Mild Cognitive ImpairmentNCT02350270
Gait, cOgnitiOn & Decline (GOOD)
An observational study of Mild Cognitive Impairment and Mild Dementia, run by University Hospital, Angers at 1 site in France.
Trial summary
The main objective of the GOOD initiative was to determine which spatio-temporal gait parameters and/or combination(s) of spatio-temporal gait parameters best differentiate between cognitively healthy individuals (CHI), patients with mild cognitive impairment (MCI) and those with mild and moderate dementia. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Mild Dementia, Moderate Dementia
- What is being tested?
- gait and cognitive testing
- Type of treatment
- Injection or infusion
- How many people
- 2,800 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Dec 2015
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients were recruited in each memory clinic by a physician
Who may be able to join
- Being 60 years old and older
- Ability to answer questions
Who cannot join
- Opposition to the use of information collected for research purposes
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Angers, 49933
Olivier Beauchet, MD, PhD, ++33 2 41 35 57 38, olbeauchet@chu-angers.fr
Olivier Beauchet, MD, PhD
About this study
The main objective of the GOOD initiative was to determine which spatio-temporal gait parameters and/or combination(s) of spatio-temporal gait parameters best differentiate between cognitively healthy individuals (CHI), patients with mild cognitive impairment (MCI) and those with mild and moderate dementia.
Read the detailed description
Gait disorders are frequent in individuals with cognitive disorders. However, the profile of spatio-temporal gait parameters in the different cognitive status in aging (from normal cognition to dementia) has been poorly studied. Determining this profile associated with the severity of cognitive disorders may be helpful to understand the complex interplay between gait and cognitive disorders and, thus, may have important implication for the diagnosis process of patients with and without dementia. For instance, defining a motor phenotype of the severity of cognitive disorders by using quantitative gait measurements could be used to improve the prediction and the diagnosis of dementia.
The investigators hypothesized that, compared to CHI, people with MCI and mild dementia could be characterized by specific phenotypes of spatio-temporal gait parameters measured with the GAITRite® system, and that these profiles could be explained by declines in domain-specific cognitive performance.
- Conditions
- Mild Cognitive Impairment, Mild Dementia, Moderate Dementia, Healthy
- Being tested
- gait and cognitive testing
- Keywords
- cognitively healthy individuals
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait and cognitive testingOther
| Study group | Role | What they receive |
|---|---|---|
| cognitively healthy individuals (CHI) | CHI were participants without objective cognitive impairment Receives: Other: gait and cognitive testing | |
| mild cognitive impairment (MCI) | MCI was diagnosed if participants met the following criteria: presence of spontaneous cognitive complaints and objective cognitive impairment Receives: Other: gait and cognitive testing | |
| mild and moderate dementia | Diagnoses of dementia were assigned according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV TR, 2000; Association, 2000; 22) at consensus diagnostic case conferences Receives: Other: gait and cognitive testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatio-temporal gait parameters
Spatio-temporal gait parameters were measured at steady state walking using GAITRite®-system.
Measured: This outcome is assessed at inclusion
Secondary outcomes (2)
Clinical assessment
This outcome was assessed by a questionnaire.
Measured: This outcome is assessed at inclusion
Cognitive status
Cognitive status was assessed by cognitive testing.
Measured: This outcome is assessed at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Biomathics
- Responsible party
- Sponsor
- Investigators
- Olivier Beauchet, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350270
- Sponsor's protocol ID
- 2014-17
- Status last verified
- Feb 2014
- First submitted
- 26 Jan 2015
- Last updated
- 29 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait, cOgnitiOn & Decline (GOOD)
- ClinicalTrials.gov ID
- NCT02350270
- Acronym / sponsor ID
- 2014-17
- Conditions
- Mild Cognitive Impairment, Mild Dementia, Moderate Dementia, Healthy
- Keywords
- cognitively healthy individuals
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Biomathics
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the GOOD initiative was to determine which spatio-temporal gait parameters and/or combination(s) of spatio-temporal gait parameters best differentiate between cognitively healthy individuals (CHI), patients with mild cognitive impairment (MCI) and those with mild and moderate dementia.
Detailed description
Gait disorders are frequent in individuals with cognitive disorders. However, the profile of spatio-temporal gait parameters in the different cognitive status in aging (from normal cognition to dementia) has been poorly studied. Determining this profile associated with the severity of cognitive disorders may be helpful to understand the complex interplay between gait and cognitive disorders and, thus, may have important implication for the diagnosis process of patients with and without dementia. For instance, defining a motor phenotype of the severity of cognitive disorders by using quantitative gait measurements could be used to improve the prediction and the diagnosis of dementia.
The investigators hypothesized that, compared to CHI, people with MCI and mild dementia could be characterized by specific phenotypes of spatio-temporal gait parameters measured with the GAITRite® system, and that these profiles could be explained by declines in domain-specific cognitive performance.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cognitively healthy individuals (CHI) | – | Other: gait and cognitive testingCHI were participants without objective cognitive impairment |
| mild cognitive impairment (MCI) | – | Other: gait and cognitive testingMCI was diagnosed if participants met the following criteria: presence of spontaneous cognitive complaints and objective cognitive impairment |
| mild and moderate dementia | – | Other: gait and cognitive testingDiagnoses of dementia were assigned according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV TR, 2000; Association, 2000; 22) at consensus diagnostic case conferences |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited in each memory clinic by a physician
Key inclusion criteria (2 listed)
- Being 60 years old and older
- Ability to answer questions
Key exclusion criteria (1 listed)
- Opposition to the use of information collected for research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gait and cognitive testing | Other | cognitively healthy individuals (CHI), mild and moderate dementia, mild cognitive impairment (MCI) |
Primary outcome
Spatio-temporal gait parameters
Time frame: This outcome is assessed at inclusion
Spatio-temporal gait parameters were measured at steady state walking using GAITRite®-system.
2 secondary outcomes
Clinical assessment
Time frame: This outcome is assessed at inclusion
Cognitive status
Time frame: This outcome is assessed at inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Beauchet, MD, PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Mild Dementia, run by University Hospital, Angers at 1 site in France.
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 2 inclusion and 1 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 29 Jan 2015. 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 France. 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?
Contact Olivier Beauchet, MD, PhD (++33 2 41 35 57 38, olbeauchet@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatio-temporal gait parameters (time frame: This outcome is assessed at inclusion). 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 29 Jan 2015.