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Most Cortexin studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from mixed-quality meta-analyses and randomised trials published 2016–2021.
Based on 7 studies · 1 meta-analysis
Confidence
Moderate
By outcome
Cognitive function
Mostly mechanism / observational7 studies
Neuroprotection & brain aging
Mostly mechanism / observational5 studies
Steady research
2 studies in the last 5 years · Latest meta-analysis: 2021
20162021
1Animal2019
Similar functional outcome was observed for saline control, Cognistar®, Cerebrolysat® and Cortexin®; in contrast, a significantly improved neurological outcome was observed with Cerebrolysin® treatment.
Zhang L, Chopp M, Wang C, Zhang Y, Lu M, Zhang T, Zhang ZG. · J Neurol Sci (2019)
Independent, prospective, randomized, double-blind, placebo-controlled rodent embolic-stroke comparison of four brain-hydrolysate drugs vs saline
Cortexin produced functional outcomes and lesion volumes NO DIFFERENT from saline
Only cerebrolysin significantly improved neurological outcome vs saline and vs the comparator drugs
The limited number of eligible studies for Actovegin (n = 2 trials,563 participants) and Cortexin, (n = 1 trial,80 participants) precluded meta-analyses but data suggested potential efficacy and no safety concerns.
Alsulaimani RA, Quinn TJ. · Cereb Circ Cogn Behav (2021)
Independent systematic review and meta-analysis of animal-derived nootropics (Cerebrolysin, Actovegin, Cortexin) in cognitive disorders, using Cochrane risk-of-bias and GRADE
For cortexin, only ONE eligible trial (80 participants) was found — too few to meta-analyse, so no pooled cortexin estimate could be generated
Across the drug class, risk of bias was moderate to high and certainty of evidence was low to very low; only cerebrolysin had enough trials to show a (modest) cognition benefit
Cortexin® (10 μg/ml) demonstrated high or moderate binding to AMPA-receptors (80.1%), kainate receptors (73.5%), mGluR1 (49.0%), GABAA1 (44.0%) and mGluR5 (39.7%).
Kurkin DV, Bakulin DA, Morkovin EI, Kalatanova AV, Makarenko IE, Dorotenko AR, Kovalev NS, Dubrovina MA, Verkholyak DV, Abrosimova EE, Smirnov AV, Shmidt MV, Tyurenkov IN. · PLoS One (2021)
Best mechanistic study: rat acute (MCAO) and chronic (carotid stenosis) ischemia models plus in-vitro receptor binding and BBB-permeability assays
Radiolabeled cortexin crossed the blood-brain barrier (6-8% of whole-blood concentration) and bound AMPA/kainate/mGluR/GABA-A receptors in vitro
Cortexin reduced necrosis size in acute ischemia, supported the antioxidant system and limited neurodegeneration in chronic ischemia — comparable to cerebrolysin, better than actovegin
The use of cellex in comparison with cortexin is more effective in terms of the dynamics of regression of neurological and neurocognitive dysfunctions in patients with ERPIS.
Khabirov FA, Khaibullin TI, Granatov EV, Akhmetova GI, Akhmetzyanov NM. · Zh Nevrol Psikhiatr Im S S Korsakova (2020)
Randomized comparative human trial (40 patients) of Cellex vs cortexin (10 mg IM daily for 10 days) in early-recovery ischemic stroke
Cellex produced significantly greater improvement on NIHSS and MMSE than cortexin
A trend toward greater regression of depressive symptoms also favored Cellex
The most complete regression of neurological deficits and manifestations of cardiac autonomic neuropathy during the acute period of ischemic stroke was observed in the group of patients treated with cortexin.
Mashin VV, Belova LA, Aizatullin IF, Pavlova VA, Slasten EV, Abramova VV, Belov DV. · Zh Nevrol Psikhiatr Im S S Korsakova (2019)
Three-arm controlled (non-blinded) trial in 90 acute ischemic-stroke patients: cortexin 20 mg/day + early verticalization vs verticalization alone vs basic therapy
The cortexin arm showed the most complete regression of neurological deficits and cardiac autonomic neuropathy
Assessed with NIHSS, modified Rankin, Barthel, Rivermead, MMSE and MoCA
It was noted more rapid and complete regression of cognitive disorders in patients of the 1st and 2nd groups, in comparison with patients of the 3rd group.
Belova LA, Mashin VV, Abramova VV, Proshin AN, Ovsjannikova AN. · Zh Nevrol Psikhiatr Im S S Korsakova (2016)
Controlled (non-blinded) trial in 90 hemispheric ischemic-stroke patients comparing single vs double cortexin courses (20 mg/day) vs basic therapy
Cortexin groups showed faster and more complete regression of cognitive deficits than basic therapy alone
The double-course regimen gave the best cognitive outcome (MMSE, FAB, clock-drawing, MoCA)