Long-term effects and safety of almitrine-raubasine in age-associated cognitive decline

Twenty elderly patients (8 men, 12 women, mean age 67.5 years, range 59-74 years) with age-associated cognitive decline (memory impairment, slowing of thought and inability to concentrate, mean Mini Mental State score 22.0, range 18-24) were included by their general practitioners in an open study of the efficacy and safety of long-term combination therapy with almitrine and raubasine. After a 2-week washout period, patients received almitrine-raubasine for 13 months. Efficacy was evaluated at 2-month intervals using two well-being scales (visual analog and psychoaffective profile) and two behavioral scales (Widlocher's scale, and a scale derived from the Sandoz Clinical Assessment Geriatric scale). Memory was assessed every 6 months. Safety was evaluated by full medical examination and routine laboratory parameters at 2- and 6-month intervals, respectively. On treatment, scores on all scales improved significantly (two-way analysis of variance) throughout the study, as did scores in the two objective memory tests (Friedman test). Safety was demonstrated by the lack of any changes in clinical or laboratory parameters outside the normal range.