Human evidence record · Cerebrolysin
Cerebrolysin in Alzheimer's disease: randomized double-blind placebo-controlled trial
CIBIC+ favoured Cerebrolysin at week 12; broad cognitive outcome differences were less consistent.
Quick read
Human evidence record
What this study tells us
Participants were assigned to comparison groups by chance, usually with placebo and/or blinding to reduce bias. This is a strong design for testing cause and effect, but the population, duration and endpoints still limit what can be concluded.
Who was studied?
Patients with Alzheimer disease
How many?
n=192
What happened?
CIBIC+ favoured Cerebrolysin at week 12; broad cognitive outcome differences were less consistent.
What stops us overclaiming?
Baseline imbalances; older trial; limited generalisability to healthy cognition.
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Key result
CIBIC+ favoured Cerebrolysin at week 12; broad cognitive outcome differences were less consistent.
Study details
Study designRandomized, double-blind, placebo-controlled trial
PhaseClinical
PopulationPatients with Alzheimer disease
Sample size192
RouteIntravenous
Regimen / exposure30 mL/day on treatment days during a 4-week course
Duration4 weeks active + follow-up to week 24
ComparatorPlacebo
Primary endpoint / questionADAS-Cog and global CIBIC+
Safety resultAEs in 64% Cerebrolysin vs 73% placebo; common events included headache, dizziness, weight loss and anxiety.
Key limitationsBaseline imbalances; older trial; limited generalisability to healthy cognition.
Registry / identifierPMID 12111446