DIHYDROERGOKRYPTINE AS LONG-TERM TREATMENT OF ALZHEIMER-TYPE DEMENTIA- A MULTICENTER 2-YEAR FOLLOW-UP

The results of a two-year treatment with alpha-dihydroergokryptine mes ylate (DEK) carried out in 142 (43 male. 99 female; aged 63-83) dement ed patients (DAV.I.D.E., DAVERIUM((R)) Italian Dementia Evaluation). a re presented here. The study design included a I-month run in placebo phase, a I-year in double-blind condition either with alpha-dihydroerg okryptine or placebo, and a further I-year (open phase) with DEK, For assessing clinical efficacy the Gottfries-Brane-Steen (GBS) rating sca le for dementia (primary variable] and the mental deterioration batter y (MDB) (secondary variable) were used. Analysis of variance on effica cy 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 patien ts previously treated with DEK maintained their clinical conditions ob served at the end of the double-blind phase; the patients previously t reated with placebo improved the motor [GBS score: -33 %). intellectua l (-26 %) and emotional (-24 %) functions, and the neuropsychological performances [MDB scores), the difference between the paired samples b eing significant. Four patients (2.8%) had adverse events, requiring d rug suspension in two cases. The results indicate that DEK treatment m ight slow down the progression of the disease as documented by both fu nctional and neuropsychological parameters. Safety was very good, indi cating that the drug is suitable for long-term treatments.