Cerebrolysin for stroke, neurodegeneration, and traumatic brain injury: review of the literature and outcomes

Covarrubias, Claudia; Wong, Amelia; Doan, Thao; Reardon, Taylor; Nikolaidis, Daniel; Sarno, Erika

doi:10.1007/s10072-021-05089-2

Cited by 25 publications

(13 citation statements)

References 57 publications

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“…Cerebrolysin is a biological agent used to treat several neurological diseases, including traumatic brain injury, vascular dementia, and ischemic stroke [ 18 ]. Clinical studies have shown the efficacy of Cerebrolysin as measured by improved functional recovery and decreased levels of depression in moderate and severe TBI [ 19 , 20 ].…”

Section: Introductionmentioning

confidence: 99%

The Effect of Cerebrolysin on Anxiety, Depression, and Cognition in Moderate and Severe Traumatic Brain Injury Patients: A CAPTAIN II Retrospective Trial Analysis

Strilciuc

Popescu

2022

Medicina

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Background and Objectives: Traumatic brain injuries represent an important source of disease burden requiring emergency inpatient care and continuous outpatient tailored rehabilitation. Although most TBIs are mild, patients are still developing post-TBI depression, anxiety, and cognitive impairments. Our secondary retrospective trial analysis aimed to (1) analyze correlations between HADS-Anxiety/HADS-Depression and scales that measure cognitive and motor processes in patients treated with Cerebrolysin compared to the placebo group and (2) compare anxiety and depression scores among the two treatment groups. Materials and Methods: Our secondary retrospective analysis focused on TBI patients with moderate and severe disability divided into two groups: Cerebrolysin (treatment) and saline solution (procedural placebo). We analyzed data from 125 patients. We computed descriptive statistics for nominal and continuous variables. We used Spearman’s correlation to find associations between HADS and other neuropsychological scales and the Mann–Whitney U test to compare HADS-Anxiety and HADS-Depression scores among the two study arms. Results: Our sample consisted of patients with a mean age of 45.3, primarily men, and with a 24 h GCS (Glasgow Coma Scale) mean of 12.67. We obtained statistically significant differences for HADS-Anxiety during the second and third visits for patients treated with Cerebrolysin. Our results show that Cerebrolysin has a large effect size (0.73) on anxiety levels. In addition, there are positive and negative correlations between HADS-Anxiety and Depression subscales and other neuropsychological scales. Conclusions: Our secondary database analysis supports the existing body of evidence on the positive effect of Cerebrolysin on post-TBI mental health status. Future confirmatory trials are necessary to clarify the link between the intervention and measured outcomes.

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Section: Introductionmentioning

confidence: 99%

The Effect of Cerebrolysin on Anxiety, Depression, and Cognition in Moderate and Severe Traumatic Brain Injury Patients: A CAPTAIN II Retrospective Trial Analysis

Strilciuc

Popescu

2022

Medicina

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“…Although Cerebrolysin is used clinically in over 50 European and Asian countries, it has not been approved for use in the USA or Australia. Therefore, more robust clinical trials with a greater number of participants are needed to clarify the clinical application of Cerebrolysin as a monotherapy and in combination with other therapeutics ( 69 ).…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Cerebrolysin Treatment as an Add-On Therapy to Mechanical Thrombectomy in Patients With Acute Ischemic Stroke Due to Large Vessel Occlusion: Study Protocol for a Prospective, Open Label, Single-Center Study With 12 Months of Follow-Up

Staszewski

Stępień²,

Piusińska‐Macoch³

et al. 2022

Front. Neurol.

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This study is designed to determine the efficacy of Cerebrolysin treatment as an add-on therapy to mechanical thrombectomy (MT) in reducing global disability in subjects with acute ischemic stroke (AIS). We have planned a single center, prospective, open-label, single-arm study with a 12-month follow-up of 50 patients with moderate to severe AIS, with a small established infarct core and with good collateral circulation who achieve significant reperfusion following MT and who receive additional Cerebrolysin within 8 h of stroke onset compared to 50 historical controls treated with MT alone, matched for age, clinical severity, occlusion location, baseline perfusion lesion volume, onset to reperfusion time, and use of iv thrombolytic therapy. The primary outcome measure will be the overall proportion of subjects receiving Cerebrolysin compared to the control group experiencing a favorable functional outcome (by modified Rankin Scale 0–2) at 90 days, following stroke onset. The secondary objectives are to determine the efficacy of Cerebrolysin as compared to the control group in reducing the risk of symptomatic secondary hemorrhagic transformation, improving neurological outcomes (NIHSS 0–2 at day 7, day 30, and 90), reducing mortality rates (over the 90-day and 12 months study period), and improving: activities of daily living (by Barthel Index), health-related quality of life (EQ-5D-5L) assessed at day 30, 90, and at 12 months. The other measures of efficacy in the Cerebrolysin group will include: assessment of final stroke volume and penumbral salvage (measured by CT/CTP at 30 days) and its change compared to baseline volume, changes over time in language function (by the 15-item Boston Naming Test), hemispatial neglect (by line bisection test), global cognitive function (by The Montreal Cognitive Assessment), and depression (by Hamilton Depression Rating Scale) between day 30 and day 90 assessments). The patients will receive 30 ml of Cerebrolysin within 8 h of AIS stroke onset and continue treatment once daily until day 21 (first cycle) and they will receive a second cycle of treatment (30 ml/d for 21 days given in the Outpatient Department or Neurorehabilitation Clinic) from day 69 to 90.

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“…Cerebrolysin has been reported to increase neuroprotective effects by protecting against excitotoxicity and oxidative stress as well as modulating the inflammatory response [34]. In addition, Cerebrolysin could enhances neurogenesis and neurorestoration through the activity of the neurotrophic factor and sonic hedgehog signaling pathways [35]. A metaanalysis of nine randomized trials reported that Cerebrolysin showed beneficial effects on both neurological deficits and functional outcomes even when its administration was initiated within three days after stroke onset [13].…”

Section: Discussionmentioning

confidence: 99%

“…A metaanalysis of nine randomized trials reported that Cerebrolysin showed beneficial effects on both neurological deficits and functional outcomes even when its administration was initiated within three days after stroke onset [13]. The recent review article revealed that Cerebrolysin could play a major role in the treatment of many neurological diseases, such as stroke, neurodegeneration, and traumatic brain injury, although more robust clinical data are needed to clarify the effects of Cerebrolysin [35]. Based on animal and human studies, it has been hypothesized that the subacute stroke phase constitutes an interval of heightened plasticity in which neural reorganization occurs, suggesting the existence of a critical period for motor recovery [36].…”

Section: Discussionmentioning

confidence: 99%

Cerebrolysin Combined with Rehabilitation Enhances Motor Recovery and Prevents Neural Network Degeneration in Ischemic Stroke Patients with Severe Motor Deficits

Chang

Lee

Shin

et al. 2021

JPM

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The objective of this study was to evaluate whether Cerebrolysin combined with rehabilitation therapy supports additional motor recovery in stroke patients with severe motor impairment. This study analyzed the combined data from the two phase IV prospective, multicenter, randomized, double-blind, placebo-controlled trials. Stroke patients were included within seven days after stroke onset and were randomized to receive a 21-day treatment course of either Cerebrolysin or placebo with standardized rehabilitation therapy. Assessments were performed at baseline, immediately after the treatment course, and 90 days after stroke onset. The plasticity of the motor system was assessed by diffusion tensor imaging and resting state fMRI. In total, 110 stroke patients were included for the full analysis set (Cerebrolysin n = 59, placebo n = 51). Both groups showed significant motor recovery over time. Repeated-measures analysis of varianceshowed a significant interaction between time and type of intervention as measured by the Fugl–Meyer Assessment (p < 0.05). The Cerebrolysin group demonstrated less degenerative changes in the major motor-related white matter tracts over time than the placebo group. In conclusion, Cerebrolysin treatment as an add-on to a rehabilitation program is a promising pharmacologic approach that is worth considering in order to enhance motor recovery in ischemic stroke patients with severe motor impairment.

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Cerebrolysin for stroke, neurodegeneration, and traumatic brain injury: review of the literature and outcomes

Cited by 25 publications

References 57 publications

The Effect of Cerebrolysin on Anxiety, Depression, and Cognition in Moderate and Severe Traumatic Brain Injury Patients: A CAPTAIN II Retrospective Trial Analysis

The Effect of Cerebrolysin on Anxiety, Depression, and Cognition in Moderate and Severe Traumatic Brain Injury Patients: A CAPTAIN II Retrospective Trial Analysis

Efficacy of Cerebrolysin Treatment as an Add-On Therapy to Mechanical Thrombectomy in Patients With Acute Ischemic Stroke Due to Large Vessel Occlusion: Study Protocol for a Prospective, Open Label, Single-Center Study With 12 Months of Follow-Up

Cerebrolysin Combined with Rehabilitation Enhances Motor Recovery and Prevents Neural Network Degeneration in Ischemic Stroke Patients with Severe Motor Deficits

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