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Trial record 1 of 24 for:    gait and brain study | Canada
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Gait as Predictor of Dementia and Falls. The Gait and Brain Cohort Study

This study is currently recruiting participants.
Verified April 2017 by Manuel Montero Odasso, Lawson Health Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT03020381
First Posted: January 13, 2017
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Manuel Montero Odasso, Lawson Health Research Institute
  Purpose

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.


Condition
Gait Apraxia Mild Cognitive Impairment Subjective Cognitive Impairment Cerebral Atrophy Alzheimer Disease Dementia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gait as Predictor of Cognitive Decline, Dementia, and Risk of Falls in MCI. A Cohort Study

Resource links provided by NLM:


Further study details as provided by Manuel Montero Odasso, Lawson Health Research Institute:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA
APOEε4 carrier status will be determined by PCR of genomic DNA extracted from anticoagulated blood. Carrier status is determined by dichotomizing into ε4- (ε2/ε3 heterozygote or ε2/ε3 homozygote) and ε4+ (ε4 homozygote or ε4 heterozygote) for consistency with previous studies.

Estimated Enrollment: 400
Study Start Date: December 2007
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cognitively Normal (Control Group)
Participants aged 65 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 65 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 65 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)

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants 65 years or older are being recruited from 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 120 months after baseline measurements.
Criteria

Inclusion Criteria:

  • Absence of Dementia (DSM IV-TR or DSM V criteria)
  • MMSE score >26
  • MoCA score <26
  • Aged 65 years and older;
  • 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 evaluaiton
  • Use of psychotropics which can affect motor performance (e.g. neuroleptics and benzodiazepines)
  • Severe Depression (score > 12/15 on the Geriatric Depression Scale).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020381


Contacts
Contact: Dr. Manuel Montero Odasso, MD, PhD 5196854292 ext 45024

Locations
Canada, Ontario
Gait and Brain Lab, Parkwood Institute Recruiting
London, Ontario, Canada, N6C 0A7
Contact: Dr. Manuel Montero Odasso    5196854292 ext 45024    mmontero@uwo.ca   
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Dr. Manuel Montero Odasso, M.D. Director, Gait and Brain Lab
  More Information

Responsible Party: Manuel Montero Odasso, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03020381     History of Changes
Other Study ID Numbers: 17200
First Submitted: January 6, 2017
First Posted: January 13, 2017
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Gait Apraxia
Brain Diseases
Gait Disorders, Neurologic
Alzheimer Disease
Dementia
Cognition Disorders
Atrophy
Mild Cognitive Impairment
Apraxias
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Pathological Conditions, Anatomical
Psychomotor Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms


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