Post-stroke Cognitive Impairment and Dementia

NCT01339195 | Completed

• 2 other identifiers: AOL10-PR-GODEFROY2010-A00657-32
• Study Type: interventional
• Target: 1,635
• Locations: 1 country
• Sites: 7

Brief Summary

Projections from epidemiological studies suggest that, among the Western adult population, one in three will present a cerebrovascular accident (stroke), severe cognitive disorders, or both. To better diagnose the Vascular Cognitive Impairment, new standards were developed by a North America working group which are under validation. It is essential to adapt these standard for French-speaking population, and especially to define cutoff scores of the cognitive battery to determine cognitive deficit. The investigators propose a study coordinated by the University-Hospital of Amiens for french speaking centers. This study will investigate this battery with 906 controls to define the standards and 302 stroke affected patients to define the frequency and cognitive mechanisms. This step is essential for people to benefit from these new standards.

Conditions

Stroke; Cognitive Disorders; Behavioral Disorders

Keywords

Dementia; Alzheimer disease; stroke; cognitive impairment

Outcome Measures

Primary Outcomes (1)

• determine the frequency of cognitive and behavioral disorders 6 months post-stroke assessed with this new NINDS-Canadian Stroke Network battery

  deficit (as compared with control performance) on battery of tests assessing instrumental (oral naming, copy of complex figure)and executive fucntions (verbal fluency, Trail Making, reaction time tests), episodic memory for verbal and visual materials and behavioral changes

  6 month

Secondary Outcomes (2)

• determine the proportion of patients with dementia

  6 month

• determine the value of cognitive screening tests

  6 month

Study Arms (1)

Behavioral

EXPERIMENTAL

Behavioral: French adaptation of NINDS-Canadian Stroke Network battery

Behavioral: French adaptation of NINDS-Canadian Stroke Network battery

Interventions

French adaptation of NINDS-Canadian Stroke Network battery BEHAVIORAL

* clinical: post-stroke neurological follow-up assessment * neuropsychological: comprising the NINDS-Canadian Stroke Network neuropsychological battery * MRI

Behavioral

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:management at the acute phase (duration \< 30 days) of stroke visualized by imaging, age between 40 and 80 years, French-speaking, reliable informant, agreeing to participate in the study.
• Controls: derived from the general population and consenting to participate in the study.

You may not qualify if:

• Patients: mental retardation, illiteracy, known dementia, schizophrenia or psychosis or history of psychiatric illness requiring a stay for \> 2 days in a psychiatry unit, comorbidities affecting cognition, persistent disturbance of consciousness, contraindication to MRI.
• Controls: illiteracy, deficit on MMSE (Mini-Mental State Examination), visual, auditory or motor deficit, history of brain disease or psychiatric illness (schizophrenia or other psychosis) or ongoing psychiatric illness (depression or other) currently requiring treatment or requiring a stay \> 2 days in psychiatry unit or anxiety requiring more than one medication at the present time, alcoholism, opiate or illicit drug use \< 3 months, ongoing antidepressant or antiepileptic treatment, recent anxiolytic or hypnotic treatment, general anaesthesia \< 3 months, history of heart surgery with cardiopulmonary bypass

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (7)

CHRU Lille

Lille, Pas-de-calais, 59000, France

Location

CHU Amiens

Amiens, Picardie, 80000, France

Location

CHU Brest

Brest, 29200, France

Location

CHU Dijon

Dijon, 21000, France

Location

CH La Rochelle

La Rochelle, 17000, France

Location

HIA Val de Grâce

Paris, 75000, France

Location

CHU Saint Etienne

Saint-Etienne, 42000, France

Location

Related Publications (6)

• Godefroy O, Fickl A, Roussel M, Auribault C, Bugnicourt JM, Lamy C, Canaple S, Petitnicolas G. Is the Montreal Cognitive Assessment superior to the Mini-Mental State Examination to detect poststroke cognitive impairment? A study with neuropsychological evaluation. Stroke. 2011 Jun;42(6):1712-6. doi: 10.1161/STROKEAHA.110.606277. Epub 2011 Apr 7.

  PMID: 21474808 BACKGROUND

• Godefroy O, Just A, Ghitu A, Leclercq C, Garcia PY, Lamy C, Canaple S, Bugnicourt JM. The Rankin scale with revised structured interview: effect on reliability, grading of disability and detection of dementia. Int J Stroke. 2012 Feb;7(2):183. doi: 10.1111/j.1747-4949.2011.00743.x. No abstract available.

  PMID: 22264374 BACKGROUND

• Godefroy O; GRECOG-VASC study group; Leclercq C, Bugnicourt JM, Roussel M, Moroni C, Quaglino V, Beaunieux H, Taillia H, Nedelec-Ciceri C, Bonnin C, Thomas-Anterion C, Varvat J, Aboulafia-Brakha T, Assal F. Neuropsychological assessment and cerebral vascular disease: the new standards. Rev Neurol (Paris). 2013 Oct;169(10):779-85. doi: 10.1016/j.neurol.2013.07.009. Epub 2013 Aug 30.

  PMID: 23999023 RESULT

• Godefroy O, Leclercq C, Roussel M, Moroni C, Quaglino V, Beaunieux H, Tallia H, Nedelec-Ciceri C, Bonnin C, Thomas-Anterion C, Varvat J, Aboulafia-Brakha T, Assal F; GRECOG-VASC Neuropsychological Committee. French adaptation of the vascular cognitive impairment harmonization standards: the GRECOG-VASC study. Int J Stroke. 2012 Jun;7(4):362-3. doi: 10.1111/j.1747-4949.2012.00794.x. No abstract available.

  PMID: 22583525 RESULT

• Barbay M, Taillia H, Nedelec-Ciceri C, Bompaire F, Bonnin C, Varvat J, Grangette F, Diouf M, Wiener E, Mas JL, Roussel M, Godefroy O; GRECOG-VASC Study Group. Prevalence of Poststroke Neurocognitive Disorders Using National Institute of Neurological Disorders and Stroke-Canadian Stroke Network, VASCOG Criteria (Vascular Behavioral and Cognitive Disorders), and Optimized Criteria of Cognitive Deficit. Stroke. 2018 May;49(5):1141-1147. doi: 10.1161/STROKEAHA.117.018889. Epub 2018 Apr 11.

  PMID: 29643258 RESULT

• Godefroy O, Yaiche H, Taillia H, Bompaire F, Nedelec-Ciceri C, Bonnin C, Varvat J, Vincent-Grangette F, Diouf M, Mas JL, Canaple S, Lamy C, Arnoux A, Leclercq C, Tasseel-Ponche S, Roussel M, Barbay M; GRECogVASC Study Group. Who should undergo a comprehensive cognitive assessment after a stroke? A cognitive risk score. Neurology. 2018 Nov 20;91(21):e1979-e1987. doi: 10.1212/WNL.0000000000006544. Epub 2018 Oct 17.

  PMID: 30333160 RESULT

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction; Mental Disorders; Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• Olivier Godefroy, PhD-MD

  CHU Amiens

  STUDY CHAIR

• Hilde Henon, MD

  CHRU LILLE

  PRINCIPAL INVESTIGATOR

• Hervé Taillia, PhD-MD

  HIA val de grace

  PRINCIPAL INVESTIGATOR

• Serge Timsit, PhD-MD

  CHU Brest

  PRINCIPAL INVESTIGATOR

• Claudine Nedelec, MD

  CH La Rochelle

  PRINCIPAL INVESTIGATOR

• catherine thomas, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

• Maurice Giroud, PhD-MD

  CHU Dijon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: April 20, 2011
• Study Start: August 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

FR (7)