Metabolic AbnormalitiesPhase 4MIFNCT07923240
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 study testing Mexidol sequential therapy in people with Metabolic Abnormalities and Obesity & Overweight, run by Research Center of Neurology, Russia at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Metabolic Abnormalities, Obesity & Overweight, Cerebral Atherosclerosis
- What is being tested?
- Mexidol sequential therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2026to 25 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cerebrovascular disease (I67.8) and/or cerebral atherosclerosis (I67.2)
- metabolic disorders (diabetes and/or BMI 27 or higher) for Group1
- no metabolic disorders - for Group 2
Who cannot join
- decompensated somatic pathology
- history of neoplasia
- acute stroke/myocardial infarction
Trial locations and contacts
1 site in 1 country.
Russia1 site
Russian Center of Neurology and Neurosciences
Moscow, Moscow, 125367
About this study
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).
- Conditions
- Metabolic Abnormalities, Obesity & Overweight, Cerebral Atherosclerosis, Cerebrovascular Disease
- Being tested
- Mexidol sequential therapy
- Medical subject headings
- Obesity, Overweight, Intracranial Arteriosclerosis, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mexidol sequential therapyDrug
14 days of 10,0 ml of Mexidol intravenous, followed by 2 months of oral administration
| Study group | Role | What they receive |
|---|---|---|
| Cerebrovascular disease without metabolic disorders | Active comparator | Not described Receives: Drug: Mexidol sequential therapy |
| Cerebrovascular disease with metabolic disorders (obesity and/or DM2) | Experimental | Not described Receives: Drug: Mexidol sequential therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI
Functional brain imaging changes (rest and task-based) - pre- and post-saline vs pre- and post-Mexidol
Measured: Days 1,2,14,74
Secondary outcomes (2)
BMI
Body mass index canhge
Measured: 74 days
Cognitive
Cognitive dynamics via MOCA test (maximum - 30, more = better)
Measured: 74 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Apr 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Center of Neurology, Russia
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923240
- Sponsor's protocol ID
- 1-7/26
- Acronym
- MIF
- Status last verified
- Nov 2026
- First submitted
- 19 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07923240
- Acronym / sponsor ID
- MIF / 1-7/26
- Conditions
- Metabolic Abnormalities, Obesity & Overweight, Cerebral Atherosclerosis, Cerebrovascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Research Center of Neurology, RussiaOther government
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebrovascular disease without metabolic disorders | Active comparator | Drug: Mexidol sequential therapy |
| Cerebrovascular disease with metabolic disorders (obesity and/or DM2) | Experimental | Drug: Mexidol sequential therapy |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cerebrovascular disease (I67.8) and/or cerebral atherosclerosis (I67.2)
- metabolic disorders (diabetes and/or BMI 27 or higher) for Group1
- no metabolic disorders - for Group 2
Key exclusion criteria (3 listed)
- decompensated somatic pathology
- history of neoplasia
- acute stroke/myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mexidol sequential therapy14 days of 10,0 ml of Mexidol intravenous, followed by 2 months of oral administration | Drug | Cerebrovascular disease with metabolic disorders (obesity and/or DM2), Cerebrovascular disease without metabolic disorders |
Primary outcome
fMRI
Time frame: Days 1,2,14,74
Functional brain imaging changes (rest and task-based) - pre- and post-saline vs pre- and post-Mexidol
2 secondary outcomes
BMI
Time frame: 74 days
Cognitive
Time frame: 74 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mexidol sequential therapy in people with Metabolic Abnormalities and Obesity & Overweight, run by Research Center of Neurology, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI (time frame: Days 1,2,14,74). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.