Cognitive Diseases Clinical Trial
— COACHESOfficial title:
The Cognitive and Cardiovascular Health in the Elderly Study
| NCT number | NCT01979432 |
| Other study ID # | I11014 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2013 |
| Est. completion date | December 12, 2015 |
| Verified date | January 2019 |
| Source | University Hospital, Limoges |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 17 |
| Est. completion date | December 12, 2015 |
| Est. primary completion date | December 12, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 70 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU of Limoges | Limoges |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Limoges |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | one time point |