NCT01330160

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
229

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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 Start

First participant enrolled

February 27, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2010

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

10.9 years

First QC Date

October 1, 2010

Last Update Submit

December 9, 2025

Conditions

Cerebrovascular DisordersDementia

Keywords

strokeBrain ischemiaIntracranial hemorrhageDementia, VascularAlzheimer's disease

Outcome Measures

Primary Outcomes (1)

  • dementia occurrence

    This evaluation will be based on a neurological and general clinical examination, and on the evaluation of activities of daily life using the Instrumental Activities Daily Life scale after an interview with the patient and his/her family.

    60 months

Secondary Outcomes (4)

  • dementia occurrence and cognitive impairment

    6 months

  • dementia occurrence and cognitive impairment

    12 months

  • dementia occurence and cognitive impairment

    36 months

  • cognitive impairment

    36 months

Study Arms (1)

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

Eligibility Criteria

Age40 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients without dementia displaying an hemispheric ischemic or hemorrhagic stroke hospitalized during the 72h following the beginning of stroke

You may qualify if:

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

You may not qualify if:

  • non hemispheric stroke
  • malformative intracranial hemorrhage
  • traumatic intracranial hemorrhage
  • subarachnoidal hemorrhage
  • contra-indication to MRI
  • patients unable to answer to cognitive battery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Amiens University Hospital

Amiens, 80000, France

Location

Caen University Hospital

Caen, 14000, France

Location

Lille University Hospital

Lille, 59045, France

Location

Rouen University Hospital

Rouen, 76000, France

Location

Related Publications (3)

  • 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.

    PMID: 29301969RESULT

  • 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.

    PMID: 40107034DERIVED

  • 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.

    PMID: 27413577DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

standard biological parameters (ionogram, blood count, glycemia, lipids, renal function, vitamin B12, thyroid hormones, homocysteinemia), specialized biology (inflammation, oxidative, vascular biomarkers ; amyloid and tau markers), genotype (apolipoprotein E, apolipoprotein C, kinesin, Angiotensin Converting Enzyme...).

MeSH Terms

Conditions

Cerebrovascular DisordersDementiaStrokeBrain IschemiaIntracranial HemorrhagesDementia, VascularAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurocognitive DisordersMental DisordersHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesTauopathiesNeurodegenerative Diseases

Study Officials

  • Regis Bordet, MD PhD

    University Hospital, Lille

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2010

First Posted

April 6, 2011

Study Start

February 27, 2010

Primary Completion

January 15, 2021

Study Completion

January 15, 2021

Last Updated

December 16, 2025

Record last verified: 2025-12

Locations

FR(4)