DIHYDROERGOCRISTINE IN ORGANIC BRAIN-SYNDROME - PLACEBO-CONTROLLED MULTICENTER CLINICAL DOUBLE-BLIND-STUDY IN 240 PATIENTS

The aim of this 3-month study was to assess the activity of dihydroergocristine (DHEC CAS 17479-15-5) on organic brain syndrome. DHEC is an ergot alkaloid derivative with a dopaminergic activity on the central nervous system (CNS). It improves cerebral metabolism and increases the bioelectric potential in the cerebral cortex. The randomized double-blind trial versus placebo involved 240 outpatients (138 females and 102 males, mean age 68 years) recruited in 6 hospitals. Subjects with Hachinski Ischemic Score > 6 and Mini Mental State < 22 were excluded Patients were randomly divided into 4 groups of 60 subjects each to receive either one 6-mg DHEC oral vial or placebo vial, or one 6-mg DHEC tablet or placebo tablet once daily for 3 months. Neuropsychological tests were performed at baseline, and then after 45 and 90 days of treatment. The statistical analysis of results showed a significant difference (p < 0. 01) between DHEC and placebo groups with regard to the following tests: ''Scale of Clinical Assessment for Geriatrics (SCAG), Digit Symbol Digit Span, Toulouse-Pieron, Hamilton Depression Rating Scale and Rey's Words''. The amelioration of clinical symptoms pointed out the equivalence of DHEC oral vials and tablets. The drug was well tolerated It is concluded that DHEC is an effective and safe drug in the treatment of organic brain syndrome.