Long-Term Nicergoline Treatment of Mild to Moderate Senile Dementia : Results of a Multicentre, Double-Blind, Placebo-Controlled Study.

ABSTRACT

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 degenerative, 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) for 12 months. Treatment efficacy on cognitive and behavioural performances was assessed by the Sandoz Clinical Assessment Geriatric scale (SCAG) and Mini Mental State Examination (MMSE), at baseline and after 3, 6, 9 and 12 months of treatment. Investigators and patients or caregivers provided a global evaluation of treatment outcome at 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 improvement in the nicergoline-treated group compared with placebo-treated patients. The MMSE total score was maintained with nicergoline treatment. Global treatment evaluations, both by physician and patients, were consistently in favour of nicergoline (p < 0.001). Nicergoline was well tolerated; incidence of adverse events (7% in the nicergoline and 2% in the placebo group), withdrawals and haemodynamic changes were comparable with placebo.