cleanly randomized: untreated patients chose no drug, clinicians allocated treatment roughly, baseline severity differed, and seven treatment switchers were excluded.
The aniracetam-only group mostly maintained scores rather than improving them. A depression-scale change at three months was not sustained, and the broader neuropsychiatric scale did not support relief of anxiety, apathy or agitation.
Clinical efficacy of aniracetam, either as monotherapy or combined with cholinesterase inhibitors, in patients with cognitive impairment: a comparative open study.
Primary prospective human cohort
Koliaki CC et al. CNS Neuroscience & Therapeutics. 2012. PMID 22070796.
The aniracetam-only group largely maintained cognition and function; a three-month depression-scale change was not sustained and broader neuropsychiatric ratings did not support anxiety relief.
- Participants / model
- 276 patients with cognitive disorders across untreated, aniracetam, standard-drug and combination groups
- Follow-up
- 12 months
- Study design
- Prospective open nonrandomized comparative cohort
Treatment choice, rough clinician allocation, baseline imbalance and exclusion of treatment switchers prevent a clean causal comparison.
Read the original sourceWhat did the Chinese encephalitis study find?
A 2004 report randomized 40 patients with memory problems after herpes-simplex encephalitis to usual care with or without aniracetam for three weeks.
Scores favored add-on treatment at p<0.05. The 30 healthy people in the report supplied baseline reference values; they were not treated. The abstract omits the treatment magnitude, blinding, attrition and adverse-event counts.
茴拉西坦治疗单纯疱疹病毒性脑炎患者记忆障碍的临床研究 / Aniracetam after herpes simplex encephalitis
Primary human randomized study
李宇彤, 杜玉凤, 窦志杰 / Li Y, Du Y, Dou Z. 临床荟萃 / Clinical Focus. 2004;19(11):629 to 630.
Add-on aniracetam favored clinical memory scores after three weeks; the abstract reports P<0.05.
- Participants / model
- 40 encephalitis patients; 30 separate healthy baseline comparators
- Study design
- 20 patients per randomized treatment group
The abstract does not report an absolute effect size, confidence interval, blinding method, or detailed adverse events.
Read the original sourceWhat do the human data say about exposure and risk?
A 20-person bioequivalence study found rapid and highly variable parent-drug exposure after one 400 mg capsule; it did not test benefit or chronic safety.
Parent aniracetam peaked at about 0.4 hours and had a measured half-life around 0.47 to 0.49 hours. Active metabolites may contribute, so this is not a 30-minute effect-duration claim.
The open dementia cohort reported mild anxiety, irritability and insomnia. Controlled reports are too small or incomplete to estimate uncommon harms, interactions, pregnancy risk or the contents of internet powder.
Pharmacokinetics and bioequivalence study of aniracetam after single-dose administration in healthy Chinese male volunteers.
Primary human pharmacokinetic study
Tian Y et al. Arzneimittelforschung. 2008. PMID 19025058.
After single 400 mg oral doses, parent aniracetam peaked at about 0.4 hours and had a measured plasma half-life about 0.47 to 0.49 hours.
- Participants / model
- 20 healthy Chinese men
- Follow-up
- Single-dose periods
- Study design
- Randomized two-period crossover bioequivalence study
The study measured formulation bioequivalence, not cognition or chronic safety; active metabolites may outlast parent drug.
Read the original sourceAniracetam (Ro 13-5057) in the treatment of senile dementia of Alzheimer type (SDAT): results of a placebo controlled multicentre clinical study.
Primary human study
Senin U et al. European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology. 1991. PMID 1822317. DOI 10.1016/0924-977x(91)90004-e.
The aniracetam group improved on psychobehavioral measures relative to placebo after six months.
- Participants / model
- 109 older patients with mild-to-moderate probable Alzheimer-type dementia
- Follow-up
- 6 months
- Study design
- Double-blind randomized placebo-controlled multicenter study
The abstract gives significance statements but not detailed effect sizes, allocation counts, attrition, or a complete adverse-event table.
Read the original sourceClinical efficacy of aniracetam, either as monotherapy or combined with cholinesterase inhibitors, in patients with cognitive impairment: a comparative open study.
Primary prospective human cohort
Koliaki CC et al. CNS Neuroscience & Therapeutics. 2012. PMID 22070796.
The aniracetam-only group largely maintained cognition and function; a three-month depression-scale change was not sustained and broader neuropsychiatric ratings did not support anxiety relief.
- Participants / model
- 276 patients with cognitive disorders across untreated, aniracetam, standard-drug and combination groups
- Follow-up
- 12 months
- Study design
- Prospective open nonrandomized comparative cohort
Treatment choice, rough clinician allocation, baseline imbalance and exclusion of treatment switchers prevent a clean causal comparison.
Read the original sourceIs aniracetam FDA approved?
No. FDA names aniracetam among unapproved drugs involved in a US distribution-enforcement case. Online sale does not authenticate the product or create an approved cognitive indication.
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 sourceStudies and sources
Aniracetam (Ro 13-5057) in the treatment of senile dementia of Alzheimer type (SDAT): results of a placebo controlled multicentre clinical study.
Primary human study
Senin U et al. European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology. 1991. PMID 1822317. DOI 10.1016/0924-977x(91)90004-e.
The aniracetam group improved on psychobehavioral measures relative to placebo after six months.
- Participants / model
- 109 older patients with mild-to-moderate probable Alzheimer-type dementia
- Follow-up
- 6 months
- Study design
- Double-blind randomized placebo-controlled multicenter study
The abstract gives significance statements but not detailed effect sizes, allocation counts, attrition, or a complete adverse-event table.
