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Active, not recruitingNCT07923240MIFUpdated Nov 6, 2026

Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders

A Phase 4 interventional study of Mexidol sequential therapy in Metabolic Abnormalities, Obesity & Overweight and Cerebral Atherosclerosis, sponsored by Research Center of Neurology, Russia. Active, not recruiting at 1 site in Russia. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Research Center of Neurology, Russia · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Apr 2026, registered Oct 2026).
Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
50 Years to 74 Years
Sex
All
01

Study summary

We aim to elucidate the metabolic and neuroactive properties of sequential Mexidol therapy in patients with and without cerebrometabolic disorders using blood biomarkers, anthropometry and brain functional MRI (task- and rest).

02

Conditions studied

  • Metabolic Abnormalities
  • Obesity & Overweight
  • Cerebral Atherosclerosis
  • Cerebrovascular Disease
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 30 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Research Center of Neurology, Russia is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • cerebrovascular disease (I67.8) and/or cerebral atherosclerosis (I67.2)
  • metabolic disorders (diabetes and/or 27 or higher) for Group1
  • no metabolic disorders - for Group 2

Exclusion criteria

Exclusion Criteria:

  • decompensated somatic pathology
  • history of neoplasia
  • acute stroke/myocardial infarction
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Cerebrovascular disease without metabolic disorders

    Drug: Mexidol sequential therapy

  • Experimental
    Cerebrovascular disease with metabolic disorders (obesity and/or DM2)

    Drug: Mexidol sequential therapy

Interventions

  • DrugMexidol sequential therapy

    14 days of 10,0 ml of Mexidol intravenous, followed by 2 months of oral administration

06

What researchers measure

Primary outcomes

  1. fMRI

    Functional brain imaging changes (rest and task-based) - pre- and post-saline vs pre- and post-Mexidol

    Time frame: Days 1,2,14,74

Secondary outcomes

  1. BMI

    Body mass index canhge

    Time frame: 74 days

  2. Cognitive

    Cognitive dynamics via MOCA test (maximum - 30, more = better)

    Time frame: 74 days

07

Study locations

1 site
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07923240
Lead sponsor
Research Center of Neurology, Russia
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Apr 1, 2026
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 25, 2026 (estimated)
Last update
Nov 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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