A double-blind randomized study of two ergot derivatives in mild to moderate dementia

Abstract

A double-blind, randomized, parallel-group, multicenter trial was carried out to compare the efficacy and safety of nicergoline, 60 mg daily, and ergoloid mesylates, 4.5 mg daily, for six months in 146 patients suffering from mild to moderate dementia. Clinical evaluation was performed by two scales: the Sandoz Clinical Assessment-Geriatric (SCAG) and a polarity profile. The results of the trial, which included a one-month run-in placebo period, showed that both treatments were associated with a sizeable and progressive improvement in all items evaluated. Covariance analysis of data, however, demonstrated a significantly greater benefit from nicergoline, with the 95% confidence intervals of the difference in percent improvements ranging from 2.8 to 10.7 for total SCAG and from 1.6 to 12.7 for total polarity profile. No serious side effects, either certainly or probably drug-related, were observed, although the sum of adverse events occurring during nicergoline treatment was higher than during ergoloid mesylates treatment. It is debatable whether the modest superiority of nicergoline is linked to a simple dose factor or to a different pharmacodynamic profile.