Cerebrolysin Improves Cognitive Recovery After Stroke: Randomized Controlled Trial
Guekht A.B., Gusev E.I., Skvortsova V.I.
Russian National Research Medical University
Stroke 44(4): 1093-1100
Abstract
Cognitive impairment affects 30-50% of stroke survivors and severely impacts quality of life. This multicenter, randomized, placebo-controlled trial evaluated Cerebrolysin (brain neurotrophic peptide mixture) for post-stroke cognitive recovery. A total of 238 patients with ischemic stroke and documented cognitive deficits (MMSE 18-26) were randomized to receive standard stroke care plus Cerebrolysin (30mL IV daily for 21 days, n=119) or placebo (n=119). Primary outcome was change in MMSE score at 90 days. The Cerebrolysin group showed significantly greater improvement in MMSE (+5.8±2.3 points vs. +2.1±1.9 in placebo, p<0.0001). Montreal Cognitive Assessment (MoCA) scores improved by 6.2±2.7 vs. 2.8±2.1 (p<0.001). Modified Rankin Scale scores were better in Cerebrolysin group (good outcome 68% vs. 47%, p<0.01). Domain-specific testing revealed particular improvements in executive function, attention, and memory. Quality of life (EQ-5D) increased significantly. Brain MRI showed reduced perilesional edema and enhanced neuroplasticity markers.
Study Population
Ischemic stroke patients (age 55-78 years) with cognitive deficits (MMSE 18-26), within 7 days of stroke onset, stable neurologically
Background
Stroke survivors often suffer persistent cognitive deficits even after physical recovery. Current treatments are limited. Cerebrolysin contains neurotrophic peptides hypothesized to promote brain repair.
Trial Design
This was a rigorous multicenter, double-blind, placebo-controlled RCT - the highest quality evidence design. 238 stroke patients were randomized and followed for 90 days.
Results
Cognitive Recovery
Cerebrolysin patients showed nearly 3x greater improvement in MMSE scores compared to placebo:
- Cerebrolysin: +5.8 points
- Placebo: +2.1 points
Functional Outcomes
68% of Cerebrolysin patients achieved good functional outcome (independent living) compared to only 47% of placebo patients - a 45% relative improvement.
Domain-Specific Benefits
Particular improvements in:
- Executive function: Complex task performance improved dramatically
- Memory: Word recall increased significantly
- Attention: Processing speed enhanced
Brain Imaging
MRI showed reduced brain swelling and markers of enhanced neuroplasticity, suggesting actual structural brain repair.
Significance
This high-quality RCT provides strong evidence that Cerebrolysin genuinely enhances cognitive recovery after stroke, offering hope for millions of survivors worldwide.
Statistical Results
MMSE improvement: Cerebrolysin +5.8±2.3 points vs. placebo +2.1±1.9 (p<0.0001). MoCA improvement: +6.2±2.7 vs. +2.8±2.1 (p<0.001). Good outcome (mRS 0-2): 68% vs. 47% (RR=1.45, p<0.01). Executive function (TMT-B): -38.2s improvement vs. -15.7s (p<0.001). Memory (RAVLT): +4.8 words vs. +2.1 words (p<0.01).
Study Limitations
- •Limited to ischemic stroke (excludes hemorrhagic)
- •Relatively short follow-up (90 days)
- •Single country study
- •Mechanism of cognitive enhancement incompletely understood
- •No neuroimaging correlation with functional outcomes
Adverse Events
- •Injection site reactions (4.2%)
- •Headache (6.7%, similar to placebo 5.9%)
- •No serious adverse events
- •Well tolerated
Key Findings
- ✓Dramatic cognitive improvement (2.8x better than placebo)
- ✓Enhanced functional independence
- ✓Improved executive function and memory
- ✓Better quality of life
- ✓Evidence of brain repair on imaging
Mechanism of Action
Neurotrophic support via BDNF/NGF-like effects, enhancement of neuroplasticity, reduction of excitotoxicity, and promotion of synaptogenesis.