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

NCT03020381 | Recruiting

• 1 other identifier: 17200
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Progression to Dementia

  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

  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 Outcomes (6)

• Development of Mobility Decline

  25 years of follow-up

• Incidence of Falls

  25 years of follow-up

• Brain anatomical changes (grey matter)

  25 years of follow-up

• Brain anatomical changes (white matter)

  25 years of follow-up

• Brain anatomical changes (ventricular volume)

  25 years of follow-up

Study Arms (3)

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)

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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);

You may not qualify if:

• 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).

Sponsors & Collaborators

• Manuel Montero Odasso: lead

Study Sites (1)

Gait and Brain Lab, Parkwood Institute

London, Ontario, N6C 0A7, Canada

RECRUITING

Related Publications (19)

• Pieruccini-Faria F, Sarquis-Adamson Y, Montero-Odasso M. Mild Cognitive Impairment Affects Obstacle Negotiation in Older Adults: Results from "Gait and Brain Study". Gerontology. 2019;65(2):164-173. doi: 10.1159/000492931. Epub 2018 Oct 12.

  PMID: 30317237 BACKGROUND

• Pieruccini-Faria F, Muir-Hunter SW, Montero-Odasso M. Do depressive symptoms affect balance in older adults with mild cognitive impairment? Results from the "gait and brain study". Exp Gerontol. 2018 Jul 15;108:106-111. doi: 10.1016/j.exger.2018.04.004. Epub 2018 Apr 10.

  PMID: 29653157 BACKGROUND

• Montero-Odasso M, Speechley M, Muir-Hunter SW, Sarquis-Adamson Y, Sposato LA, Hachinski V, Borrie M, Wells J, Black A, Sejdic E, Bherer L, Chertkow H; Canadian Gait and Cognition Network. Motor and Cognitive Trajectories Before Dementia: Results from Gait and Brain Study. J Am Geriatr Soc. 2018 Sep;66(9):1676-1683. doi: 10.1111/jgs.15341. Epub 2018 Apr 2.

  PMID: 29608780 BACKGROUND

• Montero-Odasso M, Speechley M. Falls in Cognitively Impaired Older Adults: Implications for Risk Assessment And Prevention. J Am Geriatr Soc. 2018 Feb;66(2):367-375. doi: 10.1111/jgs.15219. Epub 2018 Jan 10.

  PMID: 29318592 BACKGROUND

• Montero-Odasso M, Camicioli R, Muir-Hunter SW. Dual-Task Gait And Incident Dementia-A Step Forward, But Not There Yet-Reply. JAMA Neurol. 2017 Nov 1;74(11):1380-1381. doi: 10.1001/jamaneurol.2017.2880. No abstract available.

  PMID: 29049479 BACKGROUND

• Sakurai R, Montero-Odasso M. Apolipoprotein E4 Allele and Gait Performance in Mild Cognitive Impairment: Results From the Gait and Brain Study. J Gerontol A Biol Sci Med Sci. 2017 Nov 9;72(12):1676-1682. doi: 10.1093/gerona/glx075.

  PMID: 28482102 BACKGROUND

• Montero-Odasso MM, Barnes B, Speechley M, Muir Hunter SW, Doherty TJ, Duque G, Gopaul K, Sposato LA, Casas-Herrero A, Borrie MJ, Camicioli R, Wells JL. Disentangling Cognitive-Frailty: Results From the Gait and Brain Study. J Gerontol A Biol Sci Med Sci. 2016 Nov;71(11):1476-1482. doi: 10.1093/gerona/glw044. Epub 2016 Mar 16.

  PMID: 26984391 BACKGROUND

• Montero-Odasso M, Sarquis-Adamson Y, Song HY, Bray NW, Pieruccini-Faria F, Speechley M. Polypharmacy, Gait Performance, and Falls in Community-Dwelling Older Adults. Results from the Gait and Brain Study. J Am Geriatr Soc. 2019 Jun;67(6):1182-1188. doi: 10.1111/jgs.15774. Epub 2019 Jan 30.

  PMID: 30698285 BACKGROUND

• Pieruccini-Faria F, Montero-Odasso M. Obstacle Negotiation, Gait Variability, and Risk of Falling: Results From the "Gait and Brain Study". J Gerontol A Biol Sci Med Sci. 2019 Aug 16;74(9):1422-1428. doi: 10.1093/gerona/gly254.

  PMID: 30380013 BACKGROUND

• Pieruccini-Faria F, Hassan Haddad SM, Bray NW, Sarquis-Adamson Y, Bartha R, Montero-Odasso M. Brain Structural Correlates of Obstacle Negotiation in Mild Cognitive Impairment: Results from the Gait and Brain Study. Gerontology. 2023;69(9):1115-1127. doi: 10.1159/000530796. Epub 2023 Apr 25.

