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Efficacy and safety of cerebrolysin in moderate to moderately severe Alzheimer’s disease: Results of a randomized, double‐blind, controlled trial investigating three dosages of cerebrolysin


Alvarez, X. A., Cacabelos, R., Sampedro, C., Aleixandre, M., Linares, C., Granizo, E., Doppler, E., Moessler, H.


European Journal of Neurology, Volume: 18, No.: 1, Pages.: 59-68

Year of Publication



Background: Cerebrolysin is a neuropeptide preparation mimicking the effects of neurotrophic factors. This subgroup analysis assessed safety and efficacy of Cerebrolysin in patients with moderate to moderately severe Alzheimer’s disease (AD) (ITT data set: N = 133; MMSE: 14–20) included in a dose‐finding study (ITT data set: N = 251; MMSE: 14–25). Results of the mild AD subgroup (ITT data set: N = 118; MMSE: 21–25) are also presented. Methods: Patients with AD received 100 ml IV infusions of Cerebrolysin (10, 30 or 60 ml diluted in saline; N = 32, 34 and 35, respectively) or placebo (saline; N = 32) over twelve weeks (5 days per week for 4 weeks and 2 days per week for another 8 weeks). Primary efficacy criteria ADAS‐cog + (Alzheimer’s Disease Assessment Scale Cognitive Subpart Modified) and CIBIC + (Clinical Interview‐based Impression of Change with Caregiver Input) were assessed 24 weeks after baseline. Results: At week 24, Cerebrolysin improved the global clinical function significantly with all three dosages and induced significant improvements in cognition, initiation of activities of daily living (ADL) and neuropsychiatric symptoms at 10‐, 30‐ and 60‐ml doses, respectively. Treatment effects on total ADL and other secondary parameters (MMSE, Trail‐making test) were not significant. Cerebrolysin was safe and well tolerated. Conclusions: These results demonstrate the efficacy of Cerebrolysin in moderate to moderately severe AD, showing dose‐specific effects similar to those reported for patients with mild to moderate AD. The benefits of Cerebrolysin in advanced AD need to be confirmed in larger trials. (PsycINFO Database Record (c) 2014 APA, all rights reserved). (journal abstract)

Bibtex Citation

@article{Alvarez_2010, doi = {10.1111/j.1468-1331.2010.03092.x}, url = {}, year = 2010, month = {dec}, publisher = {Wiley-Blackwell}, volume = {18}, number = {1}, pages = {59--68}, author = {X. A. Alvarez and R. Cacabelos and C. Sampedro and M. Aleixandre and C. Linares and E. Granizo and E. Doppler and H. Moessler}, title = {Efficacy and safety of Cerebrolysin in moderate to moderately severe Alzheimer's disease: results of a randomized, double-blind, controlled trial investigating three dosages of Cerebrolysin}, journal = {European Journal of Neurology} }


adverse, alzheimer’s disease, cerebrolysin, clinical trials, drug dosages, drug efficacy, drug safety, drug therapy, events, moderately severe alzheimers disease, neuropeptides, safety, severity disorders

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

ADLs/IADLs, Cognition, Other

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions