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Motoric Cognitive Risk SyndromeNCT05046275

MCR Syndrome in Quebec : Results From NuAge Study

An observational study of Motoric Cognitive Risk Syndrome and Aging Disorder, run by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The overall objective of the proposal is to examine the epidemiology of the newly reported "motoric cognitive risk" (MCR) syndrome, which is a pre-dementia syndrome combining subjective cognitive complaint (i.e.; memory complaint) with objective slow gait speed, in the Quebec elderly population. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Data analysis
How many people
1,741 participants
Where
1 siteCanada
Study dates
3 Nov 2020to 1 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 65 years and older
  • All sexes
  • Older adult

Study population: All included participants of NuAge Study were healthy and, in particular, they were cognitively intact at baseline and had no mobility disability.

Who may be able to join

  • All included participants of NuAge Study

Who cannot join

  • no information about cognitive complaint in NuAge database
  • no measure of walking speed in NuAge database
  • no follow-up completed in NuAge database

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • CRIUGM

    Montreal, Quebec, H3W 1W5

Other trials in Canada

About this study

Official title: The "Motoric Cognitive Risk" Syndrome in the Quebec Population: Results From the NuAge Study - Sub-study: The Biological Underpinnings of Motoric Cognitive Risk Syndrome: a Multicenter Study

The overall objective of the proposal is to examine the epidemiology of the newly reported "motoric cognitive risk" (MCR) syndrome, which is a pre-dementia syndrome combining subjective cognitive complaint (i.e.; memory complaint) with objective slow gait speed, in the Quebec elderly population.

Cognition and locomotion are two human abilities controlled by the brain. Their decline is highly prevalent with physiological and pathological aging, and is greater than the simple sum of their respective prevalence, suggesting a complex age-related interplay between cognition and locomotion. Both declines in cognition and locomotion are associated, furthermore the temporal nature of their association has been unclear for a long time. Recently, a systematic review and meta-analysis has provided evidence that poor gait performance predicts dementia and, in particular, has demonstrated that MCR syndrome is a pre-dementia syndrome, suggesting that low gait performance is the first symptom of dementia. The uniqueness of MCR syndrome is that it does not rely on a complex evaluation or laboratory investigations. Indeed, this syndrome combined subjective cognitive complaint and objective slow gait speed, and is easy to apply in population-based settings.

Prevalence and incidence of MCR syndrome, as well as its association with incidence of cognitive decline and impairment, have never been reported in Canada. Nutrition as a determinant of successful aging: The Quebec longitudinal Study (the NuAge study) is a Quebec population-based observational cohort study performed in healthy older community-dwellers adults which provides a unique opportunity to: 1) obtain reliable estimates of MCR syndrome prevalence and incidence, 2) determine the distribution of clinical and biological (blood biomarkers and genetic) characteristics associated with MCR syndrome, 3) examine the association of MCR syndrome and its biological characteristics with cognitive decline and incidence of cognitive impairment in the Quebec elderly population.

Being tested
Data analysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Data analysisOther

    No intervention, data analysis only

Study groups in NCT05046275
Study groupRoleWhat they receive
MCR syndromsSummarize of participants' characteristics using means and standard deviations or frequencies and percentages First, prevalence of MCR syndrome will be determined by classifying participants into MCR and non-MCR syndrome groups. Second, between-group comparisons of participants' characteristics will be performed using unpaired t-test, Mann-Whitney, analysis of variance with LSD correction or Chi-square test, as appropriate. Third, multiple regressions will be performed to examine the association between MCR syndrome (dependent variable) and cardio-vascular risk factors and/or diseases (independent variables) adjusted on participants' characteristics. Fourth, the incidence of MCR syndrome during the follow-up period of NuAge study will be reported. Fifth, regression will be performed to examine the association between MCR syndrome (dependent variable) and cognitive decline as well cognitive impairment (independent variables, separated model) adjusted on participants' characteristics.
Receives: Other: Data analysis
Non MCR syndromsSummarize of participants' characteristics using means and standard deviations or frequencies and percentages First, prevalence of MCR syndrome will be determined by classifying participants into MCR and non-MCR syndrome groups. Second, between-group comparisons of participants' characteristics will be performed using unpaired t-test, Mann-Whitney, analysis of variance with LSD correction or Chi-square test, as appropriate. Third, multiple regressions will be performed to examine the association between MCR syndrome (dependent variable) and cardio-vascular risk factors and/or diseases (independent variables) adjusted on participants' characteristics. Fourth, the incidence of MCR syndrome during the follow-up period of NuAge study will be reported. Fifth, regression will be performed to examine the association between MCR syndrome (dependent variable) and cognitive decline as well cognitive impairment (independent variables, separated model) adjusted on participants' characteristics.
Receives: Other: Data analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. prevalence of MCR syndrome

    Diagnosis of MCR syndrome following Verghese et al. criteria

    Measured: 3 years

Secondary outcomes (7)

  1. Cognitive decline and impairment

    Modified Mini-Mental State (3MS) in the NuAge study.

    Measured: 3 years

  2. Covariates

    Cardio-vascular risk factors and diseases assessed using reported health condition

    Measured: 3 years

  3. Covariates

    Cardio-vascular risk factors and diseases assessed using physical examination: body mass index

    Measured: 3 years

  4. Covariates

    Cardio-vascular risk factors and diseases assessed using physical examination: hip waist ratio from hip and waist circumference

    Measured: 3 years

  5. Covariates

    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: 3 years

  6. Biological characteristics

    we selected biomarkers that consistently show associations with clinical risk factors for MCR : IL-6, high-sensitivity CRP and Malondialdehyde (MDA). These biomarkers are associated with individual MCR components. CRP was associated with plaques. Inflammation is hypothesized to be a precursor to neurofibrillary tangles and amyloid plaques; hallmarks of AD. Oxidative stress damage is elevated in vulnerable brain regions in early AD and MCI.

    We propose a multi-level examination of vascular pathways in MCR including biomarkers (CRP and homocysteine).

    We include homocysteine, a vascular biomarker, linked to gait and cognitive deficits in other studies.

    Measured: 3 years

  7. Genetic approach

    we propose to derive polygenic risk scores for cognitive and obesity phenotypes in NuAge, and to examine its predictive validity for MCR syndrome and incident cognitive impairment

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2021
  2. Study start3 Nov 2020
  3. Primary completion2 Nov 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

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
1,741 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05046275
Sponsor's protocol ID
2021-245
Status last verified
Oct 2026
First submitted
8 Sep 2021
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Motoric Cognitive Risk Syndrome and Aging Disorder, run by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal 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 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

prevalence of MCR syndrome (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05046275.

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 2 Nov 2026.

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