Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-27 @ 9:55 PM
Study NCT ID:
NCT01351961
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2011-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular Alteration and Evolution of Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D001794', 'term': 'Blood Pressure'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2011-04-22', 'studyFirstSubmitQcDate': '2011-05-10', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global memory, visual retention and verbal fluency composite score', 'timeFrame': 'up to two years'}], 'secondaryOutcomes': [{'measure': 'vascular exploration', 'timeFrame': 'up to two years', 'description': 'Pulse wave velocity, VWF, IMT'}, {'measure': 'white matter hyperintensities by fazekas score.', 'timeFrame': 'up to two years', 'description': 'Hyperintensities of white matter will be classified following the Fazekas scale (6 ranks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Cognitive function'], 'conditions': ['Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '28279605', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis longitudinal study (Adelahyde 2) aims to confirm the role of vascular factors in the evolution of cognitive function and dementia.', 'detailedDescription': '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.\n\nObjectives: 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.\n\nMethods: 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.\n\nAs 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.\n\nExpected 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patient who have participated Adelahyde 1 study\n* patient who have signed a consent\n* patient who have a social security\n\nExclusion Criteria:\n\n* patient who can't understand information letter and who is not under legal protection"}, 'identificationModule': {'nctId': 'NCT01351961', 'acronym': 'ADELAHYDE2', 'briefTitle': 'Vascular Alteration and Evolution of Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Arterial Function and Structure and Evolution of Cognitive Impairment in Elderly Hypertensive Subjects With Subjective Memory Complaints', 'orgStudyIdInfo': {'id': '2010-A01399-30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Elderly hypertensive patients with mnemonic subjective', 'description': 'Elderly hypertensive patients with mnemonic subjective without dementia. Interventions :\n\nblood 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', 'interventionNames': ['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']}], 'interventions': [{'name': 'blood sampling', 'type': 'BIOLOGICAL', 'description': 'take a sample of blood, 46 ml', 'armGroupLabels': ['Elderly hypertensive patients with mnemonic subjective']}, {'name': 'brain MRI and TEP cerebral', 'type': 'PROCEDURE', 'description': 'magnetic resonance imaging', 'armGroupLabels': ['Elderly hypertensive patients with mnemonic subjective']}, {'name': 'Assessment of cognitive functions', 'type': 'OTHER', '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 .', 'armGroupLabels': ['Elderly hypertensive patients with mnemonic subjective']}, {'name': 'Electrocardiogram and blood pressure', 'type': 'OTHER', 'description': 'Electrocardiogramm Blood pressure monitoring', 'armGroupLabels': ['Elderly hypertensive patients with mnemonic subjective']}, {'name': 'Vascular explorations', 'type': 'PROCEDURE', 'description': 'Pulse wave velocity, VWF, IMT', 'armGroupLabels': ['Elderly hypertensive patients with mnemonic subjective']}, {'name': 'Urine sample', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Elderly hypertensive patients with mnemonic subjective']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Nancy', 'country': 'France', 'facility': 'Chu Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Athanase BENETOS, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU NANCY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinating Investigator', 'investigatorFullName': 'Pr Athanase BENETOS', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}