Recruiting

Observational Study

Sponsor:

Manuel Montero Odasso

Code:

NCT03020381

Conditions

Gait Apraxia

Mild Cognitive Impairment

Subjective Cognitive Impairment

Cerebral Atrophy

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT03020381

Start date

Dec, 2007

Status verified date

Dec, 2023

Completion date

Jan, 2033

Anticipated

Primary completion date

Jan, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

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

600 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Primary outcome measure

  • Progression to Dementia [ Time Frame: 25 years of follow-up ]
  • Type of Dementia [ Time Frame: 25 years of follow-up ]

Central Contacts and Locations

Central contacts

Dr. Manuel Montero Odasso, MD, PhD

5196854292

Locations

Gait and Brain Lab, Parkwood Institute

Recruiting

London, Ontario, Canada, N6C 0A7

Contacts

Dr. Manuel Montero Odasso

5196854292mmontero@uwo.ca

More Information

Sponsor

Manuel Montero Odasso

Last update posted

Dec 21, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Manuel Montero Odasso on 2023-12-21.