A double-blind, placebo-controlled study with oxiracetam in demented patients administered the Luria-Nebraska Neuropsychological Battery

A formal multicenter, double-blind, between-patient trial was carried out to evaluate the efficacy and tolerability of oxiracetam (OXIR) (800-mg tablets), in comparison with placebo, each given twice daily for 24 weeks to patients suffering from probable or possible Alzheimer's disease (AD). Efficacy was assessed by the Inventory of Psychic and Somatic Complaints in the Elderly (IPSC-E), administered at entry and after 8, 16, and 24 weeks of treatment, and by the Luria-Nebraska Neuropsychological Battery (LNNB), administered at the beginning and at the end of the study. Thirty patients (16 on OXIR and 14 on placebo), 20 males and 10 females, mean age 62 years (range 52-79), were enrolled and completed the study. A significant (P <0.01) difference between treatments in the total score of the IPSC-E, as well as in some LNNB scales, was observed. In particular, patients on OXIR showed an improvement over time, while the condition of patients on placebo remained unchanged or tended to get worse. No difference in tolerability between the active drug and placebo was observed.