pramiracetam
Pramiracetam has small human studies in brain injury, age-related memory complaints and drug-induced amnesia, plus regulated medical use in Romania. Results range from selected positive memory scores to a failed Alzheimer replication. No controlled trial establishes a dependable cognitive boost in healthy rested adults.
Small-molecule racetam
- The best-known brain-injury crossover enrolled four men; its 18-month continuation was open-label.
- A 60-person blinded older-adult trial reported psychometric improvement, but the abstract omits between-group effect sizes and had six placebo withdrawals.
- In a 10-person Alzheimer study, only two of eight apparent initial responders reproduced a response.
- A 24-man healthy-volunteer study tested protection from scopolamine-induced amnesia, not ordinary unchallenged enhancement.
- Two healthy-volunteer PK studies found a variable plasma half-life measured in hours.
- Romanian product information summarizes safety across 1,110 treated subjects and reports lower clearance with impaired kidney function.
What is pramiracetam, and does the salt matter?
Pramiracetam, also called CI-879 or Pramistar, is a racetam. The Romanian medicine uses pramiracetam sulfate expressed as an equivalent amount of the parent drug. A study of that regulated formulation does not verify the identity or exposure of an online powder.
PubChem: pramiracetam chemical identity
Government chemical identity database
National Library of Medicine. PubChem CID 51712.
C14H27N3O2; molecular weight 269.38 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 sourceOfficial Pramistar label and 1,110-subject safety summary
Official medicine label
Romanian National Agency for Medicines and Medical Devices. Pramistar summary of product characteristics. 2019.
The label summarizes adverse reactions across 1,110 treated subjects, contraindications, renal clearance and formulation details.
- Participants / model
- Clinical safety population summarized by the regulator; 1,110 treated subjects
- Follow-up
- Varied exposure in the underlying clinical program
- Study design
- Regulatory synthesis of clinical and product data
Common reactions include agitation, insomnia, dizziness, nausea and upper-abdominal pain. Part of the interaction rationale is extrapolated from piracetam.
Read the original source2024 Romanian regulatory review
Official regulatory assessment
Romanian National Agency for Medicines and Medical Devices. Pramiracetamum evaluation. 2024.
The authority records a licensed indication for degenerative or vascular memory and concentration problems, particularly in older adults.
- Participants / model
- Romanian regulatory context
- Follow-up
- Current at the 2024 report date
- Study design
- Health-technology and reimbursement assessment
This establishes regulated local medical use, not a new placebo-controlled efficacy result or US approval.
Read the original sourceWhat did the four-person brain-injury study find?
Four young men with memory problems after head injury or oxygen deprivation completed a 12-week double-blind placebo crossover. Delayed recall and other memory measures improved during pramiracetam exposure. Four people are too few to estimate a stable average effect or uncommon harms.
The authors reported that improvement continued through an 18-month open extension and one month after treatment stopped. Everyone received treatment during the extension, so it cannot supply an 18-month placebo comparison. The cited report does not provide full numerical tables or washout details.
Four-man brain-injury crossover and open extension
Primary human study
McLean A et al. Brain Injury. 1991. PMID 1786500. DOI 10.3109/02699059109008110.
Delayed recall and other memory measures improved during the controlled phase; improvement was reported through an open extension and one month after cessation.
- Participants / model
- Four young men with cognitive impairment after head injury or anoxia
- Follow-up
- 12-week controlled phase; 18-month open extension
- Study design
- 12-week double-blind placebo crossover followed by open treatment
NARIC supplies the sample and crossover details missing from the abstract. The cited records do not report full tables, washout details, or adverse-event counts.
Read the original sourceBrain-injury study cohort and design
Government bibliographic study record
National Rehabilitation Information Center. REHABDATA record J28403; McLean and colleagues, 1991.
The indexed study involved four men in a 12-week blinded crossover, followed by an 18-month open extension.
- Participants / model
- Four young men with cognitive impairment after brain injury or anoxia
- Follow-up
- 12-week controlled phase
- Study design
- Bibliographic abstract describing randomized treatment order
This index record supplies the sample size and controlled-phase duration. Its journal issue and page fields differ from PubMed, and secondary summaries disagree about dose frequency. The exact regimen remains unresolved.
Read the original sourceWhat happened in Alzheimer disease and older-adult studies?
