Mexidol® Efficacy and Safety in Treatment of VCIND in Older Adults

Trial details

Who runs it

Pharmasoft

Trial code

NCT07700615

Record updated

14 July 2026

Original description

The primary objective of this study is to evaluate the efficacy of Mexidol® sequential parenteral and oral administration as part of comprehensive therapy in older adults with chronic brain ischemia and vascular cognitive impairment, no dementia (VCIND).Read full original descriptionShow less

Open-label, Randomized, Comparative, Controlled Study of the Efficacy and Safety of Mexidol® Used as an Add-On to Standard Therapy in Older Adults With Vascular Cognitive Impairment, No Dementia

The primary objective of this study is to evaluate the efficacy of Mexidol® sequential parenteral and oral administration as part of comprehensive therapy in older adults with chronic brain ischemia and vascular cognitive impairment, no dementia (VCIND).

Inclusion: Signed and dated Informed Consent Form (ICF) by the patient or an impartial witness (in case of physical inability to sign); Men and women aged ≥ 75 years at the time of signing the ICF; 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; A total MoCA score of ≤23 points; MRI evidence of vascular brain damage obtained within 1 year prior to screening; 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: Hypersensitivity to ethylmethylhydroxypyridine succinate or any other components of the investigational product; Acute infectious diseases (influenza, upper respiratory tract infections, or other) within 4 weeks prior to screening; 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; Use of medications based on ethylmethylhydroxypyridine succinate, trimetazidine, cytoflavin, or meldonium within 2 months prior to study initiation; Systemic autoimmune diseases or connective tissue diseases, requiring prior or current treatment with systemic corticosteroids, cytostatics, or other immunosuppressants; Participation in another clinical trial within 3 months prior to study enrollment; 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; Chronic heart failure, class III-IV, according to the New York Heart Association (NYHA) Functional Classification at screening; Uncontrolled arterial hypertension; Uncontrolled diabetes mellitus; History of Human Immunodeficiency Virus (HIV), syphilis, hepatitis B, and/or hepatitis C; Purulent inflammatory diseases of any site; 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; 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); History of and/or current alcoholism, drug addiction, or substance abuse at screening; History of schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorders; Any other conditions that, in the investigator's opinion, preclude the patient's inclusion in the study; Galactose intolerance, lactase deficiency, or glucose-galactose malabsorption; Impaired renal function (creatinine clearance calculated by the Cockcroft-Gault formula of less than 50 mL/min) at screening; 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; Clinical depression, confirmed by a standardized scale score (e.g., Beck Depression Inventory score of ≥ 29 points) or by a psychiatrist's evaluation; Thyroid dysfunction: hypothyroidism or hyperthyroidism; Severe vitamin B12 deficiency (less than 150 pmol/L); Unwillingness or inability of the patient to comply with the Protocol procedures (in the investigator's opinion).

ClinicalTrials.gov NCT07700615