The cognitive and behavioral effects and the safety of
oxiracetam therapy during a placebo-controlled trial and the relevant follow-up up to 1 year in patients with
senile dementia of Alzheimer type (SDAT) and
multi-infarct dementia (MID) of mild to moderate degree were studied. Sixty male and female outpatients participated in the double-blind, placebo-controlled, parallel-group, randomized trial, comparing the effects of
oxiracetam 800 mg b.i.d. and placebo during 90 days of treatment. At the end of
therapy, statistical analysis evidenced significant improvements in the group receiving
oxiracetam in respect to the placebo group on Mini Mental State Examination, Auditory Continuous Performance Test, Rey's 15 Words Test, Block Tapping Test, Mattis Word Fluency, Luria Alternating Series and Instrumental
Activities of Daily Living. Afterwards, 29 of the 30 patients who received
oxiracetam, participated in the open follow-up study, receiving 800 mg b.i.d.
oxiracetam for a total standard period of 1 year. Statistical improvements in comparison to baseline were again found on the same tests of the first 90 days (except for Rey's 15 Words Test) and on the Memory item of the Inventory of Psychic and Somatic Complaints Elderly. During the late phase of the follow-up, statistically significant worsenings in comparison to baseline were observed on Digit Span Backward, Gibson's Spiral and some non-memory items of IPSC-E. Neither severe adverse events were observed during the whole study, nor changes in routine laboratory examinations. In conclusion, in the present population of patients with mild to moderate degree
dementia, the safety of 1,600 mg/day of
oxiracetam also up to 1 year of treatment was confirmed.(ABSTRACT TRUNCATED AT 250 WORDS)