[Observational study of the efficacy and safety of the drug Ampasse in patients with moderate cognitive impairment in chronic cerebral ischemia].

Objective: The study of the efficacy and safety of drug Ampasse in the treatment of mild cognitive impairment syndrome (MCI) in patients with chronic cerebral ischemia (CCI) and as an adjuvant therapy in the treatment of chronic pain syndromes of various origins.

Material And Methods: 50 patients with an average age of 67±7.4 years with MCI syndrome against the background of CCI, suffering from chronic pain syndromes of various origins, received the drug Ampasse at a dose of 25 mg per day intravenously by bolus for 15 days. At the screening visit, day 15 of therapy, day 30, and day 180 of the observation period, cognitive functions, emotional sphere, severity of pain syndrome, sleep quality, and quality of life were assessed.

Results: In 95% of patients during therapy, an improvement in cognitive functions was noted (increase by 2 points on scales MoCA and MMSE, <0.05). The maximum severity of cognitive improvement was achieved by the 30th day of observation. By the 180th day of observation, 5% of patients had returned to their original cognitive status, which is probably due to the need for a repeated course of therapy to maintain the clinical effect. The antiamnestic effect of Ampasse was also manifested in patients with a multifunctional amnestic phenotype of MCI, which may indicate a comorbidity with a neurodegenerative disease. A total of 84% of patients experienced a decrease in pain intensity during treatment (decrease by 2.3 points on VAS, decrease in consumption of analgesics by 1.5 tablets per day, <0.05). This effect persisted throughout the observation period and was associated with improved sleep quality. In the course of treatment, no cases of anxiety or depression were detected. All patients showed an improvement in their quality of life according to the scale SF-36. The use of Ampasse showed a good level of tolerability and safety.

Conclusion: The use of Ampasse is effective and safe in the treatment of MCI in CCI and helps to reduce the clinical manifestations of pain syndromes of various origins. The mechanism of the analgesic action of Ampasse, as well as the need for and optimal timing of repeated courses of therapy, require further study.