Multicenter Double-blind Placebo-controlled Randomized Parallel-group Clinical Study of Efficacy and Safety of MMH-MAP in the Treatment of Mild Cognitive Impairment in Subjects in Early Rehabilitation Period of Ischemic Stroke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 28
- 主要终点
- Percentage of Patients With Improved Cognitive Function (The Montreal Cognitive Assessment Test Total Score of the Baseline +1 or More)
研究概览
简要总结
The purpose of this study is:
- to evaluate efficacy of MMH-MAP in the treatment of mild cognitive impairment in subjects in early rehabilitation period of ischemic stroke
- to evaluate safety of MMH-MAP in the treatment of mild cognitive impairment in subjects in early rehabilitation period of ischemic stroke
详细描述
A double-blind, placebo-controlled randomized clinical trial in parallel groups.
The study patients are subjects of either gender, aged 45-80 years old, after an ischemic stroke within 3-6 months prior to enrollment and confirmed by neuroimaging, having mild cognitive impairment.
After the patients provide signed Participant Information Sheet and Informed Consent, they will be interviewed for complaints and medical history and undergo physical examination and laboratory tests. The doctor will rate the severity of patients' cognitive impairments on the Mini Mental State Examination (MMSE) scale and Montreal Cognitive Assessment (MoCA) scale, assess their performance in activities of daily living on the Barthel Index scale [Collin C, Wade DT, Davies S, Horne V. "The Barthel ADL Index: a reliability study." Int Disability Study.1988;10:61-63.], and administer the Stroke Specific Quality of Life Scale (SS-QOL) questionnaire [Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a stroke-specific quality of life scale. Stroke 1999 Jul;30(7):1362-9]. Eligible participants will have to have moderate cognitive impairments (MMSE score - at least 21 and MoCA - less than 26). Therapy received by patients for their co-morbidities and primary diagnosis will be recorded. All women of childbearing potential will be administered pregnancy tests.
If a patient meets all inclusion criteria and does not have any exclusion criteria at Visit 1, he/she is randomized to one of the two groups: group 1 will receive MMH-MAP at 2 tablets twice daily; group 2 will receive Placebo using the study product dosing regimen. The total duration of follow-up and treatment will be 28 weeks, which will include 5 additional visits.
At Visit 2 (Week 4±7 days), the doctor records patients' complaints and physical examination data, reviews the progress of study and basic and concomitant therapy, and assesses treatment safety and patient compliance with treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex, aged 45 to 80 years old inclusively.
- •Patients with a history of one stroke sustained 3 to 6 months prior to study entry and confirmed by neuroimaging.
- •Patients with cognitive impairment (MoCA score < 26).
- •Patients with moderate performance in activities of daily living (Barthel score = 61-80).
- •Agreement to use a reliable method of birth control for the duration of the study (men and women of reproductive potential).
- •Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.
排除标准
- •Patients with a history of subarachnoid/parenchymatous/ventricular hemorrhage, brain neoplasm, or any other condition which has caused neurological dysfunction.
- •History of central nervous system (CNS) disorders, including:
- •inflammatory diseases of the CNS (G00-G09)
- •systemic atrophies primarily affecting the CNS (G10-G13)
- •extrapyramidal and movement disorders (G20-G26)
- •other degenerative diseases of the nervous system (G30-G32)
- •demyelinating diseases of the CNS (G35-G37)
- •epilepsy (G40-41)
- •polyneuropathies and other disorders of the peripheral nervous system (G60-64), with marked movement and/or sensory impairments that cause movement disorders
- •diseases of neuromuscular junction and muscle (G70-73)
- •hydrocephalus (G91)
- •compression of brain (G93.5).
- •Dementia (20 or less on the MMSE score).
- •Speech disorders affecting investigator-patient communication.
- •Prior diagnosis of heart failure defined by the New York Heart Association classification (1964) as IV Functional Classification or poorly treated hypothyroidism or diabetes mellitus.
- •Patients having unstable angina or myocardial infarction in the past 6 months.
- •History/suspicion of oncology of any location (except for benign neoplasms).
- •Any other co-morbidity which, in the opinion of the investigator, may affect patient participation in the clinical trial.
- •Patients allergic to/intolerant of any components of the study treatment.
- •Patients with hereditary lactose intolerance.
- •Malabsorption syndrome, including congenital or acquired lactase deficiency (or any other disaccharidase deficiency) and galactosemia.
- •Pregnancy, breast-feeding or unwillingness to use birth control during the study.
- •Patients who, from the investigator's point of view, will not comply with the observation requirements of the study or adhere to study drug dosing regimens.
- •Patients with a history of non-adherence to medication; mental disorder (except for cognitive deficits); or alcoholism or abuse of psychoactive substances, which, in the investigator's opinion, will compromise compliance with study procedures.
- •Patients who have used medications listed in 'Prohibited Concomitant Treatment' in the past week.
- •Participation in other clinical trials in the previous 3 months.
- •Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
- •Patients who work for MATERIA MEDICA HOLDING (i.e. the company's employees, temporary contract workers, appointed officials responsible for carrying out the research or immediate relatives of the aforementioned).
研究组 & 干预措施
Placebo
Placebo for 24 weeks, according to the MMH-MAP dosing regimen.
干预措施: Placebo (Drug)
MMH-MAP
Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in mouth without chewing until complete dissolution. The duration of treatment will be 24 weeks.
干预措施: MMH-MAP (Drug)
结局指标
主要结局
Percentage of Patients With Improved Cognitive Function (The Montreal Cognitive Assessment Test Total Score of the Baseline +1 or More)
时间窗: 24 weeks of the treatment as compared to the baseline
MoCa is the test for assessment of cognitive impairment. The score ranges between 0 and 30. A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome.
次要结局
未报告次要终点