Vascular Alteration and Evolution of Cognitive Impairment (ADELAHYDE2)
|ClinicalTrials.gov Identifier: NCT01351961|
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : February 25, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Impairment||Biological: blood sampling Procedure: brain MRI and TEP cerebral Other: Assessment of cognitive functions Other: Electrocardiogram and blood pressure Procedure: Vascular explorations Biological: Urine sample||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Arterial Function and Structure and Evolution of Cognitive Impairment in Elderly Hypertensive Subjects With Subjective Memory Complaints|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
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
Biological: blood sampling
take a sample of blood, 46 mlProcedure: brain MRI and TEP cerebral
magnetic resonance imagingOther: 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 .Other: Electrocardiogram and blood pressure
Electrocardiogramm Blood pressure monitoringProcedure: Vascular explorations
Pulse wave velocity, VWF, IMTBiological: Urine sample
- Global memory, visual retention and verbal fluency composite score [ Time Frame: up to two years ]
- vascular exploration [ Time Frame: up to two years ]Pulse wave velocity, VWF, IMT
- white matter hyperintensities by fazekas score. [ Time Frame: up to two years ]Hyperintensities of white matter will be classified following the Fazekas scale (6 ranks.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351961
|Nancy, France, 54500|
|Principal Investigator:||Athanase BENETOS, professor||CHU Nancy|