Treatment of the organic brain syndrome in the elderly. A double-blind comparison on the effects of a neurotropic drug and placebo.
100 inpatients of both sexes, most of them older than 65 years and suffering from symptoms of the organic brain syndrome (OBS), primarily associated with aging were included in a 6-week double-blind study. Patients were randomly assigned to two treatment groups of 50 patients each and received either a neurotropic drug (3 X 200 mg EMD 21657) or placebo coated tablets of identical appearance. Patients were evaluated at the beginning of the study and after 6 weeks of treatment using a physician's symptom rating, the Nurses' Observation Scale for Inpatient Evaluation ( NOSIE ), EEG, and a psychometric test battery to assess level of mental and memory functioning ( Rey test, Benton visual retention test, block design test by Kohs ). At the final assessment global response and overall tolerance were rated by the physician. The therapeutic effects of EMD 21657 were shown to be statistically significant compared to placebo in global response (p less than or equal to 0.05), in the factor 'cognitive disturbances' (p less than or equal to 0.05 doctor's symptom rating) and in the negative factors of the NOSIE (p less than or equal to 0.05). In the other parameters of the scales, the EEG and the mental ability tests no statistically significant changes could be demonstrated in the two groups after 6 weeks of treatment. The drugs were well tolerated. EMD 21657 treatment was interrupted because of side effects (increased aggressiveness, rash) in 2 cases.
D000368:Aged; D002986:Clinical Trials as Topic; D003704:Dementia / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D004569:Electroencephalography; D006801:Humans; D011939:Mental Recall / Q000187:drug effects; D011581:Psychological Tests; D011725:Pyridines / Q000627:therapeutic use*; D011746:Pyrithioxin / Q000031:analogs & derivatives / Q000627:therapeutic use*
D011725:Pyridines; C016928:tamitinol; D011746:Pyrithioxin