Back to resultsThe Cognitive and Cardiovascular Health in the Elderly Study (COACHES)
Primary Purpose
Cognitive Diseases
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiovascular evaluation
Sponsored by
About this trial
This is an interventional diagnostic trial for Cognitive Diseases focused on measuring Alzheimer, cognitive diseases, Ankle-to-brachial index
Eligibility Criteria
Inclusion Criteria:
- free-living community-dwelling men and women aged ≥ 70 years,
- subjects free of clinical CVD related to atherosclerosis
- preserved basic activities of daily living (ADL = 6)
- without cognitive impairment (MMSE≥24)
Exclusion Criteria:
- 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)
- subjects with neurodegenerative, locomotor and ophtalmological diseases unable to perform the cognitive tests
- subjects unable to give written informed consent.
Sites / Locations
- CHU of Limoges
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cardiovascular evaluation
Arm Description
Measure of the index of systolic pressure Echo doppler Echography Measure of the speed of the wave of pulse and the central pressure
Outcomes
Primary Outcome Measures
Incident "MCI" according to the following criteria
(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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01979432
First Posted
November 4, 2013
Last Updated
January 9, 2019
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT01979432
Brief Title
The Cognitive and Cardiovascular Health in the Elderly Study
Acronym
COACHES
Official Title
The Cognitive and Cardiovascular Health in the Elderly Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of patients
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 12, 2015 (Actual)
Study Completion Date
December 12, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Diseases
Keywords
Alzheimer, cognitive diseases, Ankle-to-brachial index
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiovascular evaluation
Arm Type
Other
Arm Description
Measure of the index of systolic pressure Echo doppler Echography Measure of the speed of the wave of pulse and the central pressure
Intervention Type
Other
Intervention Name(s)
Cardiovascular evaluation
Primary Outcome Measure Information:
Title
Incident "MCI" according to the following criteria
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.
Time Frame
one time point
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
free-living community-dwelling men and women aged ≥ 70 years,
subjects free of clinical CVD related to atherosclerosis
preserved basic activities of daily living (ADL = 6)
without cognitive impairment (MMSE≥24)
Exclusion Criteria:
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)
subjects with neurodegenerative, locomotor and ophtalmological diseases unable to perform the cognitive tests
subjects unable to give written informed consent.
Facility Information:
Facility Name
CHU of Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France
12. IPD Sharing Statement
Learn more about this trial
The Cognitive and Cardiovascular Health in the Elderly Study
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