Evaluation of Efficacy and Safety of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution for the Treatment of Motoric Cognitive Risk Syndrome: A Multi-centre, Randomised, Double Blind and Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Change of ADAS-Cog
研究概览
简要总结
This is a multi-centre, randomised, double blind, placebo controlled study on participants with Motoric Cognitive Risk Syndrome to evaluate the efficacy and safety of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution.
详细描述
Cognition and locomotion are two human abilities controlled by the brain. Their decline is highly prevalent with aging, and is greater than the simple sum of their respective prevalence, suggesting a complex age-related interplay between cognition and locomotion.
Recently, a systematic review and meta-analysis has provided evidence that poor gait performance predicts dementia and, in particular, has demonstrated that "motoric cognitive risk" (MCR) syndrome, which has been described in cognitively healthy individuals and combines subjective cognitive complaint with objective slow gait speed, is a pre-dementia syndrome.
MCR as a relatively new recognised clinical syndrome is with a high prevalence calculated around 10% in world population aged 60 and above. MCR syndrome predicts mild and major neurocognitive disorders. MCR syndrome does not rely on a complex and time-consuming assessment, making it applicable to the aging population. Thus, MCR syndrome seems to be a good syndrome to identify individuals at risk of mild and major neurocognitive disorders in any type of healthcare setting.
Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution has proven efficacy for cognitive function deterioration in preliminary studies. The aim of this study is to evaluate its efficacy and safety for MCR.
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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent form
- •Capability of independent living (capability of dressing, bathing, walking, and bed-chair transfer)
- •Met Motoric Cognitive Risk Syndrome (MCR) criteria:
- •Single task slow gait ( male 60 to 74 y, gait <75.4 cm/s; male ≥ 75 y, gait < 59.1 cm/s; female 60 to 74 y, gait <70.0 cm/s; female ≥ 75 y, gait < 48.3 cm/s) And The Montreal Cognitive Assessment (MoCA) ≤ 26 (≥ 12 education year) or MoCA ≤ 25 (< 12 education year)
- •Anticipated good compliance per protocol
排除标准
- •Illiteracy
- •The Mini-Mental State Examination (MMSE) ≤ 23
- •Medical history of mental illness such as schizophrenia, severe anxiety and depression.
- •Medical history of Alzheimer's disease, Parkinson's disease, frontotemporal dementia or Huntington's disease.
- •Dementia caused by other causes (such as central nervous system trauma, tumor, infection, metabolic disease, normal pressure hydrocephalus, folic acid, vitamin B12 deficiency, thyroid Inferior functions, etc.).
- •History of epilepsy, or taking anti-epileptic drugs.
- •History of myocardial infarction or stroke
- •History of malignant tumor
- •Coagulation disorder, systemic bleeding; or previous coagulation disorder or systemic bleeding disease history.
- •History of thrombocytopenia or neutropenia.
- •History of blood system diseases or liver function abnormalities caused by medication
- •Contraindications to ginkgo drugs and a history of known allergies.
- •Aphasia, severe hearing or visual impairment, dominant hemiplegia, and other impacts on cognitive evaluation The status of the test.
- •Known slow gait causes (non-neurological causes [such as: arthritis, heart disease] and neurological causes [bias Paralysis, ataxia, spasticity, Parkinson's disease and frontal lobe disease])
- •Severe heart and lung diseases (coronary heart disease, LVEF<40%, NYHA heart failure grade ≥III, asthma asthma).
- •Severe arrhythmia, heart rate >120bpm or <50bpm. (17) Blood pressure <90/60mmHg
- •Severe anemia, Hb<100g/L
- •Severe liver or renal insufficiency (ALT > 2 times the upper limit of normal or AST > 2 times the upper limit of normal; Creatinine >1.5 times the upper limit of normal)
- •Leukopenia (<2×109/l) or thrombocytopenia (<100×109/l)
- •Currently enrolled in other drug or medical device study
- •Planned any surgery within 6 months at screening
- •Considered by investigators as unsuitable participant of this study
研究组 & 干预措施
Study Arm
Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution, TID
干预措施: Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution (Drug)
Control Arm
Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution, TID
干预措施: Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution (Drug)
结局指标
主要结局
Change of ADAS-Cog
时间窗: 6 month after enrolment
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) test is one of the most frequently used tests to measure cognition in research studies and clinical trials for new drugs and other interventions.The test administrator adds up points for the errors in each task of the ADAS-Cog for a total score ranging from 0 to 70. The greater the dysfunction, the greater the score. A score of 70 represents the most severe impairment and 0 represents the least impairment.
次要结局
- Change of each items from ADAS-Cog(6 month after enrolment)
- TMT-B Score(6 month after enrolment)
- Functional Activities Questionnaire score(6 month after enrolment)
- Percentage of change of ADAS-Cog score 4 or more(6 month after enrolment)
- Frequency of Falls(6 month after enrolment)
- TMT-A Score(6 month after enrolment)
- The Neuropsychiatric Inventory Questionnaire(6 month after enrolment)
- Dementia Conversion Rate(6 month after enrolment)
- Dual-task gait speed test-naming animals(6 month after enrolment)
- Activities of Daily Living (ADLs) score(6 month after enrolment)
- Single-task gait speed test(6 month after enrolment)
研究者
Jingjing Li
Professor
Beijing Tiantan Hospital