Cognition Disorders in Old AgeMCR-CardioVNCT03679026
The "Motoric Cognitive Risk" Syndrome in the Canadian Population
An observational study of Cognition Disorders in Old Age and Cardiovascular Diseases, run by Jewish General Hospital at 1 site in Canada.
Trial summary
Cognition and locomotion are two human abilities controlled by the brain. Their decline is highly prevalent with aging, and is greater than the simple sum of their respective prevalence, suggesting a complex age-related interplay between cognition and locomotion. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Cognition Disorders in Old Age, Cardiovascular Diseases, Dementia
- What is being tested?
- Summarize of participants' characteristics using means and standard deviations or frequencies and percentages
- How many people
- 1,461 participants
- Where
- 1 siteCanada
- Study dates
- 22 Aug 2017to 21 Dec 2024
- Phase
- Observational
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals eligible for this study will be participants of the comprehensive Canadian Longitudinal Study on Aging (n=30,097). They are separated in four age groups (i.e.; 45-54, 54-64, 65-74 and 75-85). Each group will be divided in two subgroups: individuals with and without cardio-vascular risk factors and diseases.
Who may be able to join
- Individuals eligible for this study will be participants of the NuAge study
Who cannot join
- Individuals not eligible for the NuAge study
- dementia
- mobility disability
- no information about cognitive complaint
- no measure of walking speed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The "Motoric Cognitive Risk" Syndrome in the Canadian Population: Analysis of Baseline Assessment of the Canadian Longitudinal Study on Aging (CLSA)
Cognition and locomotion are two human abilities controlled by the brain. Their decline is highly prevalent with aging, and is greater than the simple sum of their respective prevalence, suggesting a complex age-related interplay between cognition and locomotion. Recently, a systematic review and meta-analysis has provided evidence that poor gait performance predicts dementia and, in particular, has demonstrated that "motoric cognitive risk" (MCR) syndrome, which has been described in cognitively healthy individuals and combines subjective cognitive complaint with objective slow gait speed, is a pre-dementia syndrome. The uniqueness of "motoric cognitive risk" (MCR)syndrome is that it does not rely on a complex evaluation or laboratory investigations. Thus, it is easy to apply in population-based settings. The overall objective of the proposal is to examine the epidemiology of the newly reported "motoric cognitive risk" (MCR) syndrome, in the Quebec population using the database of the NuAge study.
- Being tested
- Summarize of participants' characteristics using means and standard deviations or frequencies and percentages
- Medical subject headings
- Cardiovascular Diseases, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Summarize of participants' characteristics using means and standard deviations or frequencies and percentagesOther
Participants' baseline characteristics will be summarized using means and standard deviations or frequencies and percentages, as appropriate.
| Study group | Role | What they receive |
|---|---|---|
| CVRF | individuals with cardio-vascular risk factors and diseases Receives: Other: Summarize of participants' characteristics using means and standard deviations or frequencies and percentages | |
| WCVRF | individuals without cardio-vascular risk factors and diseases Receives: Other: Summarize of participants' characteristics using means and standard deviations or frequencies and percentages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardio-vascular risk factors and diseases assessed using reported health condition
medical history
Measured: 1 day
Secondary outcomes (16)
Cardio-vascular risk factors and diseases assessed using physical examination: BMI
body mass index
Measured: 1 day
Cardio-vascular risk factors and diseases assessed using physical examination: HW ratio
hip-waist ratio
Measured: 1 day
Cardio-vascular risk factors and diseases assessed using physical examination: blood pressure
(value of systolic, diastolic when participants are seated in an upright position in a chair)
Measured: 1 day
Disability and functional limitations
Disability and functional limitations : ADL (activities of daily life)
Measured: 1 day
Disability and functional limitations
Disability and functional limitations : IADL (instrumental activities of daily life)
Measured: 1 day
Disability and functional limitations
History of falls during the past 12 months
Measured: 12 months
Depression
measured by the 10 items of the Center for Epidemiological Studies Short Depression Scale. Participants with a score of 10 or greater are considered as depressed. Scores with more than 2 missing items will be excluded.
