Vascular Alteration and Evolution of Cognitive Impairment (ADELAHYDE2)
Primary Purpose
Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sampling
brain MRI and TEP cerebral
Assessment of cognitive functions
Electrocardiogram and blood pressure
Vascular explorations
Urine sample
Sponsored by
About this trial
This is an interventional prevention trial for Cognitive Impairment focused on measuring Hypertension, Cognitive function
Eligibility Criteria
Inclusion Criteria:
- patient who have participated Adelahyde 1 study
- patient who have signed a consent
- patient who have a social security
Exclusion Criteria:
- patient who can't understand information letter and who is not under legal protection
Sites / Locations
- Chu Nancy
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Elderly hypertensive patients with mnemonic subjective
Arm Description
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
Outcomes
Primary Outcome Measures
Global memory, visual retention and verbal fluency composite score
Secondary Outcome Measures
vascular exploration
Pulse wave velocity, VWF, IMT
white matter hyperintensities by fazekas score.
Hyperintensities of white matter will be classified following the Fazekas scale (6 ranks.
Full Information
NCT ID
NCT01351961
First Posted
April 22, 2011
Last Updated
February 24, 2014
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT01351961
Brief Title
Vascular Alteration and Evolution of Cognitive Impairment
Acronym
ADELAHYDE2
Official Title
Arterial Function and Structure and Evolution of Cognitive Impairment in Elderly Hypertensive Subjects With Subjective Memory Complaints
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
Keywords
Hypertension, Cognitive function
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elderly hypertensive patients with mnemonic subjective
Arm Type
Other
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
blood sampling
Intervention Description
take a sample of blood, 46 ml
Intervention Type
Procedure
Intervention Name(s)
brain MRI and TEP cerebral
Intervention Description
magnetic resonance imaging
Intervention Type
Other
Intervention Name(s)
Assessment of cognitive functions
Intervention Description
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 .
Intervention Type
Other
Intervention Name(s)
Electrocardiogram and blood pressure
Intervention Description
Electrocardiogramm Blood pressure monitoring
Intervention Type
Procedure
Intervention Name(s)
Vascular explorations
Intervention Description
Pulse wave velocity, VWF, IMT
Intervention Type
Biological
Intervention Name(s)
Urine sample
Primary Outcome Measure Information:
Title
Global memory, visual retention and verbal fluency composite score
Time Frame
up to two years
Secondary Outcome Measure Information:
Title
vascular exploration
Description
Pulse wave velocity, VWF, IMT
Time Frame
up to two years
Title
white matter hyperintensities by fazekas score.
Description
Hyperintensities of white matter will be classified following the Fazekas scale (6 ranks.
Time Frame
up to two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient who have participated Adelahyde 1 study
patient who have signed a consent
patient who have a social security
Exclusion Criteria:
patient who can't understand information letter and who is not under legal protection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athanase BENETOS, professor
Organizational Affiliation
CHU Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Nancy
City
Nancy
ZIP/Postal Code
54500
Country
France
12. IPD Sharing Statement
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Vascular Alteration and Evolution of Cognitive Impairment
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