DIHYDROERGOKRYPTINE VS PLACEBO IN DEMENTIA OF ALZHEIMER-TYPE - INTERIM RESULTS OF A RANDOMIZED MULTICENTER STUDY AFTER A 1-YEAR FOLLOW-UP

In order to evaluate the efficacy of dihydroergokryptine mesylate (DEK ) - a semisynthetic ergot alkaloid having a neuroprotective activity t hrough the activation of antioxidant enzymatic systems - in dementia o f Alzheimer type, a long-term, randomized, placebo-controlled, double- blind study was carried out. The interim analysis after 1-year follow- up is here reported. Two-hundred-and-fifteen patients fulfilling the N INCDS-ADRDA criteria for probable Alzheimer's disease were enrolled by 14 geriatric and neurologic Italian centers. The study design include d a 1-month pre-treatment phase with placebo;l-year double-blind treat ment with DEK or placebo; a further 1-year open phase of treatment wit h DEK. The active drug dosage was 5 mg bid orally administered for the first 2 weeks, 10 mg bid for the following 2 weeks, 20 mg bid for the following 11 months. Efficacy was assessed by means of Gottfries-Bran e-Steen (GBS) Rating Scale for dementia and Mental Deterioration Batte ry. The univariate analysis showed a significant improvement of GBS su bscales and factors (with the exception of the Factor III, depression- anxiety). Multivariate analysis showed a significant difference betwee n treatments in GBS scale (P = 0.002) without any influence of age and illness duration. These results were confirmed by the end-point analy sis carried out on GBS scores using baseline value as covariate. Minor adverse events were observed in 9 out of 108 patients (8.3%) of the D EK group and in 7 out of 107 (6.5%) of the placebo group. No change in blood pressure, heart rate and routine laboratory tests was observed. These preliminary results suggest positive symptomatic effects of DEK on elderly patients with probable Alzheimer's disease indicating a sl owing down of the cognitive decline.