NCT05046275

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,741

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

5 years

First QC Date

September 8, 2021

Last Update Submit

February 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • prevalence of MCR syndrome

    Diagnosis of MCR syndrome following Verghese et al. criteria

    3 years

Secondary Outcomes (7)

  • Cognitive decline and impairment

    3 years

  • Covariates

    3 years

  • Covariates

    3 years

  • Covariates

    3 years

  • Covariates

    3 years

  • +2 more secondary outcomes

Study Arms (2)

MCR syndroms

Summarize 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.

Other: Data analysis

Non MCR syndroms

Summarize 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.

Other: Data analysis

Interventions

No intervention, data analysis only

MCR syndromsNon MCR syndroms

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All included participants of NuAge Study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRIUGM

Montreal, Quebec, H3W 1W5, Canada

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Senior researcher, Director of laboratory

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 16, 2021

Study Start

November 3, 2020

Primary Completion

November 2, 2025

Study Completion

December 1, 2025

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations