BRINK (BRain In Kidney Disease) Memory Study 2.0

NCT04975464 | Active Not Recruiting

• 1 other identifier: 11-3393
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

In this study, the investigators will be looking at results of tests of memory and thinking and daily activities in a group of people without known chronic kidney disease (CKD) , and a group of CKD patients, and follow the participants for up to four more years, including after the participants start dialysis or receive a transplant. The investigators are doing this study to compare how often memory loss, confusion and difficulty with daily activities occur in those without and those with CKD. Additionally, the investigators are doing this study to identify risk factors for memory and thinking problems in CKD patients. The information received through the NDI will be utilized to help track our study population and help provide useful information regarding cause of death of those in our study.

Conditions

Chronic Kidney Diseases; Dementia; Dementia, Vascular; Stroke; Alzheimer Disease; Cognitive Decline; Cognitive Impairment; Cognitive Dysfunction; Kidney Diseases; Diabetes; Cerebral Atrophy; Small Vessel Ischemic Disease

Outcome Measures

Primary Outcomes (13)

• Screening Interview

  A screening interview will be conducted via telephone to determine eligibility (using criteria listed below) to continue to participate in BRINK 2.0 when scheduling the first visit.

  5 years

• Classification

  All BRINK 2.0 participants will continue to be classified as CKD (GFR \< 60 ml/min/1.73m2) or non- CKD controls (eGFR ≥ 60 ± 5 ml/min/1.73 m2) based on their initial classification at their baseline visit.

  5 years

• Medical History Interview

  At the initial and three subsequent annual face-to-face visits, the medical history interview and questionnaires, cognitive testing, and physical function assessment will take approximately 75-90 minutes

  5 years

• Informant Interview

  If the participant scores \< 88 on 3MSE or \< 18 on MOCA, an informant interview is triggered either in-person or by telephone to assess the participant's risk of MCI or dementia. The informant interview will be conducted with the Functional Assessment Questionnaire (FAQ) instrument. If no informant is available, conduct the UPSA performance-based assessment with the participant at the same time as current visit.

  5 years

• Structured Telephone Interview

  A structured telephone interview will be conducted at intervening six months with brief questionnaires.

  5 years

• Missed Visits

  If the participant has missed their last annual visit, they will be scheduled for a face-to-face visit at six months ± two months from their last scheduled annual visit with cognitive battery two (from previous six month visits, and using MOCA instead of 3MS).

  5 years

• TICS

  If a participant is unable to attend an annual face to face visit, the TICS cognitive phone test will be conducted within ± 2 months instead of their scheduled face-to-face annual visit.

  phone visit

• Dialysis/Transplant baseline

  If the participant initiates any modality of dialysis, or undergoes renal transplant, a follow-up visit will be scheduled as soon as possible. The participant will then continue to be seen at six month intervals from the initial post dialysis visit. For the dialysis or transplant patients, at 6, 18, and 30 month follow-up visits, a person identified as the participant's informant will be interviewed with the ADCS- IADL to assess the participant's functional status and dementia status

  5 years

• Follow Up MRI

  For the subset of non-dialysis / transplant subjects who received a baseline MRI, a three year and five year follow-up MRI will be obtained if still within their three month window from previous respective annual visit. If a participant has missed their 3 year and/or 5 year MRI, additional MRIs should be obtained following their 4th, 6th, 7th, or 8th year visit in order to obtain a total of a maximum of three MRIs. Follow up MRIs need to be completed with a two year gap in-between each MRI.

  5 years

• Dialysis MRI

  An MRI will also be obtained within 90 days after dialysis initiation and then at 1 year and annually thereafter for a maximum of 5 MRI's after dialysis initiation, each with a 90 day window from their in person visit..

  5 years

• Lab Measures

  Laboratory measures: renal panel (sodium, potassium, chloride, carbon dioxide, anion gap, albumin, calcium, creatinine, phosphorus, glucose, blood urea nitrogen, eGFR), hemoglobin, hemoglobin A1c, urine albumin, urine microalbumin/creatinine ratio, creatinine, and lipid panel will be collected at baseline and annually.

  5 years

• Research Biomarker labs

  Research biomarker labs: serum and plasma for cystatin C, IL-6 in serum, IL-6 in urine, TNFα receptor-1, 8-isoprostane, parathyroid hormone, 25-OH vitamin D, advanced glycation end products, clusterin, asymmetric dimethylarginine (ADMA). were obtained at baseline BRINK 1 visit, and at the 3 year annual visit, or if missed then, at the next in- person BRINK 2 visit. If research labs are unable to be obtained during the first BRINK 2.0 in person visit, the sample will be collected at the next annual in person visit.

  1 year

• COVID 19 survey

  Starting April 10, 2020, The COVID Survey will be added to the BRINK Subject Interview administered at every annual visit (by phone or in person) and to every six month interview phone visit, starting with their next scheduled visits.for up to two years.

  5 years

Study Arms (4)

Control

eGFR ≥ 60 ± 5 ml/min/1.73m2 at the first baseline visit in BRINK 1.0. Non-CKD population.

Mild CKD

eGFR 45 - \<60

CKD

eGFR \< 45

Dialysis/Transplant

active dialysis for dialysis participants or kidney transplant for transplant participants

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All potential participants must be previous BRINK participants

You may qualify if:

• In stages 3b-5 of chronic kidney disease (GFR ≤ 60 ± 5 ml/min/1.73m2) at the first baseline visit in BRINK 1.0.
• Able to complete an approximately 90 minute cognitive and physical testing battery.
• Able to sign the informed consent, or allow a caregiver, relative, surrogate, or witness to sign the informed consent if participant is unable to do so.
• GFR ≥ 60 ± 5 ml/min/1.73m2 at the first baseline visit in BRINK 1.0.
• Able to complete an approximately 90 minute cognitive and physical testing battery.
• Able to sign the informed consent, or allow a caregiver, relative, surrogate, and/or witness to sign the informed consent if participant is unable to do so.

You may not qualify if:

• Acute psychiatric illness that would impede cognitive testing
• Active chemical dependence
• Legally blind or unable to complete cognitive tests due to visual loss or deafness

Sponsors & Collaborators

• Anne Murray: lead
• National Institute on Aging (NIA): collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator
• Mayo Clinic: collaborator
• HealthPartners Institute: collaborator

Study Sites (2)

Minneapolis VA Healthcare System

Minneapolis, Minnesota, 55378, United States

Location

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55404, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

11\. Laboratory measures: renal panel (sodium, potassium, chloride, carbon dioxide, anion gap, albumin, calcium, creatinine, phosphorus, glucose, blood urea nitrogen, eGFR), hemoglobin, hemoglobin A1c, urine albumin, urine microalbumin/creatinine ratio, creatinine, and lipid panel will be collected at baseline and annually. 12\. Research biomarker labs: serum and plasma for cystatin C, IL-6 in serum, IL-6 in urine, TNFα receptor-1, 8-isoprostane, parathyroid hormone, 25-OH vitamin D, advanced glycation end products, clusterin, asymmetric dimethylarginine (ADMA).

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Dementia; Dementia, Vascular; Stroke; Alzheimer Disease; Cognitive Dysfunction; Kidney Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Tauopathies; Neurodegenerative Diseases; Cognition Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, Berman Center for Outcomes and Clinical Research

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 23, 2021
• Study Start: November 15, 2011
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-05

Locations

US (2)