A six-month open clinical trial of the efficacy of Akatinol was conducted in 40 patients with moderate cognitive impairments (MCI) using piracetam (20 patients) as reference agent; mean age was 67.7 +/- 7.2 years. Patient status was evaluated using a number of scales, questionnaires, and neuropsychological tests prior to treatment and at three and six months of treatment. Akatinol was given at a dose of 10 mg/day, and 20 patients received piracetam at a dose of 1200 mg/day. Studies were completed by 38 patients (95%) in the Akatinol arm and 18 (90%) in the piracetam arm. In the group treated with Akatinol, 5% reported deterioration, 20% no change, 35% moderate improvement, 25% marked improvement, and 15% great improvement. In the Akatinol arm, the proportion of patients without effects was significantly lower, while the proportions of patients with marked and great improvements were significantly higher than in the piracetam arm. Overall evaluation of cognitive functions on the MMSE scale showed significant increases in both groups by the end of the third month, though only patients receiving Akatinol maintained the improvements to the end of the sixth month. Akatinol treatment also produced positive changes in the symptoms of depression, subjective symptoms, and quality of life. More marked positive changes were seen in the dysregulatory type of MCI than in the amnestic type of MCI. The concept of MCI with a high risk of transformation to dementia is introduced; in this situation, treatment with Akatinol may be particularly relevant.