Vascular Alteration and Evolution of Cognitive Impairment
Condition: Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      In the cross sectional study "Adelahyde 1" which took place between 2001 and 2005, the
      investigators data suggest that vascular alterations may play a role in the setting of
      subjective memory complaints.

      This longitudinal study (Adelahyde 2) aims to confirm the role of vascular factors in the
      evolution of cognitive function and dementia.
    

Detailed description: 
      Background: The role of arterial hypertension and vascular alterations in the development of
      cognitive decline is a major issue in both research and clinical practice. In a recently
      published cross-sectional study (Kearney-Schwartz, Rossignol et al. 2009), conducted on the
      "ADELAHYDE" cohort comprised of older hypertensive patients with memory complaints, the
      investigators showed the association of arterial changes (hypertrophy and arterial stiffness,
      endothelial dysfunction) with cognitive functions and/or white matter hyperintensities on
      MRI. A longitudinal study is the only means to confirm the role of vascular factors in the
      evolution of cognitive function and onset of dementia.

      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.
    

Intervention name(s): blood sampling; brain MRI and TEP cerebral; Assessment of cognitive functions; Electrocardiogram and blood pressure; Vascular explorations; Urine sample
Intervention type(s): Biological; Procedure; Other; Other; Procedure; Biological
Intervention description(s): take a sample of blood, 46 ml; magnetic resonance imaging; 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 .; Electrocardiogramm Blood pressure monitoring; Pulse wave velocity, VWF, IMT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypertension; Cognitive function