A multidimensional approach in testing nootropic drug effects (Cerebrolysin).

In an attempt to improve indicators of validity for the therapeutic efficacy of nootropics, the effects of Cerebrolysin(R) were compared across three different dimensions of variables in a randomized placebo-controlled double-blind study. A group of 27 geriatric patients suffering from an organic brain syndrome with moderate cognitive impairment of a vascular or/and degenerative nature received a series of ten Cerebrolysin + multivitamin infusions. They were compared to a second group with 14 clinically comparable patients, who received multivitamin infusions alone. Pre-posttreatment differences from (1) clinical scales (SCAG, Plutchik Geriatric Rating Scale and a self-evaluation scale); (2) psychometric test performance (trail-making and maze subtests from the Nürnberg Age Inventory); and (3) event-related brain activity (contingent negative variation (CNV) amplitude) were in favor of the Cerebrolysin-treated group. A high degree of association as well as high classification rates (95% joint correct classification) underlined their clinical significance. It was concluded that the multidimensional measurement approach could increase the clinical validity of nootropic drug effects.

[Therapy of organic brain syndrome with nicergoline given once a day]. / Therapie des hirnorganischen Psychosyndroms mit Nicergolin in täglicher Einmalgabe.

In a double-blind, active-controlled study 30 patients with mild to moderate multiinfarct dementia diagnosed according to DSM III definition were treated by either 20 mg nicergoline or 4.5 mg co-dergocrine mesilate once daily during eight weeks. Therapeutic effects on symptoms of the organic brain syndrome were quantitatively measured by standardized psychological and psychometric methods evaluating cognitive and thymopsychic functions. Main criteria, which were tested by inferential analysis, were SCAG total score (Sandoz Clinical Assessment Geriatric Scale), SCAG overall impression and the AD Test (alphabetischer Durchstreichtest). Other results were assessed by descriptive statistics. Both treatments resulted in a statistically significant improvement in most of the tested functions. The effects of 4.5 mg co-dergocrine mesilate s.i.d. were in accordance with published results. Although differing slightly with respect to individual results 20 mg of nicergoline once daily showed the same efficacy on the whole.

[The usefulness of event-related negativity in demonstrating the therapeutic effects of nootropic drugs using cerebrolysin as an example]. / Die Brauchbarkeit der ereigniskorrelierten Negativität zum Nachweis therapeutischer Wirkungen von Nootropika am Beispiel von Cerebrolysin.

This study investigated the usefulness of the Contingent Negative Variation (CNV) in the assessment of therapeutic efficacy of a nootropic substance, Cerebrolysin. A total of 41 geriatric patients with the diagnosis of moderate organic brain syndrome of different etiology were included in this randomized placebo-controlled double-blind study. After ten Cerebrolysin- plus multi-vitamins-Infusions, the treatment group of 27 patients showed a significant CNV-amplitude increase as compared to pre-treatment values. In the placebo group of 14 patients CNV-amplitudes even decreased after ten Infusions with multi-vitamins alone. These findings were interpreted in line with the vigilance model of nootropic drug effects as a vigilance-increasing effect of Cerebrolysin, i.e. as an increased neuronal performance readiness. The results confirmed the usefulness of the CNV method by providing an EEG-index of nootropic drug effects.

Video rating analysis of effect of maprotiline in patients with dementia and depression.

In patients with dementia and mild depression (DSM-III-R 290.21), the effect of low doses of the antidepressant maprotiline (up to 75 mg/d) was examined. The main parameter was a video rating of global impression. The Mini-Mental State Examination (MMS) and the Geriatric Depression Scale (GDS) were applied to evaluate the effect of maprotiline on cognitive and depressive symptoms. The double-blind, placebo-controlled trial was of eight weeks' duration and included 127 patients, randomized in two groups. The antidepressant effect of maprotiline was reflected in the GDS. There was, however, no indication of an effect of maprotiline on cognitive performance. The global impression, evaluated by video rating, gave no indication as to a beneficial effect of the treatment. - The video analysis showed a significant interrater reliability. The discrepancy between the results of the video rating and the GDS is discussed. - The results confirm similar findings of other authors; i.e., that a sedating antidepressant with some anticholinergic effects cannot be expected to improve cognitive functions despite its antidepressant effect. The main interest of this study, however, lies in its methodology (video analysis).