ИНВАЛИДНОСТЬ

Про испытания препарата в Узбекистане, мне к сожалению ничего не известно, я опирался на информацию полученную вот из этих источников: http://www.pharmateca.ru/ru/archive/article/6020
http://health-ua.com/pics/pdf/ZU_2011_06/5-6.pdf

Cerebrolysin in Mild-to-Moderate Alzheimer«s Disease: A Meta-Analysis of Randomized Controlled Clinical Trials

Summary
The meta-analysis results of 6 randomized placebo-controlled trials demonstrate beneficial effect of Cerebrolysin compared to placebo on the global clinical state and cognitive function at week 4 and month 6. The global clinical change showed statistical significance in the short-term analysis (after 4 weeks of treatment) as well as for the long-term follow-up after 6 months. This applies to the OC analysis as well as to the LOCF sensitivity analysis.

The meta-analysis of cognitive data reproduced the results obtained with the global clinical change for the short-term analysis. For the long-term analysis, a comparable effect size was observed, but it missed statistical significance. The meta-analysis of global benefit (multivariate analysis combining global clinical change and cognitive function) shows a statistically significant advantage of Cerebrolysin as compared to placebo at all points in time, in the OC analysis as well as in the alternative LOCF analysis (p ≤ 0.01). The NNT showed a significant global benefit after 1 month (OC: generalized NNT = 7.1) as well as after 6 months (OC: generalized NNT = 7.0).

With respect to safety aspects, negligible differences varying around the benchmark for equality were found regarding premature discontinuations due to AE, patients with at least 1 TEAE, and patients with at least 1 SAE (crude pooling of all studies). The rate of overall premature discontinuations was slightly lower in the Cerebrolysin group.

Conclusion
This meta-analysis provides evidence that Cerebrolysin has an overall beneficial effect on cognitive function and global clinical change in patients with mild-to-moderate AD. The safety aspects of Cerebrolysin were comparable to placebo, thus suggesting a favorable benefit-risk ratio.

When comparing the findings of this meta-analysis with those of donepezil [45] or memantine [46] at 6 months, Cerebrolysin can be placed with its effects on cognitive function (SMD = 0.29 in fixed-effects model; SMD = 0.37 in random-effects model) between the smaller effect sizes of memantine (SMD = 0.14) and the higher effect sizes of 10 mg donepezil (SMD = 0.5). Evaluating the benefit-risk relation as compared to donepezil, it has to be considered that there were no safety concerns at all with respect to Cerebrolysin, while for 10 mg donepezil, significant safety findings were reported in the Cochrane meta-analyses.

There is still a need for further research to evaluate the effects of Cerebrolysin on cognitive performance and activities of daily living in various dementias. Clinicians should consider Cerebrolysin as a therapeutic agent when seeking more treatment options for mild-to-moderate AD, as it may also be combined with standard registered drugs, e.g. acetylcholinesterase inhibitors.
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Vol. 39, No. 5-6, 2015
Issue release date: May 2015
Section title: Review Article

//www.karger.com/Article/FullText/377672

Department of Family Medicine and Geriatrics, Pundang CHA Hospital, Pochon CHA Medical University, Kyonggido, Korea.
Abstract
OBJECTIVE:
To assess the efficacy and safety of Cerebrolysin over 4 weeks in patients with probable Alzheimer«s disease (AD).
DESIGN:
A 4-week randomized, double-blind, placebo-controlled, multicenter clinical trial. An unequal (Cerebrolysin:placebo = 2:1) randomization was used to assign more patients to the treatment group.
SETTINGS:
University medical centers and community geriatric hospitals in Korea.
PARTICIPANTS:
Fifty-three men and women at least 50 years of age admitted to hospitals with mild to moderate AD and otherwise in good health.
INTERVENTION:
The treatment group (n = 34) received Cerebrolysin (30 mL Cerebrolysin in 100 mL physiologic saline IV) once a day from Monday to Friday for 4 weeks. The control group (n = 19) received placebo.
MEASUREMENTS:
Primary outcome measures were the Alzheimer»s Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and the Clinical Global Impression of Severity/ Change (CGIS/C). Secondary outcome measures included Mini-Mental State Examination (MMSE), Geriatric Depression Scale (GDS), Katz Index of Activities of Daily Living (ADL), and Lawton Instrumental Activities of Daily Living (IADL) Scale.
RESULTS:
After 4 weeks of treatment, Cerebrolysin-treated patients demonstrated significant improvements in the ADAS-Cog (P = .02), CGIS/C (P = .01), and MMSE (P = .04) compared with placebo-treated patients. Among Cerebrolysin-treated patients, 82%, 62%, and 44% were rated improved on ADAS-Cog, CGIS/C, and MMSE, respectively, compared with 31.6%, 22%, and 17% of placebo-treated patients, respectively. However, there were no significant improvements in the Cerebrolysin group compared with the placebo group on the GDS, ADL, and IADL. There were no dropouts in either groups, with 100% compliance to Cerebrolysin and placebo. Only one patient reported a febrile sensation, which was transient and mild in severity.
CONCLUSIONS:
This study indicates that Cerebrolysin is a safe drug that improves the cognitive deficits and global function in patients with mild to moderate AD. Long-term efficacy and safety of Cerebrolysin in Alzheimer«s patients should be evaluated in the future.