Cognitive DiseasesCOACHESNCT01979432
The Cognitive and Cardiovascular Health in the Elderly Study
A study testing Cardiovascular evaluation in people with Cognitive Diseases, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cognitive Diseases
- What is being tested?
- Cardiovascular evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to 12 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cognitive Diseases
- Being tested
- Cardiovascular evaluation
- Keywords
- Alzheimer, cognitive diseases, Ankle-to-brachial index
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular evaluationOther
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular evaluation | Other | Measure of the index of systolic pressure Echo doppler Echography Measure of the speed of the wave of pulse and the central pressure Receives: Other: Cardiovascular evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startDec 2013
- Primary completion12 Dec 2015
- Study completion12 Dec 2015
Why it stopped: Lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979432
- Sponsor's protocol ID
- I11014
- Acronym
- COACHES
- Status last verified
- Jan 2019
- First submitted
- 4 Nov 2013
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cognitive and Cardiovascular Health in the Elderly Study
- ClinicalTrials.gov ID
- NCT01979432
- Acronym / sponsor ID
- COACHES / I11014
- Conditions
- Cognitive Diseases
- Keywords
- Alzheimer, cognitive diseases, Ankle-to-brachial index
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- 12 Dec 2015 (actual)
- Study completion
- 12 Dec 2015 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular evaluation | Other | Other: Cardiovascular evaluationMeasure of the index of systolic pressure Echo doppler Echography Measure of the speed of the wave of pulse and the central pressure |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular evaluation | Other | Cardiovascular evaluation |
Primary outcome
Incident "MCI" according to the following criteria
Time frame: one time point
(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.
Results and safety
The study was stopped early (reason given: Lack of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular evaluation in people with Cognitive Diseases, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident "MCI" according to the following criteria (time frame: one time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.