Could a russian drug boost brain function in chronic ischemia?
NCT ID NCT06834490
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether the drug Mexidol (given first as injections, then as pills) can improve thinking and memory in people with chronic cerebral ischemia, a condition where the brain doesn't get enough blood flow. 318 adults aged 40-90 with mild to moderate cognitive impairment took part. The main goal was to see if their scores on a cognitive test (MoCA) improved after treatment compared to a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mexidol (ethylmethylhydroxypyridine succinate)
- What this could lead to
- If it works, this could offer a treatment option to slow cognitive decline in people with chronic cerebral ischemia.
- What could go wrong
- This is a completed Phase 3 trial, but results are not yet published. The improvement in cognitive scores may be small or not clinically meaningful.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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318 people
The number who actually took part.
- Started
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Nov 2019
- Finished
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Dec 2020
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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) cognitive impairment 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 performed within 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 drugs during the previous month, including (if indicated): antiplatelet therapy, therapy of cerebral atherosclerosis and arterial hypertension, ischemic heart disease or other chronic diseases. 9. Negative pregnancy test 10. 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). 11. Patients who are able to understand all study requirements and who have consented to all 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 to a clinically significant protocol deviation/violation. 3. 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. 4. Any adverse event (which may be unrelated to the investigational drug) requiring observations, procedures, and/or medications not approved by the clinical trial protocol. 5. Participant's refusal to continue participation in the study or their lack of discipline 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 affecting the function of the autonomic nervous system and other drugs that may, in the investigator's opinion, distort the study results. 10. Pregnancy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre for Neurology and Neurorehabilitation n.a. N. M. Madzhido, OOO "Neyromed Servis"
Tashkent, 100187, Uzbekistan
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City Hospital No.40 of the Kurortny District
Sestroretsk, 197706, Russia
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Federal State Budget Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education"
Moscow, 125445, Russia
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Federal State Budget Educational Institution of Higher Education "Kazan State Medical University"
Kazan', 420012, Russia
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Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy n.a. S.M.Kirov"
Saint Petersburg, 194044, Russia
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Federal State Budget Research Institution "Federal Research Center for Fundamental and Translational Medicine"
Novosibirsk, 630117, Russia
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Federal State Budget Research Institution "Research Center of Neurology"
Moscow, 125367, Russia
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Municipal Autonomous Healthcare Insitution of the Order of the Red Banner of Labour "City Clinical Hospital No.1"
Chelyabinsk, 454092, Russia
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OOO "Centre for Evidence-Based Medicine"
Yaroslavl, 150000, Russia
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Private Healthcare Institution "Clinical Hospital "RR-Medicine" of Voronezh
Voronezh, 394024, Russia
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Regional Budget Healthcare Institution "Ivanovo Regional Clinical Hospital"
Ivanovo, 152040, Russia
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State Budget Healthcare Institution of the Novosibirsk Region "City Hospital № 34"
Novosibirsk, 630054, Russia
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State Budget Healthcare Institution of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1"
Yekaterinburg, 620102, Russia
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State Budget Healthcare Institution of the Yaroslavl Region "Clinical Hospital No.2"
Yaroslavl, 150030, Russia
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