- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05046275
MCR Syndrome in Quebec : Results From NuAge Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H3W 1W5
- CRIUGM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
No intervention, data analysis only
|
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.
|
No intervention, data analysis only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevalence of MCR syndrome
Time Frame: 3 years
|
Diagnosis of MCR syndrome following Verghese et al. criteria
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive decline and impairment
Time Frame: 3 years
|
Modified Mini-Mental State (3MS) in the NuAge study.
|
3 years
|
Covariates
Time Frame: 3 years
|
Cardio-vascular risk factors and diseases assessed using reported health condition
|
3 years
|
Covariates
Time Frame: 3 years
|
Cardio-vascular risk factors and diseases assessed using physical examination: body mass index
|
3 years
|
Covariates
Time Frame: 3 years
|
Cardio-vascular risk factors and diseases assessed using physical examination: hip waist ratio from hip and waist circumference
|
3 years
|
Covariates
Time Frame: 3 years
|
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
|
Biological characteristics
Time Frame: 3 years
|
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
|
Genetic approach
Time Frame: 3 years
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-245
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Motoric Cognitive Risk Syndrome
-
Tufts UniversityBoston Older Americans Independence Center; Somerville Council on Aging, MassachusettsCompleted
-
Jewish General HospitalActive, not recruitingFrailty | Motoric Cognitive Risk Syndrome | Cognitive-prefrailtyCanada
-
Jewish General HospitalActive, not recruitingMotoric Cognitive Risk Syndrome | Cognitive-prefrailty | PrefrailtyCanada
-
Parc Sanitari Pere VirgiliInstitut Català de la Salut; Fundacio Ictus Malaltia Vascular; Hospital de la... and other collaboratorsEnrolling by invitationCognitive Impairment | Motoric Cognitive Risk SyndromeSpain
-
Beijing Tiantan HospitalBeijing Stroke AssociationRecruitingAging | Mild Cognitive Impairment | Motoric Cognitive Risk Syndrome | Locomotive SyndromeChina
-
University Hospital, CaenRecruitingDementia | Alzheimer Disease | Mild Cognitive Impairment | Motoric Cognitive Risk SyndromeFrance
-
Lund UniversityAnti-Diabetic Food CentreCompletedMood | Cognitive Performance | Cardiometabolic Risk MarkersSweden
-
Northumbria UniversityCherry Marketing InstituteCompletedCognitive Function | Exercise Capacity | Cardiometabolic Risk FactorsUnited Kingdom
-
Peking University Sixth HospitalRecruitingCerebral Blood Flow | Cognitive Change | Cardiovascular Risk Factors | fMRI | Normal CognitionChina
-
University of DelawareCompletedCardiovascular Risk Factors | Age-Related Cognitive DeclineUnited States
Clinical Trials on Data analysis
-
GEMA LEÓN BRAVOCompleted
-
Hospices Civils de LyonCompleted
-
Shandong UniversityNational Health Medical Data (North Center)Recruiting
-
Heinrich-Heine University, DuesseldorfActive, not recruitingCardiac Imaging TechniquesGermany
-
University Hospital, Basel, SwitzerlandCompleted
-
Centre Hospitalier Universitaire de NiceRecruitingCentral Nervous System DiseasesFrance
-
Brno University HospitalMasaryk UniversityCompleted
-
University Hospital TuebingenRecruitingRare Diseases | Genetic PredispositionGermany
-
Hacettepe UniversityCompletedTo Evaluate the Efficacy of Platelet-rich Fibrin in Papilla Reconstruction | To Evaluate the Efficacy of Connective Tissue Graft in Papilla ReconstructionTurkey
-
Vienna Institute for Research in Ocular SurgeryCompleted