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DementiaNor-CoastNCT02650531

Norwegian COgnitive Impairment After STroke (NorCOAST) Study

An observational study of Dementia and Mild Cognitive Impairment, run by Norwegian University of Science and Technology at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A prospective observational multicenter study aiming to describe incidence, and identify predictors for development of poststroke dementia (PSD) and mild cognitive impairment (MCI) after stroke Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dementia, Mild Cognitive Impairment, Stroke
How many people
816 participants
Where
1 siteNorway
Study dates
May 2015to 8 Oct 2018
Phase
Observational
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with acute stroke

Who may be able to join

  • Stroke diagnosis according to the WHO criteria

Who cannot join

  • Not scandinavian speaking

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Norwegian University of Science and Technology

    Trondheim, 7006

Other trials in Norway

About this study

A prospective observational multicenter study aiming to describe incidence, and identify predictors for development of poststroke dementia (PSD) and mild cognitive impairment (MCI) after stroke

Read the detailed description

About 15000 Norwegians suffer a stroke every year and 2/3 will be more or less disabled. In addition to motor impairments and comorbidities, disability after stroke is often related to post stroke dementia (PSD) or mild neurocognitive disorder (NCD). However, these problems are hardly addressed in stroke or dementia research and frequently ignored in clinical practise. In the Nor-COAST study an interdisciplinary research group will collaborate to establish a research platform across all Norwegian Health Authorities. The overall aim of the study is to improve competence on PSD and NCD in order to improve individual health outcomes following a stroke. The specific objectives are to determine the incidence of PSD and NCD and the consequences on function and use of health care services and to enhance the early detection of PSD and NCD by identifying a set of risk factors, ranging from genetics to physical activity. The incidence and impact of PSD and NCD on function and use of health care services, medication and life-style changes are important when planning future health care services. Tools identifying patients at risk might improve diagnostic work up and together with knowledge on pathogenic aspects it will contribute to future treatment and prevention of PSD and NCD.

Keywords
Follow up studies, Risk factors
Medical subject headings
Dementia, Cognitive Dysfunction, Stroke

What is being measured

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

  1. Score on the Montreal cognitive assessment (MOCA)

    Performance based test

    Measured: 18 months

Secondary outcomes (8)

  1. Score on the Montreal cognitive assessment (MOCA)

    Performance based test

    Measured: 3 months

  2. Time spent in upright position

    measured by bodyworn sensors

    Measured: 3 months

  3. Time spent in upright position

    measured by bodyworn sensors

    Measured: 18 months

  4. Brain Imaging

    MRI

    Measured: 18 months

  5. Score on Short Physical Performance Battery (sppb)

    Performance based test for mobility and lower extremity function

    Measured: 3 months

  6. Score on Short Physical Performance Battery (sppb)

    Physical function by performance based tests

    Measured: 18 months

  7. Selfreported habits concerning smoking, alcohol, diet and medication using standardised questionnaires

    Measured: 3 months

  8. Selfreported habits concerning smoking, alcohol, diet and medication using standardised questionnaires

    Measured: 18 months

Timeline

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

  1. First posted8 Jan 2016 (estimated)
  2. Study startMay 2015
  3. Primary completion8 Oct 2018
  4. Study completion8 Oct 2018

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
816 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02650531
Sponsor's protocol ID
2015/171/REK nord
Acronym
Nor-Coast
Status last verified
Feb 2022
First submitted
10 Dec 2015
Last updated
23 Feb 2022
Results posted
No
Data monitoring committee
No

Publications

  • Thingstad P, Askim T, Beyer MK, Brathen G, Ellekjaer H, Ihle-Hansen H, Knapskog AB, Lydersen S, Munthe-Kaas R, Naess H, Pendlebury ST, Seljeseth YM, Saltvedt I. The Norwegian Cognitive impairment after stroke study (Nor-COAST): study protocol of a multicentre, prospective cohort study. BMC Neurol. 2018 Nov 26;18(1):193. doi: 10.1186/s12883-018-1198-x.

    PubMed 30477436

  • Waehler IS, Saltvedt I, Lydersen S, Fure B, Askim T, Einstad MS, Thingstad P. Association between in-hospital frailty and health-related quality of life after stroke: the Nor-COAST study. BMC Neurol. 2021 Mar 4;21(1):100. doi: 10.1186/s12883-021-02128-5.

    PubMed 33663430

  • Sandvig HV, Saltvedt I, Edwin TH, Aam S, Alme KN, Eldholm RS, Lydersen S, Mollnes TE, Munthe-Kaas R, Ueland PM, Ulvik A, Wethal T, Knapskog AB. Associations between systemic inflammation and cognitive trajectories post-stroke. Sci Rep. 2025 Nov 28;15(1):42791. doi: 10.1038/s41598-025-27119-1.

    PubMed 41315409

  • Munthe-Kaas R, Lydersen S, Quinn T, Aam S, Pendlebury ST, Ihle-Hansen H. Impact of Pre-Stroke Frailty on Outcome Three Years after Acute Stroke: The Nor-COAST Study. Cerebrovasc Dis. 2025;54(4):527-535. doi: 10.1159/000541565. Epub 2024 Sep 25.

