Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2026-02-25 @ 4:40 PM
Study NCT ID:
NCT01979432
Status:
TERMINATED
Last Update Posted:
2019-01-11
First Post:
2013-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cognitive and Cardiovascular Health in the Elderly Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Lack of patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2015-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-09', 'studyFirstSubmitDate': '2013-11-04', 'studyFirstSubmitQcDate': '2013-11-04', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incident "MCI" according to the following criteria', 'timeFrame': 'one time point', 'description': '(1) cognitive complaint (self-reported and/or informant) ; (2) preserved basic activities of daily living (ADL) ; (3) cognitive impairment (not normal for age and education) or decline in cognition evidenced by performance on objective cognitive tasks defined as a test performance \\<1.0 standard deviations below the mean of the reference group ; (4) preserved general cognitive functioning and (5) absence of dementia.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Alzheimer, cognitive diseases, Ankle-to-brachial index'], 'conditions': ['Cognitive Diseases']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to look for the interest forecast of the IPS as infra-clinical cardiovascular marker in the prediction of a change of the cognitive functions (MCI) at the elderly of 70 and more years old without clinical cardiovascular pathology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* free-living community-dwelling men and women aged ≥ 70 years,\n* subjects free of clinical CVD related to atherosclerosis\n* preserved basic activities of daily living (ADL = 6)\n* without cognitive impairment (MMSE≥24)\n\nExclusion Criteria:\n\n* subjects with clinical history of any of the following CVD diseases : coronary artery disease (angina, myocardial infarction, coronary revascularization), cerebrovascular disease (stroke, TIA, carotid revascularization), clinical peripheral artery disease (claudication, critical limb ischemia)\n* subjects with neurodegenerative, locomotor and ophtalmological diseases unable to perform the cognitive tests\n* subjects unable to give written informed consent.'}, 'identificationModule': {'nctId': 'NCT01979432', 'acronym': 'COACHES', 'briefTitle': 'The Cognitive and Cardiovascular Health in the Elderly Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'The Cognitive and Cardiovascular Health in the Elderly Study', 'orgStudyIdInfo': {'id': 'I11014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cardiovascular evaluation', 'description': 'Measure of the index of systolic pressure Echo doppler Echography Measure of the speed of the wave of pulse and the central pressure', 'interventionNames': ['Other: Cardiovascular evaluation']}], 'interventions': [{'name': 'Cardiovascular evaluation', 'type': 'OTHER', 'armGroupLabels': ['Cardiovascular evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87000', 'city': 'Limoges', 'country': 'France', 'facility': 'CHU of Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}