[An experimental, randomized, double-blind, placebo-controlled clinical trial to infestigate the effect of nicardipine on cognitive function in patients with vascular dementia. Spanish group of nicardipine study in vascular dementia].
OBJECTIVE
Experimental and clinical data suggest that calcium channel blockers could be effective in the treatment of vascular dementia (VD). The aim of this study is to evaluate the effect of nicardipine on the progression of cognitive impairment in patients with VD.


METHODS
We selected outpatients, of both sexes, between 55 and 80 years old, with VD. Following a placebo wash-out period (4 weeks), the patients received nicardipine 20 mg t.i.d. or placebo for one year. The primary efficacy variable was the loss of over 10% of the basal score on the Mini-Mental State Examination after one year. The time it took to reach this degree of impairment, the evolution of Pfeiffer score, the effect on functional disability and the drug safety were also evaluated.


RESULTS
156 patients were included, 109 completed the study, and 142 underwent intent-to-treat analysis. At the end of the study, 34.6% of patients with placebo and 21.1% with nicardipine had lost over 10% of their basal MMSE score. Favorable effects of nicardipine were found on females (40.9% vs 10.5%, p = 0.01876), patients without previous treatments (46.2% vs 13.3%, p = 0.00748) and patients with concomitant antiplatelet treatment (35.0% vs 15.9; p = 0.03836). Survival analysis showed that the patients with nicardipine took longer to lose cognitive capacities (p = 0.031; RR = 1.15-3.99).


CONCLUSIONS
Nicardipine did not reduce the cognitive decline at the stated period in the total group but it significantly delayed this decline and produces better evolution in females, in patients without previous treatments, and those with antiplatelet treatment.
D000368:Aged; D000369:Aged, 80 and over; D001921:Brain / Q000098:blood supply / Q000187:drug effects*; D002545:Brain Ischemia / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy; D002121:Calcium Channel Blockers / Q000494:pharmacology* / Q000627:therapeutic use; D003071:Cognition / Q000187:drug effects*; D003072:Cognition Disorders / Q000175:diagnosis; D015140:Dementia, Vascular / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D009529:Nicardipine / Q000494:pharmacology* / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
D002121:Calcium Channel Blockers; D009529:Nicardipine
Ensayo clínico experimental, doblemente ciego, aleatorizado, controlado con placebo, del efecto de nicardipino en la función cognitiva en pacientes afectos de demencia vascular. Grupo Español de Estudio de Nicardipino en Demencia Vascular.