Safety and Efficacy of Sequential Treatment with Mexidol® in Patients with Chronic Cerebral Ischemia

Inclusion criteria:

1. Patients of either sex aged from 40 to 90 years inclusive

2. MoCA scale score of 25 and lower

3. Patients meeting the criteria for the diagnosis: Mild (moderate) cognitiveimpairment when assessed by DSM-5.

4. Chronic Cerebral Ischemia (ICD-10 code 167.8)

5. Foci of leukoaraiosis or "silent" brain infarction documented by MRI/CT performedwithin the past 12 months.

6. Patients who signed an informed consent to the study participation

7. History of progressive multifocal or diffuse brain disease from 1 to 5 years

8. Patients receiving background therapy with a fixed dose and combination of drugsduring the previous month, including (if indicated): antiplatelet therapy, therapyof cerebral atherosclerosis and arterial hypertension, ischemic heart disease orother chronic diseases.

9. Negative pregnancy test

10. Patients who have agreed to use a reliable method of contraception during the studyparticipation until completion (for women of childbearing potential, includingpartners of study participants).

11. Patients who are able to understand all study requirements and who have consented toall the limitations imposed by the study

Exclusion Criteria:

1. Inclusion by mistake (overlooked inclusion or non-inclusion criteria)

2. Investigator's or Sponsor's decision to exclude a participant from the study due toa clinically significant protocol deviation/violation.

3. Serious adverse events or adverse events that do not meet the criteria forseriousness but may, in the investigator's opinion, be detrimental to the health orwell-being of a participant if they continue participation in the study.

4. Any adverse event (which may be unrelated to the investigational drug) requiringobservations, procedures, and/or medications not approved by the clinical trialprotocol.

5. Participant's refusal to continue participation in the study or their lack ofdiscipline

6. Allergic reaction to the investigational drug that requires cancelling the treatment

7. Participant's desire to terminate their participation early for any reason.

8. Loss of contact with the patient followed by failure to attend the visit.

9. The need to take therapies prohibited by this protocol: nootropic drugs,ethylmethylhydroxypyridine succinate, trimetazidine or meldonium, drugs affectingthe function of the autonomic nervous system and other drugs that may, in theinvestigator's opinion, distort the study results.

10. Pregnancy.