EFFICACY OF THE PEPTIDERGIC NOOTROPIC DRUG CEREBROLYSIN IN PATIENTS WITH SENILE DEMENTIA OF THE ALZHEIMER-TYPE (SDAT)

Cerebrolysin is a peptidergic nootropic drug with a multimodal mechani sm of action. It is expected to have a positive influence on neurodege nerative diseases such as senile dementia of the Alzheimer type (SDAT) . Experimental studies have shown Cerebrolysin to have a regulatory ef fect on energy metabolism, a positive influence on behavior through ne uromodulation due to its peptide fraction, and most important, a neuro trophic stimulation. In SDAT and related disorders the neurotrophic ef fect of the drug could play a major role and influence the progress of the illness. A placebo-controlled double-blind trial was designed to examine the efficacy of the drug in SDAT Confirmatory statistics were used for analysis. 120 subjects with mild to moderate dementia accordi ng to the Global Deterioration Scale (GDS) were included in the trial. Their performance on the Mini Mental State Examination (MMSE) was bet ween 15 and 25. The diagnosis was substantiated by the Hachinski Ische mic Score and cranial computed tomography. The inclusion and exclusion criteria were formulated so as to prevent a distortion between the tw o arms by secondary dementia or other disease. The two arms received e ither placebo or the drug once a day (30 ml Cerebrolysin in 100ml phys iological saline i.v.) from Monday to Friday for four weeks. Physiolog ical saline (130 ml) was used as placebo. Primary variables used for t he statistical analysis were the Clinical Global Impression (CGI), whi ch measures the improvement in symptoms, the SCAG score, and the perfo rmance in the trail-making test (ZVT-G). The self-assessment in the Bf -S and the activities of daily living in the NAT were used as secondar y variables. Adverse effects and undesired drug effects were evaluated by the international standardized procedures DOTES and TWIS. An impro vement in the treated group versus the controls was seen in the CGI, t he SCAG, and the trail-making test. The statistical probability of err or p was smaller than 0.0001, which is highly significant. The improve ments in the secondary variables were parallel to those in the primary ones. There were no dropouts. Adverse effects were not recorded. The responder rate in the treated group was 61.7%, i.e., the majority of s ubjects reacted to therapy with a clinically relevant improvement. It may be concluded that Cerebrolysin treatment leads to a fast and relev ant improvement in the clinical symptoms of SDAT patients.