IDEBENONE IN THE TREATMENT OF MULTIINFARCT DEMENTIA - A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED MULTICENTER TRIAL

A controlled double blind randomised open multicentre study was carried out on 104 patients with multi-infarct dementia (MID) from a mild to a moderate degree. The patients were randomly assigned to balanced blocks in each center and treated for 90 days either with idebenone (CV-2619) 90 mg/daily or placebo, after a 2-week turn-in period. The Gottfries Rating Scale, SCAG, Rey's A Figure Test, Rey's 15 Words Test, Token Test, Verbal Fluidity Test and the Blessed Dementia Test were used for assessment. The data were statistically analyzed using parametric and non-parametric tests. Seven patients were excluded (5 idebenone + 2 placebo) after a few days treatment, for reasons not related to drug administration; therefore, 97 patients were assessed for efficacy and 104 for tolerability. A certain placebo effect was found in the examination results but it never achieved the efficacy levels of idebenone. The latter is particularly effective for improving recent and remote memory, attention, orientation, vigilance and verbal comprehension and the effects continued even after a month of placebo treatment. There were no important adverse reactions and neither laboratory parameters nor clinical vital signs were significantly altered.