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.
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 = 51; 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.
Alvarez
X A
XA
EuroEspes Biomedical Research Centre, Santa Maria de Babio, 15166 Bergondo, La Coruna, Spain. xantonal@yahoo.es
Cacabelos
R
R
Sampedro
C
C
Aleixandre
M
M
Linares
C
C
Granizo
E
E
Doppler
E
E
Moessler
H
H
D000203:Activities of Daily Living; D000368:Aged; D000544:Alzheimer Disease / Q000188:drug therapy*; D000596:Amino Acids / Q000008:administration & dosage* / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009483:Neuropsychological Tests; D018697:Nootropic Agents / Q000008:administration & dosage / Q000009:adverse effects; D016017:Odds Ratio; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000596:Amino Acids; D018697:Nootropic Agents; C006952:cerebrolysin