Study of Factors Influencing Post-stroke Dementia

NCT ID: NCT01330160

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

229 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-27

Study Completion Date

2021-01-15

Brief Summary

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If the risk of dementia occurrence after stroke is well known, few data exist about the factors influencing positively or negatively the developement of cognitive disorders or dementia. The aim of the study is so to determine prospectively the clinical, biological, lesional and pharmacological factors associated with post-stroke dementia by the long-term follow-up of a stroke patient cohort.

Detailed Description

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The STROKDEM study is based on the 5-year prospective follow-up of a population of 1100 stroke patients without dementia. At inclusion in the cohort, main antecedents and risk factors, previous treatment and lifestyle, initial severity and etiology are recorded. Biological samples (for standard ans specialized analyses) and MRI are performed at 72h after stroke occurrence. Thereafter, patients are regularly (6 months, 12 months, 36 months, 60 months) examined for clinical and cognitive assessment with biological samples and Magnetic Resonance Imaging. Patients with dementia will be compared to patients without stroke to identify, by logistic regression analysis and Cox model, the factors associated with dementia occurrence.

Conditions

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Cerebrovascular Disorders Dementia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cohort of stroke patients

patients, over 40 years old and without dementia, displaying an hemorrhagic or an ischemic stroke, with a sus-tentorial localization, and included 72h before the onset of symptoms

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patients \> 40 years olds
* hemispheric stroke
* stroke dating from less 72h
* IQ-code \< 64
* patient (or his family) given an informed consent

Exclusion Criteria

* non hemispheric stroke
* malformative intracranial hemorrhage
* traumatic intracranial hemorrhage
* subarachnoidal hemorrhage
* contra-indication to MRI
* patients unable to answer to cognitive battery
Minimum Eligible Age

40 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Regis Bordet, MD PhD

Role: STUDY_CHAIR

Lille University Hospital

Locations

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Amiens University Hospital

Amiens, , France

Site Status

Caen University Hospital

Caen, , France

Site Status

Lille University Hospital

Lille, , France

Site Status

Rouen University Hospital

Rouen, , France

Site Status

Countries

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France

References

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Deplanque D, Bastide M, Bordet R. Transient Ischemic Attack and Minor Stroke: Definitively Not So Harmless for the Brain and Cognitive Functions. Stroke. 2018 Feb;49(2):277-278. doi: 10.1161/STROKEAHA.117.020013. Epub 2018 Jan 4. No abstract available.

Reference Type RESULT
PMID: 29301969 (View on PubMed)

Mazella E, Mendyk AM, Accart B, Borsotto M, Heurteaux C, Bordet R, Mazella J, Dondaine T. Serum sortilin-derived propeptide concentrations as markers of depression in chronic stroke. J Neurol Sci. 2025 May 15;472:123459. doi: 10.1016/j.jns.2025.123459. Epub 2025 Mar 8.

Reference Type DERIVED
PMID: 40107034 (View on PubMed)

Ponchel A, Labreuche J, Bombois S, Delmaire C, Bordet R, Henon H. Influence of Medication on Fatigue Six Months after Stroke. Stroke Res Treat. 2016;2016:2410921. doi: 10.1155/2016/2410921. Epub 2016 Jun 19.

Reference Type DERIVED
PMID: 27413577 (View on PubMed)

Other Identifiers

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2008/API1901

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2009-A00141-56

Identifier Type: OTHER

Identifier Source: secondary_id

2008_42/0907

Identifier Type: -

Identifier Source: org_study_id

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