Study of Factors Influencing Post-stroke Dementia (strokdem)
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ClinicalTrials.gov Identifier: NCT01330160 |
Recruitment Status
:
Recruiting
First Posted
: April 6, 2011
Last Update Posted
: April 24, 2018
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Condition or disease |
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Cerebrovascular Disorders Dementia |
Study Type : | Observational |
Estimated Enrollment : | 1100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Characterization of Clinical, Biological, Morphological and Pharmacological Factors Influencing Occurrence of Dementia or Cognitive Disorders After Stroke |
Actual Study Start Date : | February 27, 2010 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | December 2023 |

Group/Cohort |
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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
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- 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.
- 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
- 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
- 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
- cognitive impairment [ Time Frame: 36 months ]Impairment of some tests of cognitive battery without significant impairment in activities of daily living
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 40 Years to 95 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330160
Contact: Regis Bordet, MD PhD | +33 (0)3 20 44 54 49 | regis.bordet@chru-lille.fr | |
Contact: Didier Leys, MD PhD | +33 (0)3 20 44 68 14 | dleys@chru-lille.fr |
France | |
Amiens University Hospital | Active, not recruiting |
Amiens, France, 80000 | |
Caen University Hospital | Active, not recruiting |
Caen, France, 14000 | |
Lille University Hospital | Recruiting |
Lille, France, 59045 | |
Contact: Régis Bordet, MD PhD +33 (0)3 20 44 54 49 regis.bordet@chru-lille.fr | |
Contact: Didier Leys, MD PhD +33 (0)3 20 44 68 14 dleys@chru-lille.fr | |
Principal Investigator: Régis Bordet, MD PhD | |
Principal Investigator: Didier Leys, MD PhD | |
Sub-Investigator: Hilde Henon, MD PhD | |
Sub-Investigator: Lucas Christian, MD PhD | |
Sub-Investigator: Girot Marie, MD phD | |
Sub-Investigator: Cordonnier Charlotte, MD PhD | |
Sub-Investigator: Frederic Dumont, MD | |
Sub-Investigator: Bodenant Marie, MD | |
Principal Investigator: Florence Pasquier, MD PhD | |
Sub-Investigator: Stéphanie Bombois, MD PhD | |
Sub-Investigator: Marie-Anne Mackowiak, MD | |
Sub-Investigator: Vincent Deramecourt, MD PhD | |
Sub-Investigator: Marion Paulin, MD | |
Sub-Investigator: Florence Lebert, MD PhD | |
Rouen University Hospital | Recruiting |
Rouen, France, 76000 | |
Contact: Didier Hannequin, MD PhD Didier.Hannequin@chu-rouen.fr | |
Principal Investigator: Didier Hannequin, MD PhD | |
Sub-Investigator: Evelyne Guegan-Massardier, MD | |
Sub-Investigator: Aude Triquenot-Bagan, MD |
Study Chair: | Regis Bordet, MD PhD | Lille University Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University Hospital, Lille |
ClinicalTrials.gov Identifier: | NCT01330160 History of Changes |
Other Study ID Numbers: |
2008_42/0907 2008/API1901 ( Other Grant/Funding Number: PHRC ) 2009-A00141-56 ( Other Identifier: ID-RCB number, ANSM ) |
First Posted: | April 6, 2011 Key Record Dates |
Last Update Posted: | April 24, 2018 |
Last Verified: | April 2018 |
Keywords provided by University Hospital, Lille:
stroke Brain ischemia Intracranial hemorrhage Dementia, Vascular Alzheimer's disease |
Additional relevant MeSH terms:
Dementia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Neurocognitive Disorders Mental Disorders Vascular Diseases Cardiovascular Diseases |