Study on Ginkgo Biolba Extract Fifty in the Treatment of Mild Cognitive Impairment Associated With Cerebral Small Vessel Disease
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 主要终点
- Change from baseline in Montreal Cognitive Assessment Scale
研究概览
简要总结
This study aimed to explore the efficacy and safety of Ginkgo Biolba Extract fifty in treating mild cognitive impairment associated with cerebral small vessel disease (CSVD). Subjects included based on eligibility criteria were randomized into treatment and control groups. Patients will receive the drug or placebo for 12 months. Patients were followed at baseline and at 3 months, 6 months, and 12 months after randomization. The primary outcome was the difference from baseline in the Montreal Cognitive Assessmen (MoCA) score at 12 months after randomization.
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)
盲法说明
This trial is a double-blind design using simulants to ensure blinding. In order to ensure the unbiased clinical operation, observation, and evaluation of this trial, a centralized randomization system will be used to achieve the allocation of subject random numbers and therapeutic drugs.
The simulants are consistent with the corresponding subject medications in terms of specifications, appearance, packaging, labeling, and marking, and are labeled for clinical trial use.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-75 years old, with no limitation on sex.
- •Head MRI showed SVD lesions. High white matter signal, Fazekas score ≥2 and meet one of the following requirements:
- •Have ≥2 vascular risk factors (hypertension, hyperlipidemia, diabetes, current smoking); Combined lacunar foci; Combined with a new subcortical lacunar infarction (within 7 days of onset);
- •Mild vascular cognitive impairment (memory and/or other cognitive domain abnormalities lasting for at least 3 months) with a score of 18 ≤MoCA score <
- •Insufficient cognitive impairment to affect independence of life (mRS≤2).
- •After enrollment, you can live in the local stable for more than two years.
- •Sign the informed consent form.
排除标准
- •Known or suspected allergy to the components of the investigational drug or allergic constitution.
- •With other brain diseases: Alzheimer's disease, Lewy body dementia, Parkinson's disease frontotemporal dementia, Crohn's disease, as well as other diseases that can lead to cognitive impairment, such as subdural hematoma, communicating hydrocephalus, brain tumors, drug poisoning, alcoholism, thyroid disease, and vitamin deficiency.
- •Previous diagnosis of genetic/degenerative/inflammatory related small cerebral vascular diseases, such as CADASIL, CARASIL, etc.
- •Concomitant with major depressive disorder (≥24 score in HAMD-17) or other transient organic psychosis (e.g., schizophrenia) that meets DSM-V criteria.
- •Any medication used to treat cognitive impairment in the 4 weeks prior to randomization.
- •Combined with severe neurological impairment, such as convenient hand hemiplegia, aphasia, auditory and visual impairment, the relevant examination or scale evaluation can not be completed.
- •Combined with severe gastrointestinal diseases such as indigestion, gastrointestinal obstruction, gastric and duodenal ulcers that can affect drug absorption, or inability to swallow medication.
- •Liver enzymes (ALT, AST)>2 times the upper limit of normal value, creatinine>1.2 times the upper limit of normal value, and decreased glomerular filtration rate (<90ml/min).
- •Life expectancy < 1 year, or other reasons for not being able to complete follow-up.
- •Pregnant or lactating women, or those with fertility plans.
- •Has participated in other clinical trials.
研究组 & 干预措施
Ginkgo biloba extract 50 dropping pills treatment group
Ginkgo biloba extract 50 dropping pills, oral administration, 8 dropping pills /time, 3 times/day
干预措施: Ginkgo biloba extract 50 dropping pills (Drug)
Ginkgo biloba extract 50 dropping pills Simulant treatment group
Ginkgo biloba extract 50 dropping pills simulant, oral administration, 8 dropping pills /time, 3 times/day
干预措施: Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant (Drug)
结局指标
主要结局
Change from baseline in Montreal Cognitive Assessment Scale
时间窗: At 12months±14days after randomization.
Montreal Cognitive Assessment Scale (Beijing Edition) scores from 0 to 30. A higher score indicates better cognitive function.
次要结局
- Changes from baseline in Mini-mental State Examination score(At 3months±7days, 6months±14days and 12months±14days after randomization.)
- Changes from baseline in total cerebral small vessel disease burden(At 12months±14days after randomization.)
- Change from baseline in the Ability Daily Living score(At 3months±7days, 6months±14days and 12months±14days after randomization.)
- Change from baseline in biomarkers(At 3months±7days, 6months±14days and 12months±14days after randomization.)
- Change from baseline in Montreal Cognitive Assessment Scale(At 3months±7days and 6months±14days after randomization.)
- Change from baseline in Social functioning questionnaire(At 3months±7days, 6months±14days and 12months±14days after randomization.)
研究者
yilong Wang
Vice President of Beijing Tiantan Hospital
Beijing Tiantan Hospital