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Nicergoline in mild to moderate dementia. A multicenter, double-blind, placebo-controlled study.

Abstract
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.
AuthorsA Battaglia, G Bruni, A Ardia, G Sacchetti
JournalJournal of the American Geriatrics Society (J Am Geriatr Soc) Vol. 37 Issue 4 Pg. 295-302 (Apr 1989) ISSN: 0002-8614 [Print] United States
PMID2646350 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Ergolines
  • Nicergoline
Topics
  • Aged
  • Aged, 80 and over
  • Clinical Trials as Topic
  • Dementia (drug therapy)
  • Double-Blind Method
  • Ergolines (therapeutic use)
  • Female
  • Hemodynamics (drug effects)
  • Humans
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Nicergoline (adverse effects, therapeutic use)
  • Random Allocation

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