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

December 15, 2023 updated by: Manuel Montero Odasso

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

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 and falls for the Canadian Health System is over $4.9 billion per year.

Establishing reliable and easy to obtain predictors to accurately identify MCI patients at highest risk of progressing to dementia is essential first, to determine who will benefit from additional and/or invasive testing and second, to implement preventative strategies, including cognitive training, physical exercises, and aggressive vascular risk factors correction to delay progression. Even a modest one-year delay in dementia incidence could save Canada $109 billion over 30 years.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Manuel Montero Odasso, MD, PhD
  • Phone Number: 45024 5196854292

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6C 0A7
        • Recruiting
        • Gait and Brain Lab, Parkwood Institute
        • Contact:
          • Dr. Manuel Montero Odasso
          • Phone Number: 45024 5196854292
          • Email: mmontero@uwo.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants 60 years or older are being recruited from the community, our Geriatrics and Memory Clinics at University of Western Ontario affiliated hospitals, from advertisements placed in local (London, ON) newspapers, and referrals from family physicians or community partners. Participants are being followed-up for up to 25 years after baseline measurements (twice annual or annual follow-up visits).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cognitively Normal (Control Group)
Participants aged 60 and older, with absence of Dementia (by DSM IV and DSM V) criteria. Normal age-, sex-, and education-adjusted performance on standardized cognitive tests, which are used to classify mild cognitive impairment (MCI) or prodromal AD.
Subjective Cognitive Impairment (SCI)
Participants aged 60 and older, with absence of Dementia (by DSM IV and DSM V) criteria. Normal age-, sex-, and education-adjusted performance on standardized cognitive tests, which are used to classify mild cognitive impairment (MCI) or prodromal AD. Self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event. Answering "yes" to both of the following questions: "Do you feel like your memory or thinking is becoming worse?" and "Does this concern you?"
Mild Cognitive Impairment (MCI)
Participants aged 60 and older that have self-experienced persistent decline in cognitive capacity and unrelated to an acute event. MCI is operationalized following Peterson's criteria as: i) presence of subjective memory complaints from the patient and family; ii) objective memory impairment in cognitive tests (below 1.5 SD on standardized cognitive tests adjusted by age, sex, and education-); iii) preserved activities of daily living (assessed using the Lawton-Brody scale); iv) absence of clinical dementia established using DSM-IV-TR (from 2007 to 2013) and DSM V (from 2014 and onwards)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression to Dementia
Time Frame: 25 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.
25 years of follow-up
Type of Dementia
Time Frame: 25 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).
25 years of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of Mobility Decline
Time Frame: 25 years of follow-up
It is expected that MCI individuals with higher gait variability at baseline will develop mobility decline, defined as incident slowing in gait velocity (cm/s) by 10 cm/s
25 years of follow-up
Incidence of Falls
Time Frame: 25 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).
25 years of follow-up
Brain anatomical changes (grey matter)
Time Frame: 25 years of follow-up
Changes in grey matter volume are being as absolute change (in cm3) across assessments
25 years of follow-up
Brain anatomical changes (white matter)
Time Frame: 25 years of follow-up
Changes in white matter volume is being evaluated as absolute change (in cm3) across assessments.
25 years of follow-up
Brain anatomical changes (ventricular volume)
Time Frame: 25 years of follow-up
Changes in ventricular volume is being evaluated as absolute change (in cm3) across assessments
25 years of follow-up
Mortality
Time Frame: 25 years of follow up
When a participant pass away informed/documented by caregiver or medical record
25 years of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manuel Montero Odasso

Investigators

  • Principal Investigator: Dr. Manuel Montero Odasso, M.D., Director, Gait and Brain Lab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Estimated)

January 1, 2033

Study Completion (Estimated)

January 1, 2033

Study Registration Dates

First Submitted

January 6, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimated)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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