A 24-month, double-blind, placebo-controlled multicentre pilot study of the efficacy and safety of nicergoline 60 mg per day in elderly hypertensive patients with leukoaraiosis

In this pilot study, 72 non-demented and non-depressive elderly hypertensiv e patients with evidence of leukoaraiosis on cerebral computed tomography s can (Rezek score: greater than or equal to 16) were randomly assigned to re ceive either nicergoline 30 mg b.i.d. (n = 36) or a placebo (n = 36) for 24 months. All patients received antihypertensives and their hypertension was controlled under treatment. They were evaluated by nine neuropsychological tests exploring memory, concentration, verbal and motor performances, admi nistered at baseline and at every six-month interval during the study perio d. At baseline, the two groups n ere comparable for all demographic and cli nical characteristics, including cognitive functions, except for the delaye d recall of the Auditory Verbal Learning Test (AVLT), which was better in t he placebo group (P = 0.04). Changes in scores over time were compared betw een the two groups. At the last visit, patients on nicergoline (n = 31) wer e found to have deteriorated less or to have improved more on test scores t han the patients on placebo (n = 30), Significant differences n ere observe d for memory function (AVLT short term recall, P = 0.026; AVLT delayed reca ll, P = 0.013; and, Benton Visual Retention Test, P = 0.002) and attention and concentration (Letter Cancellation Test, P = 0.043; and, WAIS-R Digit S ymbol subtest, P = 0.006). The Rezek score remained unchanged in the two gr oups. Tolerance of nicergoline was similar to that of placebo. In conclusio n, this study shows that nicergoline 30 mg b.i.d. administered over a 24-mo nth period attenuates the deterioration in cognitive functions in elderly h ypertensive patients with leukoaraiosis. Whether these effects were specifi c for this type of white matter changes could not be determined in the cont est of this pilot study. Eur J Neurol 6:313-322 (C) 1999 Lippincott William s & Wilkins.