    PubMed 39321786

  • Sandvig HV, Aam S, Alme KN, Lydersen S, Magne Ueland P, Ulvik A, Wethal T, Saltvedt I, Knapskog AB. Neopterin, kynurenine metabolites, and indexes related to vitamin B6 are associated with post-stroke cognitive impairment: The Nor-COAST study. Brain Behav Immun. 2024 May;118:167-177. doi: 10.1016/j.bbi.2024.02.030. Epub 2024 Feb 28.

    PubMed 38428649

  • Luzum G, Thrane G, Aam S, Eldholm RS, Grambaite R, Munthe-Kaas R, Thingstad P, Saltvedt I, Askim T. A Machine Learning Approach to Predict Post-stroke Fatigue. The Nor-COAST study. Arch Phys Med Rehabil. 2024 May;105(5):921-929. doi: 10.1016/j.apmr.2023.12.005. Epub 2024 Jan 17.

    PubMed 38242298

  • Navickaite E, Saltvedt I, Lydersen S, Munthe-Kaas R, Ihle-Hansen H, Grambaite R, Aam S. Diagnostic accuracy of the Clock Drawing Test in screening for early post-stroke neurocognitive disorder: the Nor-COAST study. BMC Neurol. 2024 Jan 9;24(1):22. doi: 10.1186/s12883-023-03523-w.

    PubMed 38195396

  • Luzum G, Gunnes M, Lydersen S, Saltvedt I, Tan X, Thingstad P, Thrane G, Askim T. Physical Activity Behavior and Its Association With Global Cognitive Function Three Months After Stroke: The Nor-COAST Studydagger. Phys Ther. 2023 Dec 6;103(12):pzad092. doi: 10.1093/ptj/pzad092.

    PubMed 37440440

  • Sandvig HV, Aam S, Alme KN, Askim T, Beyer MK, Ellekjaer H, Ihle-Hansen H, Lydersen S, Mollnes TE, Munthe-Kaas R, Naess H, Saltvedt I, Seljeseth YM, Thingstad P, Wethal T, Knapskog AB. Plasma Inflammatory Biomarkers Are Associated With Poststroke Cognitive Impairment: The Nor-COAST Study. Stroke. 2023 May;54(5):1303-1311. doi: 10.1161/STROKEAHA.122.041965. Epub 2023 Apr 7.

    PubMed 37026459

  • Gynnild MN, Hageman SHJ, Spigset O, Lydersen S, Saltvedt I, Dorresteijn JAN, Visseren FLJ, Ellekjaer H. Use of lipid-lowering therapy after ischaemic stroke and expected benefit from intensification of treatment. Open Heart. 2022 Apr;9(1):e001972. doi: 10.1136/openhrt-2022-001972.

    PubMed 35459718

  • Munthe-Kaas R, Aam S, Saltvedt I, Wyller TB, Pendlebury ST, Lydersen S, Hagberg G, Schellhorn T, Rostoft S, Ihle-Hansen H. Is Frailty Index a better predictor than pre-stroke modified Rankin Scale for neurocognitive outcomes 3-months post-stroke? BMC Geriatr. 2022 Feb 19;22(1):139. doi: 10.1186/s12877-022-02840-y.

    PubMed 35183106

  • Einstad MS, Thingstad P, Lydersen S, Gunnes M, Saltvedt I, Askim T. Physical Performance and Cognition as Predictors of Instrumental Activities of Daily Living After Stroke: A Prospective Multicenter Cohort Study. Arch Phys Med Rehabil. 2022 Jul;103(7):1320-1326. doi: 10.1016/j.apmr.2022.01.153. Epub 2022 Feb 16.

    PubMed 35181266

  • Alme KN, Ulvik A, Askim T, Assmus J, Mollnes TE, Naik M, Naess H, Saltvedt I, Ueland PM, Knapskog AB. Neopterin and kynurenic acid as predictors of stroke recurrence and mortality: a multicentre prospective cohort study on biomarkers of inflammation measured three months after ischemic stroke. BMC Neurol. 2021 Dec 8;21(1):476. doi: 10.1186/s12883-021-02498-w.

    PubMed 34879833

  • Alme KN, Askim T, Assmus J, Mollnes TE, Naik M, Naess H, Saltvedt I, Ueland PM, Ulvik A, Knapskog AB. Investigating novel biomarkers of immune activation and modulation in the context of sedentary behaviour: a multicentre prospective ischemic stroke cohort study. BMC Neurol. 2021 Aug 16;21(1):318. doi: 10.1186/s12883-021-02343-0.

    PubMed 34399717

  • Schellhorn T, Zucknick M, Askim T, Munthe-Kaas R, Ihle-Hansen H, Seljeseth YM, Knapskog AB, Naess H, Ellekjaer H, Thingstad P, Wyller TB, Saltvedt I, Beyer MK. Pre-stroke cognitive impairment is associated with vascular imaging pathology: a prospective observational study. BMC Geriatr. 2021 Jun 14;21(1):362. doi: 10.1186/s12877-021-02327-2.

    PubMed 34126944

Questions about this trial

What is this clinical trial studying?

An observational study of Dementia and Mild Cognitive Impairment, run by Norwegian University of Science and Technology at 1 site in Norway.

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: finished, as of the sponsor's last update on 23 Feb 2022. 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 Norway. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Score on the Montreal cognitive assessment (MOCA) (time frame: 18 months). 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 NCT02650531, which also lists 20 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 23 Feb 2022.

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