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

NCT03020381 · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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Official title
Gait as Predictor of Cognitive Decline, Dementia, and Risk of Falls in MCI. A Cohort Study
About this study
This longitudinal cohort study started in 2007 and is aiming to assess 600 older persons (60 y/o to 85 y/o) at risk of development cognitive impairment and dementia, during a 25 year of follow-up, since we expanded the study to recruit more participants, which was approved by our Institutional Research Board. The follow-up period was selected in order to cover the potential progression to dementia of at least two-third of the participants. From 2007 to 2023, for the first five years of follow up, assessments were conducted at baseline and every 6 months; since 2023, this was changed by which assessments are being conducted every 12-months along with performing a virtual assessment of outcomes only, every 6-months. After the visit at 60 months, participants will then be followed once a year for 20 years. The six months period between assessments during the first 5 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 five 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 12-month follow-up visits. From 2010 to 2021, 3Tesla Magnetic Resonance Imaging (structural and functional -resting state-) and MRI spectroscopy are being performed at four different time points: at baseline, month 18 and month 36, and month 60, following the Canadian Dementia Imaging protocol (http://www.cdip-pcid.ca.). Since 2021, the 18-month MRI timepoint changed to be performed at 12-month visit to align MRI timepoints with blood draw, which allows analysis of MRI and biomarker comparisons over time. For the 20-month Follow-Up period, MRI was performed at Year-2, Year-5 and Year-7 until 2018. Since 2018, the 20-Year Follow-Up MRI timepoints changed to Year-3, Year-5, Year-7 and Year-10. Blood and brain imaging were added after the second wave of the study, in 2010.
Eligibility criteria
General Inclusion Criteria: * Absence of Dementia (DSM IV-TR or DSM V criteria) * Aged 60-85 years * Able to walk independently 10 meters without any gait aid (for example: walker, cane); Exclusion Criteria: * Unable to understand English; * Parkinsonism or any neurological disorder with residual motor deficit (e.g.: stroke, epilepsy); * Musculoskeletal disorder detected by clinical examination which affects gait performance; * Active osteoarthritis affecting the lower limbs at clinical evaluation * Use of psychotropics which can affect motor performance (e.g. neuroleptics and benzodiazepines) * Severe Depression (score \> 12/15 on the Geriatric Depression Scale).
Study design
Enrollment target: 600 participants
Age groups: adult, older_adult
Timeline
Starts: 2007-12
Estimated completion: 2033-01
Last updated: 2023-12-21
Primary outcomes
  • Progression to Dementia (25 years of follow-up)
  • Type of Dementia (25 years of follow-up)
Sponsor
Manuel Montero Odasso · other
Contacts & investigators
ContactDr. Manuel Montero Odasso, MD, PhD · contact · 5196854292
InvestigatorDr. Manuel Montero Odasso, M.D. · principal_investigator, Director, Gait and Brain Lab
All locations (1)
Gait and Brain Lab, Parkwood InstituteRecruiting
London, Ontario, Canada