Study of Factors Influencing Post-stroke Dementia

Dementia Clinical Trial

— strokdem  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01330160
• Other study ID #: 2008_42/0907
• Secondary ID: 2008/API19012009
• Status: Recruiting
• Start date: February 27, 2010
• Est. completion date: December 2023

Study information

• Verified date: March 2021
• Source: University Hospital, Lille
• Contact: Regis Bordet, MD PhD
• Phone: +33 (0)3 20 44 54 49
• Email: regis.bordet[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Dementia

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens
France	Caen University Hospital	Caen
France	Lille University Hospital	Lille
France	Rouen University Hospital	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	6 months
Secondary	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	12 months
Secondary	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	36 months
Secondary	cognitive impairment	Impairment of some tests of cognitive battery without significant impairment in activities of daily living	36 months