Status:
UNKNOWN
Blood-Brain Barrier Evaluation In Nephrology (BREIN)
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
End Stage Renal Disease and Cognitive Impairment
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with Chronic Kidney Disease (CKD) have impaired psycho-cognitive functions in parallel with deteriorating kidney function. The pathophysiology of cognitive impairment in CKD is poorly underst...
Eligibility Criteria
Inclusion
- Patients :
- over 18 years old
- social security recipients
- in chronic hemodialysis at least 3 times 4 hours a week for at least 3 months
- having a negative pregnancy test less than 2 weeks old for women of childbearing age
- who have given informed consent to participate in the study
- Healthy controls, matched in age (+/- 5 years) and sex to a patient :
- over 18 years old
- social security recipients
- having a negative pregnancy test less than 2 weeks old for women of childbearing age
- who have given informed consent to participate in the study
Exclusion
- • Patients and healthy controls :
- Pregnant or breastfeeding women, a negative pregnancy test less than 2 weeks old will be required prior to inclusion for women of childbearing age.
- Majors under legal protection
- Lack of affiliation to a social security scheme
- Inability to give informed consent
- Persons deprived of liberty
- Date of last menstrual period \> 1 month in the absence of effective contraception in patients of childbearing age with a conserved menstrual cycle
- Known neurodegenerative disease
- Major Cardiovascular Disease : Unbalanced hypertension (defined as systolic blood pressure \> 160 mmHg), history of stroke or coronary artery disease.
- Ongoing neoplastic or infectious disease
- Taking non-steroidal anti-inflammatory drugs within 48 hours before inclusion
- Ongoing drug treatment that may induce attention and/or cognitive deficits (anticholinergics, sedatives, neuroleptics)
- Known hypersensitivity to the radiotracer or a component of it
- • Patients :
- Non-compliance with dialysis sessions
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 7 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04328415
Start Date
June 1 2020
End Date
June 7 2022
Last Update
March 31 2020
Active Locations (1)
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1
Assistance Publique Des Hopitaux de Marseille
Marseille, France, 13354