Mild Cognitive DisorderVieillissementNCT04754906
Analysis of Motor Skills in Subjects Aged 55 and Over: the Role of Cognitive Abilities for Planning Movement.
An observational study of Mild Cognitive Disorder, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Falling is an event that is more frequent and severe in older age. It can lead to a loss of autonomy and a decrease in quality of life. It is therefore important to understand this phenomenon in order to better prevent it. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Disorder
- What is being tested?
- Sequence 1, Sequence 2 and Sequence 3
- How many people
- 684 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2021to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: young subjects, elderly neurotypical subjects and elderly subjects with mild cognitive disorder
Who may be able to join
- Neurotypical subjects group:
- Person aged 18 to 40 years
- Person who has given oral consent
- Affiliated to national health insurance
- Right-handed person
- Group of elderly neurotypical subjects:
Show all 16Show fewer
- Person over 55 years of age
- Person who has given oral consent
- Affiliated to national health insurance
- No cognitive problems (MMSE score >26)
- Right-handed person
- Elderly mild cognitive disorder subject group:
- Person over 55 years of age
- Person who has given oral consent
- Diagnosis of Mild Cognitive Disorder made by a neurologist at the Centre Mémoire Ressources et Recherche (CMRR) of the University Hospital of Dijon, following the recommendations of the National Institute for Aging and Alzheimer's Association (Albert et al., 2011) This diagnosis is based on psychometric tests, brain imaging and the evolution of cognitive disorders, including an MMSE test.
- Right-handed person
Who cannot join
- Neurological or psychiatric history with the exception of the TCL group.
- Follow-up of drug treatment in the last three months that may affect cognitive and/or motor skills.
- Received a shoulder prosthesis on the dominant side.
- Received a hip and/or knee replacement less than a year ago.
- Disabling joint disease of the hip or knee shoulder
- Protected adults (curatorship, guardianship)
Show all 9Show fewer
- Person deprived of their liberty b judicial or administrative decision
- Pregnant, parturient or breastfeeding woman
- Major unable to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Patrick MANCKOUNDIA, 0380293970, patrick.manckoundia@chu-dijon.fr
About this study
Falling is an event that is more frequent and severe in older age. It can lead to a loss of autonomy and a decrease in quality of life. It is therefore important to understand this phenomenon in order to better prevent it. Among the multiple risk factors associated with falling, recent research has shown a link between the decline in cognitive abilities (i.e., the mental processes that form our knowledge, such as memory) and the risk of falling. However, the impact of this cognitive decline on motor skills is still poorly understood. The purpose of this research is to study how the changes induced by aging affect motor skills. This would make it possible to take a new look at the phenomenon of falls occurring in the elderly and, in the long term, to improve the prevention and rehabilitation.
- Conditions
- Mild Cognitive Disorder
- Being tested
- Sequence 1, Sequence 2, Sequence 3
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequence 1Other
perform arm movements towards a target
Sequence 2Other
judge the verticality of an object
Sequence 3Other
In standing position, point as quickly as possible with the right arm at the diode that will light up in front of the participant.
| Study group | Role | What they receive |
|---|---|---|
| young neurotypical subjects | people from 18 to 40 years old Receives: Other: Sequence 1; Other: Sequence 2; Other: Sequence 3 | |
| elderly neurotypical subjects | people over 55 years of age Receives: Other: Sequence 1; Other: Sequence 2; Other: Sequence 3 | |
| Elderly subjects with mild cognitive impairment | people over 55 years of age, with a diagnosis of mild cognitive impairment Receives: Other: Sequence 1; Other: Sequence 2; Other: Sequence 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequence 1: symmetry ratio of the finger speed profile
Measured: through study completion, an average of 3 years
Sequence 2 : perception bias (error in degrees of angle) of dynamic subjective visual vericality
Measured: through study completion, an average of 3 years
Sequence 3 : activation time of the focal muscles in relation to the postural muscles
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start25 Jan 2021
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 684 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754906
- Sponsor's protocol ID
- MANCKOUNDIA 2018
- Acronym
- Vieillissement
- Status last verified
- Sep 2025
- First submitted
- 6 Oct 2020
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Motor Skills in Subjects Aged 55 and Over: the Role of Cognitive Abilities for Planning Movement.
- ClinicalTrials.gov ID
- NCT04754906
- Acronym / sponsor ID
- Vieillissement / MANCKOUNDIA 2018
- Conditions
- Mild Cognitive Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 684 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Feb 2021 (actual)
- 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.
Falling is an event that is more frequent and severe in older age. It can lead to a loss of autonomy and a decrease in quality of life. It is therefore important to understand this phenomenon in order to better prevent it. Among the multiple risk factors associated with falling, recent research has shown a link between the decline in cognitive abilities (i.e., the mental processes that form our knowledge, such as memory) and the risk of falling. However, the impact of this cognitive decline on motor skills is still poorly understood. The purpose of this research is to study how the changes induced by aging affect motor skills. This would make it possible to take a new look at the phenomenon of falls occurring in the elderly and, in the long term, to improve the prevention and rehabilitation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| young neurotypical subjects | – | Other: Sequence 1, Other: Sequence 2, Other: Sequence 3people from 18 to 40 years old |
| elderly neurotypical subjects | – | Other: Sequence 1, Other: Sequence 2, Other: Sequence 3people over 55 years of age |
| Elderly subjects with mild cognitive impairment | – | Other: Sequence 1, Other: Sequence 2, Other: Sequence 3people over 55 years of age, with a diagnosis of mild cognitive impairment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- young subjects, elderly neurotypical subjects and elderly subjects with mild cognitive disorder
Key inclusion criteria (16 listed)
- Neurotypical subjects group:
- Group of elderly neurotypical subjects:
- Elderly mild cognitive disorder subject group:
Key exclusion criteria (9 listed)
- Neurological or psychiatric history with the exception of the TCL group.
- Follow-up of drug treatment in the last three months that may affect cognitive and/or motor skills.
- Received a shoulder prosthesis on the dominant side.
- Received a hip and/or knee replacement less than a year ago.
- Disabling joint disease of the hip or knee shoulder
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 |
|---|---|---|
| Sequence 1perform arm movements towards a target | Other | Elderly subjects with mild cognitive impairment, elderly neurotypical subjects, young neurotypical subjects |
| Sequence 2judge the verticality of an object | Other | Elderly subjects with mild cognitive impairment, elderly neurotypical subjects, young neurotypical subjects |
| Sequence 3In standing position, point as quickly as possible with the right arm at the diode that will light up in front of the participant. | Other | Elderly subjects with mild cognitive impairment, elderly neurotypical subjects, young neurotypical subjects |
Primary outcome
Sequence 1: symmetry ratio of the finger speed profile
Time frame: through study completion, an average of 3 years
Sequence 2 : perception bias (error in degrees of angle) of dynamic subjective visual vericality
Time frame: through study completion, an average of 3 years
Sequence 3 : activation time of the focal muscles in relation to the postural muscles
Time frame: through study completion, an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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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.
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 Disorder, run by Centre Hospitalier Universitaire Dijon 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 16 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 22 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick MANCKOUNDIA (0380293970 ext. +33, patrick.manckoundia@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sequence 1: symmetry ratio of the finger speed profile (time frame: through study completion, an average of 3 years). The study lists 3 primary outcomes in all. 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 22 Sep 2025.