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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05046275
Other study ID # 2021-245
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 3, 2020
Est. completion date December 1, 2025

Study information

Verified date February 2024
Source Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1741
Est. completion date December 1, 2025
Est. primary completion date November 2, 2025
Accepts healthy volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - All included participants of NuAge Study Exclusion Criteria: - no information about cognitive complaint in NuAge database - no measure of walking speed in NuAge database - no follow-up completed in NuAge database

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data analysis
No intervention, data analysis only

Locations

Country Name City State
Canada CRIUGM Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal

Country where clinical trial is conducted

Canada, 

Outcome

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