Mexidol® Efficacy and Safety in Treatment of VCIND in Older Adults (NCT07700615) | Clinical Trial Compass
CompletedPhase 4
Mexidol® Efficacy and Safety in Treatment of VCIND in Older Adults
Russia120 participantsStarted 2025-09-14
Plain-language 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).
Who can participate
Age range
75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Montreal Cognitive Assessment (MoCA) Total Score at Visit 4 compared to Visit 0 by treatment groups
Timeframe: Visit 0 (Baseline, Day -4 to Day 0) and Visit 4 (Day 65±2 days)
. 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