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DepressionNCT03679221

Motoric Cognitive Risk and Depression

An observational study of Depression and Geriatrics, run by Jewish General Hospital at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The overall objective of the proposal is to examine the association between depression and the newly reported "motoric cognitive risk" (MCR) syndrome, which is a pre-dementia syndrome combining subjective cognitive complaint (i.e.; memory complaint) with objective slow gait speed, in the Canadian population, with the… Read more about this study

Who is it for?
Ages 45 to 85 years
Conditions the study is for
Depression, Geriatrics, Neurocognitive Disorders
What is being tested?
Data collection
How many people
30,000 participants
Where
1 siteCanada
Study dates
24 Jul 2019to 1 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 85 years
  • All sexes
  • Adult, Older adult

Study population: Individuals eligible for this study will be the participants of the CLSA

Who may be able to join

  • be participant of the comprehensive CLSA

Who cannot join

  • dementia,
  • mobility disability,
  • no information about cognitive complaint,
  • no measure of walking speed

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

Other trials in Canada

About this study

Official title: The Association of Depression With "Motoric Cognitive Risk" Syndrome in the Canadian Population

The overall objective of the proposal is to examine the association between depression and the newly reported "motoric cognitive risk" (MCR) syndrome, which is a pre-dementia syndrome combining subjective cognitive complaint (i.e.; memory complaint) with objective slow gait speed, in the Canadian population, with the baseline assessment of the Canadian Longitudinal Study on Aging (CLSA).

The Canadian and global population are continuously aging. Moreover, the number of individuals affected by dementia is on the rise. One good predictor of dementia is Motoric Cognitive Risk (MCR) syndrome. MCR syndrome is a highly prevalent, newly defined syndrome that combines slow gait and subjective cognitive complaint. Depression is also highly prevalent in the older population and can affect both cognition and gait. Thus, an overlap between MCR and depression is possible. Yet few studies have examined the association between MCR and depression, thus emphasizing the importance of further investigating this association. This project encompasses determining the association of MCR syndrome with depression in the Canadian context as a step to better understand MCR syndrome in Canada.

Read the detailed description

Motoric Cognitive Risk syndrome (MCR) is a new clinical syndrome associating subjective cognitive complaint and objective slow gait speed with a high prevalence calculated around 10% in population aged 60 and above. MCR syndrome predicts mild and major neurocognitive disorders. MCR syndrome does not rely on a complex and time-consuming assessment, making it applicable to the aging population. Thus, MCR syndrome seems to be a good syndrome to identify individuals at risk of mild and major neurocognitive disorders in any type of healthcare setting.

Slow gait speed and cognitive complaint are unspecific symptoms that can apply to a wide variety of morbidities (i.e., having a disease or a symptom of disease), thus causing overlap with other syndromes which may influence the predictive value of MCR syndrome. One example of the same seen in previous literature is the overlap between MCR syndrome and Mild Cognitive Impairment (MCI) which is, a pre-dementia syndrome similar to MCR syndrome. Patients diagnosed with MCR syndrome can also be diagnosed with MCI, however, this is not always the case. It has been suggested that patients cumulating both syndromes could be more at risk of mild and major neurocognitive disorders. Similarly, anxiety, depressive symptomatology and/or clinical depression (ADSCD) may be associated with slow gait speed and cognitive complaint. Prevalence of ADSCD like MCR syndrome is high and estimated around 9%, with some age dependent variation: younger adults have a higher prevalence compared to older adults. Due to the high prevalence of both MCR syndrome and ADSCD, and in conjunction that subjective cognitive complaint (for MCR syndrome definition) has previously been extracted from an item of depressive questionnaires like Center for Epidemiologic Studies Depression scale (CESD) or Geriatric Depression Scale (GDS), there is a high probability of overlap between MCR syndrome and depression. As ADSCD is not a pre-dementia stage, an overlap between ADSCD and MCR syndrome can conversely to MCI syndrome result in a decreased risk for mild and major neurocognitive disorders.

Few studies have examined the association between ADSCD and MCR syndrome and reported diverging results. They found both significant and not significant associations between MCR syndrome and ADSCD. These mixed results may be explained by the definition used for ADSCD. For instance, studies have used depressive questionnaires or antidepressant use. Moreover, this divergence could also be related to the nature of the symptomology (e.g., anxiety or mood disorders), as well as age. Thus, it is important to examine the association between ADSCD and MCR syndrome taking in consideration these parameters.

The investigator has the opportunity with the baseline assessment of a large population-based prospective and observational study in Canada, known as the Canadian Longitudinal Study on Aging (CLSA) to better understand the parameters influencing the association between ADSCD and MCR syndrome.

Being tested
Data collection
Medical subject headings
Depression, Neurocognitive Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Data collectionOther

    telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site

Study groups in NCT03679221
Study groupRoleWhat they receive
Group 45-54 years olddivided in two subgroups: individuals with and without cardio-vascular risk factors and diseases
Receives: Other: Data collection
Group 54-64 years olddivided in two subgroups: individuals with and without cardio-vascular risk factors and diseases
Receives: Other: Data collection
Group 65-74 years olddivided in two subgroups: individuals with and without cardio-vascular risk factors and diseases
Receives: Other: Data collection
Group 75-85 years olddivided in two subgroups: individuals with and without cardio-vascular risk factors and diseases
Receives: Other: Data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective cognitive complaint

    elicited from the 60-minute interview telephone questionnaire item Chronic Conditions Tracking (CTT_19 CCT_MEMPB_TRM) done in CLSA study

    Measured: 1 hour

Secondary outcomes (1)
  1. Slow gait speed

    defined as gait speed that is one standard deviation (SD) or more below age-and sex-appropriate mean values

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2018
  2. Study start24 Jul 2019
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
30,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03679221
Sponsor's protocol ID
2019-1501
Status last verified
Feb 2024
First submitted
18 Sep 2018
Last updated
23 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Depression and Geriatrics, run by Jewish General Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective cognitive complaint (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.

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