Vascular Alteration and Evolution of Cognitive Impairment
NCT ID: NCT01351961
Last Updated: 2025-09-15
Study Results
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Basic Information
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COMPLETED
NA
131 participants
INTERVENTIONAL
2011-04-30
2013-11-30
Brief Summary
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This longitudinal study (Adelahyde 2) aims to confirm the role of vascular factors in the evolution of cognitive function and dementia.
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Detailed Description
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Objectives: i) Primary: To establish, in the "ADELAHYDE" cohort, the relationship between vascular alterations assessed at baseline during the cross-sectional study (hypertrophy and arterial stiffness, endothelial dysfunction) and the evolution of cognitive function (primary study endpoint) over a 8-year follow-up period; ii) Secondary a) To investigate the evolution of white matter hyperintensities on MRI (secondary study endpoint) as a function of peripheral vascular status, and especially of endothelial function. b) Determine the role of genetic factors and biomarkers of oxidative stress (from DNA and serum biobanks collected at the first visit) in the evolution of cognitive functions and white matter hyperintensities.
Methods: Prospective longitudinal single center study. All patients (378 subjects) who participated in the baseline cross-sectional study conducted between 2001 and 2005, will be reconvened at the Clinical Investigation Centre (CIC) of Nancy.
As in the cross-sectional study, the following will be assessed in this longitudinal phase: pulse wave velocity (PWV), carotid ultrasonography, flow-mediated dilation, brain MRI with semi-quantification of white matter hyperintensities, cognitive function evaluation and measurement of various biomarkers of endothelial function.
Expected fallouts: A major benefit of this project is that this cohort has already been explored in terms of cognitive function, arterial properties and neurovascular imaging (MRI). Thus, the programmed reconvening of these subjects for this project in 2011 will enable us to identify the role of vascular alterations in the evolution of cognitive function and leucoaraiosis in this population at high risk of dementia over a period of at least 8 years. Finally, it could pave the way for further investigations, notably in the field of cognitive impairment prevention, aimed at reducing or delaying the onset of dementia by acting on the "vascular factor", which is potentially modifiable.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Elderly hypertensive patients with mnemonic subjective
Elderly hypertensive patients with mnemonic subjective without dementia. Interventions :
blood sampling brain MRI Assessment of cognitive functions brain MRI and TEP cerebral Electrocardiogram and blood pressure Pulse wave velocity Quality of life questionnaire Urine sample Vascular explorations
blood sampling
take a sample of blood, 46 ml
brain MRI and TEP cerebral
magnetic resonance imaging
Assessment of cognitive functions
Folstein MMSE, Mac Nair scale, Depression (GDS) scale, The Benton Visual Retention Test, Test of verbal fluency, formal and categorical, Trail Making Test, Grober et Buschke scale (RL/RI-16), Apathy Robert scale, Praxis rating Scale .
Electrocardiogram and blood pressure
Electrocardiogramm Blood pressure monitoring
Vascular explorations
Pulse wave velocity, VWF, IMT
Urine sample
Interventions
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blood sampling
take a sample of blood, 46 ml
brain MRI and TEP cerebral
magnetic resonance imaging
Assessment of cognitive functions
Folstein MMSE, Mac Nair scale, Depression (GDS) scale, The Benton Visual Retention Test, Test of verbal fluency, formal and categorical, Trail Making Test, Grober et Buschke scale (RL/RI-16), Apathy Robert scale, Praxis rating Scale .
Electrocardiogram and blood pressure
Electrocardiogramm Blood pressure monitoring
Vascular explorations
Pulse wave velocity, VWF, IMT
Urine sample
Eligibility Criteria
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Inclusion Criteria
* patient who have signed a consent
* patient who have a social security
Exclusion Criteria
65 Years
85 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Pr Athanase BENETOS
Coordinating Investigator
Principal Investigators
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Athanase BENETOS, professor
Role: PRINCIPAL_INVESTIGATOR
CHU NANCY
Locations
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Chu Nancy
Nancy, , France
Countries
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References
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Ferreira JP, Kearney Schwartz A, Watfa G, Zohra L, Felblinger J, Boivin JM, Bracard S, Hossu G, Verger A, Joly L, Zannad F, Rossignol P, Benetos A. Memory Alterations and White Matter Hyperintensities in Elderly Patients With Hypertension: The ADELAHYDE-2 Study. J Am Med Dir Assoc. 2017 May 1;18(5):451.e13-451.e25. doi: 10.1016/j.jamda.2017.01.008. Epub 2017 Mar 6.
Other Identifiers
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2010-A01399-30
Identifier Type: -
Identifier Source: org_study_id
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