To Evaluate the Effects of Different Treatment Schemes on Cognitive Function of Patients With Idiopathic Membranous Nephropathy and Explore the Possible Mechanism by Using Functional Magnetic Resonance Imaging (fMRI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- The cognitive function of the two groups was evaluated and analyzed by the Chinese version of Montreal Cognitive Assessment Scale (MoCA)
研究概览
简要总结
This study intends to apply prospective, open, single-center, randomized controlled study to evaluate the cognitive status of patients with Idiopathic membranous nephropathy and the influence of different treatment schemes on the cognitive status of patients with Idiopathic membranous nephropathy, and explore the possible pathophysiological mechanism by using brain magnetic resonance imaging technology.
详细描述
Proteinuia is an independent risk factor for cognitive dysfunction and dementia. There is no relevant research on whether patients with Idiopathic membranous nephropathy with normal renal function are complicated with cognitive impairment. In the process of clinical diagnosis and treatment, it was observed that the cognitive function of patients with Idiopathic membranous nephropathy decreased significantly after treatment compared with that before treatment. However, there is no clinical study to confirm this phenomenon at present, and the causes of cognitive function damage are not clear. This study intends to apply prospective, open, single-center, randomized controlled study to evaluate the cognitive status of patients with Idiopathic membranous nephropathy and the influence of different treatment schemes on the cognitive status of patients with Idiopathic membranous nephropathy, and explore the possible pathophysiological mechanism by using brain magnetic resonance imaging technology, so as to fill the research gap of clinical cognitive status of Idiopathic membranous nephropathy and provide theoretical basis for better clinical treatment scheme selection and prevention of cognitive impairment.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放(无盲法)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Patients with nephrotic syndrome and normal renal function.
- Patients with idiopathic membranous nephropathy diagnosed by pathology.
- not received hormone or other immunosuppressive treatment in the past six months.
排除标准
- Unable to treat patients with hormones and immunosuppression.
- Patients with definite intracranial diseases such as previous cerebral infarction and cerebral hemorrhage;
- Patients who have been diagnosed with cognitive decline or dementia in the past;
- Patients with claustrophobia or have other contraindications for magnetic resonance imaging, such as pacemakers and metal foreign bodies in the body.
- Pregnant and lactating women
研究组 & 干预措施
Ponticelli group
Patients with idiopathic membranous nephropathy were treated with Ponticelli protocol,that is alternating prednisone or methylprednisone -cyclophosphamide every other month
干预措施: prednisone,methylprednisone and cyclophosphamide (Drug)
Rituximab group
Patients with idiopathic membranous nephropathy were treated with Rituximab.The specific dosage of rituximab depends on the guidance of peripheral blood B cells.
干预措施: Rituximab (Drug)
结局指标
主要结局
The cognitive function of the two groups was evaluated and analyzed by the Chinese version of Montreal Cognitive Assessment Scale (MoCA)
时间窗: enrollment, half a year after treatment and one year after treatment.
The two groups of patients were given a quiet environment and completed the test within 10 minutes. The cognitive function of the two groups was evaluated and analyzed by the Chinese version of Montreal Cognitive Assessment Scale (MoCA). The possible score was between 0 and 30. The higher the score, the better the cognitive state. We defined cognitive impairment as a total score of less than 26 for participants with high school education or below and less than 27 for participants with high school education or above, because the average score of MOCA varies according to the level of education
次要结局
- Brain magnetic resonance high-resolution structural imaging was performed to observe the changes of brain structure(enrollment, half a year after treatment and one year after treatment.)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT06245707
- 其他研究编号
- 2023-P2-233
日期
- 首次提交
- (3年前)
- 首次发布
- (2年前)
- 主要完成日期
- (去年)
- 研究完成日期
- (去年)
- 最近核实
- 最近更新
- (2年前)
监管与共享
- FDA 监管药物
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
