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Chronic Kidney DiseaseNCT07093684

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

An observational study of Chronic Kidney Disease and Acute Kidney Injuries, run by Karolinska Institutet at 1 site in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Kidney disease
How many people
200,000 participants
Where
1 siteSweden
Study dates
1 Jan 2007to 31 Dec 2026
How long will I take part?
15 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska Institutet

    Stockholm, 171 77

Other trials in Sweden

About this study

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:

Read more
  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.

Being tested
Kidney disease
Medical subject headings
Renal Insufficiency, Chronic, Acute Kidney Injury, Dementia, Cognitive Dysfunction, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kidney diseaseOther

    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.

Study groups in NCT07093684
Study groupRoleWhat they receive
Swedish Dementia Registry (SveDem) CohortSveDem 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.
Receives: Other: Kidney disease
The SCREAM projectSCREAM 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. All-cause mortality

    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.

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

  2. Incidence of advanced dementia

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study start1 Jan 2007
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200,000 participants (estimated)
Target duration
15 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07093684
Sponsor's protocol ID
VR Starting grant #2022-01428
Status last verified
Jul 2025
First submitted
7 Jul 2025
Last updated
3 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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)).

Publications

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

    PubMed 7974647

  • 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.

    PubMed 28192452

  • 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.

    PubMed 33741639

  • 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.

    PubMed 15809354

  • 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.

    PubMed 23727170

  • 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.

    PubMed 23727165

  • 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.

    PubMed 28960209

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Disease and Acute Kidney Injuries, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07093684, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.

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