The controlled studies do not point in one direction. A 10-person Alzheimer enrichment study failed to reproduce most apparent initial responses. A separate 60-person blinded older-adult study reported psychometric improvement, but the abstract does not give a direct effect estimate.
| Study | Result | What limits it |
|---|---|---|
| Alzheimer disease: 10 | Eight appeared to have a best dose initially; only two reproduced a similar response | Responder selection and tiny sample; authors judged tested doses unlikely to give symptomatic benefit |
| Older adults with memory impairment: 60 randomized 30/30 | Psychometric scores improved in the active arm; six placebo participants and no active participants withdrew | The abstract does not report a between-arm effect size, variance, dropout analysis, or multiplicity handling |
| Memory complaints: 35 | Objective memory improved in the drug-only and drug-plus-training groups | Open four-group study; drug-only group 8 and control group 7 |
| Probable vascular impairment: 104 | Scores improved during three months of treatment | Open, noncomparative study; complete numerical tables not reported in the cited record |
10-person Alzheimer trial with failed response replication
Primary placebo-controlled human study
Claus JJ et al. 1991. PMID 2011259.
Eight patients appeared to have an initial best dose; only two reproduced a similar response in the replication stage.
- Participants / model
- 10 people with probable Alzheimer disease
- Study design
- Two-stage placebo-controlled dose-enrichment and replication study
The authors concluded that the tested exposures were unlikely to provide symptomatic benefit. The sample was too small for a precise effect estimate.
Read the original source60-person blinded older-adult memory trial
Primary randomized double-blind placebo-controlled study
Marini G et al. Advances in Therapy. 1992;9(3):136-146.
The abstract reports psychometric improvement in the active arm and no significant placebo change; six placebo participants and no active participants withdrew.
- Participants / model
- 60 older adults, mean age 74.6; 30 randomized to each arm
- Follow-up
- 12 weeks after a two-week placebo washout
- Study design
- Randomized double-blind placebo-controlled study after a placebo washout
The abstract omits between-arm effects, variance, dropout handling, and multiplicity correction.
Read the original source35-person open memory-training pilot
Primary exploratory human study
De Vreese LP et al. Archives of Gerontology and Geriatrics. 1996. PMID 18653001. DOI 10.1016/0167-4943(96)86906-8.
Objective memory gains favored the drug groups; subjective memory results were less clear.
- Participants / model
- 35 older adults with memory complaints and without dementia or depression
- Follow-up
- Not reported in the abstract
- Study design
- Open random allocation to training, drug, both or control
Group sizes were 10, 8, 10 and 7. There was no blinding or placebo, and the abstract lacks detailed effects and safety counts.
Read the original source104-person open vascular-impairment study
Primary open human study
Scarpazza P, Guffanti EE, Marchi E, Corsonello F, Vozza A, Spezie I. Multicenter evaluation of pramiracetam for the treatment of memory impairment of probable vascular origin. Advances in Therapy. 1993;10(5):217-225.
The indexed abstract reports improved cognitive-test scores during treatment.
- Participants / model
- 104 older patients with probable vascular cognitive impairment
- Follow-up
- Three months
- Study design
- Open, noncomparative multicenter study
Without a concurrent comparator, practice effects, recovery, and changes in care remain possible. The report does not provide full tables or adverse-event denominators.
Read the original sourceDoes the choline mechanism prove a stack or a cognitive effect?
Rat experiments found increased hippocampal high-affinity choline uptake at selected exposures. Higher and lower exposures were ineffective. This does not show that people need supplemental choline or that a pramiracetam and choline combination improves cognition.
| Experiment | Positive result | Null or boundary |
|---|---|---|
| Normal-rat object recognition | One of three exposures improved 24-hour recognition | Nonmonotonic response; no human result |
| Radial-arm maze | Reference memory improved after pretreatment | Working memory did not improve |
| Nitric-oxide synthase | Higher exposure increased cortical activity about 20% | No hippocampal increase or mRNA change; lower exposure ineffective |
| Developing-rat hypoxia | First afterdischarge shortened in 18-day-old animals | No effect in 12-day-old pups or on repeated afterdischarges |
Rat hippocampal choline-uptake study
Preclinical primary study
Shih YH, Pugsley TA. Life Sciences. 1985. PMID 2987637. DOI 10.1016/0024-3205(85)90311-X.
Intermediate pramiracetam exposures increased sodium-dependent high-affinity choline uptake; higher and lower exposures were ineffective.
- Participants / model
- Rats and isolated hippocampal nerve-terminal preparations
- Follow-up
- Acute experiments
- Study design
- Controlled neuropharmacology experiments
This finding does not establish a human cognitive effect or a need for a choline supplement.
Read the original sourceNormal-rat object-recognition experiment
Preclinical primary study
Ennaceur A et al. 1989. PMID 2765166.
