NCT07700615已完成4 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pharmasoft
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Change in the Montreal Cognitive Assessment (MoCA) Total Score at Visit 4 compared to Visit 0 by treatment groups
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Use of medications based on ethylmethylhydroxypyridine succinate, trimetazidine, cytoflavin, or meldonium within 2 months prior to study initiation
- •Systemic autoimmune diseases or connective tissue diseases, requiring prior or current treatment with systemic corticosteroids, cytostatics, or other immunosuppressants
- •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
- •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)
- •Unwillingness or inability of the patient to comply with the Protocol procedures (in the investigator's opinion)
- •History of and/or current alcoholism, drug addiction, or substance abuse at screening
- •History of schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorders
- •Participation in another clinical trial within 3 months prior to study enrollment
- •Any other conditions that, in the investigator's opinion, preclude the patient's inclusion in the study.
研究组 & 干预措施
Standard Therapy Alone
Active Comparator
Patients receive standard background therapy alone.
干预措施: Standard Therapy (Other)
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.
干预措施: Mexidol (Drug)
结局指标
主要结局
Change in the Montreal Cognitive Assessment (MoCA) Total Score at Visit 4 compared to Visit 0 by treatment groups
时间窗: 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 \[30-point scale: min value 0, max value 30, higher scores mean a better outcome\].
次要结局
- 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))
- Change in the Barthel Index (BI) for Activities of Daily Living Total Score at Visit 4 compared to Visit 1(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(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(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(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(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(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(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(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(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(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(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(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(Visit 1 (Day 1) and Visit 4 (Day 65±2 days))
- Assessment of Safety(From Day 1 (Visit 1) to Day 65 (Visit 4))
研究者
研究点 (4)
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