Cognitive Prefrail and Frailty, and Motoric Cognitive Risk Syndrome: Prevalence and Association W… (NCT04275817) | Clinical Trial Compass
UnknownNot Applicable
Cognitive Prefrail and Frailty, and Motoric Cognitive Risk Syndrome: Prevalence and Association With Incident Adverse Health Events
Canada30,000 participantsStarted 2020-12-01
Plain-language 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.
Who can participate
Age range
45 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. participants of the CLSA with baseline assessment (tracking and comprehensive assessment) and first 18-month follow-up assessment
. age \> 50
Exclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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