EFFICACY OF XANTINOLNICOTINATE IN PATIENTS WITH DEMENTIA

Activation of cerebral metabolism and improvement of microcirculation by influencing rheological parameters are claimed to be the underlying pharmacological principles responsible for the efficacy of xantinolnicotinate. This dual mechanism of action led the authors to perform a double-blind, randomized, placebo-controlled study in patients with mild to moderate dementia (DSM III), characterized by a score of 40 - 90 on the Sandoz Clinical Geratric Scale (SCAG), with a separate randomization for patients with Multi-Infarct Dementia (MID) and Senile Dementia of Alzheimer Type (SDAT). It was calculated that 150 patients would have to be recruited for each group. Allocation to the respective group (MID or SDAT) was based on the Hachinski Ischemic Score and computer tomogram. Preceded by a 2-week placebo run-in period, a 12-week treatment period followed with either 3 x 1 g xantinolnicotinate (Complamin®) or placebo. Prior to the study, the physician's rating of the global therapeutic effect from the clinical global impression (CGI) was designated as the primary criterion of efficacy. Secondary efficacy criteria were SCAG, the BGP nursing rating, and, as psychometric variables, tests from the Nuremberg Psychogeriatric Inventory (NAI). The improvement compared to placebo was statistically significant for the CGI in both treatment groups (p < 0.0001) and hence independent of etiology. Concerning the nurses' rating (BGP), apart from a marginally statistically significant difference for the factor ''need of help'' in the SDAT group, no remarkable changes were registered during treatment. However, in the SCAG the differences between verum and placebo were significant (MID p < 0.0002; SDAT p < 0.0001). Similar significant differences were observed in most of the psychometric tests. Treatment response proved to be independent of the severity of the disease.