Safety and Efficacy of Sequential Therapy With Mexidol® in Patients With Chronic Cerebral Ischemia

Inclusion criteria

• Patients of either sex aged from 40 to 90 years inclusive
• MoCA scale score of 25 and lower
• Patients meeting the criteria for the diagnosis: Mild (moderate) cognitive impairment when assessed by DSM-5.
• Chronic Cerebral Ischemia (ICD-10 code 167.8)
• Foci of leukoaraiosis or "silent" brain infarction documented by MRI/CT performed within the past 12 months.
• Patients who signed an informed consent to the study participation
• History of progressive multifocal or diffuse brain disease from 1 to 5 years
• Patients receiving background therapy with a fixed dose and combination of drugs during the previous month, including (if indicated): antiplatelet therapy, therapy of cerebral atherosclerosis and arterial hypertension, ischemic heart disease or other chronic diseases.
• Negative pregnancy test
• Patients who have agreed to use a reliable method of contraception during the study participation until completion (for women of childbearing potential, including partners of study participants).
• Patients who are able to understand all study requirements and who have consented to all the limitations imposed by the study

Exclusion Criteria

• Inclusion by mistake (overlooked inclusion or non-inclusion criteria)
• Investigator's or Sponsor's decision to exclude a participant from the study due to a clinically significant protocol deviation/violation.
• Serious adverse events or adverse events that do not meet the criteria for seriousness but may, in the investigator's opinion, be detrimental to the health or well-being of a participant if they continue participation in the study.
• Any adverse event (which may be unrelated to the investigational drug) requiring observations, procedures, and/or medications not approved by the clinical trial protocol.
• Participant's refusal to continue participation in the study or their lack of discipline
• Allergic reaction to the investigational drug that requires cancelling the treatment
• Participant's desire to terminate their participation early for any reason.
• Loss of contact with the patient followed by failure to attend the visit.
• The need to take therapies prohibited by this protocol: nootropic drugs, ethylmethylhydroxypyridine succinate, trimetazidine or meldonium, drugs affecting the function of the autonomic nervous system and other drugs that may, in the investigator's opinion, distort the study results.
• Pregnancy.