Cerebrolysin enhances cognitive recovery of mild traumatic brain injury patients: double-blind, placebo-controlled, randomized study

Abstract

In adults, mild traumatic brain injury (MTBI) frequently results in impairments of cognitive functions which would lead to psychological consequences in the future. Cerebrolysin is a nootropic drug, and can significantly improve cognitive function in patients with Alzheimer's disease and stroke. The purpose of this study was to investigate how Cerebrolysin therapy enhances cognitive recovery for mild traumatic brain injury patients using a double-blinded, placebo-controlled, randomized phase II pilot study. Patients having head injury within 24 h sent to our hospital were screened and recruited if patients were alert and conscious, and had intracranial contusion haemorrhage. From July 2009 to June 2010, totally, thirty-two patients were recruited in the double-blinded, placebo-controlled, and randomized study. Patients were randomized to receive Cerebrolysin (Group A, once daily intravenous infusion of 30 mL Cerebrolysin over a 60-min period for 5 days) or placebo (Group B, same dosage and administration of normal saline as Group A). The primary outcome measures were differences of cognitive function including Mini-Mental Status Examination (MMSE), and Cognitive Abilities Screening Instrument (CASI) scores between baseline and week 1, between baseline and week 4, and between baseline and week 12. Thirty-two patients completed the trial. For Group A, the CASI score difference between baseline and week 12 was 21.0 ± 20.4, a significantly greater change than that of Group B (7.6 ± 12.1) (p = 0.0461). Besides, drawing function (one of the domains of CASI; p = 0.0066) on week 4 and both drawing function (p = 0.0472) and long-term memory (one of the domains of CASI; p = 0.0256) on week 12 were also found to be significantly improved in the patients receiving Cerebrolysin treatment. Our results suggest that Cerebrolysin improves the cognitive function of the MTBI in patients at 3rd month after injury, especially for long-term memory and drawing function.

Pharmacologic Neuroprotection for Functional Outcomes After Traumatic Brain Injury: A Systematic Review of the Clinical Literature

“…A recent double-blind, placebo-controlled, randomized phase II pilot study investigated the effects of Cerebrolysin on cognition in patients after mild TBI [38]. Patients were randomly assigned to receive either a once-daily intravenous infusion of Cerebrolysin at 30 mL over 60 min for 5 days, or placebo (same volume and administration of normal saline).…”

Strategies targeting endogenous neurogenic cell response to improve recovery following traumatic brain injury

“…Strategies targeting growth/neurotrophic factor signaling pathways with small molecules/peptides could retain similar beneficial effects with better translation potential. For example, cerebrolysin, a pharmacologically prepared low molecular weight neuropeptide derived from purified porcine brain proteins, which has pharmacodynamic properties similar to endogenous neurotrophic factors (Plosker and Gauthier, 2009), have shown enhancing cognitive improvements in mild TBI in clinical trials (Chen et al, 2013), In a mild impact acceleration model, intraperitoneal injection of cerebrolysin in rats increases the number of DCX labeled neuroblasts and BrdU/NeuN double-labeled newly generated mature neurons in the DG, and significantly improves long-term learning and memory functions of the injured animals (Zhang et al, 2015). …”

Hope Dies Last—Evidence Again Fails to Support a Neuroprotectant

“…6 Randomized clinical trials addressed its safety and efficacy in several conditions like Alzheimer's disease 7 and traumatic brain injury. 8 One recent Cochrane review based on 6 trials evaluates the effects of cerebrolysin in acute ischemic stroke and concludes that the use of cerebrolysin has no effect on fatality. 9,10 Five of the included trials were small, and in the largest trial, the comparison groups were not balanced for prognostic factors.…”