One of three exposures improved 24-hour object recognition without changing total exploration.
- Participants / model
- Normal rats
- Follow-up
- Acute treatment with 24-hour memory test
- Study design
- Controlled object-recognition experiment
The response was not monotonic and does not provide a human effect estimate.
Read the original sourceRat reference-memory positive and working-memory null
Preclinical primary study
Radial-arm maze learning study. 1986. PMID 3088666.
Reference memory improved at both tested exposures; working memory did not improve significantly.
- Participants / model
- Rats
- Follow-up
- Seven weeks of pretreatment
- Study design
- Controlled radial-arm maze experiment
The domain-specific null prevents describing the result as broad memory enhancement.
Read the original sourceRat cortical NOS experiment
Preclinical primary study
Nitric-oxide synthase study. 1995. PMID 8557218.
A higher exposure increased cortical NOS activity about 20%; lower exposure was ineffective.
- Participants / model
- Rats
- Follow-up
- Acute experimental period
- Study design
- Controlled biochemical experiment
No hippocampal increase or significant NOS mRNA change was found. Lithium interaction was animal-only.
Read the original sourceAge-dependent hypoxia experiment
Preclinical primary study
Hypobaric hypoxia study. PMID 9200217.
The first afterdischarge shortened in 18-day-old animals.
- Participants / model
- Developing rats
- Follow-up
- Acute experimental period
- Study design
- Controlled hypobaric-hypoxia experiment
No effect occurred in 12-day-old pups or on repeated afterdischarges. This does not establish adult human neuroprotection.
Read the original sourceWhat did the Chinese pharmacokinetic study measure?
The Chinese study measured pramiracetam in dogs and rats. Dog plasma half-life was 2.3 to 3.9 hours; rats had highest measured tissue concentrations in kidney, with brain exposure detected. These values cannot replace the human formulation studies.
Measured protein binding was about 20% to 22% in the tested animal system. The separately indexed Chinese journal record may describe the same program and is not counted as independent human evidence.
Chinese dog and rat pharmacokinetics
Preclinical primary pharmacokinetic study
Fang Z, Liu X, Xiao Y. Pramiracetam pharmacokinetics in animals. PMID 11387954.
Dog plasma half-life was 2.3 to 3.9 hours; rat distribution was highest in kidney with brain exposure detected.
- Participants / model
- Dogs and rats
- Follow-up
- Acute pharmacokinetic sampling
- Study design
- HPLC pharmacokinetic and tissue-distribution experiments
These species-specific measurements do not define human clearance. A separate Chinese journal record may describe the same program.
Read the original sourceDoes the healthy-volunteer study show everyday enhancement?
Twenty-four healthy men received pramiracetam or placebo for 10 days before a scopolamine challenge. Pramiracetam partially reduced the induced amnesia. Scopolamine still impaired episodic memory and selective attention, and the abstract does not show a useful improvement at unchallenged baseline.
A separate Russian-language report followed 20 neurologically healthy older adults, mean age 62, for 20 days. Memory, attention, subjective health and selected EEG or Doppler measures improved from baseline; anxiety and most vascular measures did not. With no placebo group, practice effects and time remain possible explanations.
24-man scopolamine challenge
Randomized placebo-controlled human challenge study
Mauri M et al. Archives of Gerontology and Geriatrics. 1994. PMID 15374306. DOI 10.1016/0167-4943(94)00542-7.
Pramiracetam partially reduced scopolamine-induced amnesia; other challenged domains remained impaired or unaffected.
- Participants / model
- 24 healthy men in younger and older age strata
- Follow-up
- 10 treatment days before a single challenge
- Study design
- Placebo-controlled treatment followed by scopolamine challenge
The abstract does not show a useful unchallenged-baseline effect or a reusable treatment effect size.
Read the original source20-person uncontrolled older-adult study
Primary uncontrolled human study
Korsunskaya LL. Crimean Therapeutic Journal. 2007;2(2):119-123.
Memory, attention, subjective health and selected EEG or Doppler measures improved; anxiety and most vascular measures did not.
- Participants / model
- 20 neurologically healthy older adults, mean age 62; mild hypertension permitted
- Follow-up
- 20 days
- Study design
- Uncontrolled before-and-after study
All participants completed and no adverse effects were reported. With no comparator, the changes cannot establish prevention or a causal treatment effect.
Read the original sourceWhat do the regional brain-injury reports add?
