NCT07093684

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. 1.Does kidney disease increase the risk or worsen the progression of dementia?
  2. 2.Does having dementia increase the risk or worsen the progression of kidney disease (both chronic and acute)?
  3. 3.Do reno-protective drugs help protect cognitive decline?
  4. 4.Do anti-dementia drugs help preserve kidney function?
  5. 5.The Swedish Dementia Registry (SveDem)
  6. 6.The Stockholm CREAtinine Measurements (SCREAM) project
  7. 7.The Swedish Renal Registry (SRR)
  8. 8.The GeroCovid Cohort
  9. 9.The Registry of Dementia of Girona (ReDeGi)
  10. 10.Cognitive impairment cohort from memory clinic, Karolinska University Hospital

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jan 2007Dec 2026

Study Start

First participant enrolled

January 1, 2007

Completed
18.5 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

20 years

First QC Date

July 7, 2025

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mini Mental Status Examination

    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 Outcomes (2)

  • All-cause mortality

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

  • Incidence of advanced dementia

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

Study Arms (2)

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

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.

Interventions

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.

Swedish Dementia Registry (SveDem) Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 171 77, Sweden

Location

Related Publications (7)

  • Greenwald R. The handling of corneal donor tissue before penetrating keratoplasty. Todays OR Nurse. 1994 Sep-Oct;16(5):33-5.

    PMID: 7974647BACKGROUND
  • Tsai HH, Yen RF, Lin CL, Kao CH. Increased risk of dementia in patients hospitalized with acute kidney injury: A nationwide population-based cohort study. PLoS One. 2017 Feb 13;12(2):e0171671. doi: 10.1371/journal.pone.0171671. eCollection 2017.

    PMID: 28192452BACKGROUND
  • Xu H, Garcia-Ptacek S, Jonsson L, Wimo A, Nordstrom P, Eriksdotter M. Long-term Effects of Cholinesterase Inhibitors on Cognitive Decline and Mortality. Neurology. 2021 Apr 27;96(17):e2220-e2230. doi: 10.1212/WNL.0000000000011832. Epub 2021 Mar 19.

    PMID: 33741639BACKGROUND
  • Saeed RW, Varma S, Peng-Nemeroff T, Sherry B, Balakhaneh D, Huston J, Tracey KJ, Al-Abed Y, Metz CN. Cholinergic stimulation blocks endothelial cell activation and leukocyte recruitment during inflammation. J Exp Med. 2005 Apr 4;201(7):1113-23. doi: 10.1084/jem.20040463.

    PMID: 15809354BACKGROUND
  • Gansevoort RT, Correa-Rotter R, Hemmelgarn BR, Jafar TH, Heerspink HJ, Mann JF, Matsushita K, Wen CP. Chronic kidney disease and cardiovascular risk: epidemiology, mechanisms, and prevention. Lancet. 2013 Jul 27;382(9889):339-52. doi: 10.1016/S0140-6736(13)60595-4. Epub 2013 May 31.

    PMID: 23727170BACKGROUND
  • Eckardt KU, Coresh J, Devuyst O, Johnson RJ, Kottgen A, Levey AS, Levin A. Evolving importance of kidney disease: from subspecialty to global health burden. Lancet. 2013 Jul 13;382(9887):158-69. doi: 10.1016/S0140-6736(13)60439-0. Epub 2013 May 31.

    PMID: 23727165BACKGROUND
  • Wang J, Gu BJ, Masters CL, Wang YJ. A systemic view of Alzheimer disease - insights from amyloid-beta metabolism beyond the brain. Nat Rev Neurol. 2017 Sep 29;13(10):612-623. doi: 10.1038/nrneurol.2017.111.

    PMID: 28960209BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, ChronicAcute Kidney InjuryDementiaCognitive DysfunctionAlzheimer Disease

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Hong Xu

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 30, 2025

Study Start

January 1, 2007

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

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)).

Locations