跳至主要内容
临床试验/NCT04275817
NCT04275817进行中(未招募)不适用

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

Jewish General Hospital1 个研究点 分布在 1 个国家目标入组 30,000 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30,000
试验地点
1
主要终点
Cognitive-prefrailty

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
45 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)
  • age < 50 and demented LCSA participants if they meet the following criteria:
  • History of dementia or Alzheimer's disease and/or use of anti-dementia drugs (i.e., Donepezil, Rivastigmine, Galentamine, regardless the dose taken)
  • 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

结局指标

主要结局

Cognitive-prefrailty

时间窗: 1 day

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?").

次要结局

  • Falls(12 months)
  • Motoric Cognitive Risk(1 day)
  • Depression(1 day)
  • Activities daily living (ADL)(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olivier Beauchet

MD, PhD, Professor of Geriatrics

Jewish General Hospital

研究点 (1)

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