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)
Overview
- Phase
- Not Applicable
- Intervention
- prednisone,methylprednisone and cyclophosphamide
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Beijing Friendship Hospital
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- The cognitive function of the two groups was evaluated and analyzed by the Chinese version of Montreal Cognitive Assessment Scale (MoCA)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Ponticelli group
Patients with idiopathic membranous nephropathy were treated with Ponticelli protocol,that is alternating prednisone or methylprednisone -cyclophosphamide every other month
Intervention: prednisone,methylprednisone and cyclophosphamide
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.
Intervention: Rituximab
Outcomes
Primary Outcomes
The cognitive function of the two groups was evaluated and analyzed by the Chinese version of Montreal Cognitive Assessment Scale (MoCA)
Time Frame: 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
Secondary Outcomes
- 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.)