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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03633253
Other study ID # CODIM-FLP-16 288
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 7, 2016
Est. completion date December 7, 2025

Study information

Verified date February 2024
Source Jewish General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1741
Est. completion date December 7, 2025
Est. primary completion date December 7, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Individuals eligible for this study will be participants of the NuAge study Exclusion Criteria: Individuals not eligible for the NuAge study, No information about cognitive complaint, No measure of walking speed, No follow-up completed

Study Design


Intervention

Other:
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.

Locations

Country Name City State
Canada Jewish General Hospital Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary MCR syndrome criteria Diagnosis of MCR syndrome following Verghese et al. criteria 1 day
Secondary Cognitive decline and impairment Modified Mini-Mental State (3MS) in the NuAge study. 1 day
Secondary Covariates Cardio-vascular risk factors and diseases assessed using reported health condition 1 day
Secondary Covariates Cardio-vascular risk factors and diseases assessed using physical examination: body mass index 1 day
Secondary Covariates Cardio-vascular risk factors and diseases assessed using physical examination: hip waist ratio from hip and waist circumference 1 day
Secondary 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) 1 day
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