  PMID: 37166343 BACKGROUND

• Pieruccini-Faria F, Black SE, Masellis M, Smith EE, Almeida QJ, Li KZH, Bherer L, Camicioli R, Montero-Odasso M. Gait variability across neurodegenerative and cognitive disorders: Results from the Canadian Consortium of Neurodegeneration in Aging (CCNA) and the Gait and Brain Study. Alzheimers Dement. 2021 Aug;17(8):1317-1328. doi: 10.1002/alz.12298. Epub 2021 Feb 16.

  PMID: 33590967 BACKGROUND

• Montero-Odasso M, Oteng-Amoako A, Speechley M, Gopaul K, Beauchet O, Annweiler C, Muir-Hunter SW. The motor signature of mild cognitive impairment: results from the gait and brain study. J Gerontol A Biol Sci Med Sci. 2014 Nov;69(11):1415-21. doi: 10.1093/gerona/glu155. Epub 2014 Sep 2.

  PMID: 25182601 BACKGROUND

• Osman A, Speechley M, Ali S, Montero-Odasso M. Fall-Risk-Increasing Drugs and Gait Performance in Community-Dwelling Older Adults: Exploratory Results from the Gait and Brain Study. Drugs Aging. 2023 Aug;40(8):721-730. doi: 10.1007/s40266-023-01045-1. Epub 2023 Jun 22.

  PMID: 37347412 BACKGROUND

• Sakurai R, Bartha R, Montero-Odasso M. Entorhinal Cortex Volume Is Associated With Dual-Task Gait Cost Among Older Adults With MCI: Results From the Gait and Brain Study. J Gerontol A Biol Sci Med Sci. 2019 Apr 23;74(5):698-704. doi: 10.1093/gerona/gly084.

  PMID: 29767690 BACKGROUND

• Montero-Odasso MM, Sarquis-Adamson Y, Speechley M, Borrie MJ, Hachinski VC, Wells J, Riccio PM, Schapira M, Sejdic E, Camicioli RM, Bartha R, McIlroy WE, Muir-Hunter S. Association of Dual-Task Gait With Incident Dementia in Mild Cognitive Impairment: Results From the Gait and Brain Study. JAMA Neurol. 2017 Jul 1;74(7):857-865. doi: 10.1001/jamaneurol.2017.0643.

  PMID: 28505243 BACKGROUND

• Snir JA, Bartha R, Montero-Odasso M. White matter integrity is associated with gait impairment and falls in mild cognitive impairment. Results from the gait and brain study. Neuroimage Clin. 2019;24:101975. doi: 10.1016/j.nicl.2019.101975. Epub 2019 Aug 6.

  PMID: 31421507 BACKGROUND

• Montero-Odasso M, Annweiler C, Hachinski V, Islam A, Yang N, Vasudev A. Vascular burden predicts gait, mood, and executive function disturbances in older adults with mild cognitive impairment: results from the gait and brain study. J Am Geriatr Soc. 2012 Oct;60(10):1988-90. doi: 10.1111/j.1532-5415.2012.04180.x. No abstract available.

  PMID: 23057459 BACKGROUND

• Annweiler C, Beauchet O, Bartha R, Montero-Odasso M; WALK Team-Working group Angers-London for Knowledge. Slow gait in MCI is associated with ventricular enlargement: results from the Gait and Brain Study. J Neural Transm (Vienna). 2013 Jul;120(7):1083-92. doi: 10.1007/s00702-012-0926-4. Epub 2012 Nov 30.

  PMID: 23196981 BACKGROUND

• Figgins E, Choi YH, Speechley M, Montero-Odasso M. Associations Between Potentially Modifiable and Nonmodifiable Risk Factors and Gait Speed in Middle- and Older-Aged Adults: Results From the Canadian Longitudinal Study on Aging. J Gerontol A Biol Sci Med Sci. 2021 Sep 13;76(10):e253-e263. doi: 10.1093/gerona/glab008.

  PMID: 33420785 BACKGROUND

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.

MeSH Terms

Conditions

Gait Apraxia; Cognitive Dysfunction; Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Gait Disorders, Neurologic; Neurologic Manifestations; Nervous System Diseases; Apraxias; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Dr. Manuel Montero Odasso, M.D.

  Director, Gait and Brain Lab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Manuel Montero Odasso, MD, PhD

CONTACT

5196854292

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 13, 2017
• Study Start: December 1, 2007
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2033
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

CA (1)