A double-blind, placebo-controlled, crossover trial was carried out in 20 patients with mild to moderate senile dementia. Nicergoline was given i.m. 4 mg b.i.d. for the first two weeks and then orally 20 mg t.i.d. for 12 weeks, totalling a 14-week treatment course. A 13-week washout period was included at the crossover point. Rating scales, i.e., SCAG and a semantic differential polarity profile scale (P.P.) and quantified EEG, were used for the objective measurement of changes. An overall improvement ranging from about 20% (SCAG) to 30% (P.P.) was observed after nicergoline but there was no improvement after placebo. EEG data were consistent with clinical outcome. In fact, central nervous sytem changes after nicergoline were characterized by a decrease of slow activity and an increase of fast activity. A deterioration was observed after placebo, i.e., an increase of delta and theta and a decrease of beta bands. No adverse drug reactions were complained of by the patients nor observed by the investigators and no modifications were revealed by routine laboratory tests, electrocardiography and peripheral haemodynamic vital data.
|Number of pages||9|
|Journal||International Journal of Clinical Pharmacology Research|
|Issue number||4 Suppl. 1|
|Publication status||Published - 1982|
ASJC Scopus subject areas
- Pharmacology (medical)
- Pharmacology, Toxicology and Pharmaceutics(all)