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NCT Number: NCT01330160

Study of Factors Influencing Post-stroke Dementia

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.

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Key information

Conditions

Cerebrovascular Disorders Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Dementia Dementia, Vascular Hemorrhage Intracranial Arterial Diseases Intracranial Arteriosclerosis Intracranial Hemorrhages Leukoencephalopathies Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Tauopathies Vascular Diseases

Age range

40 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Amiens University Hospital, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. cognitive impairment

    Time frame: 36 months

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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: strokdem

Important dates

Study start
2010
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2011
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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