Dihydroergokryptine as long-term treatment of alzheimer type dementia: A multicenter two-year follow-up

Summary The results of a two-year treatment with α-dihydroergokryptine mesylate (DEK) carried out in 142 (43 male, 99 female; aged 63–83) demented patients (DAV.I.D.E., DAVERIUM ® Italian Dementia Evaluation), are presented here. The study design included a 1-month run in placebo phase, a 1-year in double-blind condition either with a-dihydroergokryptine or placebo, and a further 1-year (open phase) with DEK. For assessing clinical efficacy the Gottfries-Brne-Steen (GBS) rating scale for dementia (primary variable) and the mental deterioration battery (MDB) (secondary variable) were used. Analysis of variance on efficacy variables and summary measures was performed using age and illness duration as covariates. The safety analysis was carried out monitoring vital signs, adverse events and routine laboratory tests. Seventy out of 142 patients were previously treated with DEK and 72 with placebo; 109 patients completed the study, 33 patients dropped out. The patients previously treated with DEK maintained their clinical conditions observed at the end of the double-blind phase; the patients previously treated with placebo improved the motor (GBS score: −33 %), intellectual (−26 %) and emotional (−24 %) functions, and the neuropsychological performances (MDB scores), the difference between the paired samples being significant. Four patients (2.8%) had adverse events, requiring drug suspension in two cases. The results indicate that DEK treatment might slow down the progression of the disease as documented by both functional and neuropsychological parameters. Safety was very good, indicating that the drug is suitable for long-term treatments.