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

2026年7月7日 更新者：Pharmasoft

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).

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is a pilot, open-label, prospective, randomized, comparative, controlled study in parallel groups designed to evaluate the efficacy and safety of sequential Mexidol® therapy used in addition to standard therapy in older adults with chronic brain ischemia and vascular cognitive impairment, no dementia (VCIND).

The study included 120 participants randomized into two groups:

  • Group 1 received standard therapy combined with Mexidol® solution (500 mg once daily, IV infusion) for the first 5 days, followed by Mexidol® FORTE 250 tablets (250 mg three times daily) for 60 days.
  • Group 2 received standard therapy only.

Within each treatment group, a pre-specified subgroup analysis was performed based on the presence or absence of frailty, followed by a comparative analysis of the secondary outcome measures for each subgroup.

研究の種類

介入

入学 (実際)

120

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • ロシア
      • Ivanovo、ロシア、153040
        • Ivanovo Regional Clinical Hospital
      • Saint Petersburg、ロシア、197706
        • City Hospital № 40 of Kurortny District
      • Saint Petersburg、ロシア、197136
        • Medinet, LLC
      • Vsevolozhsk、ロシア、188643
        • Vsevolozhsk Clinical Interdistrict Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. Signed and dated Informed Consent Form (ICF) by the patient or an impartial witness (in case of physical inability to sign)
  2. Men and women aged ≥ 75 years at the time of signing the ICF
  3. 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
  4. A total MoCA score of ≤23 points
  5. MRI evidence of vascular brain damage obtained within 1 year prior to screening

  6. 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 Criteria:

  1. Hypersensitivity to ethylmethylhydroxypyridine succinate or any other components of the investigational product
  2. Galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
  3. 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
  4. Clinical depression, confirmed by a standardized scale score (e.g., Beck Depression Inventory score of ≥ 29 points) or by a psychiatrist's evaluation
  5. Chronic heart failure, class III-IV, according to the New York Heart Association (NYHA) Functional Classification at screening
  6. Uncontrolled arterial hypertension
  7. Uncontrolled diabetes mellitus
  8. Thyroid dysfunction: hypothyroidism or hyperthyroidism
  9. Impaired renal function (creatinine clearance calculated by the Cockcroft-Gault formula of less than 50 mL/min) at screening
  10. 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
  11. History of Human Immunodeficiency Virus (HIV), syphilis, hepatitis B, and/or hepatitis C
  12. Severe vitamin B12 deficiency (less than 150 pmol/L)
  13. Acute infectious diseases (influenza, upper respiratory tract infections, or other) within 4 weeks prior to screening
  14. Purulent inflammatory diseases of any site
  15. 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
  16. Use of medications based on ethylmethylhydroxypyridine succinate, trimetazidine, cytoflavin, or meldonium within 2 months prior to study initiation
  17. Systemic autoimmune diseases or connective tissue diseases, requiring prior or current treatment with systemic corticosteroids, cytostatics, or other immunosuppressants
  18. 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
  19. 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)
  20. Unwillingness or inability of the patient to comply with the Protocol procedures (in the investigator's opinion)
  21. History of and/or current alcoholism, drug addiction, or substance abuse at screening
  22. History of schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorders
  23. Participation in another clinical trial within 3 months prior to study enrollment
  24. Any other conditions that, in the investigator's opinion, preclude the patient's inclusion in the study.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Mexidol® + Standard Therapy
Patients receive standard background therapy combined with sequential parenteral and oral administration of Mexidol® for a total duration of 65 days.
薬：Mexidol

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.
アクティブコンパレータ：Standard Therapy Alone
Patients receive standard background therapy alone.
他の：Standard Therapy
Standard background therapy administered in accordance with institutional protocols and applicable clinical guidelines, including cognitive training.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in the Montreal Cognitive Assessment (MoCA) Total Score at Visit 4 compared to Visit 0 by treatment groups
時間枠：Visit 0 (Baseline, Day -4 to Day 0) and Visit 4 (Day 65±2 days)
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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in the Montreal Cognitive Assessment (MoCA) Total Score at Visit 2 compared to Visit 1
時間枠：Visit 1 / Visit 0 (Baseline, Day -4 to Day 1) and Visit 2 (Day 5)

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].

Note: Per protocol, the MoCA assessment is performed at Visit 0 (Screening). For patients where Visit 1 (Randomization) and Visit 0 do not coincide, the screening data are used as the baseline values for 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
時間枠：Visit 1 (Day 1) and Visit 2 (Day 5)
The Clinical Global Impression (CGI) scale is a 3-item observer-rated scale used to evaluate illness severity, global improvement or change, and treatment response. It consists of three independent subscales, each rated separately: CGI-Severity (CGI-S) rates the severity of illness on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients); CGI-Improvement (CGI-I) rates the patient's change over time on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse); CGI-Efficacy Index is a 4x4 rating scale that assesses the therapeutic effect and treatment-related adverse events. Scores range from 00 (not assessed) or 01 (marked improvement and no side effects) to 16 (unchanged or worse and side effects outweigh the therapeutic effects). A lower score reflects a better therapeutic 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
時間枠：Visit 1 (Day 1) and Visit 2 (Day 5)
The Beck Anxiety Inventory (BAI) consists of 21 self-report items (scored on a 4-point scale) used to assess the severity of physical and cognitive anxiety symptoms during the past week. Total scores range from 0 to 63: minimal anxiety (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63). [Scale range: 0 to 63; lower scores indicate a better outcome].
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
時間枠：Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
The Mini-Mental State Examination (MMSE) is a 30-point questionnaire of global cognitive status that assesses five key areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Total scores range from 0 to 30, with higher scores indicating better cognition. A score of 24 or more indicates normal cognition. Scores below 24 indicate cognitive impairment, categorized as mild (19-23 points), moderate (10-18 points), or severe (≤9 points) [30-point scale: min value 0, max value 30, higher scores mean a better outcome].
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
時間枠：Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
The Lawton Instrumental Activities of Daily Living (IADL) Scale is an 8-item instrument used to assess independent living skills and complex occupational performance. The scale evaluates 8 functional domains: ability to use telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for own medications, and ability to handle finances. Each item is scored as either 0 (dependent) or 1 (independent). The total score is calculated as the sum of all 8 domains ranging from 0 to 8. A score of 0 represents low functioning (maximum dependence) and a score of 8 represents high functioning (full independence) [Scale range: 0 to 8; higher scores indicate a better outcome].
Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
Change in the Barthel Index (BI) for Activities of Daily Living Total Score at Visit 4 compared to Visit 1
時間枠：Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
The Barthel Index (BI) for Activities of Daily Living is a validated 10-item clinician- or caregiver-reported rating scale used to assess a patient's performance and level of independence in basic activities of daily living (ADL) and mobility. The index evaluates 10 functional domains: feeding, bathing, grooming, dressing, bowels, bladder, toilet use, transfers, mobility, and stairs. Items are scored in increments of 5. The total score is calculated as the sum of all 10 items, ranging from 0 to 100. A score of 0 represents complete dependence, while a score of 100 represents complete independence. [Scale range: 0 to 100; higher scores indicate a better outcome].
Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
Change in the Short Physical Performance Battery (SPPB) Total Score at Visit 4 compared to Visit 1
時間枠：Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
The Short Physical Performance Battery (SPPB) is a standardized assessment tool used to evaluate lower extremity function and mobility in older adults. It consists of three objective subtests designed to mimic everyday physical demands: a 4-meter walk to assess gait speed, a repeated chair stand test (rising from a seated position 5 times) to assess lower limb strength, and three 10-second static balance tests in different foot positions (side-by-side, semi-tandem, and tandem). Each of the three subtests is scored from 0 to 4, resulting in a total summary score ranging from 0 to 12. Lower scores indicate poorer physical function and higher disability, while higher scores indicate better lower extremity performance and functional independence. [Scale range: 0 to 12; higher scores indicate a better outcome].
Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
Change in the Digit Symbol Substitution Test (DSST) Total Score at Visit 4 compared to Visit 0
時間枠：Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
The Digit Symbol Substitution Test (DSST) is used to measure attention, processing speed and executive function. It is a pencil and paper test of psychomotor performance in which the subject is given a key grid of numbers and matching symbols and a test section with numbers and empty boxes. The test consists of filling as many empty boxes as possible with a symbol matching each number. The score is the number of correct number-symbol matches achieved in 90 s. Scores range from 0 to 100, with higher scores indicating higher cognitive function.
Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
Change in the Multidimensional Fatigue Inventory (MFI-20) Total Score at Visit 4 compared to Visit 1
時間枠：Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
The Multidimensional Fatigue Inventory (MFI-20) is a 20-item self-administered questionnaire designed to measure fatigue in five 4-item subscales: General fatigue, Physical fatigue, Reduced activity, Reduced motivation and Mental fatigue. MFI-20 has an even proportion of positively and negatively worded items that are rated on a 5-point Likert scale. Subscale scores (range 4-20) are calculated as the sum of item ratings and a total fatigue score (range 20-100) is calculated as the sum of subscale scores. Higher scores indicate a higher level of fatigue.
Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
Change in the Beck Anxiety Inventory (BAI) Total Score at Visit 4 compared to Visit 1
時間枠：Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
The Beck Anxiety Inventory (BAI) consists of 21 self-report items (scored on a 4-point scale) used to assess the severity of physical and cognitive anxiety symptoms during the past week. Total scores range from 0 to 63: minimal anxiety (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63). [Scale range: 0 to 63; lower scores indicate a better outcome].
Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
Change in the Tinetti Gait and Balance Test Total Score at Visit 4 compared to Visit 1
時間枠：Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
The Tinetti Gait and Balance Test is a clinical test for the assessment of balance and gait. It has a gait score and a balance score using a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totaling 28. The lower the score on the Tinetti test, the higher the risk of falling. Tinetti test score equal or less than 18 shows high risk of fall, 19-23 scores show moderate risk of fall, and score equal or higher than 24 shows low risk of fall. Min value is 0, max value is 28, higher scores mean a better outcome.
Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
Change in the 36-Item Short Form Survey (SF-36) Total Score at Visit 4 compared to Visit 1
時間枠：Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
The 36-Item Short Form Health Survey (SF-36) consists of eight scales yielding two summary measures: physical and mental health. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate a better health status, and a mean score of 50 represents a normative value for all scales. [Scale range: 0 to 100; higher scores indicate a better outcome].
Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
Change in the Clinical Global Impression (CGI) Scale Scores at Visit 4 Compared to Visit 1, Including Severity of Illness, Global Clinical Change, and Efficacy Index
時間枠：Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
The Clinical Global Impression (CGI) scale is a 3-item observer-rated scale used to evaluate illness severity, global improvement or change, and treatment response. It consists of three independent subscales, each rated separately: CGI-Severity (CGI-S) rates the severity of illness on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients); CGI-Improvement (CGI-I) rates the patient's change over time on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse); CGI-Efficacy Index is a 4x4 rating scale that assesses the therapeutic effect and treatment-related adverse events. Scores range from 00 (not assessed) or 01 (marked improvement and no side effects) to 16 (unchanged or worse and side effects outweigh the therapeutic effects). A lower score reflects a better therapeutic index.
Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
Change in the Morse Fall Scale (MFS) Total Score at Visit 4 compared to Visit 1
時間枠：Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
The Morse Fall Scale (MFS) is a validated 6-item clinician-reported tool used to assess a participant's risk of falling. It evaluates six variables: history of falling, secondary diagnosis, ambulatory aid, intravenous therapy, gait/transferring, and mental status. The total score is calculated as the sum of all items, ranging from 0 to 125. Scores are stratified into low risk (0-24), moderate risk (25-44), and high risk (≥45) of falling. [Scale range: 0 to 125; higher scores indicate a worse outcome].
Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
Change in the Falls Risk Self-Assessment Scale Total Score at Visit 4 compared to Visit 1
時間枠：Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
The Falls Risk Self-Assessment Scale is a 12-item self-administered questionnaire used to evaluate a participant's perceived risk of falling. For each question, a "no" answer is scored as 0 points, while a "yes" answer is scored as either 1 or 2 points, depending on the item weight. The total score is calculated as the sum of all 12 items. Total scores are interpreted as follows: a score of less than 4 points indicates a low risk of falling, and a score of 4 or more points indicates a high risk of falling. [Scale range: 0 to 14; lower scores indicate a better outcome].
Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
Change in the Insomnia Severity Index (ISI) Total Score at Visit 4 compared to Visit 1
時間枠：Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
The Insomnia Severity Index (ISI) is a 7-item self-administered instrument used to assess the nature, severity, and impact of sleep disturbances experienced over the past 2 weeks. Individual items are rated on a 5-point Likert scale (0 to 4), with the total score calculated as the sum of all 7 items, ranging from 0 to 28. Total scores are interpreted as follows: no clinically significant insomnia (0-7 points), subthreshold insomnia (8-14 points), clinical insomnia of moderate severity (15-21 points), and severe clinical insomnia (22-28 points). [Scale range: 0 to 28; lower scores indicate a better outcome].
Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
Change in Time to Complete the Trail Making Test Part A (TMT-A) at Visit 4 compared to Visit 1
時間枠：Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
The Trail Making Test Part A (TMT-A) is a neuropsychological instrument used to assess visual search, scanning, speed of processing, and executive function. Participants are required to connect a set of 25 encircled numbers in numerical order as rapidly as possible. Performance is scored based on the total time taken to complete the task, where each second equals 1 point. A higher score (longer completion time) indicates cognitive impairment, while a lower score indicates better cognitive performance and faster processing speed. [Scale range: not applicable; lower scores indicate a better outcome].
Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
Change in Time to Complete the Trail Making Test Part B (TMT-B) at Visit 4 compared to Visit 1
時間枠：Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
The Trail Making Test Part B (TMT-B) is a neuropsychological instrument used to assess visual search, scanning, speed of processing, cognitive flexibility, and executive function. Participants are required to connect a set of 25 encircled numbers and letters, alternating between numerical and alphabetical order (e.g., 1-A-2-B) as rapidly as possible. Performance is scored based on the total time taken to complete the task, where each second equals 1 point. A higher score (longer completion time) indicates cognitive impairment, while a lower score indicates better cognitive performance. [Scale range: not applicable; lower scores indicate a better outcome].
Visit 1 (Day 1) and Visit 4 (Day 65±2 days)
Assessment of Safety
時間枠：From Day 1 (Visit 1) to Day 65 (Visit 4)

Total number of adverse events (AEs), stratified by severity and frequency; Incidence of adverse drug reactions (ADRs); Incidence of serious adverse events (SAEs) related to the investigational product; Proportion of participants with at least one reported AE; Proportion of participants who discontinued treatment due to AEs.

Note: All clinically significant deviations in patient health status (based on physical examination, laboratory, and instrumental assessments) from baseline screening data and reference ranges were recorded as adverse events. Adverse medical events detected during the screening period were classified as medical history (pre-existing/concomitant conditions).
From Day 1 (Visit 1) to Day 65 (Visit 4)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Pharmasoft

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年9月14日

一次修了 (実際)

2025年11月5日

研究の完了 (実際)

2025年11月5日

試験登録日

最初に提出

2026年7月7日

QC基準を満たした最初の提出物

2026年7月7日

最初の投稿 (実際)

2026年7月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月14日

QC基準を満たした最後の更新が送信されました

2026年7月7日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PHS-PS-REAB-002-MEX-SOL-TAB

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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