Real-world Patient Registry Study of Cerebral Small Vessel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline in Montreal Cognitive Assessment (MoCA) at 6 month
研究概览
简要总结
The incidence of cerebral small vessel disease (CSVD) increases with age, affecting approximately 5% of individuals over 50 years old and nearly all individuals over 90 years old. CSVD is also the most important vascular factor contributing to cognitive decline, with 45% of dementia patients attributed to CSVD. Existing interventions are similar to secondary prevention strategies for cardiovascular and cerebrovascular diseases, and no specific therapies are currently available.
CSVD-related cognitive impairment (CSVDCI) predominantly involves attention, processing speed, and executive functions, with relatively preserved memory function, and may be accompanied by non-cognitive clinical manifestations such as gait disturbances, emotional and behavioral disorders, and bladder dysfunction. Although CSVDCI can be classified under vascular cognitive impairment (VCI), there are certain differences in its clinical manifestations.
In summary, it is necessary to develop more targeted treatments for CSVD. We attempt to establish a "symptom-tongue coating-gut microbiota-imaging" system to provide data support for the subsequent exploration of CSVD treatments based on traditional Chinese medicine (TCM) syndrome differentiation and treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 50 years (including 50-year-old);
- •MRI confirmed the presence of typical imaging changes of CSVD;
- •Voluntary participation in the study and be willing to sign the Informed Consent Form.
排除标准
- •Patients with acute ischemic stroke or acute intracranial hemorrhage (e.g., epidural hematoma, subdural hematoma, subarachnoid hemorrhage, intracerebral hemorrhage, etc.) or a history of cerebral infarction (non-lacunar) or intracranial hemorrhage within the past 3 months;
- •Significant non-vascular white matter lesions (e.g., multiple sclerosis, adult-onset leukoencephalopathy, metabolic encephalopathy, etc.);
- •Patients with a history of cognitive impairment due to other causes (e.g., normal pressure hydrocephalus, Alzheimer's disease, Parkinson's disease, multiple sclerosis, encephalitis, etc.);
- •Severe hepatic, renal, or cardiac insufficiency (ALT or AST >2 times the upper limit of normal, or serum creatinine >1.5 times the upper limit of normal, or New York Heart Association [NYHA] functional class III or IV);
- •Patients with psychiatric disorders that affect study medication administration and evaluation;
- •Contraindications to MRI examination (e.g., claustrophobia, presence of an implantable pacemaker, etc.);
- •Patients unable to comply with follow-up examinations or other study procedures due to residential location or other reasons;
- •Participation in other clinical trial projects.
结局指标
主要结局
Change from baseline in Montreal Cognitive Assessment (MoCA) at 6 month
时间窗: 6 months
Change from baseline in Montreal Cognitive Assessment (MoCA). Score range is 0-30. Higher score means good cognition.
次要结局
- Change from baseline in Mini-Mental State Examination (MMSE) at 6 month(6 months)
- Changes in whole-brain fiber connectivity at 6 month(6 months)
- Change from baseline in trail making test (TMT) at 6 month(6 months)
- Change from baseline in Tinetti Performance Oriented Mobility Assessment (POMA) at 6 month(6 months)
- Change from baseline in instrumental activities of daily living (IADL) at 6 month(6 months)
- Change from baseline in Modified Rankin Scale (mRS) at 6 month(6 months)
- Change from baseline in the symptom at 6 month(6 months)
- Change from baseline in gut microbiota at 6 month(6 months)
研究者
Ying Gao
Prof.
Dongzhimen Hospital, Beijing