Cerebrovascular DisordersstrokdemNCT01330160
Study of Factors Influencing Post-stroke Dementia
An observational study of Cerebrovascular Disorders and Dementia, run by University Hospital, Lille at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Cerebrovascular Disorders, Dementia
- How many people
- 229 participants
- Where
- 4 sitesFrance
- Study dates
- 27 Feb 2010to 15 Jan 2021
- 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 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients without dementia displaying an hemispheric ischemic or hemorrhagic stroke hospitalized during the 72h following the beginning of stroke
Who may be able to join
- patients > 40 years olds
- hemispheric stroke
- stroke dating from less 72h
- IQ-code < 64
- patient (or his family) given an informed consent
Who cannot join
- non hemispheric stroke
- malformative intracranial hemorrhage
- traumatic intracranial hemorrhage
- subarachnoidal hemorrhage
- contra-indication to MRI
- patients unable to answer to cognitive battery
Trial locations and contacts
4 sites in 1 country.
France4 sites
Amiens University Hospital
Amiens, 80000
Caen University Hospital
Caen, 14000
Lille University Hospital
Lille, 59045
Rouen University Hospital
Rouen, 76000
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebrovascular Disorders, Dementia
- Keywords
- stroke, Brain ischemia, Intracranial hemorrhage, Dementia, Vascular, Alzheimer's disease
- Medical subject headings
- Cerebrovascular Disorders, Dementia, Stroke, Brain Ischemia, Intracranial Hemorrhages, Dementia, Vascular, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 months
Secondary outcomes (4)
dementia occurrence and cognitive impairment
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
Measured: 6 months
dementia occurrence and cognitive impairment
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
Measured: 12 months
dementia occurence and cognitive impairment
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
Measured: 36 months
cognitive impairment
Impairment of some tests of cognitive battery without significant impairment in activities of daily living
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study start27 Feb 2010
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Regis Bordet, MD PhD, Study chair, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330160
- Sponsor's protocol ID
- 2008_42/0907
- Other IDs
- 2008/API1901, 2009-A00141-56
- Acronym
- strokdem
- Status last verified
- Dec 2025
- First submitted
- 1 Oct 2010
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29301969Mazella 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.
PubMed 40107034Ponchel 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.
PubMed 27413577
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Clinical, Biological, Morphological and Pharmacological Factors Influencing Occurrence of Dementia or Cognitive Disorders After Stroke
- ClinicalTrials.gov ID
- NCT01330160
- Acronym / sponsor ID
- strokdem / 2008_42/0907
- Conditions
- Cerebrovascular Disorders, Dementia
- Keywords
- stroke, Brain ischemia, Intracranial hemorrhage, Dementia, Vascular, Alzheimer's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 27 Feb 2010 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients without dementia displaying an hemispheric ischemic or hemorrhagic stroke hospitalized during the 72h following the beginning of stroke
Key inclusion criteria (5 listed)
- patients > 40 years olds
- hemispheric stroke
- stroke dating from less 72h
- IQ-code < 64
- patient (or his family) given an informed consent
Key exclusion criteria (6 listed)
- non hemispheric stroke
- malformative intracranial hemorrhage
- traumatic intracranial hemorrhage
- subarachnoidal hemorrhage
- contra-indication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
dementia occurrence and cognitive impairment
Time frame: 6 months
dementia occurrence and cognitive impairment
Time frame: 12 months
dementia occurence and cognitive impairment
Time frame: 36 months
cognitive impairment
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Results publication: PubMed 29301969Deplanque 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.
- Derived from this study: PubMed 40107034Mazella 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.
- Derived from this study: PubMed 27413577Ponchel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regis Bordet, MD PhD study chair
University Hospital, Lille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Disorders and Dementia, run by University Hospital, Lille at 4 sites in France.
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 5 inclusion and 6 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 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
dementia occurrence (time frame: 60 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 NCT01330160, which also lists 3 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 16 Dec 2025.