Study of Factors Influencing Post-stroke Dementia (strokdem)

December 9, 2025 updated by: University Hospital, Lille

Characterization of Clinical, Biological, Morphological and Pharmacological Factors Influencing Occurrence of Dementia or Cognitive Disorders After Stroke

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

229

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80000
        • Amiens University Hospital
      • Caen, France, 14000
        • CAEN University Hospital
      • Lille, France, 59045
        • Lille University Hospital
      • Rouen, France, 76000
        • Rouen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dementia occurrence
Time Frame: 60 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive impairment
Time Frame: 36 months
Impairment of some tests of cognitive battery without significant impairment in activities of daily living
36 months
dementia occurrence and cognitive impairment
Time Frame: 6 months

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.

Impairment of some tests of cognitive battery without significant impairment in activities of daily living
6 months
dementia occurrence and cognitive impairment
Time Frame: 12 months

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 ans his/her family.

Impairment of some tests of cognitive battery without significant impairment in activities of daily living
12 months
dementia occurence and cognitive impairment
Time Frame: 36 months

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 ans his/her family.

Impairment of some tests of cognitive battery without significant impairment in activities of daily living
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Ministry of Health, France

Investigators

  • Study Chair: Regis Bordet, MD PhD, Lille University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2010

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

October 1, 2010

First Submitted That Met QC Criteria

April 4, 2011

First Posted (Estimated)

April 6, 2011

Study Record Updates

Last Update Posted (Estimated)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008_42/0907
  • 2008/API1901 (Other Grant/Funding Number: PHRC)
  • 2009-A00141-56 (Other Identifier: ID-RCB number, ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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