Clinical Trial: Gait as Predictor of Dementia and Falls. The Gait and Brain Cohort Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Gait as Predictor of Cognitive Decline, Dementia, and Risk of Falls in MCI. A Cohort Study

Brief Summary:

Motor slowing and cognitive slowing are more prevalent as we age. Importantly, the presence of both in an older person increases their risk of having dementia by ten times. Currently, there are no clinically meaningful predictors of progression to dementia in people with mild cognitive impairment (MCI). The main hypothesis is that subtle variations in gait while performing a simple cognitive task is a reliable, easy to perform, and feasible methodology to detect those older adults at higher risk of progression to dementia and also, at higher risk of further mobility decline and falls.

Rationale. The Canadian population is aging. According to recent estimates, the proportion of the population aged 65 and older will increase rapidly from 13% in 2005 to 25% by 2031. This increase in proportion is accompanied by a considerable amount of disability and subsequent dependency which has major effects on both the quality of life of older adults and their caregivers, and on the Canadian health care system. An important goal of geriatric medicine is to reduce the gap between life expectancy and disability-free life expectancy by reducing disability and dependency in the later years of life. A substantial portion of this disability stems from two major geriatric syndromes: cognitive impairment and mobility limitation. The ultimate manifestations of these syndromes are dementia and falls. Interestingly, these manifestations often coexist in elderly people: falling is a common geriatric syndrome affecting about a third of older adults each year, and dementia affects about a third of Canadians aged 80 and over. Together, dementia and falls are responsible for much of the discomfort, disability, and health care utilization in older adults and each will become more prevalent as older Canadians are expected to number approximately $9 million by 2031. The combined direct cost of dementia an

Detailed Summary:

This longitudinal cohort study started in 2007 and is aiming to assess 400 older persons (65 y/o to 85 y/o) at risk of development cognitive impairment and dementia, during a 10 year of follow-up. The follow-up period was selected in order to cover the potential progression to dementia of at least two-third of the participants. For the first three years of follow up, assessments are conducted at baseline and every 6 months; after the visit at 36 months, participants will then be followed once a year for 7 years (total follow-up of 120 months). The six months period between assessments during the first 3 years was selected since it is the minimum time required for detecting significant changes between assessments in cognitive measurements and for avoiding testing learning effects. If changes are not noted within the first three years, then the annual follow-up period will provide sufficient time periods to detect significant changes in cognition, gait, and balance measures.

Blood test for genotyping (ApoE4 carrier) is being performed only at baseline assessments. Cognitive, gait and balance assessments are being performed in all the visits. 3Tesla Magnetic Resonance Imaging (structural and functional -resting state-) and MRI spectroscopy are being performed at three different time points: at baseline, month 18 and month 36, following the Canadian Dementia Imaging protocol (http://www.cdip-pcid.ca.) Blood and brain imaging were adedd after the second wave of the study, in 2010.

Sponsor: Lawson Health Research Institute

Current Primary Outcome:

• Progression to Dementia [ Time Frame: 10 years of follow-up ]
  The primary outcome is "progression to dementia" ascertained by clinician investigator using DSM-IV-TR (from 2007 to 2013) and DSM V (from 2014 and onwards). At the time of diagnosis, clinicians are blinded to baseline gait or baseline neuro-psychological test scores. Participants are being re-assessed after six months of the time point of ascertainment of dementia to confirm dementia status.
• Type of Dementia [ Time Frame: 10 years of follow-up ]
  Type of dementia is being established using standardized criteria for Alzheimer's disease (AD) dementia, frontotemporal dementia, Lewy body dementia, and vascular dementia (VaD).

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Development of Mobility Decline [ Time Frame: 10 years of follow-up ]
  It is expected that MCI individuals with higher gait variability at baseline will develop mobility decline, defined as incident sloving in gait velocity (cm/s) by 10 cm/s
• Incidence of Falls [ Time Frame: 10 years of follow-up ]
  Falls is defined as 'an unintentionally coming to rest on the ground, floor, or other lower level and not due to a seizure or an acute stroke. Recurrent falls are defined as two or more events in a 12 months period. This outcome will be analyzed as the rate of falls over 36 months (defined as number of falls person-time at risk), the proportion of participants who fall (0, 1) and the proportion of recurrent fallers (2+ falls).
• Brain anatomical changes (grey matter) [ Time Frame: 10 years of follow-up ]
  Changes in grey matter volume are being as absolute change (in cm3) across assessments
• Brain anatomical changes (white matter) [ Time Frame: 10 years of follow-up ]
  Changes in white matter volume is being evaluated as absolute change (in cm3) across assessments.
• Brain anatomical changes (ventricular volume) [ Time Frame: 10 years of follow-up ]
  Changes in ventricular volume is being evaluated as absolute change (in cm3) across assessments

Original Secondary Outcome:

• Development of Mobility Decline [ Time Frame: 10 years of follow-up ]
  It is expected that MCI individuals with higher gait variability at baseline will develop mobility decline, defined as incident sloving in gait velocity (cm/s) by 10 cm/s
• Increased Incidence of Falls [ Time Frame: 10 years of follow-up ]
  Falls is defined as 'an unintentionally coming to rest on the ground, floor, or other lower level and not due to a seizure or an acute stroke. Recurrent falls are defined as two or more events in a 12 months period. This outcome will be analyzed as the rate of falls over 36 months (defined as number of falls person-time at risk), the proportion of participants who fall (0, 1) and the proportion of recurrent fallers (2+ falls).
• Brain anatomical changes (grey matter) [ Time Frame: 10 years of follow-up ]
  Changes in grey matter volume are being as absolute change (in cm3) across assessments
• Brain anatomical changes (white matter) [ Time Frame: 10 years of follow-up ]
  Changes in white matter volume is being evaluated as absolute change (in cm3) across assessments.
• Brain anatomical changes (ventricular volume) [ Time Frame: 10 years of follow-up ]
  Changes in ventricular volume is being evaluated as absolute change (in cm3) across assessments

Information By: Lawson Health Research Institute

Dates:
Date Received: January 6, 2017
Date Started: December 2007
Date Completion: December 2020
Last Updated: April 22, 2017
Last Verified: April 2017