Cognitive Prefrail and Frailty, and Motoric Cognitive Risk Syndrome: Prevalence and Association With Incident Adverse Health Events

Frailty Clinical Trial

Official title:

Cognitive Prefrail and Frailty, and Motoric Cognitive Risk Syndrome: Prevalence and Association With Incident Adverse Health Events in the Canadian Longitudinal Study on Aging

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04275817
• Other study ID #: 2020-2183
• Status: Active, not recruiting
• Start date: December 1, 2020
• Est. completion date: February 1, 2025

Study information

• Verified date: April 2024
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We defined a new and early condition in the spectrum of cognitive frailty: the "cognitive-prefrailty" which is a combination of prefrailty stage and subjective cognitive impairment (SCI). This study aims to: (1) examine and compare the prevalence of cognitive-prefrailty, cognitive frailty and motoric cognitive risk syndrome (MCR) syndromes in participants of the Canadian Longitudinal Study of Aging (CLSA) using the (tracking and comprehensive) baseline assessment, (2) examine the association of cognitive-prefrailty, cognitive frailty and MCR syndromes with incident adverse health events using the information collected during the first CLSA 18-month follow-up, and (3) compare the criteria performances (i.e., sensitivity, specificity, positive predictive value, negative predictive value, area under receiver operating characteristic curve, positive and negative likelihood ratio) for incident adverse health events of the cognitive-prefrailty, cognitive frailty and MCR syndromes.

Description:

Background Cognitive frailty is the simultaneous presence of both physical frailty and cognitive impairment, excluding concurrent dementia. This condition confers a greater risk of incident cognitive impairment and decline, dementia, falls and disabilities compared to either condition alone. Current definitions of co-existent frailty and cognitive impairment exist, including the International Academy on Nutrition and Aging (IANA) and the International Association of Gerontology and Geriatrics (IAGG) consensus for cognitive frailty. There is also an analogous construct known as the motoric cognitive risk syndrome (MCR) associating slow gait speed and subjective cognitive impairment (SCI). Current operational criteria identify individuals later in the trajectory of frailty and cognitive decline, which may be too late for effective interventions. We propose to define a new and early condition in the spectrum of Cognitive frailty known as "cognitive-prefrailty", which is a combination of prefrailty stage and SCI.

Overall objective This study aims to: 1) Examine and compare the prevalence of cognitive-prefrailty, cognitive frailty and motoric cognitive risk syndrome (MCR) syndromes in participants of the Canadian Longitudinal Study of Aging (CLSA) using the (tracking and comprehensive) baseline assessment, 2) Examine the association of cognitive-prefrailty, cognitive frailty and MCR syndromes with incident adverse health events using the information collected during the first CLSA 18-month follow-up, 3) Compare the criteria performances (i.e., sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), area under receiver operating characteristic curve, positive and negative likelihood ratio (LR)) for incident adverse health events of the cognitive-prefrailty, cognitive frailty and MCR syndromes.

Methods This study will use the database of the CLSA, which is population-based observational and prospective cohort study that assesses and follows the health condition of the Canadian population. All items of cognitive-prefrailty, cognitive frailty and MCR syndromes have been collected during the baseline assessment in the tracking and the comprehensive assessments. In addition, all information needed to determine incident adverse health events including falls and related injuries, depression, functional decline, motoric cognitive risk syndrome, cognitive decline and dementia has been also collected during the first 18-month follow-up period.

Anticipated results Prefrailty is an intermediate and potentially reversible stage between robust and frailty that occur upstream in the continuum of frailty and hence constitute more suitable targets for screening and early intervention in older adults.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30000
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

1. participants of the CLSA with baseline assessment (tracking and comprehensive assessment) and first 18-month follow-up assessment

2. age > 50

Exclusion Criteria:

1. no information which may directly or indirectly determine the occurrence of incident adverse health events (falls and related injuries, depression, functional decline, motoric cognitive risk syndrome, cognitive decline and dementia)

2. age < 50 and demented LCSA participants if they meet the following criteria:

1. History of dementia or Alzheimer's disease and/or use of anti-dementia drugs (i.e., Donepezil, Rivastigmine, Galentamine, regardless the dose taken)

2. Objective cognitive impairment (i.e., performance =2 SDs below the age-appropriate mean) in two cognitive domains (i.e., episodic memory and executive function) and abnormal scores on the ADL and IADL scales

Related Conditions & MeSH terms

• Cognitive-prefrailty
• Frailty
• Motoric Cognitive Risk Syndrome
• Syndrome

Intervention

Other:
• Data collection
Telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site

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	Cognitive-prefrailty	Defined as frailty and subjective cognitive impairment combined. Frailty (as proposed by Fried et al.) will be identified by the presence of = 3 of the 5 components: 1) unintentional weight loss, 2) Weakness (maximal grip strength); 3) Poor energy (answer of "no" to the question "Do you feel full of energy?" from the 15-item Geriatric Depression Scale); 4) Slowness as identified by an average walk speed, and 5) Low physical activity level. Participants with none of the above components will be considered to be vigorous and those with 1 or 2 components will be considered to be in a prefrail stage.; SCI will be defined using a proxy for subjective cognitive complaint (i.e. memory complaint) based on standardized memory loss question on the 15-item Geriatric Depression Scale (GDS; "Do you feel you have more problems with memory than most?").	1 day
Secondary	Falls	Number of falls	12 months
Secondary	Depression	10 items from the Center for Epidemiological Studies' Short Depression Scale (CES-D) score =10	1 day
Secondary	Activities daily living (ADL)	ADL score out of 6. Where a score of 3-5 is indicative of mild stages of neurocognitive disorders.	1 day
Secondary	Motoric Cognitive Risk	Defined as having subjective cognitive complaint and slow walking speed (subjective cognitive complaint will be defined using the variable trouble concentrating or the self-reported memory problem, and slow walking speed will be defined as walking speed one standard deviation (SD) below the average of the cohort using the information of modules psychological health and physical health)	1 day