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.