Regional reports describe improvement during pramiracetam-containing care, but do not isolate a clean drug effect. A 65-person mild-traumatic-brain-injury comparison omits group sizes, randomization, masking and numerical effects. A later 108-patient report used extensive co-treatment and may overlap with the earlier series.
| Report | Finding | Missing information |
|---|---|---|
| Mild brain injury: 65 | Orientation, well-being and amnesia favored pramiracetam-containing care over piracetam-containing care | Arm sizes, randomization, masking and effect estimates |
| Acute concussion: 108 | Abstract emphasizes improvement in asthenic symptoms | Quantitative treatment contrast; cohort independence from the earlier report |
| Chronic cerebrovascular insufficiency or stroke sequelae | Abstract reports changes across several symptoms | Sample size, allocation, comparator, duration and effect estimates |
65-patient mild-brain-injury comparison
Primary human clinical report
Tkachev AV. Russian-language clinical report. 2007. PMID 18418926.
Orientation, subjective well-being and amnesia measures favored pramiracetam-containing care over piracetam-containing care.
- Participants / model
- 65 patients with mild traumatic brain injury
- Follow-up
- Assessments on days 1, 10 and 30
- Study design
- Comparison within complex clinical care; allocation and masking not reported in the abstract
Both groups received other treatment. Arm sizes and numerical between-group effects are absent from the abstract.
Read the original source108-patient concussion co-treatment report
Primary human clinical report
Tkachev AV. Russian-language clinical report. 2008. PMID 19145827.
The abstract reports improvement in asthenic symptoms during pramiracetam-containing care.
- Participants / model
- 108 patients: 37 received piracetam and 71 Pramistar; 30 healthy controls
- Follow-up
- Assessments on days 1, 10 and 30
- Study design
- Clinical comparison with analgesics, tranquilizers, B vitamins, magnesium sulfate and diuretics
No quantitative treatment contrast is supplied. Investigator and schedule match an earlier series, so cohort overlap is possible.
Read the original sourceCerebrovascular clinical report with missing design details
Primary human clinical report
Russian-language cerebrovascular clinical report. 2004. PMID 14965012.
The abstract reports changes in several cognitive and neurologic symptoms.
- Participants / model
- People with chronic cerebrovascular insufficiency or stroke sequelae
- Follow-up
- Not specified in the abstract
- Study design
- Design, allocation and comparator not specified in the abstract
The abstract omits sample size, allocation, comparator, duration and effect estimates.
Read the original sourceDoes pramiracetam improve cognition or prevent decline in healthy people?
The cited blinded trials did not test ordinary cognitive enhancement in healthy rested adults without a drug challenge. The uncontrolled 20-person older-adult report is too weak to show prevention. The cited human trials did not measure dementia incidence, stroke prevention, lifespan, or healthspan.
Normal-animal memory results and disease-model biomarkers can support a research hypothesis. They do not establish a human anti-aging outcome.
20-person uncontrolled older-adult study
Primary uncontrolled human study
Korsunskaya LL. Crimean Therapeutic Journal. 2007;2(2):119-123.
Memory, attention, subjective health and selected EEG or Doppler measures improved; anxiety and most vascular measures did not.
- Participants / model
- 20 neurologically healthy older adults, mean age 62; mild hypertension permitted
- Follow-up
- 20 days
- Study design
- Uncontrolled before-and-after study
All participants completed and no adverse effects were reported. With no comparator, the changes cannot establish prevention or a causal treatment effect.
Read the original sourceNormal-rat object-recognition experiment
Preclinical primary study
Ennaceur A et al. 1989. PMID 2765166.
One of three exposures improved 24-hour object recognition without changing total exploration.
- Participants / model
- Normal rats
- Follow-up
- Acute treatment with 24-hour memory test
- Study design
- Controlled object-recognition experiment
The response was not monotonic and does not provide a human effect estimate.
Read the original sourceRat reference-memory positive and working-memory null
Preclinical primary study
Radial-arm maze learning study. 1986. PMID 3088666.
Reference memory improved at both tested exposures; working memory did not improve significantly.
- Participants / model
- Rats
- Follow-up
- Seven weeks of pretreatment
- Study design
- Controlled radial-arm maze experiment
The domain-specific null prevents describing the result as broad memory enhancement.
Read the original source2026 Parkinson-model combination study
Preclinical primary study
Ukraine and Kyrgyzstan-affiliated animal study. Wiadomosci Lekarskie. 2026.
The Pramistar combination row lacked significance marks for the reported HIF, HSP70 and c-Fos endpoints, and the abstract did not list it among favored combinations.
