Sustained improvement of cognition and global function in patients with moderately severe Alzheimer's disease: a double-blind, placebo-controlled study with the neurotrophic agent Cerebrolysin.
BACKGROUND
In a recent study, Cerebrolysin (Cere), a compound with neurotrophic activity, has been shown to be effective in the treatment of mild to moderate Alzheimer's disease (AD). A subgroup analysis of this double-blind, placebo-controlled study was performed to assess the effects of Cere in cases with more advanced forms of AD.


METHODS
Patients received infusions of 30 ml Cere or placebo five days/week for four weeks. This treatment was repeated after a two-months therapy-free interval. Effects on cognition, global function, behavioural symptoms and activities of daily living were evaluated 4, 12, 16, and 28 weeks after the beginning of the infusions. 109 patients with MMSE scores <20 were included in this analysis.


RESULTS
The responder rate of the Cere group was 65% on the CGI, compared to 24.5% in the placebo group (p < 0.004). In the ADAS-cog, a score difference of 4.1 points in favour of Cere was observed (p < 0.0001). Notably, improvements were largely maintained in the Cere group up to the week 28 visit.


CONCLUSIONS
The data clearly demonstrate the efficacy of Cere treatment in moderate to severe forms of AD with sustained treatment effects on cognition and global function even after discontinuation of treatment.
Ruether
E
E
Göttingen University Clinic for Psychiatry, Göttingen, Federal Republic of Germany.
Alvarez
X A
XA
Rainer
M
M
Moessler
H
H
D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy*; D000596:Amino Acids / Q000008:administration & dosage* / Q000009:adverse effects; D003072:Cognition Disorders / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018697:Nootropic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D010919:Placebos; D016896:Treatment Outcome
D000596:Amino Acids; D018697:Nootropic Agents; D010919:Placebos; C006952:cerebrolysin