LONG-TERM NICERGOLINE TREATMENT OF MILD-TO-MODERATE SENILE DEMENTIA -RESULTS OF A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

The efficacy and tolerability of nicergoline were evaluated in a long- term, double-blind, placebo-controlled trial. 108 patients, fulfilling DSM III-R criteria for mild to moderate senile dementia of degenerati ve, vascular or mixed origin, were selected from a pool of outpatients attending five Italian neurological centres and randomised to receive nicergoline 30mg twice daily (54 patients) or placebo (54 patients) f or 12 months. Treatment efficacy on cognitive and behavioural performa nces was assessed by the Sandoz Clinical Assessment Geriatric scale (S CAG) and Mini Mental State Examination (MMSE), at baseline and after 3 , 6, 9 and 12 months of treatment. Investigators and patients or careg ivers provided a global evaluation of treatment outcome lit study end. The efficacy analysis was carried out on 101 patients (51 nicergoline ; 50 placebo) who completed the 12-month study. at study end, the SCAG total score and its clusters showed statistically significant improve ment in the nicergoline-treated group compared with Placebo-treated pa tients. The MMSE total score was maintained with nicergoline treatment . Global treatment evaluations, both by physician and patients, were c onsistently in favour of nicergoline (p < 0.001). Nicergoline was well tolerated: incidence of adverse events (7% in tile nicergoline and 2% in the placebo group), withdrawals and haemodynamic changes were comp arable with placebo.