- Participants / model
- 90 rats described across nine groups
- Study design
- Combination-treatment Parkinson-model experiment
Group denominators and several table symbols conflict. The experiment cannot establish pramiracetam monotherapy, Parkinson treatment efficacy or healthy cognition.
Read the original sourceWhat has been measured in people?
In 12 fasting healthy men, single oral exposure produced peak plasma concentrations after two to three hours and half-lives of 4.5 to 6.5 hours. An 11-person formulation study found mean half-lives of 4.7 plus or minus 2.4 hours for solution and 4.3 plus or minus 2.2 hours for tablets, with an overall two-to-eight-hour range.
Solution was absorbed faster than tablets. Plasma PK does not establish brain exposure, how long a cognitive effect lasts or a schedule for self-treatment.
12-man fasting single-dose pharmacokinetics
Primary human pharmacokinetic study
Chang T et al. Journal of Clinical Pharmacology. 1985. PMID 4008675. DOI 10.1002/j.1552-4604.1985.tb02841.x.
Peak plasma concentrations occurred at two to three hours; half-lives ranged from 4.5 to 6.5 hours.
- Participants / model
- 12 healthy men in two groups of six
- Follow-up
- Single-dose sessions
- Study design
- Randomized blinded alternating placebo and fasting single oral exposures
No significant adverse effects were reported in this tiny acute study. It does not define repeated-use safety or cognitive-effect duration.
Read the original source11-person solution-versus-tablet pharmacokinetics
Primary human pharmacokinetic study
Pramiracetam formulation pharmacokinetic study. 1992. PMID 1473879.
Mean half-lives were 4.7 plus or minus 2.4 hours for solution and 4.3 plus or minus 2.2 hours for tablets; solution absorption was faster.
- Participants / model
- 11 fasting volunteers
- Follow-up
- Single-exposure pharmacokinetic sampling
- Study design
- Oral solution and tablet formulation comparison
Individual half-lives ranged from two to eight hours. The study did not measure cognition.
Read the original sourceWhat risks are documented?
Romanian product information draws on 1,110 treated subjects. It lists agitation, insomnia, dizziness, nausea and upper-abdominal pain as common, with confusion and tremor less frequent. It contraindicates severe kidney impairment, liver impairment, pregnancy and breastfeeding, and reports lower clearance as kidney function declines.
The label cautions about anticoagulant or antiplatelet treatment and thyroid extract, while noting that part of this interaction rationale comes from piracetam rather than direct pramiracetam trials. Rat platelet experiments show exact-compound biological activity but do not provide a human bleeding rate.
A 2024 Romanian authority report confirms a licensed use for degenerative or vascular memory and concentration problems, especially in older adults. That status does not establish healthy enhancement or US approval.
Official Pramistar label and 1,110-subject safety summary
Official medicine label
Romanian National Agency for Medicines and Medical Devices. Pramistar summary of product characteristics. 2019.
The label summarizes adverse reactions across 1,110 treated subjects, contraindications, renal clearance and formulation details.
- Participants / model
- Clinical safety population summarized by the regulator; 1,110 treated subjects
- Follow-up
- Varied exposure in the underlying clinical program
- Study design
- Regulatory synthesis of clinical and product data
Common reactions include agitation, insomnia, dizziness, nausea and upper-abdominal pain. Part of the interaction rationale is extrapolated from piracetam.
Read the original source2024 Romanian regulatory review
Official regulatory assessment
Romanian National Agency for Medicines and Medical Devices. Pramiracetamum evaluation. 2024.
The authority records a licensed indication for degenerative or vascular memory and concentration problems, particularly in older adults.
- Participants / model
- Romanian regulatory context
- Follow-up
- Current at the 2024 report date
- Study design
- Health-technology and reimbursement assessment
This establishes regulated local medical use, not a new placebo-controlled efficacy result or US approval.
Read the original sourceRat platelet experiment
Preclinical primary study
Russian-language platelet study. 2012. PMID 22702111.
Pramiracetam showed antiaggregatory activity in an alloxan-hyperglycemia model.
- Participants / model
- Rats with experimental hyperglycemia
- Follow-up
- Experimental treatment period
- Study design
- Controlled platelet-function experiment
Exact-compound biological activity does not establish a human bleeding rate.
Read the original sourceRat platelet-mechanism follow-up
Preclinical primary study
Platelet mechanism study. 2014. PMID 24824701.
Pramiracetam-associated antiaggregation was linked to thromboxane-A2 metabolism in this model.
- Participants / model
- Rats with chronic experimental hyperglycemia
- Follow-up
- Experimental treatment period
- Study design
- Controlled platelet-mechanism experiment
Related work from the same research line is not independent human confirmation.
