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NCT Number: NCT07093684

Dementia and Kidney Disease: Epidemiological Approaches to Risk Factors and Treatment Strategies

Kidney disease and dementia are both common in older adults, posing a significant burden on individuals and society. Growing evidence suggests that there may be links between the kidney and the brain. However, few studies have explored how these two conditions are connected in the general population. Understanding this link could help improve care for people living with either or both conditions.

This observational project aims to explore the two-way relationship between kidney disease and dementia. The main questions the investigators want to answer are:

1. Does kidney disease increase the risk or worsen the progression of dementia? 2. Does having dementia increase the risk or worsen the progression of kidney disease (both chronic and acute)? 3. Do reno-protective drugs help protect cognitive decline? 4. Do anti-dementia drugs help preserve kidney function?

To answer these questions, the investigators will analyze data collected over a period of 12 years, including people diagnosed with dementia, kidney disease, or both, using several large Swedish and international health registries:

1. The Swedish Dementia Registry (SveDem) 2. The Stockholm CREAtinine Measurements (SCREAM) project 3. The Swedish Renal Registry (SRR) 4. The GeroCovid Cohort 5. The Registry of Dementia of Girona (ReDeGi) 6. Cognitive impairment cohort from memory clinic, Karolinska University Hospital

This study will apply both traditional and advanced epidemiological methods, including multivariable regression, survival analysis, mixed-effects models, and machine learning (ML) techniques to examine long-term trends and associations.

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This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Population with dementia (all type) and kidney function measurements/Chronic kidney diagnosis

Exclusion criteria

  • Population lack of important baseline and follow-up information such as year of birth and sex.

Treatment and study plan

Kidney disease

Other

This is a registry-based observational study investigating the association between kidney disease and dementia-related outcomes. Kidney disease is not assigned or manipulated by the researchers but is classified as an exposure based on diagnostic codes (e.g., ICD codes), and related laboratory test recorded in health registers.

Primary outcomes

  1. Mini Mental Status Examination

    Time frame: MMSE will be assessed at baseline (dementia diagnosis) and at each follow-up visit every 12 months, up to 15 years or until death, whichever occurs first. Data will be reported at each time point and at study completion.

    The Mini-Mental State Examination (MMSE) is a standardized test used to screen for cognitive impairment and dementia. It assesses five domains of cognitive function including: orientation, registration, attention and calculation, recall, and language. The score range from 0 to 30. A score of 23 or lower is indicative of cognitive impairment. The MMSE takes only 5-10 minutes to test. MMSE is used at both baseline and follow-up visits.

Secondary outcomes

  1. All-cause mortality

    Time frame: Will be assessed continuously from baseline up to 15 years until the end of follow-up.

    All-cause mortality will be defined as death from any cause, identified through linkage with the national death registry. Date of death will be recorded to calculate time-to-death from baseline.

  2. Incidence of advanced dementia

    Time frame: Will be assessed annually from baseline (dementia) up to 15 years or until death, whichever occurs first.

    Advanced dementia will be defined based on MMSE score ≤10. MMSE scores range from 0 to 30, with lower scores indicating worse cognitive function. MMSE score will be identified from clinical follow-up records.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2007
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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