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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.

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  • Authors+Show Affiliations

    ,

    Medical Department, Farmitalia Carlo Erba, Milan, Italy.

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    MeSH

    Aged
    Aged, 80 and over
    Clinical Trials as Topic
    Dementia
    Double-Blind Method
    Ergolines
    Female
    Hemodynamics
    Humans
    Male
    Middle Aged
    Multicenter Studies as Topic
    Nicergoline
    Random Allocation

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    2646350

    Citation

    Battaglia, A, et al. "Nicergoline in Mild to Moderate Dementia. a Multicenter, Double-blind, Placebo-controlled Study." Journal of the American Geriatrics Society, vol. 37, no. 4, 1989, pp. 295-302.
    Battaglia A, Bruni G, Ardia A, et al. Nicergoline in mild to moderate dementia. A multicenter, double-blind, placebo-controlled study. J Am Geriatr Soc. 1989;37(4):295-302.
    Battaglia, A., Bruni, G., Ardia, A., & Sacchetti, G. (1989). Nicergoline in mild to moderate dementia. A multicenter, double-blind, placebo-controlled study. Journal of the American Geriatrics Society, 37(4), pp. 295-302.
    Battaglia A, et al. Nicergoline in Mild to Moderate Dementia. a Multicenter, Double-blind, Placebo-controlled Study. J Am Geriatr Soc. 1989;37(4):295-302. PubMed PMID: 2646350.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Nicergoline in mild to moderate dementia. A multicenter, double-blind, placebo-controlled study. AU - Battaglia,A, AU - Bruni,G, AU - Ardia,A, AU - Sacchetti,G, PY - 1989/4/1/pubmed PY - 1989/4/1/medline PY - 1989/4/1/entrez SP - 295 EP - 302 JF - Journal of the American Geriatrics Society JO - J Am Geriatr Soc VL - 37 IS - 4 N2 - 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. SN - 0002-8614 UR - https://www.unboundmedicine.com/medline/citation/2646350/Nicergoline_in_mild_to_moderate_dementia__A_multicenter_double_blind_placebo_controlled_study_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0002-8614&date=1989&volume=37&issue=4&spage=295 DB - PRIME DP - Unbound Medicine ER -