Read the original sourceStudies and sources
Four-man brain-injury crossover and open extension
Primary human study
McLean A et al. Brain Injury. 1991. PMID 1786500. DOI 10.3109/02699059109008110.
Delayed recall and other memory measures improved during the controlled phase; improvement was reported through an open extension and one month after cessation.
- Participants / model
- Four young men with cognitive impairment after head injury or anoxia
- Follow-up
- 12-week controlled phase; 18-month open extension
- Study design
- 12-week double-blind placebo crossover followed by open treatment
NARIC supplies the sample and crossover details missing from the abstract. The cited records do not report full tables, washout details, or adverse-event counts.
Read the original sourcePubChem: pramiracetam chemical identity
Government chemical identity database
National Library of Medicine. PubChem CID 51712.
C14H27N3O2; molecular weight 269.38 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 sourceChinese dog and rat pharmacokinetics
Preclinical primary pharmacokinetic study
Fang Z, Liu X, Xiao Y. Pramiracetam pharmacokinetics in animals. PMID 11387954.
Dog plasma half-life was 2.3 to 3.9 hours; rat distribution was highest in kidney with brain exposure detected.
- Participants / model
- Dogs and rats
- Follow-up
- Acute pharmacokinetic sampling
- Study design
- HPLC pharmacokinetic and tissue-distribution experiments
These species-specific measurements do not define human clearance. A separate Chinese journal record may describe the same program.
Read the original source24-man scopolamine challenge
Randomized placebo-controlled human challenge study
Mauri M et al. Archives of Gerontology and Geriatrics. 1994. PMID 15374306. DOI 10.1016/0167-4943(94)00542-7.
Pramiracetam partially reduced scopolamine-induced amnesia; other challenged domains remained impaired or unaffected.
- Participants / model
- 24 healthy men in younger and older age strata
- Follow-up
- 10 treatment days before a single challenge
- Study design
- Placebo-controlled treatment followed by scopolamine challenge
The abstract does not show a useful unchallenged-baseline effect or a reusable treatment effect size.
Read the original sourceRat hippocampal choline-uptake study
Preclinical primary study
Shih YH, Pugsley TA. Life Sciences. 1985. PMID 2987637. DOI 10.1016/0024-3205(85)90311-X.
Intermediate pramiracetam exposures increased sodium-dependent high-affinity choline uptake; higher and lower exposures were ineffective.
- Participants / model
- Rats and isolated hippocampal nerve-terminal preparations
- Follow-up
- Acute experiments
- Study design
- Controlled neuropharmacology experiments
This finding does not establish a human cognitive effect or a need for a choline supplement.
Read the original sourceBrain-injury study cohort and design
Government bibliographic study record
National Rehabilitation Information Center. REHABDATA record J28403; McLean and colleagues, 1991.
The indexed study involved four men in a 12-week blinded crossover, followed by an 18-month open extension.
- Participants / model
- Four young men with cognitive impairment after brain injury or anoxia
- Follow-up
- 12-week controlled phase
- Study design
- Bibliographic abstract describing randomized treatment order
This index record supplies the sample size and controlled-phase duration. Its journal issue and page fields differ from PubMed, and secondary summaries disagree about dose frequency. The exact regimen remains unresolved.
Read the original source65-patient mild-brain-injury comparison
Primary human clinical report
Tkachev AV. Russian-language clinical report. 2007. PMID 18418926.
Orientation, subjective well-being and amnesia measures favored pramiracetam-containing care over piracetam-containing care.
- Participants / model
- 65 patients with mild traumatic brain injury
- Follow-up
- Assessments on days 1, 10 and 30
- Study design
- Comparison within complex clinical care; allocation and masking not reported in the abstract
Both groups received other treatment. Arm sizes and numerical between-group effects are absent from the abstract.
Read the original source12-man fasting single-dose pharmacokinetics
Primary human pharmacokinetic study
Chang T et al. Journal of Clinical Pharmacology. 1985. PMID 4008675. DOI 10.1002/j.1552-4604.1985.tb02841.x.
Peak plasma concentrations occurred at two to three hours; half-lives ranged from 4.5 to 6.5 hours.
- Participants / model
- 12 healthy men in two groups of six
- Follow-up
- Single-dose sessions
- Study design
- Randomized blinded alternating placebo and fasting single oral exposures
No significant adverse effects were reported in this tiny acute study. It does not define repeated-use safety or cognitive-effect duration.
