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

Active, not recruiting

• Conditions: Dementia; Chronic Kidney Disease; Real World Study; Cognitive Decline; Acute Kidney Injuries; Alzheimer Dementia (AD); Cholinergic System; Cholinesterase Inhibitors

• Registration Number: NCT07093684
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-22
• Study First Posted: 2025-07-30
• Last Update Submitted: 2025-07-30
• Last Update Posted: 2025-08-03
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mini Mental Status Examination	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 Outcome Measures

Name	Time	Method
All-cause mortality	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.
Incidence of advanced dementia	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.

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden