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

July 30, 2025 updated by: Hong Xu, Karolinska Institutet

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 171 77
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This project uses the Swedish Dementia Registry (SveDem), merged with the Stockholm CREAtinine Measurements (SCREAM) project, to access healthcare data and obtain measurements of serum creatinine from both inpatient and outpatient care. It also uses the Swedish National Patient Registry (NPR) to include diagnoses made in specialist clinics and hospitals, the Prescribed Drug Registry (which includes all prescribed medications), and the Total Population Register and Causes of Death Registry (CDR) to obtain dates of death.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Swedish Dementia Registry (SveDem) Cohort
SveDem was established in 2007 with the purpose of increasing the quality of dementia care in Sweden. SveDem aims to register all dementia patients in Sweden at the time of dementia diagnosis and includes annual follow-ups. The registry stores data on demographics, living conditions, cognitive evaluation by Mini-Mental State Examination (MMSE), type of dementia, community support and pharmacological management.
Other: Kidney disease
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.
The SCREAM project
SCREAM is a healthcare utilization cohort of all Stockholm residents that accessed SLL healthcare and had a measurement of serum creatinine in either in- or outpatient care. The database includes 2 million individuals (and >60 million laboratory tests). The kidney function and other laboratory tests are already collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Will be assessed continuously from baseline up to 15 years until the end of follow-up.
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.
Will be assessed annually from baseline (dementia) up to 15 years or until death, whichever occurs first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Hong Xu, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2007

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 7, 2025

First Submitted That Met QC Criteria

July 22, 2025

First Posted (Actual)

July 30, 2025

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VR Starting grant #2022-01428

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data contains specific categories of personal data according to Article 9 of the General data protection regulation (GDPR) and KI is thus prohibited from sharing the data without an explicit consent from the registered or approval from the Swedish Ethical Review Authority (according to Section 3 and section 6 of the Ethical Review Act (2003:456)).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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