Measured: 1 day
Cognitive performance
Prospective Memory Test (PMT)
Measured: 1 day
Cognitive performance
Stroop Neurological Screening Test
Measured: 1 day
Cognitive performance
Controlled Oral Word Association Test (FAS)
Measured: 1 day
Cognitive performance
Choice Reaction Time Test (CRT)
Measured: 1 day
physical and mental health
Number of drugs daily taken
Measured: 1 day
physical and mental health
Self-perception of health and mental health
Measured: 1 day
Physical performance
Muscle strength estimated using the handgrip strength
Measured: 1 day
Physical performance
five-time sit-to-stand test
Measured: 1 day
Physical performance
Physical Activity Scale for the Elderly, scored between 0 and 400, low scores indicate sarcopenia
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start22 Aug 2017
- Primary completion21 Aug 2021
- Study completion21 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition Disorders in Old AgeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,461 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Beauchet, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679026
- Sponsor's protocol ID
- CODIM-FLP-16 261
- Acronym
- MCR-CardioV
- Status last verified
- Apr 2024
- First submitted
- 21 Aug 2018
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "Motoric Cognitive Risk" Syndrome in the Canadian Population: Analysis of Baseline Assessment of the Canadian Longitudinal Study on Aging (CLSA)
- ClinicalTrials.gov ID
- NCT03679026
- Acronym / sponsor ID
- MCR-CardioV / CODIM-FLP-16 261
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,461 participants (estimated)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 21 Aug 2021 (actual)
- Study completion
- 21 Dec 2024 (estimated)
- First posted
- 20 Sep 2018 (actual)
- 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.
Cognition and locomotion are two human abilities controlled by the brain. Their decline is highly prevalent with aging, and is greater than the simple sum of their respective prevalence, suggesting a complex age-related interplay between cognition and locomotion. Recently, a systematic review and meta-analysis has provided evidence that poor gait performance predicts dementia and, in particular, has demonstrated that "motoric cognitive risk" (MCR) syndrome, which has been described in cognitively healthy individuals and combines subjective cognitive complaint with objective slow gait speed, is a pre-dementia syndrome. The uniqueness of "motoric cognitive risk" (MCR)syndrome is that it does not rely on a complex evaluation or laboratory investigations. Thus, it is easy to apply in population-based settings. The overall objective of the proposal is to examine the epidemiology of the newly reported "motoric cognitive risk" (MCR) syndrome, in the Quebec population using the database of the NuAge study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVRF | – | Other: Summarize of participants' characteristics using means and standard deviations or frequencies and percentagesindividuals with cardio-vascular risk factors and diseases |
| WCVRF | – | Other: Summarize of participants' characteristics using means and standard deviations or frequencies and percentagesindividuals without cardio-vascular risk factors and diseases |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals eligible for this study will be participants of the comprehensive Canadian Longitudinal Study on Aging (n=30,097). They are separated in four age groups (i.e.; 45-54, 54-64, 65-74 and 75-85). Each group will be divided in two subgroups: individuals with and without cardio-vascular risk factors and diseases.
Key inclusion criteria (1 listed)
- Individuals eligible for this study will be participants of the NuAge study
Key exclusion criteria (5 listed)
- Individuals not eligible for the NuAge study
- dementia
- mobility disability
- no information about cognitive complaint
- no measure of walking speed
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 |
|---|---|---|
| Summarize of participants' characteristics using means and standard deviations or frequencies and percentagesParticipants' baseline characteristics will be summarized using means and standard deviations or frequencies and percentages, as appropriate. | Other | CVRF, WCVRF |
Primary outcome
Cardio-vascular risk factors and diseases assessed using reported health condition
Time frame: 1 day
medical history
16 secondary outcomes
Cardio-vascular risk factors and diseases assessed using physical examination: BMI
Time frame: 1 day
Cardio-vascular risk factors and diseases assessed using physical examination: HW ratio
Time frame: 1 day
Cardio-vascular risk factors and diseases assessed using physical examination: blood pressure
Time frame: 1 day
Disability and functional limitations
Time frame: 1 day
Disability and functional limitations
Time frame: 1 day
Disability and functional limitations
Time frame: 12 months
Depression
Time frame: 1 day
Cognitive performance
Time frame: 1 day
Cognitive performance
Time frame: 1 day
Cognitive performance
Time frame: 1 day
Cognitive performance
Time frame: 1 day
physical and mental health
Time frame: 1 day
physical and mental health
Time frame: 1 day
Physical performance
Time frame: 1 day
Physical performance
Time frame: 1 day
Physical performance
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
Related trials for Cognition Disorders in Old Age
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Active, not recruiting
Effectiveness of Strength-based Intervention for Elderly With Dementia Living in the Community
Dementia, Mild Cognitive Impairment
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Not yet recruiting
Cognitive Enhancement in Recurrent Depression (The COG-D-R Study)
Aging, Depression
Not yet recruitingPhase 2
Effects of Tadalafil on Cognition and Cerebral Hemodynamics in Elderly Patients With Mild Cognitive Impairment
Mild Cognitive Impairment (MCI)
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?
An observational study of Cognition Disorders in Old Age and Cardiovascular Diseases, run by Jewish General Hospital at 1 site in Canada.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. 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 Canada. 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?
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?
Cardio-vascular risk factors and diseases assessed using reported health condition (time frame: 1 day). 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 5 Apr 2024.