Safety and Efficacy of Sequential Therapy With Mexidol® in Patients With Chronic Cerebral Ischemia
MEMO
International Multicentre Randomized, Double-blind, Placebo-controlled Adaptive Design Clinical Trial to Evaluate the Safety and Efficacy of Sequential Therapy With Mexidol® Solution for Intravenous and Intramuscular Administration, 50 mg/ml (RPC PHARMASOFT LLC, Russia) and Mexidol® FORTE 250 Film-coated Tablets, 250 mg (RPC PHARMASOFT LLC, Russia) in Patients With Chronic Cerebral Ischemia (MEMO)
Mean Score of Montreal Cognitive Assessment (MoCA) at Visit 5 in Comparison With Reference Score at Visit 0
The Montreal Cognitive Assessment (MoCA) is used to measure the degree of cognitive impairment in patients with CCI. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. Higher score than shown at Visit 0 is expected after treatment.
Day 75+2 (Visit 5) compared with the baseline level (Visit 0, 7 days before treatment)
Secondary Outcomes (9)
Changes in the Severity of Cognitive Impairment Assessed With the Montreal Cognitive Assessment Scale Between Visit 0 and Visits 2 and 4
Day 14 (Visit 2) and Day 44±2 (Visit 4) compared with the baseline level (Visit 0, 7 days before treatment)
Study Arms (2)
Main (Mexidol)
ACTIVE COMPARATOR
Participants received Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Drug: Mexidol
Control (Placebo)
PLACEBO COMPARATOR
Participants received Mexidol Placebo matching Mexidol IV 500 mg (10 ml) once daily for 14 days, then Mexidol Placebo matching Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 60 days
Drug: Placebo
Interventions
MexidolDrug
50 mg/ml IV solution, 250 mg tablets
Also known as: Ethylmethylhydroxypyridine Succinate
Main (Mexidol)
PlaceboDrug
Placebo IV solution, Placebo tablets
Control (Placebo)
Eligibility Criteria
Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
You may qualify if:
Patients of either sex aged from 40 to 90 years inclusive
Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Physical Health)
Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment)
Changes in Patients' Quality of Life Assessed With SF-36 Questionnaire (Mental Health)
Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment)
Changes in the Severity of Asthenia Assessed With the Multidimensional Fatigue Inventory (MFI-20)
Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment)
Changes in the Anxiety Level According to the Beck Anxiety Inventory
Day 14 (Visit 2), Day 44±2 (Visit 4), Day 75+2 (Visit 5) compared with the baseline level (Visit 1, Day 1 of treatment)
+4 more secondary outcomes
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
You may not qualify if:
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.
Contact the study team to confirm eligibility.
Federal State Budget Research Institution "Federal Research Center for Fundamental and Translational Medicine"
Novosibirsk, 630117, Russia
Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy n.a. S.M.Kirov"
Saint Petersburg, 194044, Russia
City Hospital No.40 of the Kurortny District
Sestroretsk, 197706, Russia
Private Healthcare Institution "Clinical Hospital "RR-Medicine" of Voronezh
Voronezh, 394024, Russia
OOO "Centre for Evidence-Based Medicine"
Yaroslavl, 150000, Russia
State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2"
Yaroslavl, 150030, Russia
State Budget Healthcare Institution of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1"
Yekaterinburg, 620102, Russia
Centre for Neurology and Neurorehabilitation n.a. N. M. Madzhido, OOO "Neyromed Servis"
State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2"
PRINCIPAL INVESTIGATOR
Aida A. Yakupova, MD, Cand.Med.Sci
Federal State Budget Educational Institution of Higher Education "Kazan State Meical University"
PRINCIPAL INVESTIGATOR
Igor V. Litvinenko, Prof., Dr.Med.Sci
Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy n.a. S.M.Kirov"
PRINCIPAL INVESTIGATOR
Irina G. Lukashevich, MD
Municipal Autonomous Healthcare Insitution of the Order of the Red Banner of Labour "City Clinical Hospital No.1"
PRINCIPAL INVESTIGATOR
Olga A. Sinitsyna, MD, Cand.Med.Sci
State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2"
PRINCIPAL INVESTIGATOR
Larisa A. Shchepankevich, MD, Dr.Med.Sci
Federal State Budget Research Institution "Federal Research Center for Fundamental and Translational Medicine"
PRINCIPAL INVESTIGATOR
Galina A. Batishcheva, Prof., Dr.Med.Sci
Private Healthcare Institution "Clinical Hospital "RR-Medicine" of Voronezh
PRINCIPAL INVESTIGATOR
Olga D. Ostroumova, Prof., Dr.Med.Sci
Federal State Budget Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education"
PRINCIPAL INVESTIGATOR
Yokutkhon N. Madzhidova, Prof., Dr.Med.Sci
Centre for Neurology and Neurorehabilitation n.a. N.M.Madzhido, OOO "Neyromed Servis"
PRINCIPAL INVESTIGATOR
Primary Completion
December 8, 2020
Actual (reported)
Study Completion
December 8, 2020
Actual (reported)
Last Updated
October 6, 2025
Results First Posted
October 6, 2025
Record last verified: 2025-09
Data Sharing
IPD Sharing
Will not share
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.