the Effects of Different Treatment Schemes on Cognitive Function of Patients With Idiopathic Membranous Nephropathy

Mild Cognitive Impairment Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245707
• Other study ID #: 2023-P2-233
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: September 2023
• Source: Beijing Friendship Hospital
• Contact: Wenhu Liu
• Phone: 15110124629
• Email: wenhuliu[@]mail.ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases
• Mild Cognitive Impairment

Intervention

Drug:
• prednisone,methylprednisone and cyclophosphamide
In the first month, methylprednisolone 500mg/d was given intravenously for 3 days, and then prednisone 0.5 mg/(kg d) * for 27 days. Oral cyclophosphamide 2.0 mg/(kg d) * 30 days in the second month. After that, the first month and the second month plan were repeated twice.
• Rituximab
The dosage of rituximab depends on peripheral blood B cells. After the treatment of rituximab, the peripheral blood B cells were in a clear state and then stopped. After monitoring the recovery of B cells, additional doses were given.

Locations

Country	Name	City	State
China	Beijing Friedship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cognitive function of the two groups was evaluated and analyzed by the Chinese version of Montreal Cognitive Assessment Scale (MoCA)	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	enrollment, half a year after treatment and one year after treatment.
Secondary	Brain magnetic resonance high-resolution structural imaging was performed to observe the changes of brain structure	All participants were examined with 3.0T MRI scanner (GE Healthcare, discovery mr750w, Milwaukee, WI), using quantitative techniques such as high-resolution structural magnetic resonance, resting state functional magnetic resonance and arteriovenous spin labeling imaging (ASL).	enrollment, half a year after treatment and one year after treatment.