Vascular Alteration and Evolution of Cognitive Impairment (ADELAHYDE2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01351961
First received: April 22, 2011
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Arterial Function and Structure and Evolution of Cognitive Impairment in Elderly Hypertensive Subjects With Subjective Memory Complaints

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • Global memory, visual retention and verbal fluency composite score [ Time Frame: up to two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • vascular exploration [ Time Frame: up to two years ] [ Designated as safety issue: No ]
    Pulse wave velocity, VWF, IMT

  • white matter hyperintensities by fazekas score. [ Time Frame: up to two years ] [ Designated as safety issue: No ]
    Hyperintensities of white matter will be classified following the Fazekas scale (6 ranks.


Enrollment: 131
Study Start Date: April 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 ml
Procedure: brain MRI and TEP cerebral
magnetic resonance imaging
Other: 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 monitoring
Procedure: Vascular explorations
Pulse wave velocity, VWF, IMT
Biological: Urine sample

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.

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01351961

Locations
France
Chu Nancy
Nancy, France, 54500
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Athanase BENETOS, professor CHU Nancy
  More Information

No publications provided

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01351961     History of Changes
Other Study ID Numbers: 2010-A01399-30
Study First Received: April 22, 2011
Last Updated: February 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Central Hospital, Nancy, France:
Hypertension
Cognitive function

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014