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Summary
Two controlled double-blind trials comparing the efficacy of 'Hydergine' and identical placebo tablets in patients suffering from mild to moderate symptoms of cerebral arteriosclerosis or senile dementia are described. The initial crossover design with a crossover point at the eighth week produced equivocal results. However, these results were encouraging enough to proceed with a redesigned parallel-group study on a further 43 patients. Assessment was made at 4-week intervals using the 10 factor Crichton Royal Behavioural Rating Scale. Of the 43 patients taking part in the second half of this study, 15 in each group completed the 12-week period of treatment. The group treated with 'Hydergine' showed a greater improvement than those treated with placebo, this improvement being statistically significant (p < 0.01).
'Hydergine' appeared to be a safe drug, showing no marked side-effects. It is suggested that 'Hydergine' enhances cerebral metabolism through greater cortical enzyme activity and increased cerebral blood flow combined with a more efficient utilization of oxygen.