In view of some controversies still existing about the real efficacy of ergot derivatives in the management of
dementia, a double-blind, randomized, parallel group trial extending up to 6 months was carried out to compare the effects of
nicergoline, 60 mg daily, and placebo in 315 patients suffering from mild to moderate
dementia. Clinical evaluation was performed by the SCAG scale. The trial, which included a 1-month placebo run-in period, showed that both placebo and
nicergoline were associated with some degree of improvement. The effect of
nicergoline, however, was significantly greater and more sustained, steadily increasing with time. In particular, the difference between
nicergoline and placebo in mean total SCAG score was 5.5 at 3 months (95% confidence interval: 3.6-7.4) and increased to 9.8 at 6 months (95% confidence interval: 7.8-11.8). A comparison of
nicergoline versus placebo in the frequencies of changes in each item of the SCAG showed also a significant difference at 6 months, the percent of patients displaying an improvement by at least 2 points ranging from 13.5 (bothersome) to 30.2 (disorientation) in
nicergoline group, against 4.1 (self-care) to 14.3 (
fatigue) in placebo group. The safety of
nicergoline, as judged by hemodynamic changes and
drug-related adverse reactions, was quite satisfactory.