Read the original source35-person open memory-training pilot
Primary exploratory human study
De Vreese LP et al. Archives of Gerontology and Geriatrics. 1996. PMID 18653001. DOI 10.1016/0167-4943(96)86906-8.
Objective memory gains favored the drug groups; subjective memory results were less clear.
- Participants / model
- 35 older adults with memory complaints and without dementia or depression
- Follow-up
- Not reported in the abstract
- Study design
- Open random allocation to training, drug, both or control
Group sizes were 10, 8, 10 and 7. There was no blinding or placebo, and the abstract lacks detailed effects and safety counts.
Read the original source10-person Alzheimer trial with failed response replication
Primary placebo-controlled human study
Claus JJ et al. 1991. PMID 2011259.
Eight patients appeared to have an initial best dose; only two reproduced a similar response in the replication stage.
- Participants / model
- 10 people with probable Alzheimer disease
- Study design
- Two-stage placebo-controlled dose-enrichment and replication study
The authors concluded that the tested exposures were unlikely to provide symptomatic benefit. The sample was too small for a precise effect estimate.
Read the original source60-person blinded older-adult memory trial
Primary randomized double-blind placebo-controlled study
Marini G et al. Advances in Therapy. 1992;9(3):136-146.
The abstract reports psychometric improvement in the active arm and no significant placebo change; six placebo participants and no active participants withdrew.
- Participants / model
- 60 older adults, mean age 74.6; 30 randomized to each arm
- Follow-up
- 12 weeks after a two-week placebo washout
- Study design
- Randomized double-blind placebo-controlled study after a placebo washout
The abstract omits between-arm effects, variance, dropout handling, and multiplicity correction.
Read the original source104-person open vascular-impairment study
Primary open human study
Scarpazza P, Guffanti EE, Marchi E, Corsonello F, Vozza A, Spezie I. Multicenter evaluation of pramiracetam for the treatment of memory impairment of probable vascular origin. Advances in Therapy. 1993;10(5):217-225.
The indexed abstract reports improved cognitive-test scores during treatment.
- Participants / model
- 104 older patients with probable vascular cognitive impairment
- Follow-up
- Three months
- Study design
- Open, noncomparative multicenter study
Without a concurrent comparator, practice effects, recovery, and changes in care remain possible. The report does not provide full tables or adverse-event denominators.
Read the original source20-person uncontrolled older-adult study
Primary uncontrolled human study
Korsunskaya LL. Crimean Therapeutic Journal. 2007;2(2):119-123.
Memory, attention, subjective health and selected EEG or Doppler measures improved; anxiety and most vascular measures did not.
- Participants / model
- 20 neurologically healthy older adults, mean age 62; mild hypertension permitted
- Follow-up
- 20 days
- Study design
- Uncontrolled before-and-after study
All participants completed and no adverse effects were reported. With no comparator, the changes cannot establish prevention or a causal treatment effect.
Read the original source108-patient concussion co-treatment report
Primary human clinical report
Tkachev AV. Russian-language clinical report. 2008. PMID 19145827.
The abstract reports improvement in asthenic symptoms during pramiracetam-containing care.
- Participants / model
- 108 patients: 37 received piracetam and 71 Pramistar; 30 healthy controls
- Follow-up
- Assessments on days 1, 10 and 30
- Study design
- Clinical comparison with analgesics, tranquilizers, B vitamins, magnesium sulfate and diuretics
No quantitative treatment contrast is supplied. Investigator and schedule match an earlier series, so cohort overlap is possible.
Read the original sourceCerebrovascular clinical report with missing design details
Primary human clinical report
Russian-language cerebrovascular clinical report. 2004. PMID 14965012.
The abstract reports changes in several cognitive and neurologic symptoms.
- Participants / model
- People with chronic cerebrovascular insufficiency or stroke sequelae
- Follow-up
- Not specified in the abstract
- Study design
- Design, allocation and comparator not specified in the abstract
The abstract omits sample size, allocation, comparator, duration and effect estimates.
Read the original source11-person solution-versus-tablet pharmacokinetics
Primary human pharmacokinetic study
Pramiracetam formulation pharmacokinetic study. 1992. PMID 1473879.
Mean half-lives were 4.7 plus or minus 2.4 hours for solution and 4.3 plus or minus 2.2 hours for tablets; solution absorption was faster.
- Participants / model
- 11 fasting volunteers
- Follow-up
- Single-exposure pharmacokinetic sampling
- Study design
- Oral solution and tablet formulation comparison
Individual half-lives ranged from two to eight hours. The study did not measure cognition.
