CompletedPhase 3

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

Russia318 participantsStarted 2019-11-05

Plain-language summary

The purpose of this study is to evaluate safety and efficacy of sequential treatment with Mexidol® in patients with chronic cerebral ischemia (CCI).

Age range40 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Mean Score of Montreal Cognitive Assessment (MoCA) at Visit 5 in Comparison With Reference Score at Visit 0

Timeframe: Day 75+2 (Visit 5) compared with the baseline level (Visit 0, 7 days before treatment)

NCT IDNCT06834490

SponsorPharmasoft

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-08

Results submitted2025-04-04

Who can participate

Age range40 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.