Could a common drug boost brain function in seniors with 'Silent' stroke damage?
NCT ID NCT07700615
First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time
Summary
This study tests whether adding the drug Mexidol to standard care can improve thinking and memory in adults aged 75 and older who have mild cognitive issues due to poor blood flow in the brain, but not dementia. Participants receive Mexidol first as an IV infusion for 5 days, then as tablets for 60 days, or standard therapy alone. The main goal is to see if Mexidol leads to better scores on a common cognitive test.
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) given first as an IV infusion then as oral tablets
- What this could lead to
- If it works, this could point toward a treatment option for older adults with early vascular-related memory and thinking problems.
- What could go wrong
- This is a small, early-phase trial, so results may not be conclusive or apply to everyone. The drug is already approved for other uses, but its benefit for cognitive impairment is not yet proven.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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120 people
The number who actually took part.
- Started
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Sep 2025
- Finished
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Nov 2025
- 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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75 years and older
- 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. Signed and dated Informed Consent Form (ICF) by the patient or an impartial witness (in case of physical inability to sign) 2. Men and women aged ≥ 75 years at the time of signing the ICF 3. Patients with the diagnosis of mild cognitive disorder / vascular cognitive impairment, no dementia (ICD-10 code F06.7) established at least 1 year prior to screening 4. A total MoCA score of ≤23 points 5. MRI evidence of vascular brain damage obtained within 1 year prior to screening 6. Agreement to use highly effective methods of contraception throughout the study and for 3 weeks after study completion. Eligible participants include: * women of childbearing potential, who have a negative pregnancy test and use the following contraceptive methods: a barrier method (condom or occlusive cap \[diaphragm or cervical/vault cap\]) or a double-barrier method (condom or occlusive cap \[diaphragm or cervical/vault cap\] plus spermicide \[foam/gel/film/cream/suppository\]); women of non-childbearing potential with documented history of hysterectomy, tubal ligation, infertility, or postmenopausal status for more than 1 year; * fertile men who agree to use barrier contraception; men with documented infertility or prior vasectomy. Exclusion Criteria: 1. Hypersensitivity to ethylmethylhydroxypyridine succinate or any other components of the investigational product 2. Galactose intolerance, lactase deficiency, or glucose-galactose malabsorption 3. Clinically confirmed dementia, defined with the Mini-Mental State Examination score of ≤ 24 points and/or a diagnosis of dementia established according to the Diagnostic and Statistical Manual of mental disorders, Fifth Edition (DSM-5) criteria 4. Clinical depression, confirmed by a standardized scale score (e.g., Beck Depression Inventory score of ≥ 29 points) or by a psychiatrist's evaluation 5. Chronic heart failure, class III-IV, according to the New York Heart Association (NYHA) Functional Classification at screening 6. Uncontrolled arterial hypertension 7. Uncontrolled diabetes mellitus 8. Thyroid dysfunction: hypothyroidism or hyperthyroidism 9. Impaired renal function (creatinine clearance calculated by the Cockcroft-Gault formula of less than 50 mL/min) at screening 10. Impaired hepatic function (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥ 2 times the upper limit of normal (ULN) and/or total bilirubin ≥ 1.5 times the ULN) at screening 11. History of Human Immunodeficiency Virus (HIV), syphilis, hepatitis B, and/or hepatitis C 12. Severe vitamin B12 deficiency (less than 150 pmol/L) 13. Acute infectious diseases (influenza, upper respiratory tract infections, or other) within 4 weeks prior to screening 14. Purulent inflammatory diseases of any site 15. Use of prohibited medications or other substances that, in the investigator's opinion, may interfere with the study results within 30 days prior to screening, or the anticipated need for such medications during the patient's participation in the study 16. Use of medications based on ethylmethylhydroxypyridine succinate, trimetazidine, cytoflavin, or meldonium within 2 months prior to study initiation 17. Systemic autoimmune diseases or connective tissue diseases, requiring prior or current treatment with systemic corticosteroids, cytostatics, or other immunosuppressants 18. History of malignant neoplasms except for patients with no evidence of disease for the past 5 years, completely cured basal cell carcinoma of the skin, or completely cured carcinoma in situ 19. Other severe, decompensated, or unstable somatic diseases (any diseases or conditions that are life-threatening, worsen the patient's prognosis, or prevent participation in a clinical trial) 20. Unwillingness or inability of the patient to comply with the Protocol procedures (in the investigator's opinion) 21. History of and/or current alcoholism, drug addiction, or substance abuse at screening 22. History of schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorders 23. Participation in another clinical trial within 3 months prior to study enrollment 24. Any other conditions that, in the investigator's opinion, preclude the patient's inclusion in the study.
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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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City Hospital № 40 of Kurortny District
Saint Petersburg, 197706, Russia
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Ivanovo Regional Clinical Hospital
Ivanovo, 153040, Russia
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Medinet, LLC
Saint Petersburg, 197136, Russia
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Vsevolozhsk Clinical Interdistrict Hospital
Vsevolozhsk, 188643, Russia