Read the original sourceOfficial Pramistar label and 1,110-subject safety summary
Official medicine label
Romanian National Agency for Medicines and Medical Devices. Pramistar summary of product characteristics. 2019.
The label summarizes adverse reactions across 1,110 treated subjects, contraindications, renal clearance and formulation details.
- Participants / model
- Clinical safety population summarized by the regulator; 1,110 treated subjects
- Follow-up
- Varied exposure in the underlying clinical program
- Study design
- Regulatory synthesis of clinical and product data
Common reactions include agitation, insomnia, dizziness, nausea and upper-abdominal pain. Part of the interaction rationale is extrapolated from piracetam.
Read the original source2024 Romanian regulatory review
Official regulatory assessment
Romanian National Agency for Medicines and Medical Devices. Pramiracetamum evaluation. 2024.
The authority records a licensed indication for degenerative or vascular memory and concentration problems, particularly in older adults.
- Participants / model
- Romanian regulatory context
- Follow-up
- Current at the 2024 report date
- Study design
- Health-technology and reimbursement assessment
This establishes regulated local medical use, not a new placebo-controlled efficacy result or US approval.
Read the original sourceNormal-rat object-recognition experiment
Preclinical primary study
Ennaceur A et al. 1989. PMID 2765166.
One of three exposures improved 24-hour object recognition without changing total exploration.
- Participants / model
- Normal rats
- Follow-up
- Acute treatment with 24-hour memory test
- Study design
- Controlled object-recognition experiment
The response was not monotonic and does not provide a human effect estimate.
Read the original sourceRat reference-memory positive and working-memory null
Preclinical primary study
Radial-arm maze learning study. 1986. PMID 3088666.
Reference memory improved at both tested exposures; working memory did not improve significantly.
- Participants / model
- Rats
- Follow-up
- Seven weeks of pretreatment
- Study design
- Controlled radial-arm maze experiment
The domain-specific null prevents describing the result as broad memory enhancement.
Read the original sourceRat cortical NOS experiment
Preclinical primary study
Nitric-oxide synthase study. 1995. PMID 8557218.
A higher exposure increased cortical NOS activity about 20%; lower exposure was ineffective.
- Participants / model
- Rats
- Follow-up
- Acute experimental period
- Study design
- Controlled biochemical experiment
No hippocampal increase or significant NOS mRNA change was found. Lithium interaction was animal-only.
Read the original sourceAge-dependent hypoxia experiment
Preclinical primary study
Hypobaric hypoxia study. PMID 9200217.
The first afterdischarge shortened in 18-day-old animals.
- Participants / model
- Developing rats
- Follow-up
- Acute experimental period
- Study design
- Controlled hypobaric-hypoxia experiment
No effect occurred in 12-day-old pups or on repeated afterdischarges. This does not establish adult human neuroprotection.
Read the original sourceRat platelet experiment
Preclinical primary study
Russian-language platelet study. 2012. PMID 22702111.
Pramiracetam showed antiaggregatory activity in an alloxan-hyperglycemia model.
- Participants / model
- Rats with experimental hyperglycemia
- Follow-up
- Experimental treatment period
- Study design
- Controlled platelet-function experiment
Exact-compound biological activity does not establish a human bleeding rate.
Read the original sourceRat platelet-mechanism follow-up
Preclinical primary study
Platelet mechanism study. 2014. PMID 24824701.
Pramiracetam-associated antiaggregation was linked to thromboxane-A2 metabolism in this model.
- Participants / model
- Rats with chronic experimental hyperglycemia
- Follow-up
- Experimental treatment period
- Study design
- Controlled platelet-mechanism experiment
Related work from the same research line is not independent human confirmation.
Read the original source2026 Parkinson-model combination study
Preclinical primary study
Ukraine and Kyrgyzstan-affiliated animal study. Wiadomosci Lekarskie. 2026.
The Pramistar combination row lacked significance marks for the reported HIF, HSP70 and c-Fos endpoints, and the abstract did not list it among favored combinations.
- Participants / model
- 90 rats described across nine groups
- Study design
- Combination-treatment Parkinson-model experiment
Group denominators and several table symbols conflict. The experiment cannot establish pramiracetam monotherapy, Parkinson treatment efficacy or healthy cognition.
Read the original sourceWhy is pramiracetam in C tier?
C reflects small human studies reporting selected memory benefits in impaired or challenged populations. A negative Alzheimer replication, tiny groups, incomplete reporting, open designs and co-treatment leave the average effect uncertain. Healthy cognition and long-term safety remain unestablished.