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.

Dietary niacin and the risk of incident Alzheimer's disease and of cognitive decline

“…There has been little previous examination of dietary niacin and AD, although niacin has been administered to older people to prevent confusional states, and there have been several published clinical trials of medications for this indication. [9][10][11] In this prospective study, we observed a protective association of niacin against the development of AD and cognitive decline within normal levels of dietary intake, which could have substantial public health implications for disease prevention if confirmed by further research.…”

“…1 Although a direct cause for the dementia has not been fully determined, a number of studies have found that niacin plays important roles in DNA synthesis and repair, [2][3][4] myelination and dendritic growth, 5 6 cellular calcium signalling, 7 and as a potent anti-oxidant in brain mitochondria. 8 Improvements in cognitive test scores 9 10 and overall function 11 have been reported by European trials of pharmacological preparations that include nicotinic acid.…”

A systematic review and meta-analysis assessing adverse event profile and tolerability of nicergoline

“…Nicergoline has been reported to cause central nervous system disturbances including diaphoresis, sleep disturbances, fainting, agitation, drowsiness, dizziness, insomnia, restlessness, flushing and increased appetite 8 22. Cardiovascular events like temporary rise in blood pressure, syncope, bradycardia and hypotension have been reported with nicergoline in a few studies 18 41…”

Cognitive impairments in cerebrovascular disease: What is between health and dementia?

“…При оценке результатов такой терапии с помощью гериатриче-ской шкалы Sandoz (SCAG) установлена эффективность ни-церголина, при этом разница показателей по сравнению с группой плацебо увеличивалась в процессе лечения и соста-вила 5,5 балла через 3 мес и 9,8 балла через 6 мес [29].…”