Read the original sourceFDA: 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 sourcePubChem: aniracetam chemical identity
Government chemical identity database
National Library of Medicine. PubChem CID 2196.
C12H13NO3; molecular weight 219.24 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茴拉西坦治疗单纯疱疹病毒性脑炎患者记忆障碍的临床研究 / Aniracetam after herpes simplex encephalitis
Primary human randomized study
李宇彤, 杜玉凤, 窦志杰 / Li Y, Du Y, Dou Z. 临床荟萃 / Clinical Focus. 2004;19(11):629 to 630.
Add-on aniracetam favored clinical memory scores after three weeks; the abstract reports P<0.05.
- Participants / model
- 40 encephalitis patients; 30 separate healthy baseline comparators
- Study design
- 20 patients per randomized treatment group
The abstract does not report an absolute effect size, confidence interval, blinding method, or detailed adverse events.
Read the original sourceModulation of excitatory synaptic transmission by drugs that reduce desensitization at AMPA/kainate receptors.
Preclinical primary study
Vyklicky L, Patneau DK, Mayer ML. Modulation of excitatory synaptic transmission by drugs that reduce desensitization at AMPA/kainate receptors. Neuron. 1991. DOI 10.1016/0896-6273(91)90342-w.
Aniracetam slowed excitatory-current decay and increased evoked currents in rat hippocampal neurons.
- Participants / model
- Rat hippocampal neurons
- Follow-up
- Acute experiments
- Study design
- Controlled neuropharmacology experiments
Animal pharmacology does not establish a human cognitive benefit.
Read the original sourceAniracetam tested in chronic psychosyndrome after long-term exposure to organic solvents. A randomized, double-blind, placebo-controlled cross-over study with neuropsychological tests.
Primary human randomized study
Somnier FE et al. Psychopharmacology. 1990. PMID 2188276.
Across three months each of aniracetam and placebo, clinicians and participants found no overall benefit; one of 19 neuropsychological measures favored aniracetam and one favored placebo.
- Participants / model
- 44 adults with chronic cognitive and behavioral illness after long-term organic-solvent exposure
- Follow-up
- Three months per treatment
- Study design
- Randomized double-blind placebo-controlled crossover
The indexed abstract supplies the overall null result but not a complete numerical outcome or adverse-event table.
Read the original sourceThe use of a scopolamine model to study the potential nootropic effects of aniracetam and piracetam in healthy volunteers.
Primary human challenge study
Wesnes K et al. Journal of Psychopharmacology. 1990. PMID 22281851.
Oral aniracetam 1,500 mg attenuated scopolamine-induced memory and information-processing deficits; the study did not test enhancement without scopolamine.
- Participants / model
- 26 healthy volunteers after experimentally induced scopolamine impairment
- Follow-up
- Acute sessions
- Study design
- Double-blind counterbalanced seven-session Latin-square challenge
Healthy enrollment does not make this a healthy-rested enhancement result because every relevant session induced impairment.
Read the original sourceThe hypoxia model in human psychopharmacology: neurophysiological and psychometric studies with aniracetam i.v.
Primary human challenge study
Saletu B et al. Human Neurobiology. 1984. PMID 6434496.
Intravenous aniracetam attenuated selected EEG, psychomotor and memory changes during acute hypoxia.
- Participants / model
- Ten healthy men breathing 11.2% oxygen in laboratory sessions
- Follow-up
- Acute sessions
- Study design
- Double-blind weekly Latin-square challenge
The abstract does not give endpoint-level effect sizes; IV hypoxia rescue does not establish oral rested-person benefit.
Read the original sourcePharmacokinetics and bioequivalence study of aniracetam after single-dose administration in healthy Chinese male volunteers.
Primary human pharmacokinetic study
Tian Y et al. Arzneimittelforschung. 2008. PMID 19025058.
After single 400 mg oral doses, parent aniracetam peaked at about 0.4 hours and had a measured plasma half-life about 0.47 to 0.49 hours.
- Participants / model
- 20 healthy Chinese men
- Follow-up
- Single-dose periods
- Study design
- Randomized two-period crossover bioequivalence study
The study measured formulation bioequivalence, not cognition or chronic safety; active metabolites may outlast parent drug.
Read the original sourceClinical efficacy of aniracetam, either as monotherapy or combined with cholinesterase inhibitors, in patients with cognitive impairment: a comparative open study.
Primary prospective human cohort
Koliaki CC et al. CNS Neuroscience & Therapeutics. 2012. PMID 22070796.
The aniracetam-only group largely maintained cognition and function; a three-month depression-scale change was not sustained and broader neuropsychiatric ratings did not support anxiety relief.
- Participants / model
- 276 patients with cognitive disorders across untreated, aniracetam, standard-drug and combination groups
- Follow-up
- 12 months
- Study design
- Prospective open nonrandomized comparative cohort
Treatment choice, rough clinician allocation, baseline imbalance and exclusion of treatment switchers prevent a clean causal comparison.
Read the original sourceAniracetam does not alter cognitive and affective behavior in adult C57BL/6J mice.
Preclinical primary study
Elston TW et al. PLoS One. 2014.
Repeated oral aniracetam did not improve spatial, associative, motor or object-recognition learning and did not show an anxiolytic effect in naïve mice.
- Participants / model
- Adult naïve C57BL/6J mice
- Follow-up
- Repeated acute testing schedule
- Study design
- Controlled behavioral experiments
A mouse null does not prove human ineffectiveness, but it directly fails to support enhancement in an unimpaired model.
Read the original sourceWhy is aniracetam in C tier?
C reflects old and mixed therapeutic-cognition signals. A 44-person oral crossover found no broad benefit. Healthy memory, anxiety relief, sleep performance, prevention and longevity remain unestablished.