NCT03633253

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 characteristics associated with MCR syndrome, 3) examine the association of MCR syndrome 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 Dec 2016

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

December 7, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2025

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

4 years

First QC Date

August 10, 2018

Last Update Submit

February 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • MCR syndrome criteria

    Diagnosis of MCR syndrome following Verghese et al. criteria

    1 day

Secondary Outcomes (5)

  • Cognitive decline and impairment

    1 day

  • Covariates

    1 day

  • Covariates

    1 day

  • Covariates

    1 day

  • Covariates

    1 day

Study Arms (2)

MCR syndroms

Other: Summarize of participants' characteristics using means and standard deviations or frequencies and percentages

Non MCR syndroms

Other: Summarize of participants' characteristics using means and standard deviations or frequencies and percentages

Interventions

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.

MCR syndromsNon MCR syndroms

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals eligible for this study will be participants of the NuAge study (n=1,793). 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:

  • Individuals eligible for this study will be participants of the NuAge study

You may not qualify if:

  • Individuals not eligible for the NuAge study, No information about cognitive complaint, No measure of walking speed, No follow-up completed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Geriatrics

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 16, 2018

Study Start

December 7, 2016

Primary Completion

December 7, 2020

Study Completion

December 7, 2025

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations