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

NCT07700615 | Completed Phase 4

• 1 other identifier: PHS-PS-REAB-002-MEX-SOL-TAB
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Vascular Cognitive Impairment no Dementia

Keywords

Vascular Cognitive Impairment; Pre-Dementia Vascular Cognitive Impairment; vascular cognitive impairment no dementia; Mild Cognitive Impairment; Pre-Dementia; VCI; MCI; Neuroprotection; Mexidol; Ethylmethylhydroxypyridine Succinate; Antioxidants; Sequential Therapy; Elderly; Geriatric Patients; VCIND; Subgroup Analysis; Older Adults

Outcome Measures

Primary Outcomes (1)

• Change in the Montreal Cognitive Assessment (MoCA) Total Score at Visit 4 compared to Visit 0 by treatment groups

  The Montreal Cognitive Assessment (MoCA) is a 30-point validated scale that covers multiple cognitive domains including spatiotemporal orientation, sustained attention, visuospatial function, executive function, verbal memory, language, naming, and abstract thinking \[30-point scale: min value 0, max value 30, higher scores mean a better outcome\].

  Visit 0 (Baseline, Day -4 to Day 0) and Visit 4 (Day 65±2 days)

Secondary Outcomes (19)

• Change in the Montreal Cognitive Assessment (MoCA) Total Score at Visit 2 compared to Visit 1

  Visit 1 / Visit 0 (Baseline, Day -4 to Day 1) and Visit 2 (Day 5)

• Change in the Clinical Global Impression (CGI) Scale Scores at Visit 2 Compared to Visit 1, Including Severity of Illness, Global Clinical Change, and Efficacy Index

  Visit 1 (Day 1) and Visit 2 (Day 5)

• Change in the Beck Anxiety Inventory (BAI) Total Score at Visit 2 compared to Visit 1

  Visit 1 (Day 1) and Visit 2 (Day 5)

• Change in the Mini-Mental State Examination (MMSE) Total Score at Visit 4 compared to Visit 0

  Visit 1 (Day 1) and Visit 4 (Day 65±2 days)

• Change in the Lawton Instrumental Activities of Daily Living (IADL) Scale Total Score at Visit 4 compared to Visit 1

  Visit 1 (Day 1) and Visit 4 (Day 65±2 days)

Study Arms (2)

Mexidol® + Standard Therapy

EXPERIMENTAL

Patients receive standard background therapy combined with sequential parenteral and oral administration of Mexidol® for a total duration of 65 days.

Drug: Mexidol

Standard Therapy Alone

ACTIVE COMPARATOR

Patients receive standard background therapy alone.

Other: Standard Therapy

Interventions

Mexidol DRUG

In addition to standard therapy, Mexidol sequential therapy was administered in two phases: * Days 1 to 5: Intravenous (IV) infusion of 10 mL (500 mg) once daily, diluted in 100-150 mL of 0.9% sodium chloride solution. Infusion rate: 40-60 drops per minute. * Days 6 to 65: Oral administration of Mexidol® FORTE 250 mg tablets, 1 tablet 3 times daily (750 mg total daily dose) for 60 consecutive days.

Mexidol® + Standard Therapy

Standard Therapy OTHER

Standard background therapy administered in accordance with institutional protocols and applicable clinical guidelines, including cognitive training.

Standard Therapy Alone

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hypersensitivity to ethylmethylhydroxypyridine succinate or any other components of the investigational product
• Galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
• 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
• Clinical depression, confirmed by a standardized scale score (e.g., Beck Depression Inventory score of ≥ 29 points) or by a psychiatrist's evaluation
• Chronic heart failure, class III-IV, according to the New York Heart Association (NYHA) Functional Classification at screening
• Uncontrolled arterial hypertension
• Uncontrolled diabetes mellitus
• Thyroid dysfunction: hypothyroidism or hyperthyroidism
• 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
• History of Human Immunodeficiency Virus (HIV), syphilis, hepatitis B, and/or hepatitis C
• Severe vitamin B12 deficiency (less than 150 pmol/L)
• Acute infectious diseases (influenza, upper respiratory tract infections, or other) within 4 weeks prior to screening
• Purulent inflammatory diseases of any site
• 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

Sponsors & Collaborators

• Pharmasoft: lead

Study Sites (4)

Ivanovo Regional Clinical Hospital

Ivanovo, 153040, Russia

Location

Medinet, LLC

Saint Petersburg, 197136, Russia

Location

City Hospital № 40 of Kurortny District

Saint Petersburg, 197706, Russia

Location

Vsevolozhsk Clinical Interdistrict Hospital

Vsevolozhsk, 188643, Russia

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

emoxypine succinate; Standard of Care

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 14, 2026
• Study Start: September 14, 2025
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (4)